BioNTech SE (BNTX)

Investigational Pancreatic Cancer Vaccine Shows Lasting Results in Early Trial, Supporting Continued Testing

$BNTX

Vaccines were custom-made for each patient based on the unique changes in the tumor DNA.
In 8 of the 16 patients, the vaccine activated tumor-specific immune cells, meaning the vaccine taught the immune system to recognize tumor cells as foreign. This triggered the body to produce immune cells called T cells to target and kill the tumor cells.
Of the 8 patients whose immune system responded to the vaccine, 7 (87.5%) were still alive 4 to 6 years after surgery.
Among the 8 patients who didn’t respond, only 2 (25%) were still alive, with a median survival time of 3.4 years.

https://www.mskcc.org/news/can-mrna-vaccines-fight-pancreatic-cancer-msk-clinical-researchers-are-trying-find-out?utm_source=X&utm_medium=Organic+Social&utm_term=&utm_content=Image+of+Dr.+Balachandran&utm_campaign=April+Social+Media+Posts+2026

Thought I would share

A new mRNA vaccine for pancreatic cancer, which is showing promising long-term results in an early trial, will be presented this Monday at the AACR Annual Meeting. @NBCNews highlights this as an encouraging step forward in the fight against cancer. https://t.co/6rvWvA8pxw #AACR26— AACR (@AACR) April 19, 2026

My reply (posted on the NWBO board) https://investorshub.advfn.com/boards/read_msg.aspx?message_id=177473714

This paper points to a third axis of antitumour immunity that has been underappreciated: B-cells and antibody responses to neoantigens, not just T-cells https://www.science.org/doi/10.1126/sciadv.adx8303

The paper suggests that adding B-cell neoepitopes may improve vaccines. So optimal designs in the (near) future might require not only targeting presented clonal neoantigens that are immunogenic, focusing on MHC-I targets (CD8+ T-cells), MHC-II targets (CD4+ T-cells), as well as B-cell epitopes (antibody response), leading to a coordinated, multi-arm immune response.

They were talking about COVID-19 back in 2015 and 2017

COVID-19 WAS A MASS SACRIFICE.

Stop posting absurd lies.

They were talking about COVID-19 back in 2015 and 2017

COVID-19 WAS A MASS SACRIFICE.

Stop posting absurd lies.

New data showing that it isn't about quantity of neoantigens, it's about clonality, immunogenicity, and evolutionary pressures https://www.nature.com/articles/s41467-026-71135-2

In colorectal cancers (dMMR/MSI-high), the tumours have a high[er] mutation burden and therefore more neoantigens. But the critical factor is clonal and immunogenic neoantigens. In the paper, just a single clonal immunogenic neoantigen was enough to drive responses. Around 75% had durable benefits if they had early PRs (around twelve weeks). But around 80% with SD went on to eventually progress.

However, even in dMMR tumours/MSI-high, not all neoantigens are clonal, many are subclonal. Immunogenic clones are targeted by clonal neoantigen-specific CD8+ T-cells, but subclones survive due to either having low immunogenicity or being antigen-negative. These then expand under immune pressure and drive relapse/progression. It is immune editing.

This has implications for neoantigen vaccine design as many don't currently ensure the neoantigens are clonal, immunogenic, and actually presented. It can lead to broad but weak responses, targeting irrelevant subclones and leaving dominant escape clones untouched.

So for effective anti-tumour immunity it will depend on clonality, presentation, immunogenicity, T-cell fitness and the tumour environment. Failure at any step can result in resistance.

I looked through the supplemental data in the first paper* and it showed that the non-responders had larger tumours in less favourable locations, as well as other worse baseline characteristics. These factors are all independently associated with poorer immune infiltration, more immunosuppressive microenvironments, and worse survival outcomes.

So when the responders versus the non-responders differ at baseline you cannot cleanly conclude that the vaccine caused he difference. This is because patients were not randomised, groups were not balanced and their prognosis was not equal at the start. It is classic confounding.

