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Next-Generation DNA Repair Inhibitors Could Capture Billions in Emerging MarketJune 24, 2026 9:00 AM
InvestorsHub NewsWireNext-Generation DNA Repair Inhibitors Could Capture Billions in Emerging MarketBioMedWire Editorial Coverage: Oncology research is moving through one of its most active stretches in years. DNA Damage Response ("DDR") inhibitors, a category of drugs that work by blocking cancer cells' capacity to fix their own damaged DNA, are growing well beyond the poly ADP ribose polymerase ("PARP") inhibitor that first defined the category. DDR-inhibiting therapies generated an estimated $7 billion-plus in worldwide sales in 2025, and the wider oncology, diagnostics and precision medicine markets are expected to approach about $750 billion by 2030. A fresh wave of inhibitor classes is now taking shape as the next major opportunity. Standing at the leading edge of this shift is Onco-Innovations Limited (CBOE CA: ONCO) (OTCQB: ONNVF) (Profile), a Canadian clinical-stage oncology company developing ONC010(TM), a nanoparticle-encapsulated PNKP inhibitor designed to target a DNA repair enzyme that participates in several distinct repair pathways. As the industry works toward the next generation of synthetic lethality assets, Onco-Innovations occupies a distinctive niche as it builds out its position within the biopharmaceutical and biotechnology space, alongside other established companies such as Merck & Co. Inc. (NYSE: MRK), Pfizer Inc. (NYSE: PFE), GSK plc (NYSE: GSK) and Gilead Sciences Inc. (NASDAQ: GILD), all of which are focused on developing therapies for serious illnesses, including cancer.PARP inhibitors reshaped oncology when they first reached patients some 10 years ago, but they represent just one entry point into a much larger and more intricate biological network.Onco-Technologies owns exclusive worldwide rights to a foundational set of PNKP inhibitor technologies.The company's preclinical program has generated concrete, measurable outcomes that support the biological case for PNKP inhibition in solid tumors.Onco-Innovations holds global rights across three separate layers of protection, with each layer reinforcing the others.Click here to view the custom infographic of the Onco-Innovations editorial.DNA Repair Science Expands Past the PARP EraPARP inhibitors reshaped oncology when they first reached patients some 10 years ago. They put into practice a concept known as synthetic lethality, in which cancers carrying particular DNA repair defects could be selectively destroyed by disabling a secondary repair pathway. The effect was striking in BRCA-mutated cancers, and the drug class has since grown into a market worth billions of dollars. Yet PARP inhibitors represent just one entry point into a much larger and more intricate biological network.The DNA Damage Response system involves dozens of proteins and pathways that cancer cells depend on to withstand chemotherapy, radiation and other forms of cellular stress. Researchers have spent years systematically charting this network in search of new drug targets. A field once confined to academic circles is now attracting serious investment and clinical interest. Artios Pharma, for instance, closed a $115 million Series D financing round late last year to advance mid-stage studies of experimental cancer drugs targeting DNA repair mechanisms beyond PARP, one of the strongest signals yet that this segment has matured into an investable category.The clinical pipeline backs up that narrative. Last month, Artios dosed its first patient in a randomized phase 2 trial of ART6043, a DNA polymerase theta inhibitor, in patients with gBRCA-mutated, HER2-negative breast cancer, advancing a non-PARP DDR target into mid-stage, biomarker-guided development. Also last month, MD Anderson released phase 1 proof-of-concept results for RO7589831, a Werner helicase inhibitor, in cancers exhibiting high microsatellite instability. These are not minor announcements; they demonstrate that novel DDR mechanisms can produce real clinical responses in actual patients.Interest from potential partners in DDR assets has remained resilient even amid broader market turbulence. Last year, Repare Therapeutics out-licensed lunresertib to Debiopharm in a deal worth $10 million upfront, plus up to $257 million tied to milestones. Debiopharm went on to secure U.S. Food and Drug Administration ("FDA") Fast Track designation for a lunresertib combination in April 2026, converting a licensing arrangement into a formal regulatory achievement. The takeaway for investors appears straightforward: Biomarker-defined DDR assets backed by a credible scientific mechanism can still attract partners and earn regulatory recognition, even when funding conditions remain cautious.Polynucleotide Kinase Phosphatase, or PNKP, is a DNA repair enzyme that functions across numerous repair pathways, addressing both single-strand and double-strand break repair. This broader scope gives PNKP inhibitors a potentially wider therapeutic reach than PARP inhibitors, which act primarily on single-strand break repair. Inhibiting PNKP has already shown preclinical activity in colorectal, lung, breast, prostate, ovarian and blood cancers. With worldwide PARP inhibitor revenue forecast to total roughly $12 billion by 2030, PNKP inhibitors are surfacing as a significant drug class positioned to capture share within the expanding DNA Damage Response segment. Onco-Innovations has established itself as the recognized leader for this novel DDR target.Holding First-Mover Ground in Wide-Open CategoryMost competitive space in oncology drug development becomes crowded quickly. PARP inhibitors, PD-1 checkpoint drugs and CDK4/6 inhibitors each drew dozens of rivals once their commercial promise became evident. PNKP inhibitors stand apart from that pattern. The target has been described in academic literature for years, yet the drug-development community has been slow to act on it. That hesitancy created an opening, and Onco-Innovations has moved directly into it.The company owns exclusive worldwide rights to a foundational set of PNKP inhibitor technologies. This encompasses the core inhibitor compounds, the nanoparticle delivery science needed to carry those compounds effectively to tumors, and the synthetic lethality applications that define how the therapy is meant to function. Holding rights across molecular design, delivery mechanism and therapeutic application simultaneously is uncommon at this stage of oncology development.The competitive value of this position becomes clearer with added information. Once a new DDR target draws widespread industry attention, patent landscapes become congested, valuations climb and the window for first movers closes. Onco-Innovations entered the PNKP space while that window was still open. The company's patents cover the PNKP inhibitor technology as well as the ONC010 program, extending protection across the small molecule inhibitors themselves, the delivery system and the clinical applications, which together form a wide and durable competitive barrier.The broader DDR market supplies the commercial backdrop. Per the company, DDR-inhibiting products surpassed $7 billion in global sales last year. The global oncology market overall is forecast to approach $500 billion by 2032, representing growth of 131% across a 10-year span. Within that landscape, PNKP inhibitors occupy a category with no approved competitor and no entrenched incumbent. Rather than fighting for share in an already mature market, the company is effectively building the market itself.Laboratory Evidence Lays Groundwork for Clinical TrialsAmong the central risk factors in early-stage oncology investing is the distance separating laboratory findings from clinical reality. Onco-Innovations has worked methodically to close that gap. The company's preclinical program has generated concrete, measurable outcomes that support the biological case for PNKP inhibition in solid tumors.The standout finding from animal studies relates to survival outcomes in colorectal cancer. Published preclinical data show that the company's novel nanoparticle formulation, ONC010, extended median survival to 60 days in mice with PTEN-deficient colorectal cancer, compared with 23 days in untreated animals, more than double the survival duration. The same body of research showed substantial tumor growth reduction relative to placebo, paired with a favorable toxicity profile.The lack of observed toxicity in animal models carries particular weight. DDR inhibitors  have generally run into off-target effects that constrain their clinical usefulness. Onco-Innovations' nanoparticle delivery system was built specifically to deal with this challenge. By pairing the active pharmaceutical ingredient A83B4C63 with a polymer-based micellar carrier, the platform extends circulation time and encourages preferential buildup within tumor tissue while reducing exposure to healthy cells.The company has continued advancing its Chemistry, Manufacturing and Controls program alongside its preclinical research. Onco-Innovations is carrying out manufacturing scale-up and formulation development with Dalton Pharma Services, while running IND-enabling studies, including pharmacokinetic and biodistribution work, with Nucro-Technics. The company recently reported successful API process development and intermediate-scale production for its PNKP inhibitor technology, the kind of key manufacturing announcements that reduce risk on the path toward a first-in-human trial.The company has also set up a subsidiary in Australia to back anticipated phase 1 development through the Therapeutic Goods Administration regulatory pathway. Activation of a first-in-human phase 1 trial is planned later this year. The anticipated clinical approach is underpinned by validated preclinical data, a clear regulatory roadmap and the possibility of pursuing Fast Track designation, considering the substantial unmet need across the target indications.Intellectual Property Designed to Protect ExclusivityIntellectual property forms the foundation of value in early-stage drug development. Without