ErnieBilco
2月前
Curanex Pharmaceuticals, Inc. (Nasdaq: CURX) ("Curanex" or the "Company"), a pharmaceutical development company focused on advancing therapeutic assets for serious diseases with significant unmet medical need, today highlighted five additional patient cases that management believes further support the potential of its lead candidate in cancer cachexia, advanced cancer supportive care and other serious disease settings characterized by profound physical decline, inflammation, metabolic dysfunction and loss of functional capacity.
The five newly highlighted cases follow the Company's previously disclosed case involving "Johnny," a senior dosimetrist at a premier cancer hospital in the Northeast, whose personal experience management believes provided an initial clinically relevant signal supporting the Company's strategic interest in cancer cachexia and supportive oncology. Taken together, management believes the growing body of patient accounts may suggest broader potential relevance of the Company's lead candidate in helping patients maintain or recover appetite, strength, physical condition, mobility, and quality of life in the setting of serious disease.
The newly highlighted cases include:
Advanced Thymic Carcinoma — 52-Year-Old Male Patient
This 52-year-old male patient was receiving care at Memorial Sloan Kettering Cancer Center (MSKCC) for advanced thymic carcinoma with pulmonary embolism, pulmonary hemorrhage, and bilateral lung and pleural metastases. The pleural tumor measured 9.9 × 3.3 cm and was visibly vascularized. His wife recounted that doctors had told them the pain in his left abdomen was so severe it could cause him to faint at any moment — and that if it happened outside the home, he might not make it back. His estimated survival was approximately one month. According to the patient's account, after taking the Company's product for approximately 20 days, all pain disappeared, night sweats resolved, hemoptysis stopped, analgesic injections were no longer needed, and his appetite and sleep improved. Visible reduction of the pleural tumor was also reported. According to the patient's account, his projected survival extended from weeks to more than one year with meaningful improvement in quality of life.
Advanced Small Cell Lung Cancer (SCLC) — 55-Year-Old Female Patient
This 55-year-old female patient was initially evaluated in Flushing, New York, and subsequently referred to Memorial Sloan Kettering Cancer Center (MSKCC) for treatment of metastatic small cell lung cancer. She had visible tumors in her neck, chest, and abdomen, with the largest neck tumor measuring approximately 1 × 1 cm. Her oncologist had told her family to prepare for her passing, saying she had only weeks to live. She had exhausted chemotherapy, radiotherapy, immunotherapy, and investigational therapies. Before taking the Company's product, she was profoundly cachectic, severely weak, and barely able to eat. According to the patient's account, within approximately one month, she gained about 17 pounds (~7.7 kg), her voice returned from weak to strong, and she resumed normal eating and physical activity. After approximately two months, she was walking briskly and jogging lightly, and the previously visible neck tumor was no longer detectable. According to the patient's account, her projected survival extended from weeks to more than three years.
Pancreatic Cancer with Post-Surgical Multi-Organ Complications — 80-Year-Old Male Patient
This 80-year-old male patient developed multi-organ failure following pancreatic cancer resection and was hospitalized for an extended period at NewYork-Presbyterian Hospital in Lower Manhattan. The hospital had notified his family of his critical condition, with expected survival of only days or hours. He was unable to eat, had severe edema in his feet and legs, was severely hypotensive, bedridden, and required nasogastric tube feeding. According to the patient's account, the morning after taking the Company's product, he was able to eat small amounts that same evening; within a week, he could eat normally, and his blood pressure and liver and kidney function had returned to normal. Within two weeks, he had regained sufficient strength to be discharged home. After returning home, he went outside daily in a wheelchair for exercise and fresh air, and his mental state continued to improve. According to the patient's account, his projected survival extended from hours to more than one year with substantial improvement in condition and quality of life.
End-Stage Liver Cirrhosis with Massive Ascites and Hepatorenal Syndrome — 82-Year-Old Male Patient, Chris
Chris, an 82-year-old male patient who had been under the long-term care of physicians at MSKCC, developed end-stage liver cirrhosis with massive ascites, causing his abdomen to swell to the size of a full-term pregnancy. He was extremely weak, unable to get out of bed independently, unable to walk, barely able to eat, and had been unable to urinate spontaneously for over a year, relying on daily drainage of ascitic fluid. After being told no further treatment options were available, he entered hospice care with an estimated life expectancy of one to two months. According to the patient's account, on the fourth day after taking the Company's product, he urinated in large quantities, and his appetite returned. By day eleven, the drainage tube had stopped producing fluid. After one month, he was using a walker and riding a stationary bicycle to exercise his legs, and was eating regularly. After two months, he was walking freely and cooking in the kitchen — and the abdomen had completely returned to normal. After three months, he had the energy to walk normally. According to the patient's account, he subsequently survived for more than one year with improved mobility and quality of life.