* https://www.nature.com/articles/s41586-023-06063-y

BioNTech shares plunge over 19% after fourth-quarter earnings missMarch 10, 2026 8:58 AM
IH Market News
BioNTech SE (NASDAQ:BNTX) reported fourth-quarter results on Tuesday that fell short of earnings expectations despite revenue coming in above forecasts.Shares of the company dropped 19.68% in pre-market trading following the announcement.The German biotechnology company posted an adjusted loss of -$0.33 per share for the quarter, missing the analyst consensus estimate of -$0.19.Revenue totaled €907.4 million ($907.2 million), beating the analyst forecast of $758.8 million, but declined 24% year over year from €1,190.0 million recorded in the fourth quarter of 2024.The drop in revenue was mainly attributed to weaker COVID-19 vaccine sales as demand for the product continued to decline.For the full year 2025, BioNTech reported revenue of €2.9 billion, up 4% from €2.8 billion in 2024. However, the company posted an adjusted net loss of €117.1 million (-$0.48 per share), compared with an adjusted net profit of €121.7 million ($0.50 per share) in the prior year.“2025 was a year of strong execution and pipeline momentum, marked by substantial progress in delivering on our strategy,” said Prof. Ugur Sahin, Chief Executive Officer and Co-Founder of BioNTech.Looking ahead to 2026, the company expects total revenue between €2.0 billion and €2.3 billion. The midpoint of €2.15 billion reflects continued pressure from declining COVID-19 vaccine demand.BioNTech also forecasts adjusted research and development expenses of €2.2 billion to €2.5 billion and adjusted selling, general and administrative expenses between €700 million and €800 million.The company also announced that its co-founders, Ugur Sahin and Özlem Türeci, plan to establish a new independent company focused on next-generation mRNA technologies, with both expected to transition to the venture by the end of 2026.BioNTech said it maintains a strong financial position, with €17.2 billion in cash, cash equivalents and security investments as of December 31, 2025.BioNTech stock price

Original: BioNTech shares plunge over 19% after fourth-quarter earnings miss

BioNTech advances DualityBio ADC into phase 3 with half the patients of Merck-Daiichi rival https://www.fiercebiotech.com/biotech/biontech-advances-dualitybio-adc-phase-3-half-patients-merck-daiichi-rival

New data in TNBC https://www.nature.com/articles/s41586-025-10004-2

''As of February 2025, out of 14 patients, 10 remained relapse-free with a median follow-up of 5 years (median 62 months, range 15–80 months) after the last vaccine dose (Fig. 1b and Extended Data Fig. 6); in addition, patient P8 remained relapse-free until their death from unknown causes 15 months after the last vaccine dose. Patients P12, P13 and P14 experienced disease recurrence.''

''Findings in patients P12, P13 and P14 point to different possible mechanisms of treatment failure and escape to neoantigen vaccines. One such mechanism may be the lack of a proficient vaccine-induced immune response in the first place, as observed in patient P14, who stands out in this regard. Although this individual developed a complete response upon anti-PD-1 treatment, an outcome rarely observed in patients with TNBC, the patient subsequently died from a systemic relapse. P12 and P13 experienced tumour recurrence despite having mounted strong multi-neoantigen immune responses.

Patient P13 had very low MHC expression in the initial tumour and loss of MHC class I in the recurrence, most probably driven by downregulation of B2M. Complete loss of HLA class I presentation remains an effective escape mechanism, and has been observed in several types of potent T cell based therapies4,20,21,22,23, highlighting the need for combination therapies such as tumour-targeting antibodies to inhibit the outgrowth of HLA-deficient cancer cells or immunomodulatory approaches to restore neoantigen recognition in ß2M-deficient tumours24,25.

The third patient with relapse, P12, had BRCA-mutated TNBC, which is associated with independently evolving unrelated synchronous or metachronous primary tumours26,27,28. The bilateral breast tumours in patient P12, only one of which was used to inform vaccine design, were found to be clonally independent at the time of diagnosis. Sequencing of multiple lesions may be advisable in genetic predispositions with the risk of antigenically distinct primaries.

Limitations of the study include the small number of participants, particularly in the cohort in which deeper immunologic analyses were conducted, and the absence of control groups to further investigate possible immune escape.