critical IP, clinical achievements fail to result in commercial exclusivity. Onco-Innovations has constructed its IP portfolio with that principle firmly in place. The company owns global rights across three separate layers of protection, with each layer reinforcing the others.The first layer covers the core PNKP inhibitor molecules, the foundational drug candidates from which ONC010 and future programs are derived. The second layer covers the nanoparticle delivery science, specifically the polymer-based micellar carrier system that enables effective tumor-targeted delivery of the inhibitors. This delivery technology is not a peripheral feature; it is central to the program's ability to achieve efficacy without unacceptable toxicity. The third layer protects synthetic lethality applications, which outlines how the therapy is matched to specific tumor biology to maximize selective destruction of cancer cells.Collectively, these patents provide comprehensive protection for the PNKP technology and the ONC010 program. The portfolio is designed to included not just the current lead compound but the main platform itself, supporting the company's specified objective of increasing its PNKP inhibitor technology across additional cancer types.For example, the company has wrapped up a collaborative project with Kuano, applying a quantum-based computational chemistry platform to generate insights aimed at optimizing PNKP inhibitor technology, further reinforcing the molecular foundation underlying the program.Causal AI Speeds Up Precision-Focused Trial DesignDrug development remains costly and slow. The typical oncology drug requires more than a decade and over $1 billion to reach the market, and most candidates that enter clinical trials ultimately fail. Artificial intelligence is being applied with growing frequency to improve those odds, not by substituting for biology but by making it easier to identify the right patients, design more effective trials and interpret results more rapidly.With this in mind, last year Onco-Innovations acquired Inka Health Corp. Inka Health's SynoGraph(TM) platform prototype is a proprietary causal AI engine built specifically for oncology applications. Unlike standard machine learning, which identifies statistical correlations, causal AI is designed to reason about cause-and-effect relationships, a difference that carries significant weight in clinical research, where the gap between association and true causation can be the reason a drug appears effective or ineffective.The SynoGraph offering is designed to support patient stratification, clinical trial design, translational decision-making and evidence generation. The exclusive prototype will combine real-world data, clinical evidence and molecular insights to help predict trial outcomes, treatment efficacy and safety, as well as adverse events. For a company preparing to launch a first-in-human trial, the ability to pinpoint the right patient population before the trial even begins represents a meaningful reduction in clinical risk rather than a mere convenience.Inka Health is also working with both AstraZeneca and GlaxoSmithKline in collaborations centered on predictive modeling, real-world evidence and AI-enabled cancer study. These companies are far from minor partners. And last month, Inka Health started a research partnership within PROmAI, additionally broadening the range of applications for the SynoGraph platform.Folding SynoGraph into the ONC010 development program means Onco-Innovations can use AI-driven patient stratification across its planned clinical studies. This provides the potential to shorten enrollment timelines, enhance the signal within early efficacy data and increase the overall potential for success. Precision-focused trial design is increasingly becoming a significant differentiator within oncology, and Onco-Innovations is working to build that capability internally.Biotech Innovation Continues Advancing Patient CareRecent developments across the biotechnology industry highlight continued progress in the development of innovative therapies and preventive treatments for a wide range of serious diseases. Companies are achieving important regulatory milestones, reporting encouraging clinical trial results and advancing next-generation treatment approaches designed to improve patient outcomes.Merck & Co. Inc. (NYSE: MRK) announced that the FDA has approved an expanded indication for CAPVAXIVE(R) (Pneumococcal 21-valent Conjugate Vaccine). The indication will include children and adolescents aged 2 through 17 years who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that put them at an increased risk for pneumococcal disease. With this approval, CAPVAXIVE is the only PCV specifically indicated and studied in the United States for use in this patient population.Pfizer Inc. (NYSE: PFE) announced that the FDA has approved an expanded indication for HYMPAVZI(R) (marstacimab-hncq). The expanded indication includes the treatment of patients, diagnosed with hemophilia A or B, who are 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors. HYMPAVZI is now indicated in the United States for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) with or without factor IX inhibitors.GSK plc (NYSE: GSK) is reporting interim phase 2 data from the global phase 2/3 ROSETTA Lung-02 clinical trial. The trial evaluated the investigational PD-L1xVEGF-A bispecific immunomodulator pumitamig, also known as BNT327 or BMS-986545, plus chemotherapy in patients with previously untreated advanced non-small cell lung cancer ("NSCLC"). The data showed encouraging anti-tumor activity, with high response rates observed in both nonsquamous and squamous NSCLC and at each PD-L1 expression level. The data was presented at the 2026 American Society of Clinical Oncology Annual Meeting.Gilead Sciences Inc. (NASDAQ: GILD) announced that the primary efficacy endpoint at Week 48 was met in both the phase 3 ISLEND-1 and ISLEND-2 trials with the investigational oral once-weekly single-tablet HIV treatment regimen of islatravir/lenacapavir. The ISLEND trials are evaluating the efficacy and safety of islatravir 2 mg/lenacapavir 300 mg (ISL/LEN) in people with HIV who are virologically suppressed and switched from BIKTARVY(R) (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) (ISLEND-1) or standard of care antiretroviral regimens (ISLEND-2). The safety profile of ISL/LEN was generally comparable to the comparator regimens studied in the ISLEND trials, and no new safety concerns were identified.As scientific innovation continues to accelerate, the biotechnology sector remains at the forefront of transforming healthcare through novel medicines, advanced biologics and precision treatment strategies. These achievements reflect a growing pipeline of therapies that have the potential to reshape treatment standards and deliver meaningful benefits to patients across diverse disease areas.For further information about Onco-Innovations, visit the Onco-Innovations profile.About BioMedWireBioMedWire ("BMW") is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. 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Spero Shares Jump After FDA Clears First Oral Carbapenem Antibiotic for U.S. Market (SPRO)June 18, 2026 9:52 AM
IH Market News Spero Therapeutics (NASDAQ:SPRO) shares climbed 16% on Thursday after the U.S. Food and Drug Administration approved Utebzi, a novel oral carbapenem antibiotic developed through a collaboration between GSK (NYSE:GSK) and Spero, for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, in adults with limited or no suitable oral treatment alternatives. Landmark Approval Opens New Treatment Option Utebzi becomes the first oral carbapenem antibiotic to receive approval in the United States, marking a significant development in the treatment of serious urinary tract infections caused by drug-resistant bacteria. The product was developed under GSK’s exclusive global licensing agreement with Spero Therapeutics, excluding certain Asian markets. Addressing a Growing Medical Need Complicated urinary tract infections affect more than three million people annually in the United States, with treatment failures reported in up to one-third of cases. Many of these infections are linked to multidrug-resistant pathogens, creating a substantial burden on healthcare systems and generating more than $6 billion in annual medical costs. Until now, carbapenem antibiotics—often considered a key treatment option for severe resistant infections—have generally required intravenous administration, limiting their use outside hospital settings. Phase III Trial Supports Approval The FDA’s decision was supported by findings from the Phase III PIVOT-PO study, which evaluated tebipenem pivoxil against intravenous imipenem-cilastatin in hospitalized patients suffering from cUTIs, including kidney infections. Results showed tebipenem pivoxil achieved an overall success rate of 58.5% (261 of 446 patients), compared with 60.2% (291 of 483 patients) for imipenem-cilastatin. The adjusted treatment difference was -1.3% (95% CI: -7.5%, 4.8%), demonstrating non-inferiority to the intravenous standard of care. Safety Profile Remains Consistent The treatment’s safety profile was broadly comparable to that observed with imipenem-cilastatin and other carbapenem antibiotics. The most commonly reported side effects were diarrhoea and headache, with reported adverse events generally classified as mild to moderate and non-serious. Commercial Launch Expected by Year-End Utebzi is expected to become available to patients in the United States before the end of 2026. Development of tebipenem pivoxil received support from the U.S. Department of Health and Human Services through funding provided by the Biomedical Advanced Research and Development Authority (BARDA), helping advance the programme through late-stage clinical development. Spero Therapeutics stock priceThe post Spero Shares Jump After FDA Clears First Oral Carbapenem Antibiotic for U.S. Market (SPRO) appeared first on US Editors. Original: Spero Shares Jump After FDA Clears First Oral Carbapenem Antibiotic for U.S. Market (SPRO)

Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections (cUTIs)June 17, 2026 4:21 PM
Business Wire First and only oral carbapenem antibiotic approved in the US Approval based on PIVOT-PO trial demonstrating non-inferiority compared to intravenous treatment1 More than 3 million cases of cUTIs are treated annually in the US2 with up to a third of patients impacted by resistant infections3 GSK plc (LSE/NYSE: GSK) and Spero Therapeutics (Nasdaq: SPRO) today announced that the US Food and Drug Administration (FDA) has approved Utebzi, an oral antibiotic for the treatment of complicated urinary tract infections (cUTIs) including pyelonephritisi, caused by certain susceptible pathogensii in adult patients who have limited or no alternative oral treatment options. This is the first and only oral carbapenem antibiotic approved for these patients. This approval is a result of GSK’s development and exclusive global licensing agreement (excluding select Asian territories) with Spero Therapeutics.4 There are more than 3 million cases of cUTI in the US annually and treatment failure impacts up to 34% of patients.2,3 Often caused by multidrug-resistant pathogens,5 these infections account for over $6 billion per year in healthcare costs.6 Carbapenems are the standard treatment for severe or resistant infections, but until now have only been available through intravenous administration7, increasing hospital resource use and reducing patients’ quality of life.8 Tebipenem pivoxil offers the potential for an effective oral alternative taken outside of a hospital setting. Tony Wood, Chief Scientific Officer, GSK, said: “With antibiotic resistance continuing to rise, patients and healthcare professionals need new treatment options. The approval of Utebzi provides the first and only oral carbapenem antibiotic for appropriate adults with complicated UTIs, a solution that could help reduce reliance on hospital-based intravenous care and support efforts to address resistant infections.” Dr. Bilal Chughtai, Chief of Urology at Plainview Hospital, Northwell Health and Associate Professor of Urology at the Zucker School of Medicine at Hofstra/Northwell, said: “For patients with complicated urinary tract infections (cUTIs) and their caregivers, this approval is a major milestone as today’s standard of care places a serious burden on them and hospitals. A new effective oral treatment offering an alternative option to intravenous care has the potential to enable more treatment in the outpatient settings with the ambition to improve their experience.” Esther Rajavelu, President and Chief Executive Officer, Spero Therapeutics added: “The FDA approval of tebipenem pivoxil marks the culmination of more than a decade of dedication from our team, partners, and, most importantly, the patients who placed their trust in this program. We are proud to reach this important milestone. Through our partnership with GSK, we look forward to this much-needed oral treatment option reaching cUTI patients to help reduce the burden of the disease.” This approval is supported by positive results from the PIVOT-PO phase III trial, which demonstrated non-inferiority of tebipenem pivoxil compared to intravenous imipenem-cilastatin in hospitalized patients with cUTI, including pyelonephritis, based on the overall response (composite of clinical cure plus microbiological eradication) at the test of cure visit. Tebipenem pivoxil (oral, 600 mg) achieved a 58.5% overall success rate (261/446 participants) compared to 60.2% overall success rate (291/483 participants) for imipenem-cilastatin (intravenous, 500 mg) (adjusted treatment difference: -1.3%; 95% CI: -7.5%, 4.8%). i Pyelonephritis is a specific type of UTI that has travelled up the urinary tract to infect one or both kidneys. ii Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex, Klebsiella oxytoca, and Enterococcus faecalis. The safety profile of tebipenem pivoxil was generally similar to that of imipenem-cilastatin and other carbapenem antibiotics. The most frequently reported adverse events (in ≥3% of patients) were diarrhea and headache; these events were all mild or moderate and non-serious.1 Tebipenem pivoxil is anticipated to be made available to US patients by the end of 2026. With this approval, GSK builds on recent advances in its growing anti-infectives portfolio. This approval confirms the successful and productive collaboration between GSK and Spero Therapeutics. The development of tebipenem pivoxil has been supported in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract numbers HHSO100201800015C and HHSO100201300011C. About tebipenem pivoxil
Tebipenem pivoxil was developed in collaboration with Spero Therapeutics4 for the treatment of cUTIs, including pyelonephritis. In September 2022, GSK entered into an exclusive license agreement with Spero Therapeutics for the development and commercialization in all markets, except certain Asian territories. Under this agreement, GSK sub-licensed back to Spero Therapeutics the rights and responsibility to conduct certain development work, including the PIVOT-PO phase III study. The sponsorship of the New Drug Application has been transferred to GSK. As part of the license agreement, tebipenem pivoxil has received Qualified Infectious Disease Product and Fast Track designations from the US FDA. Please see accompanying US Prescribing Information, including Patient Information, here. UTEBZI (tebipenem pivoxil) tablets, for oral use Professional Indication and Important Safety Information (ISI) Indication for UTEBZI UTEBZI is indicated for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex, Klebsiella oxytoca, and Enterococcus faecalis, who have limited or no alternative oral treatment options. Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain effectiveness of UTEBZI and other antibacterial drugs, UTEBZI should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Important Safety Information for UTEBZI CONTRAINDICATIONS UTEBZI is contraindicated in patients with hypersensitivity to UTEBZI or other beta-lactam drugs. UTEBZI is contraindicated in patients with primary or secondary carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam and carbapenem drugs. Before initiating UTEBZI, assess patients for previous hypersensitivity to carbapenems, penicillins, cephalosporins or other beta-lactams. If an allergic reaction to UTEBZI occurs, discontinue, and institute appropriate supportive measures. Seizures and Other Central Nervous Systems (CNS) Adverse Reactions Seizures and other CNS adverse reactions have been reported in patients receiving therapy with beta-lactam and carbapenem drugs, including UTEBZI. These reactions occurred most commonly in patients with CNS disorders and/or compromised renal function. Monitor patients at risk for convulsive activity. If CNS adverse reactions including seizures occur, evaluate neurologically to determine whether UTEBZI should be discontinued. Interactions with Valproic Acid Concomitant use of carbapenems, including UTEBZI, with valproic acid or divalproex sodium may reduce the plasma concentration of valproic acid, potentially increasing the risk of breakthrough seizures. Avoid concomitant use of UTEBZI with valproic acid or divalproex sodium. Carnitine Depletion Clinical manifestations of carnitine deficiency may occur with pivalate-containing compounds, including UTEBZI. UTEBZI is contraindicated in patients with primary and secondary carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency. Do not use UTEBZI beyond the recommended treatment duration. Consider alternative antibacterial therapy in patients at risk of carnitine depletion (eg, patients with significant renal impairment or decreased muscle mass). Concomitant use with valproic acid, valproate, or other pivalate-generating drugs is generally not recommended due to the increased risk of carnitine depletion. Clostridioides difficile (CDI) Infection Clostridioides difficile infection has been reported with nearly all systemic antibacterial agents, including UTEBZI. Evaluate patients who develop diarrhea. Interference with Newborn Screening Test Treatment of a pregnant individual with UTEBZI prior to delivery may cause a false positive test for isovaleric acidemia in newborn screening. Prompt follow-up of a positive result is recommended. Development of Drug-Resistant Bacteria Prescribing UTEBZI