End-Stage Renal Disease (ESRD) with Pleural Effusion, Hydronephrosis and Neuropathic Pain — 76-Year-Old Male Patient
This 76-year-old male patient with end-stage renal disease had been receiving thrice-weekly hemodialysis at North Flushing Dialysis Center. He was physically weak and could only walk slowly with a cane, suffering from severe bilateral leg pain, severe pleural effusion, hydronephrosis, and complete loss of spontaneous urination. According to the patient's account, spontaneous urination returned within approximately one week of taking the Company's product. Follow-up imaging subsequently confirmed complete resolution of both pleural effusion and hydronephrosis, bilateral leg pain fully resolved, and his physical strength recovered significantly. His mental state and overall condition continued to improve, and he was able to walk more than 10,000 steps per day independently, without any assistive device. Management believes this case is noteworthy because it reflects severe systemic decline involving inflammation, metabolic disruption, fluid accumulation, and loss of physical function — features that overlap substantially with broader wasting syndromes.
Management noted that across these five cases, spanning very different disease backgrounds, a consistent set of themes emerged: severe weakness, loss of appetite, impaired mobility, profound physical deterioration, metabolic instability, and loss of independent function. In several cases, according to patient accounts, improvements in overall physical condition helped patients regain the ability to eat, walk, sleep, and live more normally. Management believes these observations are particularly relevant in the context of cancer cachexia and supportive oncology, where maintaining physical condition and functional status can be highly meaningful for both quality of life and the ability to continue receiving care.
"What stands out to us is not simply the severity of these cases, but that across very different disease settings, we are repeatedly hearing from patients about the return of appetite, the rebuilding of strength, the ability to walk again, and the return to ordinary daily life," said Jun Liu, Chief Executive Officer of Curanex. "We believe this growing body of patient experience may support the possibility that our lead candidate has broader relevance in one of the most difficult areas of medicine: helping seriously ill patients maintain or rebuild the physical resilience they need to endure disease. If future research supports these observations, we believe the implications for cancer cachexia, supportive oncology, and other serious diseases involving systemic decline could be medically important and commercially significant."
As previously announced, Curanex has expanded its strategic development focus to include cancer cachexia, which management believes represents one of the largest unmet needs in supportive oncology. The Company believes this market opportunity is supported by the seriousness of the condition, the absence of approved therapies in the United States specifically for cancer cachexia, and the potential value of any candidate capable of helping patients maintain body weight, appetite, strength, mobility, or the ability to continue receiving care. The Company also believes these patient observations are consistent with its broader strategic interest in diseases involving inflammation, metabolic disruption, and physical decline.
Curanex cautions that the above reports reflect only individual patient accounts, are observational in nature, and do not establish safety or efficacy or predict similar outcomes in other patients. The Company believes, however, that the consistency of certain observations across multiple severe cases may help inform future development priorities in cancer cachexia, advanced cancer supportive care, and other serious disease settings.
ErnieBilco
5月前
Equity-Insider.com News Commentary – Biopharma M&A is entering a fever pitch, with precision oncology investments alone exploding to $138 billion as major players scramble to secure proven cancer therapies before their most profitable drugs lose protection[1]. This looming $170 billion "patent cliff" has triggered a massive capital rotation into de-risked platforms that can reach patients and the market within the next 18 to 24 months[2]. This urgent race for registration-ready assets is driving the 2026 investment case for Oncolytics Biotech Inc. (NASDAQ: ONCY), OS Therapies Inc. (NYSE-A: OSTX), SELLAS Life Sciences Group, Inc. (NASDAQ: SLS), Celcuity Inc. (NASDAQ: CELC), and RenovoRx, Inc. (NASDAQ: RNXT).
The stakes are high, as the global precision oncology market is now on a trajectory to hit $225.65 billion by 2032[3]. With the FDA’s accelerated approval pathways delivering real-world survival gains in 65% of cases, investors are increasingly focusing on companies positioned at the edge of pivotal Phase 3 trials and registration milestones[4]. For retail investors, this represents a high-velocity opportunity to own the companies building the next generation of life-saving medical infrastructure.
Clinical-stage biotech company Oncolytics Biotech Inc. (NASDAQ: ONCY) is fortifying its intellectual property position while advancing pelareorep, an investigational immunotherapy designed to activate the immune system against cancer.
In early Q3 2025, Oncolytics filed a Track 1 prioritized examination patent application with the United States Patent and Trademark Office focused on manufacturing-related innovations for pelareorep. If granted, this patent could extend protection to 2044, significantly lengthening pelareorep's commercial runway. The company received initial written feedback from the USPTO in Q4 2025 and expects a final action on this manufacturing patent application in Q3 2026.
Oncolytics plans to file additional patent applications covering novel therapeutic uses of pelareorep, which could provide IP protection beyond 2044. "Extending our intellectual property runway is a core pillar of our strategy," said Jared Kelly, Chief Executive Officer of Oncolytics. "As pelareorep continues to demonstrate meaningful clinical activity across gastrointestinal cancers, it is critical that we protect the innovation behind both how the therapy is manufactured and how it is used."
This strategic IP expansion comes as pelareorep delivers compelling clinical results across multiple gastrointestinal cancers. The company recently announced 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 population, addressing a colorectal cancer market projected to reach $20 billion by 2033.
Equally compelling anal cancer results showed a 30% response rate in second-line squamous cell anal carcinoma, more than doubling the 13.8% benchmark for the only FDA-approved immunotherapy in this setting. The median duration of response reached 15.5 months compared to 9.5 months for standard care, with two durable complete responses.