The TNBC study extends our previous findings from other tumour types and shows that this personalized vaccine approach can be broadly used. In melanoma, we demonstrated a profound reduction in the cumulative rate of metastatic events, indicating the applicability of mRNA neoantigen vaccine to tumours with high mutation load4. In pancreatic cancer, a tumour with low number of mutations and highly immune suppressive environment, this vaccine induced immune responses in 50% of patients, which correlated positively with clinical outcome5. In TNBC, a cancer with low to moderate mutational load, we now demonstrate that all patients developed neoantigen-specific T cell responses with more than 85% being of high magnitude. TNBC has a poor prognosis, especially in patients who do not achieve pathological complete response after completion of neoadjuvant chemotherapy29,30,31. Strong immunogenicity of the neoantigen vaccine in the majority of patients, durability of the induced T cell responses, and early signs of clinical activity warrant further clinical testing in this patient population.''

''Barely two months after posting two pivotal trials for their anti-PD-L1 x VEGF bispecific antibody pumitamig in gastrointestinal cancers, BioNTech and Bristol Myers Squibb have now added two more phase 3 studies, this time in lung cancer. The new entries on clinicaltrials.gov underscore the pace at which the programme and this space are moving.'' https://www.oncologypipeline.com/apexonco/pumitamig-pivotal-trials-come-pairs

There is now evidence to show that responses to potentially immunogenic antigens may be weaker due to competitive inhibition when multiple antigens are included (i.e., immunodominance amongst the antigens) https://www.biorxiv.org/content/10.1101/2025.10.26.684631v1.full

However, the trade-offs between increasing the frequency of potentially immunogenic antigens (in the vaccine) and reducing competitive inhibition (by selecting less antigens) are unknown.

Leerink cuts BioNTech to “market perform” after shares surge 24%February 2, 2026 9:48 AM
IH Market News
BioNTech SE (F:22UAy) (NASDAQ:BNTX) has been downgraded to “market perform” from “outperform” by Leerink Partners after a strong share price rally brought the stock closer to its near-term fundamental value. Leerink set a price target of $113 in a note published Monday, a move that sent BioNTech shares down more than 2%.The downgrade follows a 24% rebound in BioNTech’s share price to around $113 from December lows near $92, significantly outperforming the roughly 4% gain recorded by the S&P Biotechnology Select Industry Index over the same period. Leerink said the rally has effectively closed the valuation gap based on its discounted cash flow analysis, limiting further upside at current levels.“We are downgrading BioNTech (BNTX) to Market Perform (MP) following a successful 24% rally,” the analysts said, noting that the shares are now trading close to their revised $113 price target.While maintaining a constructive long-term view on BioNTech’s oncology strategy, Leerink highlighted pumitamig — a VEGFA/PD-L1 bispecific antibody partnered with Bristol Myers Squibb — as a key asset. However, the firm said it does not expect clinical data capable of validating the value of those combinations before 2027 or later.In the shorter term, Leerink expects BioNTech’s shares to remain volatile and move largely in response to data releases from competitors in the VEGFA/PD-(L)1 space. The analysts characterized those upcoming readouts as likely to be “negative to neutral,” a backdrop they said supports a more cautious outlook over the next 12 to 18 months.The brokerage also flagged reduced upside from BioNTech’s cancer vaccine pipeline. Leerink noted that the company’s personalized cancer vaccine, autogene cevumeran, crossed a pre-specified futility boundary in a Phase 2 study in adjuvant colorectal cancer, lowering the chances of a positive surprise from that program.Although Leerink pointed to gotistobart, BioNTech’s next-generation CTLA-4 antagonist, as a potential area of promise, it said the asset alone is unlikely to drive sustained share price gains. Data from the Phase 3 PRESERVE-003 study are expected in mid-2026, but the analysts described the outlook as “too narrow for this one win to meaningfully sustain stock appreciation.”Leerink also highlighted BioNTech’s strong cash position, which stood at $20.3 billion (€17.2 billion), while noting that this balance is expected to decline as the company continues to invest aggressively in its oncology pipeline.“We prefer to move to the sidelines until more meaningful clinical readouts begin in 2027,” the analysts wrote.At the time of the report, BioNTech shares were trading at $113.75, close to their 52-week high of $124.98. The company does not pay a dividend and carries no net debt, according to Leerink.BioNTech stock price