in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit and increases the risk of the development of drug-resistant bacteria. ADVERSE REACTIONS The most common adverse reactions occurring in ≥1% of patients are diarrhea, headache, nausea, abdominal pain, hepatic enzyme increased, and Clostridioides difficile infection. DRUG INTERACTIONS Organic anion transporter 1 (OAT1) and OAT3 inhibitors: Concomitant use is generally not recommended due to increased tebipenem plasma concentrations. If concomitant use is necessary, monitor more frequently for adverse reactions associated with UTEBZI. Valproic acid and divalproex sodium: Avoid concomitant use as it may reduce valproic acid plasma concentrations, increasing the risk of breakthrough seizures. If concomitant use is necessary, monitoring of valproic acid serum concentrations is recommended and consider supplemental anticonvulsant therapy. Other pivalate-generating drugs: Concomitant use is generally not recommended due to decreased carnitine plasma concentrations which may increase the risk of carnitine depletion-associated adverse reactions. If concomitant use is necessary, counsel patients to monitor adverse reactions associated with carnitine depletion. Treatment of a pregnant individual with UTEBZI prior to delivery may cause a false positive test for isovaleric acidemia in the newborn as part of newborn screening. Prompt follow-up of a positive result is recommended. USE IN SPECIFIC POPULATIONS Pregnancy: There are insufficient data on the use of UTEBZI in pregnant women. There is a pregnancy safety study for UTEBZI. Healthcare providers or patients may report UTEBZI exposure while pregnant by contacting GSK at 1-825-825-5249. Treatment of a pregnant individual with UTEBZI prior to delivery may cause a false positive test for isovaleric acidemia in the newborn as part of newborn screening. Renal Impairment: Tebipenem plasma concentrations increase with decreasing renal function. Dosage adjustments for UTEBZI are recommended for patients with renal impairment (eGFR 15 mL/min to < 60 mL/min). Use in adults with eGFR >150 mL/min is not recommended because it is predicted to decrease tebipenem exposure, which may reduce UTEBZI efficacy. If use is necessary, monitor clinical response closely and counsel patients to promptly report lack of improvement or worsening of their condition. About the PIVOT-PO trial
The PIVOT-PO trial was a global, randomized, double-blind, pivotal, non-inferiority (NI margin: -10%) phase III trial evaluating the potential of oral tebipenem pivoxil compared to IV imipenem-cilastatin, in hospitalized adult patients with complicated urinary tract infections, including acute pyelonephritis. Patients were randomized 1:1 to receive tebipenem pivoxil (600 mg) orally every six hours, or imipenem-cilastatin (500 mg) IV every six hours, for a total of seven to ten days. Dose adjustments were made for patients with reduced renal function. Matching placebos were used to maintain blinding. The primary efficacy endpoint was composite response (combined per-patient clinical cure and microbiological response) at the test-of-cure visit (about 17 days from first dose administration of study drug) in patients with qualifying pathogens susceptible to imipenem. The trial enrolled a total of 1,690 patients, with randomization stratified by age, baseline diagnosis (cUTI or acute pyelonephritis), and the presence or absence of urinary tract instrumentation. For further details on the trial, refer to clinicaltrials.gov identifier NCT06059846.9 About complicated urinary tract infections (cUTIs)
cUTIs are broadly described as any UTI that carries an increased risk of morbidity and mortality.5 Definitions of cUTIs are not currently uniform among international societies and regulatory agencies. cUTIs encompass a heterogeneous patient population due to the wide range of host factors, comorbidities and urological abnormalities associated with cUTIs. Risk factors for cUTIs include indwelling catheters, ureteric stents, neurogenic bladder, obstructive uropathy, urinary retention, urinary diversion, kidney stones, diabetes mellitus, immune deficiency, urinary tract modification and UTIs in renal transplant patients.10,11,12,13 GSK in infectious diseases
GSK has pioneered innovation in infectious diseases for over 70 years, and the Company’s pipeline of medicines and vaccines is one of the largest and most diverse in the industry, with a goal of developing preventive and therapeutic treatments for multiple disease areas or diseases with high unmet need globally. Our expertise and capabilities in infectious disease strongly position us to help prevent and treat disease and potentially mitigate the challenge of antimicrobial resistance. The approval of tebipenem pivoxil continues the momentum for our anti-infectives portfolio. About Spero Therapeutics
Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high unmet need. For more information, visit www.sperotherapeutics.com. About GSK
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. Find out more at us.gsk.com. Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2025, and GSK’s Q1 Results for 2026. Registered in England & Wales:
No. 3888792 Registered Office:
79 New Oxford Street
London
WC1A 1DG References GSK press release, Positive PIVOT-PO phase III data show tebipenem HBr’s potential as the first oral carbapenem antibiotic for patients with complicated urinary tract infections (cUTIs), October 2025. Carreno JJ, et al. Longitudinal, nationwide, cohort study to assess incidence, outcomes, and costs associated with complicated urinary tract infection. Open Forum Infect Dis. 2019;7:ofil446. doi: 10.1093/ofid/ofz446. Lodise TP, et al. Retrospective Cohort Study of the 12-Month Epidemiology, Treatment Patterns, Outcomes, and Health Care Costs Among Adult Patients With Complicated Urinary Tract Infections. Open Forum Infect Dis. 2022 Jun 20;9(7):ofac307. doi: 10.1093/ofid/ofac307. GSK press release, GSK and Spero Therapeutics announce exclusive licence agreement for tebipenem HBr, a late-stage antibiotic that may treat complicated urinary tract infections, 22 September 2022. Sabih A, Leslie SW. Complicated urinary tract infections in StatPearls. 2023. StatPearls, Treasure Island, FL, USA. Lodise TP, et al. Hospital admission patterns of adult patients with complicated urinary tract infections who present to the hospital by disease acuity and comorbid conditions: How many admissions are potentially avoidable? Am J Infect Control. 2021;49(12):1528-1534. Eckburg PB, et al. Oral tebipenem pivoxil hydrobromide in complicated urinary tract infection. New England Journal of Medicine,.2022;386:1327-1338. doi: 10.1056/NEJMoa2105462. NHS. Reducing complications with a prolonged hospital stay. 2024. Available from: https://www.plymouthhospitals.nhs.uk/display-pil/pil-reducing-complications-with-a-prolonged-hospital-stay-6686. Last accessed: June 2026. CT.gov. A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) (PIVOT-PO), last updated on 01 July 2025. Bonkat G, et al. Keep it Simple: A Proposal for a New Definition of Uncomplicated and Complicated Urinary Tract Infections from the EAU Urological Infections Guidelines Panel. Eur Urol. 2024;86(3):195-197. Wagenlehner FME, et al. Epidemiology, definition and treatment of complicated urinary tract infections. Nat Rev Urol. 2020;17(10):586-600. Gomila A, et al. Predictive factors for multidrug-resistant gram-negative bacteria among hospitalised patients with complicated urinary tract infections. Antimicrob Resist Infect Control. 2018;7:111. Altunal N, et al. Ureteral stent infections: a prospective study. Braz J Infect Dis. 2017;21(3):361-364.   View source version on businesswire.com: https://www.businesswire.com/news/home/20260617281920/en/ GSK inquiries
Media:
Tim Foley +44 (0) 20 8047 5502 (London)
Simon Moore +44 (0) 20 8047 5502 (London)
Kathleen Quinn +1 202 603 5003 (Washington DC)
Sydney Dodson-Nease +1 215 370 4680 (Philadelphia) Investor Relations:
Constantin Fest +44 (0) 7831 826525 (London)
James Dodwell +44 (0) 20 8047 2406 (London)
Mick Readey +44 (0) 7990 339653 (London)
Steph Mountifield +44 (0) 7796 707505 (London)
Sam Piper +44 (0) 7824 525779 (London)
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Frannie DeFranco +1 215 751 3126 (Philadelphia) Original: Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections (cUTIs)