This clinical momentum has attracted elite academic validation. Oncolytics expanded its Gastrointestinal Tumor Scientific Advisory Board with three globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center. The company 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.
CEO Jared Kelly and Chief Business Officer Andrew Aromando were both crucial contributors to their previous employer, Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson.
CONTINUED… Read this and more news for Oncolytics Biotech at: https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
In other recent industry developments and happenings in the market include:
OS Therapies Inc. (NYSE-A: OSTX) outlined its outlook for first half 2026, with preparations underway for a Biologics License Application submission to the FDA by end of January 2026 for OST-HER2 in metastatic osteosarcoma under the Accelerated Approval Program, followed by Marketing Authorisation submissions to the U.K. MHRA and Europe's EMA by end of February and March 2026 respectively. The company expects to release biomarker data from its Phase 2b trial during the J.P. Morgan Healthcare Conference week and anticipates potential approvals in the U.K. in Q2 2026, U.S. in Q3 2026, and Europe in Q4 2026.
"OS Therapies is potentially at the cusp of improving the standard of care for patients with metastatic osteosarcoma," said Chairman and CEO Paul Romness. "2025 was a transformational year in which we announced promising OST-HER2 clinical trial results and had significant interactions with regulatory agencies in the U.S., U.K. and Europe regarding the path toward conditional marketing authorizations in 2026."
OST-HER2 has received Orphan Disease, Fast Track, and Rare Pediatric Disease designations, with the company eligible for a Priority Review Voucher valued at up to $160 million if approved before September 30, 2026. OS Therapies expects to file for a go-public transaction for its OS Animal Health subsidiary in early January 2026.
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) provided an update on its pivotal Phase 3 REGAL trial evaluating galinpepimut-S in acute myeloid leukemia patients after second complete remission, announcing that 72 of the 80 events required to trigger final analysis had occurred as of December 26, 2025, with the company remaining fully blinded to all survival outcomes. The extended timeline beyond initial year-end expectations may reflect longer-than-anticipated patient survival times in this overall survival study.
"We appreciate the continued dedication of the patients, families, and investigators participating in the pivotal Phase 3 REGAL trial where survival times, fortunately for patients and caregivers, appear longer than expected," said Angelos Stergiou, MD, ScD h.c., CEO of SELLAS. "While the 80th event has not yet occurred, and we remain fully blinded, every passing month may increase the probability of a successful study."
SELLAS will announce the 80th event when it occurs, triggering the final analysis of this registration trial in a patient population with median overall survival of approximately eight months under the current standard of care, consisting of hypomethylating agents and BCL-2 inhibitors. GPS targets the WT1 protein and has received Orphan Disease and Fast Track designations from the FDA.
Celcuity Inc. (NASDAQ: CELC) recently presented updated results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial back in December at the 2025 San Antonio Breast Cancer Symposium, demonstrating compelling efficacy for gedatolisib combinations in hormone receptor positive, HER2-negative advanced breast cancer. For patients with time to progression on prior therapy exceeding 18 months, median PFS reached 12.4 months with gedatolisib triplet and 10.0 months with gedatolisib doublet versus 1.9 months for fulvestrant alone.
"The updated results provide further evidence of the potential for gedatolisib combined with fulvestrant with or without palbociclib to offer paradigm shifting results for patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer," said Igor Gorbatchevsky, Chief Medical Officer of Celcuity. "We are very excited that patients reported nearly two years of delay in definitive deterioration of their well-being."
For patients enrolled in the U.S., Canada, Western Europe and Asia Pacific, median PFS was 16.6 months with gedatolisib triplet versus 1.9 months for fulvestrant. The gedatolisib regimens demonstrated favorable safety profiles with effective stomatitis management, showing median resolution time of 12-14 days for Grade 2-3 events.
RenovoRx, Inc. (NASDAQ: RNXT) announced acceptance of a clinical data abstract at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium 2026, presenting pharmacokinetic and pharmacodynamic findings from its ongoing Phase III TIGeR-PaC trial comparing systemic drug levels of intra-arterial gemcitabine delivered via the RenovoCath device versus standard intravenous chemotherapy in locally advanced pancreatic cancer. The sub-study demonstrates decreased systemic drug levels with targeted delivery, providing scientific evidence for the reduced side effect profile observed with the TAMP therapy platform.
"This clinical data abstract further contributes to scientific basis for reported decreased clinical side effect profile with our approach to targeted drug-delivery via the TAMP therapy platform and IAG versus the standard of care, systemic intravenous therapy, which is demonstrated by decreased systemic drug levels compared to treatment delivered by systemic therapy," said Dr. Ramtin Agah, RenovoRx's Chief Medical Officer.
The presentation is scheduled for January 9, 2026 in San Francisco, with RenovoRx also commercializing its FDA-cleared RenovoCath device, having generated approximately $900,000 in revenues during the first nine months of 2025. The company received its first commercial purchase orders in December 2024, with several customers initiating repeat orders as RenovoRx expands to additional medical institutions, including high-volume National Cancer Institute-designated centers.
Source: https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
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