Original: Leerink cuts BioNTech to “market perform” after shares surge 24%

Late-Stage Breakthroughs: How 2026's Top Clinical Platforms Are Redefining Cancer TreatmentJanuary 28, 2026 2:15 PM
PR Newswire (Canada)

Issued on behalf of Oncolytics Biotech Inc.VANCOUVER, BC., Jan. 28, 2026 /CNW/ -- USANewsGroup.com News Commentary – As the global oncology clinical trials market surges toward a projected $25.61 billion valuation by 2035[1], a structural rotation is favoring 'registration-ready' platforms that demonstrate exceptional efficacy and pivotal-trial alignment with 2026's evolving FDA regulatory frameworks[2]. Investors are increasingly prioritizing late-stage and newly commercial companies poised for rapid maturation as sector fundamentals strengthen. This structural shift creates a window for Oncolytics Biotech Inc. (NASDAQ: ONCY), BioNTech (NASDAQ: BNTX), MAIA Biotechnology (NYSE-A: MAIA), Acrivon Therapeutics (NASDAQ: ACRV), and ImmunityBio (NASDAQ: IBRX).







With 2026 set to be a banner year for M&A as buyers facing patent cliffs compete for a limited pool of late-stage assets[3], companies demonstrating disciplined pivotal execution and FDA alignment command asymmetric upside in an environment where executive infrastructure determines valuation floors.Oncolytics Biotech Inc. (NASDAQ: ONCY) is strengthening its operational and clinical leadership as it advances pelareorep toward multiple registration-directed programs in gastrointestinal cancers.The company recently announced the appointments of John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, bringing deep expertise in late-stage oncology trial execution and regulatory strategy. McAdory joins from CG Oncology, where he served as Vice President of Clinical Operations leading late-stage development programs for oncolytic virus therapies. Wu arrives from Morphic Therapeutic, where he headed Biostatistics through the company's acquisition by Eli Lilly, and previously led statistical strategy for multiple Phase 3 oncology programs at Takeda. Both executives bring direct experience navigating complex registration trials and global regulatory interactions."John's background running complex, late-stage oncology trials makes him exceptionally well-suited to lead Oncolytics' next phase of execution," said Jared Kelly, CEO of Oncolytics Biotech. "As we progress toward pivotal and registration-enabling studies in anal, pancreatic, and colorectal cancers, his experience will be critical to ensuring disciplined execution, speed, and regulatory alignment."These appointments complete a transformative executive team buildout following Kelly's promotion to CEO last year and the addition of Chief Business Officer Andrew Aromando. They were both crucial contributors to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson. Oncolytics also recently expanded its Scientific Advisory Board with globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, positioning the company for accelerated clinical development across multiple indications.The company recently announced breakthrough efficacy data showing pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients when combined with standard chemotherapy. This triples the historical 6-11% response rate for chemotherapy alone in this difficult-to-treat patient population.The company is also advancing pelareorep toward potential accelerated approval in anal cancer after reporting third-line data that achieved a 29% objective response rate, nearly tripling historical benchmarks in a setting with no FDA-approved treatment options. The median duration of response reached approximately 17 months.Second-line or later results were equally compelling, with pelareorep achieving a 30% response rate, more than doubling the 13.8% benchmark for the only FDA-approved immunotherapy in this setting. The median duration of response of 15.5 months compared to 9.5 months for standard care demonstrates pelareorep's ability to deliver durable clinical benefit in patients with limited treatment options.Oncolytics has also secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this disease. This regulatory milestone clears the path for initiating a pivotal study in one of oncology's most challenging therapeutic areas.CONTINUED… Read this and more news for Oncolytics Biotech at:  https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/ In other recent industry developments and happenings in the market include:BioNTech (NASDAQ: BNTX) received FDA Fast Track designation for BNT113, an investigational mRNA cancer immunotherapy, for the treatment of patients with human papillomavirus type 16 positive head and neck squamous cell carcinoma (HNSCC) expressing PD-L1. The designation was granted based on preliminary safety and efficacy data from the ongoing pivotal Phase 2/3 AHEAD-MERIT clinical trial evaluating BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as first-line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1, a cancer type with limited treatment options where patients experience median overall survival of 20.7 months under current standard of care.Head and neck squamous cell carcinoma is the seventh most common cancer type worldwide with increasing global incidence, with about one third of cases being HPV-positive and approximately 90% of oropharyngeal cancers driven by HPV16. BNT113 is designed to induce HPV16-specific anti-tumor immune responses by encoding the E6 and E7 proteins of HPV16 that are frequently found in HPV16+ solid tumors, with the FDA Fast Track designation enabling more frequent engagement with the FDA to support development and