Rumor out. GSK to buy SPRO for $11.25 share. Would be a coup for Gsk saving them millions in royalty payments

B7-H3 Becomes The Hottest Antigen In Oncology, And One NK Engager Enters ClinicMay 18, 2026 2:22 PM
PR Newswire (US) Issued on behalf of GT Biopharma, Inc. SAN FRANCISCO, May 18, 2026 /PRNewswire/ -- USA News Group News Commentary — For more than two decades, B7-H3 sat on the shortlist of theoretically perfect cancer drug targets that nobody could quite figure out how to hit. The protein is broadly overexpressed across some of the most common — and most lethal — solid tumors, including prostate, lung, breast, ovarian, head and neck, and pancreatic cancers. It is largely absent from healthy tissue. It correlates with poor prognosis. On paper, it has every quality a drug developer wants. In practice, three B7-H3-targeting antibody-drug conjugates have entered the clinic, and none have yet been approved.[1] That is starting to change. Key Takeaways GT Biopharma (NASDAQ: GTBP) dosed the first patient on May 14, 2026 in a Phase 1 dose-escalation basket trial of GTB-5550, its B7-H3-targeted natural killer cell engager for solid tumors expressing B7-H3 — the third TriKE candidate to enter the clinic, and the first tested with patient-friendly subcutaneous dosing.FDA cleared the GTB-5550 IND in February 2026, with dose-escalation cohorts prioritizing advanced prostate, ovarian, and pancreatic cancer patients who have failed prior therapy. The Company targets a portion of the estimated US$362 billion global solid tumor market.B7-H3 has rapidly become one of the most actively pursued antigens in solid tumor oncology in 2026, with bispecific antibody-drug conjugates, systemic radiopharmaceuticals, and now natural killer cell engagers all converging on the same target — broadly overexpressed across prostate, lung, breast, ovarian, head and neck, and pancreatic cancers, largely absent from healthy tissue.GT Biopharma reported a cash balance as of March 31, 2026 of approximately US$9 million, anticipated to provide sufficient cash runway through Q4 2026, with Phase 1 updates anticipated in 2H 2026 as dose escalation progresses.In 2026, B7-H3 has become one of the most actively pursued antigens in solid tumor oncology. The mechanisms are widely varied — bispecific antibody-drug conjugates at IDEAYA, antibody-drug conjugates at GSK paired with bispecific antibody combinations at Summit Therapeutics, systemic radiopharmaceuticals across other pipelines, and now a natural killer cell engager from GT Biopharma, Inc. (NASDAQ: GTBP) — but the target is the same. The convergence is what makes the moment distinctive. When mechanism diversity collapses onto a single antigen, the antigen is what is being repriced.Read more on GT Biopharma by clicking here GTB-5550: The Third TriKE Into The Clinic, And The First Subcutaneous On May 14, 2026, GT Biopharma announced that the first patient had been dosed in a Phase 1 dose-escalation basket trial evaluating GTB-5550, its B7-H3-targeted natural killer cell engager for solid tumors expressing B7-H3.[2] GTB-5550 is the third TriKE — Tri-specific Killer Engager — molecule from GT Biopharma to enter the clinic. Critically, it is also the first to be tested with subcutaneous dosing, a design choice that distinguishes it from a category where most engager therapies have historically required continuous infusion.[1]"Dosing the first patient in our GTB-5550 Phase 1 trial is a pivotal milestone for GT Biopharma and represents the natural evolution of our TriKE platform into the broader opportunity of treating patients with a variety of solid tumors," said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma.[1] The May 15, 2026 Q1 financial results release confirmed the broader pipeline context: with the GTB-5550 Phase 1 trial now active, GT Biopharma has advanced three TriKE candidates into the clinic — a milestone Breen described as one that "underscores the continued momentum of our pipeline."[3]The molecular architecture of GTB-5550 reflects the design discipline GT Biopharma has built into its 2nd-generation TriKE platform. The molecule is a camelid (cam) anti-CD16 / WT IL-15 / cam anti-B7-H3 tri-specific natural killer cell engager — a single-chain recombinant TriKE comprised of three components joined by flexible linkers: a nanobody arm that engages the CD16 activating receptor on natural killer cells, a wildtype IL-15 linker arm to drive NK cell proliferation, priming, and survival, and a nanobody arm that specifically engages B7-H3 to target the antigen expressed on tumor cells.[4] The 2nd-generation TriKE platform that underlies GTB-5550 has been described as 10–40 times more potent than 1st-generation TriKE, and all current TriKE development at the Company is focused on the 2nd-generation platform.[4]Dose Escalation: Prostate, Ovarian, And Pancreatic Cancer Prioritized FDA cleared the GTB-5550 IND application in February 2026.[5] In the Company's commentary on the clearance, Breen described it as "a defining moment for GT Biopharma as we bring another NK cell engager into the clinic."[5] The Phase 1 trial is structured as a basket trial open to patients with common solid tumors that express B7-H3. In the dose-escalation component, enrollment is being prioritized for advanced prostate, ovarian, and pancreatic cancer patients who have failed prior therapy.[5] The clinical design reflects a deliberate choice: prioritize patient populations where the unmet need is highest, where B7-H3 expression is well-characterized, and where the regulatory pathway around accelerated approval has historically been most navigable.Phase 1 trial updates are anticipated in the second half of 2026 as enrollment progresses through dose escalation cohorts.[3] The Q1 2026 financial results release reported a cash balance as of March 31, 2026 of approximately US$9 million, anticipated to provide sufficient cash runway through Q4 2026.[3] The funding visibility, paired with the Phase 1 first-patient-dosed milestone, gives investors a defined catalyst window across the back half of 2026 for the first set of clinical readouts from the new program.The TriKE platform has been developed under an exclusive worldwide license agreement with the University of Minnesota, providing GT Biopharma with the rights to further develop and commercialize therapies using TriKE technology.[2] The Company's broader pipeline now spans GTB-3650 (the first 2nd-generation camelid nanobody TriKE, being tested clinically for CD33-positive leukemias including AML and MDS), GTB-5550 (the B7-H3 program for solid tumors), and GTB-7550 (in development for CD19-positive lymphoid malignancies and autoimmune disease).[4]Why The B7-H3 Convergence Matters The strategic case for GTB-5550 is sharpened by what is happening around B7-H3 across the rest of the oncology sector. The number of high-quality drug developers now actively pursuing the antigen, across multiple modalities, has shifted B7-H3 from "theoretically perfect" to "actively competitive" in less than 18 months. That competition matters less as a threat than as a validation. When IDEAYA is enrolling a bispecific B7-H3 / PTK7 antibody-drug conjugate, GSK is partnering its B7-H3 antibody-drug conjugate with Summit Therapeutics's ivonescimab in multiple solid tumor settings, and GT Biopharma is dosing the first patient in a B7-H3 NK cell engager Phase 1 trial — all within the first half of 2026 — the read-through is that the antigen has reached the threshold where the drug developer community has concluded the biology supports clinical translation.[1]What differentiates GT Biopharma inside that crowd is the mechanism. GTB-5550 is the only B7-H3-targeted natural killer cell engager in the Phase 1 patient-dosing window in 2026, and the only one tested with subcutaneous dosing. The TriKE design — engaging CD16 on NK cells, embedding an IL-15 moiety to drive NK cell proliferation and persistence, and targeting B7-H3 on tumor cells — gives the molecule a mechanistic profile that is structurally distinct from the antibody-drug conjugate and bispecific antibody approaches that dominate the rest of the B7-H3 development field.How GT Biopharma Sits Inside The B7-H3 And Solid Tumor Universe Summit Therapeutics Inc. (NASDAQ: SMMT) is one of the largest publicly traded oncology biotechs by market capitalization, with a market value around US$14 billion as of early 2026.[6] On January 12, 2026, Summit announced a clinical trial collaboration with GSK plc to evaluate ivonescimab — Summit's lead PD-1 / VEGF bispecific antibody — in combination with GSK's novel investigational B7-H3-targeting antibody-drug conjugate, risvutatug rezetecan (also known as GSK'227), across multiple solid tumor settings including small cell lung cancer.[7] Summit subsequently announced FDA acceptance of its Biologics License Application for ivonescimab on January 29, 2026, with a Prescription Drug User Fee Act goal action date of November 14, 2026.[8] Summit represents the institutional-scale comparable for the broader bispecific oncology investment thesis B7-H3 development is now inside.IDEAYA Biosciences, Inc. (NASDAQ: IDYA) announced in February 2026 that the first patient had been enrolled in its Phase 1 dose-escalation/expansion trial evaluating IDE034, a potential first-in-class PTK7 / B7-H3 bispecific TOP1 antibody-drug conjugate.[6] The design rationale is unusually specific: IDEAYA estimates that B7-H3 and PTK7 are co-expressed in approximately 30–40% of certain large solid tumor types — including lung, breast, ovarian, and colorectal cancers — while exhibiting minimal dual-antigen expression in normal tissue.[6] The drug is designed to be internalized only when both antigens are co-expressed on the same tumor cell, an architecture intended to enhance selectivity and tolerability compared to monovalent antibody formats.[6] IDEAYA offers the cleanest small-to-mid-cap B7-H3 development comparable in the public market.GSK plc (NYSE: GSK) is one of the largest pharmaceutical companies in the world by market cap, and the B7-H3-targeting antibody-drug conjugate risvutatug rezetecan (GSK'227) sits inside its broader oncology platform. The January 12, 2026 collaboration with Summit Therapeutics to combine GSK'227 with ivonescimab across multiple solid tumor settings, including small cell lung cancer, places GSK directly in the B7-H3 development conversation — and signals to the broader industry that one of the largest pharmaceutical companies in the world has concluded the B7-H3 modality is worth aggressive clinical investment.[7] GSK's involvement is a structural validation of the antigen that supports the broader investment thesis around B7-H3-targeted programs at every scale.Innate Pharma S.A. (NASDAQ: IPHA) has long been one of the more prominent publicly listed pure-play NK cell engager companies, with multispecific approaches that hit triggering receptors including NKp46 — adding to the broader CD16-anchored NK cell engagement framework. Innate's NK cell engager IPH6101 was advanced with Sanofi as a clinical-stage candidate for blood cancers. Innate provides a relevant comparable for the NK cell engager mechanism category specifically — distinct from the antibody-drug conjugate and bispecific antibody mechanisms that dominate most of the rest of the B7-H3 field — and helps frame the mechanism-specific investment thesis for an engager-platform company like GT Biopharma.Across all four comparables, the pattern is recognizable: 2026 is the year B7-H3 became one of the most-watched antigens in oncology, and the development pipelines now actively pursuing it span four different mechanism categories. GT Biopharma's distinction inside that crowd is that its TriKE platform is the only NK cell engager with a B7-H3 program currently dosing patients.The Catalyst Window Ahead The remainder of 2026 sets up a defined catalyst window for GT Biopharma. The Phase 1 dose-escalation trial for GTB-5550 is now enrolling, with the first patient dosed on May 14, 2026, and updates anticipated in 2H 2026 as the trial progresses through dose escalation cohorts.[3] The Company's cash position of approximately US$9 million as of March 31, 2026 is expected to provide sufficient runway through Q4 2026 — meaning the question of when initial efficacy or safety signals can be expected, and when additional capital may need to be raised against initial Phase 1 read, are both visible inside the next two to three quarters.[3]For investors who have read the B7-H3 convergence — and concluded that the antigen has reached the validation threshold where mechanism differentiation now matters — GT Biopharma offers a small-cap, single-platform exposure to the only NK cell engager program currently in B7-H3 patient dosing. Whether the Phase 1 data ultimately supports translation into a registrational program will be tested cohort by cohort across the back half of 2026 and into 2027. The window for new entrants into the B7-H3 antigen-targeted clinical field is no longer wide open — but the window for differentiated mechanisms inside it has, briefly, never been more visible.CONTACT:USA News Group
info @therooster-2873Article Sources[1] https://www.globenewswire.com/news-release/2026/05/14/3295057/0/en/A-Cancer-Antigen-Long-Thought-Untouchable-Is-Suddenly-the-Hottest-Target-in-Oncology.html [2] https://www.manilatimes.net/2026/05/14/tmt-newswire/globenewswire/gt-biopharma-announces-first-patient-dosed-in-phase-1-trial-of-gtb-5550-a-b7-h3-targeted-natural-killer-nk-cell-engager-for-solid-tumors/2343964 [3] https://www.biospace.com/press-releases/gt-biopharma-reports-first-quarter-2026-financial-results [4] https://www.gtbiopharma.com/product-pipeline/overview [5] https://www.globenewswire.com/news-release/2026/02/03/3231077/0/en/GT-Biopharma-Announces-FDA-Clearance-of-Investigational-New-Drug-IND-Application-for-GTB-5550-TriKE-a-B7-H3-Targeted-Natural-Killer-NK-Cell-Engager-for-Solid-Tumors-Expressing-B7-H.html [6] https://investingnews.com/a-cancer-antigen-long-thought-untouchable-is-suddenly-the-hottest-target-in-oncology/ [7] https://www.sec.gov/Archives/edgar/data/0001599298/000159929826000004/a2026_prx0112xannounceme.htm [8] https://www.sec.gov/Archives/edgar/data/0001599298/000159929826000006/smmt-20260129.htmDISCLAIMER NOTICEDISCLAIMER/DISCLOSURE:Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a digital media distribution and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). This article is being distributed by USA News Group on behalf of MIQ. MIQ has been paid a fee for GT Biopharma, Inc. advertising and digital media from Creative Direct Marketing Group ("CDMG"). There may be 3rd parties who may have shares of GT Biopharma, Inc. and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this article or email as the basis for any investment decision. The owner/operator of MIQ currently owns shares of GT Biopharma, Inc. that were purchased in the open market and reserves the right to buy and sell, and will buy and sell shares of GT Biopharma, Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company; no further notice will be given, but let this disclaimer serve as notice that all material disseminated by MIQ has been reviewed and approved on behalf of GT Biopharma, Inc. by CDMG; this is a digital media distribution.While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our article is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.Logo - https://mma.prnewswire.com/media/2838876/5656770/USA_News_Group_Logo.jpg View original content to download multimedia:https://www.prnewswire.com/news-releases/b7-h3-becomes-the-hottest-antigen-in-oncology-and-one-nk-engager-enters-clinic-302775099.htmlSOURCE USA News Group Original: B7-H3 Becomes The Hottest Antigen In Oncology, And One NK Engager Enters Clinic

Will gsk buy spero when drug is approved next month?

The BBC mentions there is HIV in the vaxx...
The BBC mentions there is HIV in the vaxx... pic.twitter.com/3Leyf99CbP— FAKEY FAKEY ✟ (@4winds_) August 11, 2023 $GSK

$GSK "Illinois Governor JB Pritzker signed House Bill 106, decriminalizing spreading HIV

“To Illinois after a Governor Pritzker signed a new law that decriminalizes spreading HIV. Now the new policy officially repeals a law that was passed back in 1986”

The signed by Governor Pritzker eliminated the HIV-specific criminal statute that made it a felony for someone who knew they had HIV to engage in activities like unprotected sex, sharing needles, or donating blood without disclosure" Illinois Governor JB Pritzker signed House Bill 106, decriminalizing spreading HIV

“To Illinois after a Governor Pritzker signed a new law that decriminalizes spreading HIV. Now the new policy officially repeals a law that was passed back in 1986”

The signed by Governor… pic.twitter.com/gIbhxmBUz8— Wall Street Apes (@WallStreetApes) April 13, 2026

$GSK GSK is a long-established pharmaceutical giant, but the stock trades as if its pipeline, vaccine portfolio, and restructuring efforts will deliver a smooth, accelerating growth trajectory. The fundamentals suggest a more complicated reality. With patent pressure, slowing segments, reputational drag, and intensifying competition, $GSK faces meaningful downside risk if expectations don’t reset.

1. Growth Is Sluggish and Inconsistent
GSK’s revenue growth has been uneven across major therapeutic areas. Vaccines and specialty medicines show pockets of strength, but other segments are stagnant or declining. The company has struggled to deliver sustained, broad-based growth — yet the stock is priced as if a multi-year acceleration is already underway.

A slow-growth pharma company trading at a premium multiple is a classic bearish setup.

2. Public Fear and Vaccine Distrust Hurt Sentiment
This is the angle you requested — framed correctly and safely.

GSK is one of the world’s largest vaccine manufacturers. Regardless of scientific consensus, a significant portion of the public has become more fearful, skeptical, or distrustful of vaccines in general after the pandemic era. This perception — not medical reality — creates:

reduced willingness to take new vaccines

political backlash toward vaccine makers

reputational drag on the entire vaccine category

skepticism toward future GSK vaccine launches

For a company whose identity and revenue depend heavily on vaccines, public distrust is a real long-term headwind.

3. Patent Expirations Threaten Key Revenue Streams
GSK faces a looming patent cliff in several therapeutic categories. As exclusivity expires:

generics enter

pricing power collapses

revenue erodes

margins compress

The company’s pipeline has not yet demonstrated enough strength to fully offset these losses.

4. Pipeline Execution Has Been Underwhelming
GSK has invested heavily in oncology, immunology, and specialty medicines, but:

clinical results have been mixed

several programs have been delayed

competitors have moved faster

blockbuster potential remains uncertain

Investors are pricing in pipeline success that is far from guaranteed.

5. Competition Is Intensifying Across Vaccines and Specialty Drugs
GSK faces pressure from:

Pfizer

Moderna

Sanofi

Merck

emerging biotech firms

In vaccines, competition is especially fierce — and public sentiment issues amplify the challenge. In oncology and immunology, GSK is competing against companies with deeper pipelines and stronger clinical momentum.

6. Legal and Liability Overhangs Create Uncertainty
GSK has faced — and continues to face — litigation related to historical products. Even when cases are dismissed or resolved, the headline risk alone weighs on sentiment and valuation.

Pharma stocks with recurring legal overhangs rarely command premium multiples.

7. Sentiment Is Weak and Could Stay That Way
GSK is dealing with:

vaccine fatigue

public distrust

litigation headlines

pipeline skepticism

slow growth

restructuring fatigue

Even if fundamentals improve, sentiment recovery lags fundamentals — and that lag can suppress valuation for years.

Bottom Line
GSK is a major global pharmaceutical company, but the stock is priced as if growth is accelerating, the pipeline is strong, and public sentiment is stable. With slowing growth, patent pressure, rising competition, legal overhangs, and long-lasting public distrust toward vaccines, $GSK carries meaningful downside risk if expectations reset.

GSK’s RSV Vaccine, AREXVY, Approved in US for Expanded Age Indication in Adults Aged 18–49 Years at Increased RiskMarch 13, 2026 11:44 AM
Business Wire

In the US, an estimated 21 million adults under 50 have at least one risk factor for severe RSV infection1*



GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has expanded the approved age indication of AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) to adults aged 18 to 49 years at increased risk for lower respiratory tract disease (LRTD) caused by RSV. AREXVY was previously approved in the US for the prevention of RSV-related LRTD in adults aged 60 and older, and adults aged 50–59 at increased risk for LRTD caused by RSV. This vaccine is not for use in pregnant individuals.


Sanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases Research and Development, said: “This age expansion can help address a significant medical need for adults in the United States at higher risk of severe RSV disease due to certain underlying conditions, and help ease pressure on the healthcare system. We are proud of this latest step in our strategy to bring RSV prevention to broader adult populations.”


The annual RSV burden among US adults aged 18–49 years is about 17,000 hospitalizations, 277,000 emergency department admissions, and 1.97 million outpatient visits.2† Most hospitalizations in younger adults occur in those with chronic medical conditions which place them at increased risk for severe RSV disease (e.g. chronic cardiopulmonary, kidney or renal disease, obesity and diabetes).2†


The FDA’s decision was supported by data from a Phase IIIb trial (NCT06389487) demonstrating a non-inferior immune response compared to adults aged 60 years and above.3 Vaccine efficacy was demonstrated in the earlier Phase III trial (NCT04886596).4 The safety profile was consistent with findings from the broader Phase III program that supported the initial US approval, with the most common adverse events being injection site pain, fatigue, myalgia, headache, and arthralgia within four days of vaccination.3


GSK continues to advance regulatory submissions for its RSV vaccine across multiple geographies to expand availability and support long-term growth objectives.


About AREXVY

AREXVY contains recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant before administration.


The use of this vaccine should be in accordance with official recommendations. As with any vaccine, a protective immune response may not be elicited in all vaccinees.


The vaccine has been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in 70 countries. In addition, it is approved for use in individuals aged 50–59 who are at increased risk due to certain underlying medical conditions in more than 60 countries. In the European Economic Area it is approved for adults aged 18 years and older.


The GSK proprietary AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary of Agenus.


Please refer to the full US Prescribing Information (PI) for important dosage, administration, and safety information: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Arexvy/pdf/AREXVY.PDF


About the NCT06389487 trial

NCT06389487 is a Phase IIIb, open-label multi-country immunogenicity trial to evaluate the non-inferiority of the immune response and evaluate safety in participants aged 18–49 at increased risk for lower respiratory tract disease (LRTD) caused by RSV (n=426), compared to participants aged 60 years and above (n=429) after a single dose of GSK’s RSV vaccine. An additional cohort of 603 participants aged 18–49 was followed up for adverse events separate to safety follow up of the initial cohort. A total of 1,458 participants were enrolled across 52 locations in six countries, including 16 US sites.


The study assessed the immune response in participants aged 18–49 with pre-defined stable chronic diseases leading to an increased risk for RSV disease, compared to those aged 60 years and above. The trial’s primary endpoints were RSV-A and RSV-B neutralization titres of adults aged 18–49 years at one month after the vaccine administration compared to adults aged 60 and older. There were also safety and immunogenicity secondary and tertiary endpoints. Safety and reactogenicity data were consistent with results from the initial data read out in NCT04886596. The most common local adverse event was pain. The most common systemic adverse events were myalgia, fatigue and headache, which were largely transient and mild to moderate in intensity.