expedite regulatory review of this novel HPV-targeted chemotherapy-free treatment option.MAIA Biotechnology (NYSE-A: MAIA) advanced ateganosine into pivotal development with high probability of technical success based on exceptional efficacy data in third-line non-small cell lung cancer. The telomere-targeting agent secured FDA Fast Track designation and represents the first and only direct telomere-targeting anticancer therapy in clinical development, targeting an estimated $50+ billion global immunotherapy market."MAIA's strong clinical execution in 2025 delivered exceptional efficacy data for ateganosine sequenced with a checkpoint inhibitor, including disease control, response rates, and survival data well above standard of care benchmarks," said Vlad Vitoc, M.D., founder and CEO of MAIA. "The results clearly differentiate our novel telomere-targeting science and support the U.S. FDA's Fast Track designation granted in 2025, positioning ateganosine for potential eligibility under the Accelerated Approval and Priority Review regulatory pathways."The company advanced concurrent Phase 3 and Phase 2 expansion trials targeting potential early commercial approval within 18 to 24 months. MAIA Biotechnology received a $2.3 million NIH grant supporting U.S. patient enrollment and is advancing second-generation molecules into Phase 1 development with enhanced expected efficacy.Acrivon Therapeutics (NASDAQ: ACRV) announced positive data from its ACR-368 Phase 2b registrational-intent trial showing 39% overall response rate in endometrial cancer with 52% confirmed response rate in serous subtype patients with up to two prior lines of therapy. The company submitted EU Clinical Trial Application for Arm 3 enrollment across more than 20 European sites in four major countries, with enrollment completion expected in Q4 2026."We are pleased with tangible progress accelerating across multiple high-value opportunities," said Peter Blume-Jensen, M.D., Ph.D., CEO of Acrivon. "We are particularly excited by the observation from our ongoing ACR-368 Phase 2 trial that subjects with serous endometrial cancer with up to two prior lines of therapy are showing over 50% confirmed response rate. This provides an attractive opportunity for rapid Arm 3 enrollment without the need for a pretreatment biopsy, both in the US and more than 20 newly selected sites in major EU countries."Acrivon Therapeutics has submitted a Phase 3 confirmatory protocol to the FDA for ACR-368 combined with anti-PD-1 therapy in frontline endometrial cancer based on strong preclinical synergy data. The company also reported initial ACR-2316 Phase 1 data showing tumor shrinkage in endometrial cancer, SCLC and squamous NSCLC, with ACR-6840 nominated as its next CDK11 inhibitor development candidate.ImmunityBio (NASDAQ: IBRX) announced that it recently held a Type B End-of-Phase meeting with the U.S. FDA regarding the Company's supplemental Biologics License Application for ANKTIVA plus Bacillus Calmette-Guérin in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors. The Company presented more than five years of follow-up data demonstrating durable disease-specific survival of approximately 96% at 36 months with median survival not yet reached even with five years of follow-up, high rates of cystectomy avoidance of 92% and 82% at one and three years respectively, and a safety profile consistent with the currently approved indication in CIS disease with or without papillary tumors."We appreciate the FDA's collaboration throughout this process and remain fully committed to delivering this much-needed therapy to patients who currently have no approved alternatives when standard of care fails," said Richard Adcock, President and CEO of ImmunityBio. "We have completed the assembly and analysis of the requested additional information and will submit it within the next 30 days for the Agency's review."Based on discussions with the FDA, the Agency recommended that the Company provide certain additional information for its consideration to support a potential resubmission of the sBLA initially submitted in 2025 for the papillary indication, with this additional information not contemplating the initiation or design of a new clinical trial. ImmunityBio commercially launched ANKTIVA for NMIBC CIS with or without papillary tumors in the United States and has since expanded approvals to the United Kingdom and Saudi Arabia, with conditional approval in the European Union.Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ CONTACT:
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info @acblanke1DISCLAIMER: 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 paid advertisement 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. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech 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 publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech 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, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.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 the 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.SOURCES CITED:https://www.globenewswire.com/news-release/2026/01/20/3222140/0/en/Global-Oncology-Clinical-Trials-Market-Projected-to-Reach-US-25-61-Billion-by-2035-Supported-by-Advances-in-Precision-and-Targeted-Therapies-Says-Astute-Analytica.html https://lumanity.com/perspectives/the-8-fda-regulatory-trends-shaping-2026-and-beyond/ https://www.biospace.com/business/with-biotech-back-analysts-make-their-picks-for-2026Logo: https://mma.prnewswire.com/media/2838876/5656770/USA_News_Group_Logo.jpg