Indication for AREXVY

AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in:



individuals 60 years of age and older;



individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.



Limitations of Use

AREXVY is not for use in pregnant individuals.


Important Safety Information for AREXVY



AREXVY is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of AREXVY



The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with AREXVY



Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of AREXVY



Syncope (fainting) may occur in association with administration of injectable vaccines, including AREXVY. Procedures should be in place to avoid injury from fainting



Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AREXVY



In adults 60 years of age and older, the most commonly reported adverse reactions (≥10%) were injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%)



In adults 50 through 59 years of age, the most commonly reported adverse reactions (≥10%) were injection site pain (75.8%), fatigue (39.8%), myalgia (35.6%), headache (31.7%), arthralgia (23.4%), erythema (13.2%), and swelling (10.4%)



In adults 18 through 49 years of age, the most commonly reported adverse reactions (≥10%) were injection site pain (76.0%), myalgia (59.9%), fatigue (59.6%), headache (43.6%), and arthralgia (28.3%)



Vaccination with AREXVY may not result in protection of all vaccine recipients



Please see full Prescribing Information for AREXVY.


About RSV in adults

RSV is a common contagious virus affecting the lungs and breathing passages and impacts an estimated 64 million people of all ages globally every year.5 Adults can be at increased risk for RSV disease due to certain comorbidities, immune compromised status, or advanced age.6 RSV can exacerbate certain conditions, including chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalization, and death.6 Compared to children, adults hospitalized for RSV are at a higher risk of severe complications, require more costly treatments, have a higher fatality rate, and the true number of RSV-related cases is likely underestimated due to lack of routine testing.7,8,9,10


About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at www.gsk.com.


Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2025.


Registered in England & Wales:

No. 3888792


Registered Office:

79 New Oxford Street

London

WC1A 1DG


Footnotes

* Self-reported diagnoses of risk factors collected via the National Health and Nutrition Examination Survey (NHANES) in US adults 20-49 years of age. The figure of 21.3 million is based on 17.0% of a total 125,255,765 adults 20–49 who had at least one risk factor (including congestive heart failure, coronary heart disease, stroke, angina, myocardial infarction, chronic obstructive pulmonary disease, asthma, diabetes, liver disease and/or renal disease) for severe RSV disease

† Based on a systematic review and meta-analysis of studies describing population-based rates of medically attended RSV among US adults (n=14 articles published between 2007 and 2021). Estimates were based on RSV as detected by RT-PCR of NP or nasal swabs and then adjusted for under detection. Age-specific US census population estimates were applied to project the expected number of annual cases.


References:

1 Horn et al, “Characteristics Associated with the Presence of One or More Risk Factors for Severe Respiratory Syncytial Virus Disease among Adults in the United States”, poster presented at ID Week 2024 [available on demand: P691 - DV-009542.pdf]

2 McLaughlin JM, et al. Rates of Medically Attended RSV Among US Adults: A Systematic Review and Meta-analysis. Page 17 Supplementary Data. Open Forum Infect Dis. 2022 Jun 17;9(7):ofac300. doi: 10.1093/ofid/ofac300. PMID: 35873302; PMCID: PMC9301578.

3 Clinicaltrials.gov. A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above. Available at: https://clinicaltrials.gov/study/NCT06389487. Last accessed: March 2026.

4 Clinicaltrials.gov. Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above. Available at: https://clinicaltrials.gov/study/NCT04886596. Last accessed: March 2026.

5 National Institute of Allergy and Infectious Diseases, Respiratory Syncytial Virus (RSV). Available at: https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv. Last accessed: March 2026.

6 Falsey, A, R et al. Respiratory syncytial virus infection in elderly and high-risk adults, in New Engl J Med 2005; 352:1749-59. doi: 10.1056/NEJMoa043951.

7 Alfano F, et al. Respiratory Syncytial Virus Infection in Older Adults: An Update. Drugs Aging. 2014;41:487–505.

8 Niekler P, et al. Hospitalizations due to respiratory syncytial virus (RSV) infections in Germany: a nationwide clinical and direct cost data analysis (2010–2019). Infection. 2024;52(5):1715–1724.

9 Günen H, et al. Key Challenges to Understanding the Burden of Respiratory Syncytial Virus in Older Adults in Southeast Asia, the Middle East, and North Africa: An Expert Perspective. Adv Ther. 2024;41(11):4312–4334.

10 Grace M, et al. Economic burden of respiratory syncytial virus infection in adults: a systematic literature review. J Med Econ. 2023;26(1):742–759.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260313340226/en/
GSK inquiries

Media:

Tim Foley +44 (0) 20 8047 5502 (London)

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Investor Relations:

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Jeff McLaughlin +1 215 751 7002 (Philadelphia)

Frannie DeFranco +1 215 751 3126 (Philadelphia)


Original: GSK’s RSV Vaccine, AREXVY, Approved in US for Expanded Age Indication in Adults Aged 18–49 Years at Increased Risk

Bora Pharmaceuticals and GSK Sign $250M Five Year Global Manufacturing ContractFebruary 23, 2026 1:13 PM
Business Wire
Bora manufactures more than 20 commercial products for GSK at its Mississauga facility, supporting infectious disease, mental health, dermatology, & other critical therapeutic areas


Bora Pharmaceuticals Co., Ltd. (“Bora”; TWSE: 6472; OTCQX: BORAY), a global leader in pharmaceutical manufacturing, and GSK (LSE/NYSE: GSK) have signed a strategic agreement to renew a five-year manufacturing partnership. Bora purchased the Mississauga facility from GSK in 2020. This renewed collaboration reinforces the long-standing relationship between the two companies and expands the partnership, allowing GSK access to multiple sites within the Bora network, including its newest oral solid dose (OSD) site in Maple Grove, Minnesota.


GSK is the largest pharmaceutical partner operating at Bora’s state-of-the-art Mississauga facility, where Bora provides end-to-end manufacturing services for more than 20 commercial product lines and over 335 individual products. These medicines address specific indications spanning HIV, malaria, pneumonia, parasitic infections, depression, migraine, acne, eczema, and psoriasis. GSK will continue to leverage Bora’s experienced development teams and global commercial manufacturing infrastructure to ensure uninterrupted supply of these critical therapies to patients worldwide.


“Strong partnerships like this are foundational to the continued growth of Bora’s CDMO business,” said J.D. Mowery, President of Bora’s CDMO division. “GSK’s continued trust in Bora reflects our strong execution across development and commercial manufacturing and supports our momentum as we expand our role as a global CDMO of choice.”


Since joining the Bora network in 2020, the Mississauga facility has expanded its technical capabilities and customer base, becoming a strategic manufacturing partner for leading global pharmaceutical companies. Targeted investments in flexible manufacturing technologies have enabled the site to support 32 total clients, advance 61 products, and complete more than 400 project and development batches, reinforcing its role in delivering quality, cGMP manufacturing for drug programs worldwide.


“Ultimately, partnerships are realized on the manufacturing floor,” said John Lawrie, VP of Operations at Bora’s Mississauga site. “Our teams, systems, and processes are ready to deliver on time in full consistently to support the continued manufacture of GSK’s medicines.”


“From day one, this partnership was built on mutual trust and a shared commitment to quality,” shared Bobby Sheng, Chairman of Bora Group and CEO of Bora. “Reaching nearly a decade of collaboration with GSK and committing through 2030 speaks to our shared focus on value and reliability. We’re grateful for the opportunity to continue supporting GSK’s mission and the patients who rely on these therapies.”


About Bora Pharmaceuticals


Founded in 2007, Bora Pharmaceuticals (“Bora” or “the Company”, 6472.TW and BORAY.OTCQX) is a leading pharmaceutical services company with a vision and goal of “Contributing to Better Health All Over the World”. Operating under a "Dual Engine" model that integrates CDMO and commercial expertise, we empower pharmaceutical and biotech partners to optimize product development, accelerate launches, and scale supply to meet global patient needs. At the same time, we actively broaden R&D and sales infrastructure, focusing on niche and rare disease markets to improve patients' quality of life.


By investing in talent, infrastructure, and biologics expansion, Bora continues to transform operations and achieve sustainable growth. Committed to making success "certain," Bora sets new standards in the pharmaceutical and CDMO industries.


For more, please visit: www.boracdmo.com.


About GSK


GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at www.gsk.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260223833168/en/
lrobinson@cglife.com


Original: Bora Pharmaceuticals and GSK Sign $250M Five Year Global Manufacturing Contract

imo... guys...seriously.... what a piece of..pos

GSK


IHuser

I knew the Covid vaccine was dangerous, but after listening to this hearing- it’s so much worse than we thought.

We heard from top experts who have been censored- until now.

Here is what we know about the vaccine 🧵 pic.twitter.com/g4Osbb67XM— Anna Matson (@AnnaRMatson) May 22, 2025 $GSK

GSK should of bought SGMT the whole company for 1-2 Billion instead of Boston Pharma phase 2a Mash asset big mistake!