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Original: Late-Stage Breakthroughs: How 2026's Top Clinical Platforms Are Redefining Cancer Treatment

''Our results suggest that immunizing against MHCII neoantigens alone is sufficient to orchestrate a potent and cooperative immune response against cancer.'' https://www.biorxiv.org/content/10.1101/2025.06.09.657934v1.full

''These findings highlight the importance of optimizing vaccine schedules and tailoring therapeutic strategies to tumor stage.'' https://www.biorxiv.org/content/10.1101/2025.11.16.687774v1-0.full

An update https://www.oncologypipeline.com/apexonco/bad-omens-biontech-roches-neoantigen-project

Given the historical experience of cancer vaccines targeting shared antigens, this decision isn't surprising https://www.fiercebiotech.com/biotech/biontech-fades-out-further-work-fixvac-vaccine-prospect-advanced-melanoma-setting

The published data [1] (discussed in the webinar I linked) have important implications for (personalised neoantigen) vaccine design. Monitoring a patient's baseline TCR repertoire (before vaccination) could help stratify those most likely to benefit. When combined with findings from another group [2], the evidence suggests that focusing on specific, pre-existing TCR clones is critical. Attempting to ''boost'' irrelevant and/or low-frequency clones may actually ''dilute'' the immune effect, potentially reducing (vaccine) efficacy.

Together with additional data from other groups (some I linked to in another post), these findings highlight the importance of careful neoantigen selection. So trying to target clonal, immunodominant neoantigens that correspond to pre-existing, stable TCR clones would maximise the likelihood of a robust, durable immune response.

As for the rest, I didn't go through all the list, but the first trial you linked to says it was ''terminated'' due to a strategic evaluation within Genmab's portfolio. For another, BNTX acquired the assets of MabVax, including an anti-CA19-9 mAb (coded MVT-5873), which was subsequently taken forward as BNT321. While the trial of BNT321 was ''terminated,'' it is now back as BNT329 (an ADC) [3]. Finally, NEO-PTC-01 [4].

Refs:
1 https://www.sciencedirect.com/science/article/pii/S2666379120301853
2 https://www.nature.com/articles/s41586-023-05787-1
3 https://clinicaltrials.gov/study/NCT07186842
4 https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173111214

Take a look at those terminated trials by BNTX. There are five trials that the results were uploaded. The figures are about the data on mortality.

A Study to Evaluate Safety, Tolerability, and Preliminary Effect of the GEN1053 Antibody on Malignant Solid Tumors as Monotherapy
https://clinicaltrials.gov/study/NCT05435339

Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT141 in Patients With Unresectable or Metastatic CLDN18.2-positive Gastric, Pancreatic, Ovarian and Biliary Tract Tumors
https://clinicaltrials.gov/study/NCT04683939


BNT151 as a Monotherapy and in Combination With Other Anti-cancer Agents in Patients With Solid Tumors
https://clinicaltrials.gov/study/NCT04455620


PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy) (PRO-MERIT)
https://clinicaltrials.gov/study/NCT04382898


Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy Trial of BNT411
https://clinicaltrials.gov/study/NCT04101357


Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma
https://clinicaltrials.gov/study/NCT06069778

A Clinical Study of the Safety and Activity of the Investigational Cell Therapy NEO-PTC-01 in Patients With Advanced Melanoma
https://clinicaltrials.gov/study/NCT04625205

A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
https://clinicaltrials.gov/study/NCT03871348

A Personal Cancer Vaccine (NEO-PV-01) and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma
https://clinicaltrials.gov/study/NCT03597282

Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies
https://clinicaltrials.gov/study/NCT02672917

Just come across this

Predicting melanoma therapy response! BioNTech's Dr. Balogh & Dr. Poran discuss using TCR repertoire & PBMC phenotypes with neoantigen vaccine + anti-PD-1. Responders show more clonal & stable TCRs pre-treatment.

Watch: https://t.co/YQH7u2AP4S #Webinar #Immunotherapy #Melanoma— Samba Scientific (@sambasci) September 2, 2025

Why US federal health agencies are abandoning mRNA vaccines
https://www.technologyreview.com/2025/08/15/1121885/why-us-federal-health-agencies-are-abandoning-mrna-vaccines/ $BNTX

I will add that selecting neoantigens using in-silico methods is both promising and challenging.

Also, the reasons some cancers respond to certain immunotherapies may reflect both the quantity and the quality of their neoantigens. Data shows that you ideally want to target immunogenic clonal neoantigens in essential genes which bind to multiple HLA alleles and cannot be repressed or deleted by virtue of their genomic position.

The importance of clonal neoantigens is supported by evidence that both tumour mutational burden and fraction of clonal neoantigens correlate with the response to checkpoint inhibitor therapy [1,2]. Data on immunogenicity [3-7], expression [8], HLA binding [9,10], and likelihood of neoantigen loss [11,12].

On top of all this, any vaccine needs to be able to induce a rapid, robust and consistent large number of polyfunctional neoantigen-specific CD4+ and CD8+ T-cells.

Refs:
1 https://www.science.org/doi/10.1126/science.aaf1490
2 https://www.cell.com/cell/fulltext/S0092-8674(21)00002-7
3 https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30516-8/fulltext
4 https://aacrjournals.org/cancerres/article/79/13_Supplement/943/637589/Abstract-943-Filtering-out-self-like-neoantigens
5 https://aacrjournals.org/cancerres/article/81/13_Supplement/1762/667593/Abstract-1762-InhibigensTM-subvert-otherwise
6 https://aacrjournals.org/cancerres/article/80/16_Supplement/6680/644674/Abstract-6680-Inclusion-of-inhibitory-neoantigens
7 https://aacrjournals.org/cancerres/article/82/12_Supplement/2088/702633/Abstract-2088-ATLAS-identified-Inhibigen-specific
8 https://www.nature.com/articles/s41586-019-1032-7
9 https://www.science.org/doi/10.1126/science.aao4572
10 https://www.nejm.org/doi/10.1056/NEJMoa1609279
11 https://aacrjournals.org/cancerdiscovery/article/7/3/264/5907/Evolution-of-Neoantigen-Landscape-during-Immune
12 https://aacrjournals.org/cancerdiscovery/article/11/2/282/2772/Somatic-HLA-Class-I-Loss-Is-a-Widespread-Mechanism

Now this https://www.oncologypipeline.com/apexonco/more-problems-biontech-roches-neoantigen-shot

It’s happening !!

Dr Marty Makary says there is no good data for keeping the Covid shot on the Childhood schedule and expects an announcement to be made shortly. 🔥🔥

This will also remove liability protections for Big Pharma. pic.twitter.com/THEuBuYrSX— Kat A 🌸 (@SaiKate108) May 13, 2025 $BNTX

BNTX, 10Q due Monday 5/5

$BNTX Total Debt (mrq) $254.2M

IMCODE001 has failed https://www.oncologypipeline.com/apexonco/biontech-loses-skin-neoantigen-game

In pancreatic cancer, an mRNA neoantigen vaccine is able to induce a substantial number of long-lived CD8+ T-cells with preserved function whose presence correlates with better clinical outcomes https://www.nature.com/articles/s41586-024-08508-4

Autogene cevumeran with or without atezolizumab in advanced solid tumors: a phase 1 trial https://www.nature.com/articles/s41591-024-03334-7