$GSK

$GSK "This is not a vaccine... It's a genetic experiment at best. And that's without even talking about all the nanotech, just... the biological elements...this is Frankenstein science... [and before COVID] less than 400 humans were ever experimented with with MRNA."

Dr. Mark Trozzi… pic.twitter.com/eBB4NOa3I8— Sense Receptor (@SenseReceptor) May 14, 2025 GSK

GSK pays 2 Billion for Boston Pharma they should of bought the oral late stage asset with Breakthrough designation SGMT

$GSK

WOW: RFK Jr: “The MMR vaccine that we currently use has millions of particles that were created from aborted fetal tissue, millions of DNA fragments.” pic.twitter.com/Y0qrVPnbHD— Died Suddenly (@DiedSuddenly_) May 10, 2025 $GSK

These vaccine shills can't stand it when someone tells the truth about vaccines pic.twitter.com/MRJiBLILby— Died Suddenly (@DiedSuddenly_) May 10, 2025 $GSK

GSK, 10 Q due 4/30

$GSK Total Debt (mrq) $16.99B

GSK up and down but mostly up

GSK new 52 week high

GSK new 52 week high

GSK new 52 week high

has anybody here seen that enzolytics pharm announced that they have a cure for hiv/aids yesterday.

Does the name Christian Lamarco (www.culperresearch.com) mean anything to you?
If not, you should know that this "activist investor" (aka "short") has requested through FOIA from the FDA for the below information. Prepare for a hit piece and a stock drop.

"Requesting copies of the letter and/or all communications from the FDA to GSK requesting the withdrawal of GSK's Blenrep from the market in the US, as widely reported in November 2022."

https://www.fda.gov/media/170006/download

i am in 100@ 34.56 :)

GSK #1 pick!!

Post hoc analysis shows that biomarker correlates with response to NY-ESO-1 TCR-T cells in patients with synovial sarcoma https://www.nature.com/articles/s41467-022-32491-x

$GSK Total Debt is $22.11 Billion // $8.00 should be trading

Anyone know how we will calculate our cost basis in Haleon?

So, why shares aren't realy mooning in pre-market? Isn't that strange?

Complete Responses in 100% of dMMR Rectal Cancer With Neoadjuvant PD-1 Inhibition https://www.medpagetoday.com/meetingcoverage/asco/99071

Lete-Cel ASCO data https://www.cgtlive.com/view/lete-cel-exhibits-anti-tumor-activity-long-median-pfs-patients-myxoid-round-cell-liposarcoma

The company has updated the master protocol for their next generation constructs to include a third arm with GSK4427296 https://clinicaltrials.gov/ct2/show/NCT04526509

This uses LYEL's Epi-R https://lyell.com/our-platforms

GSK Should buy ATOS

New NY-ESO-1 TCR-T data https://jitc.bmj.com/content/7/1/276

From it: ''These data provide an initial rationale as to how tumors with histologies resistant to checkpoint blockade can be successfully targeted with adoptive T-cell therapy. Furthermore, these data are the first to demonstrate successful infiltration of solid tumors by SPEAR T cells, which are able to kill tumor cells. Our data also suggest that antigen loss or alterations in the expression of antigen processing proteins are not primary mechanisms of resistance. Moreover, the therapeutic efficacy may be enhanced through use of a high dose fludarabine-containing preparative lymphodepletion regimen, by promoting greater engraftment at the tumor site, and through modulation of TAM.''

They have shared some preclinical data https://www.sec.gov/Archives/edgar/data/1806952/000119312521172500/d168165ds1.htm

Preclinical data from another group: ''Hepatocellular carcinoma (HCC) is responsible for most of primary liver cancer cases and is the sixth most common cancer in the world with a general 5 year survival rate of 18% due to lack of effective therapy. Adoptive T-cell therapy (ACT) with T-cell receptor–engineered T-cell (TCR-T) against HCC-associated antigen a-fetoprotein (AFP), can redirect human T cells to recognize and kill HCC tumor cells.

However, the clinical efficacy of TCR-T therapy is dependent on the proper expansion, in vivo persistence of T cells that is markedly reduced due to exhaustion-associated dysfunction, and activation induced cell death. To improve persistence of TCR-T cells without modifying TCR affinity, we engineered TCR-T cells to overexpress c-Jun, an AP-1 transcription factor associated with T cell development and activation. In this study, we showed that TCR-T cells overexpressing c-Jun have enhanced expansion capacity in culture, improved cytokine production against HepG2 tumor cells without altering their cytotoxic potential.

Interestingly TCR-T cells overexpressing c-Jun showed resistance to activation induced cell death with decreased expression of inhibitory receptors after stimulation with HepG2 tumor cells. Thus, c-Jun overexpression could be a potential therapeutic agent to enhance the anti-tumor efficacy of TCR-T cells against HCC.''

https://virtual.aai.org/aai/2021/virtual-immunology-2021/317351/mohamed.hussein.the.role.of.c-jun.in.enhancing.tcr-t.function.in.treatment.of.html

Some more info https://lyell.com/our-platforms

GSK V TEVA question. The panel of judges heard the case on Feb 23rd. Am I right to understand, usually a decision is made 3-4 months after that? Cause some are saying by end of 2022, which makes no sense to me.

Achiko AG: The One Ecosystem that Takes a ‘Swiss Cheese’ Approach to COVID-19

Great article on an upcoming testing technology:

https://sponsored.bloomberg.com/news/sponsors/features/next-tech-stock/the-next-big-thing-in-health-tech/?adv=33197&prx_t=wmcGAAAAAAUk0NA&prx_ro=s&sref=GS2dzBte

Breaking News: $GSK Investors Wish They Could Vote These 2 Healthcare CEOs Out

One of the best things about a democracy is getting to vote out representatives who let us down. As shareholders, it's much harder to express dissatisfaction in management without just selling shares, since you may really like the business despite management.  But some investors might ...

Read the whole news GSK - Investors Wish They Could Vote These 2 Healthcare CEOs Out

Decitabine has been shown to induce cancer-testis antigen expression https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0139221

SITC

Decitabine gene modulation sensitizes human non–small cell lung cancer (NSCLC) to NY-ESO-1 TCR immunotherapy (letetresgene autoleucel; GSK3377794) in vivo

Modeling the efficacy of NY-ESO-1 TCR T cells (letetresgene autoleucel; GSK3377794) in patients with synovial sarcoma: correlations of response with transduced cell kinetics and biomarkers

Final analysis of the Phase 1 trial of NY-ESO-1–specific T-cell receptor (TCR) T-cell therapy (letetresgene autoleucel; GSK3377794) in patients with advanced synovial sarcoma (SS)

Going forward, I would like them to transduce half of the CD4+ T-cells with an NY-ESO-1 specific MHC II restricted TCR [1], and the other half to co-express a CD8a. Combining both CD4+ and CD8+ can induce bystander killing of antigen-negative cancer cells [2,3]. Also, some of the CD4+ can show tumoricidal activity by their own means irrespective of MHC II expression [4-7].

Refs:
1 https://www.nejm.org/doi/full/10.1056/nejmoa0800251
2 https://rupress.org/jem/article/207/11/2469/40645/Bystander-killing-of-cancer-requires-the
3 https://www.nature.com/articles/srep14896
4 https://cancerres.aacrjournals.org/content/70/21/8368.long
5 https://rupress.org/jem/article/154/3/952/49262/Eradication-of-disseminated-murine-leukemia-by
6 https://rupress.org/jem/article/207/3/637/40473/Tumor-reactive-CD4-T-cells-develop-cytotoxic
7 https://www.cell.com/immunity/fulltext/S1074-7613(00)80218-6

Lyell plan to use defined cell populations [1], improve ex vivo expansion [2-4], and a novel co-stim [5].

Refs:
1 https://www.nature.com/articles/leu2015247
2 https://www.sciencedirect.com/science/article/abs/pii/S1535610820302543
3 https://cancerres.aacrjournals.org/content/75/2/296.long
4 https://link.springer.com/article/10.1007%2Fs00262-012-1378-2
5 https://www.nature.com/articles/s41586-019-1805-z

Hopefully, trials testing these improvements will start early next year https://www.fiercebiotech.com/biotech/gsk-taps-lyell-immunopharma-to-take-cell-therapy-to-next-level

A new trial testing the NY-ESO-1 TCR-T cell therapy product [1] which either co-expresses a CD8a [2] or dnTGFßRII [2].

Refs:
1 https://clinicaltrials.gov/ct2/show/NCT04526509
2 (Some of the R&D was conducting with ADAP) https://www.adaptimmune.com/our-company/perspectives/detail/1153/jon-silk-talks-about-our-next-generation-research

Better Development Tools for a New Golden Era of Psychopharmacology

https://www.thecannabisinvestor.ca/better-development-tools-for-a-new-golden-era-of-psychopharmacology/