A new paper. From it: ''BNT221 was well tolerated across both DLs, with no dose-limiting toxicities of grade 3 or higher attributed to the T cell product observed. Specifically, no cytokine release, immune effector cell-associated neurotoxicity or macrophage activation syndromes were reported. A dose of 5.0?×?108–1.0?×?1010 cells was identified for further study conduct. Six patients showed stable disease as best overall response, and tumor reductions (=20%) were reported for four of these patients.'' https://www.nature.com/articles/s41591-024-03418-4

This is what you’re up against largest sector


https://www.barchart.com/stocks/quotes/ADMA/competitors?quoteSectors=-MEBI&viewName=main&orderBy=weightedAlpha&orderDir=desc&page=5

We will know in the fullness of time

Ouch 1.2bn in settlements over covid19 vaccine royalties - will MRNA be affected too?

How it started: https://www.reuters.com/legal/litigation/biontech-sued-by-upenn-over-covid-19-vaccine-patent-royalties-2024-08-06/
https://www.fiercepharma.com/pharma/biontech-hit-notice-default-nih-tied-covid-19-vaccine-royalty-dispute

How it ended:
https://www.reuters.com/business/healthcare-pharmaceuticals/biontech-enters-settlement-with-us-agency-upenn-over-covid-vaccine-royalties-2024-12-27

Duality Biologics and BioNTech Presented Positive Interim Data for Investigational B7-H3 Antibody-Drug Conjugate BNT324/DB-1311 in Advanced Solid Tumors at the ESMO Asia Congress 2024

https://quantisnow.com/insight/duality-biologics-and-biontech-presented-positive-interim-data-for-investigational-b7h3-antibodydrug-conjugate-bnt324db1311-5802791

BNTX 10Q 11/4

BNTX under $200;

First-ever mRNA vaccine halts pancreatic cancer in its tracks

https://www.thebrighterside.news/post/first-ever-mrna-vaccine-halts-pancreatic-cancer-in-its-tracks/

BNTX new 52;week high

BNTX +11% on no company-specific news I’m aware of. The 11% gain in the BNTX’s share price and market cap equates to a roughly 40%(!) increase in BNTX’s enterprise value because the BNTX has a whopping $17B in net cash.

p.s. The impetus for today’s bounce is definitely not related to COVID.

BNTX reports 2Q24 results—opts_out_of acasunlimab phase-3 development:

https://www.globenewswire.com/news-release/2024/08/05/2924129/0/en/BioNTech-Announces-Second-Quarter-2024-Financial-Results-and-Corporate-Update.html

https://www.globenewswire.com/news-release/2024/08/05/2924128/0/en/Genmab-Takes-Full-Control-of-Acasunlimab-Development-Program.html

BNTX 10Q due AUGUST5

BNTX under $100

FDA places partial hold on ADC trial after multiple deaths https://www.biospace.com/article/fda-slaps-biontech-medilink-adc-with-partial-clinical-hold-due-to-significant-risk-of-illness-/

Medigene & BioNTech Extend T Cell Receptor Immunotherapy Collaboration https://www.contractpharma.com/contents/view_breaking-news/2024-05-21/medigene-biontech-extend-t-cell-receptor-immunotherapy-collaboration/

MRNA wins patent dispute over PFE and BNTX https://www.fiercepharma.com/pharma/eu-patent-office-backing-key-patent-moderna-wins-one-battle-covid-patent-war-against-pfizer

For_some_reason, COVID-related stocks_are_up_today:

MRNA +11%
BNTX +9%
NVAX +8%
AVIR +5%
PFE +3%

BNTX ASCO lineup:

https://www.globenewswire.com/news-release/2024/05/21/2885408/0/en/BioNTech-to-Present-Clinical-Data-Updates-for-Next-Generation-Immunotherapy-Candidates-at-the-ASCO-Annual-Meeting-2024.html

BNTX reports 1Q24 results—reiterates 2024 sales guidance:

https://finance.yahoo.com/news/biontech-announces-first-quarter-2024-104500069.html

2024 sales guidance remains $2.7-3.7B (€2.5-3.5B). Echoing partner PFE, BNTX says ~90% of 2024 COVID-vaccine revenue will come in 4Q24.

Cash at 3/31/24 was $18.2B, down $1.0B relative to 12/31/23.