OS Therapies Receives Non-Proprietary Name 'daznelimgene lisbac' for OST-HER2 from World Health OrganizationNovember 25, 2025 9:21 AM EST | Source: OS TherapiesNew York, New York--(Newsfile Corp. - November 25, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) approved 'daznelimgene ...

This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Anaptysbio and its partner GSK are suing each other, claiming breach of contract over the big drugmaker’s license to market the likely blockbuster cancer immunotherapy Jemperli. A California-based developer of immune-modulating antibody drugs, Anaptysbio claimed in a Delaware court that GSK violated the terms of its decade-old deal by testing some of its experi ...

Core Viewpoint - OS Therapies reported its third quarter 2025 financial results and highlighted significant upcoming regulatory milestones for its lead product, OST-HER2, which is aimed at treating osteosarcoma and other HER2-related cancers [3][4]. Financial Results - The company recorded a net operating loss of $6.879 million in Q3 2025, compared to a net operating loss of $2.875 million in Q3 2024, primarily due to pre-commercial activities related to the OST-HER2 program [6]. - Net loss per share was $0.21 on 31.956 million outstanding shares in Q3 2025, compared to a net loss of $0.18 per share on 15.897 million shares in Q3 2024 [6]. Regulatory Updates - A Type C meeting with the US FDA is scheduled for December 11, 2025, to discuss key items following the End of Phase 2 meeting regarding the OST-HER2 clinical trial [5][8]. - The company expects to file a Biologics Licensing Application (BLA) for OST-HER2 in January 2026, leveraging feedback from upcoming regulatory meetings [4][5]. - The UK MHRA pre-Marketing Authorization Application (MAA) meeting is set for December 8, 2025, in preparation for the January 2026 MAA filing [5][8]. Clinical Development - OST-HER2 has shown promising results in its Phase 2b trial, with a reported 2-year overall survival rate of 75% compared to a historical control of 40% (p < 0.0001) [8]. - The company anticipates that accelerated approval for OST-HER2 could catalyze further clinical development in osteosarcoma and other HER2-related cancers [4][6]. - The company is also advancing its next-generation Antibody Drug Conjugate (ADC) platform, which features tunable antibody-linker-payload candidates [10]. Future Outlook - The company expects to receive a Priority Review Voucher (PRV) if OST-HER2 is approved by September 30, 2026, which could be sold for additional revenue [5][9]. - Increased compassionate use requests have been noted, primarily from clinical sites involved in the Phase 2b trial, indicating growing interest and potential market demand for OST-HER2 [4].

Core Insights - Adagene Inc. and Third Arc Bio, Inc. have entered into a licensing agreement for the use of Adagene's SAFEbody technology platform to develop masked CD3 T cell engagers targeting unique tumor-associated antigens [1][2] - Adagene will receive an upfront payment of $5 million and potential milestone payments totaling up to $840 million, along with royalties on end-user sales [1] - Adagene retains a no-cost option to develop and commercialize the candidate molecules in Greater China, Singapore, and South Korea [1] Company Overview: Adagene - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies using computational biology and artificial intelligence [3] - The company has established strategic collaborations leveraging its SAFEbody precision masking technology [3][4] - Adagene's lead clinical program, ADG126 (muzastotug), is currently in Phase 1b/2 and Phase 2 studies, targeting CTLA-4 in regulatory T cells within the tumor microenvironment [5] Technology Insights - The SAFEbody technology is designed to enhance safety and tolerability of antibody therapeutics by activating antibodies specifically in the tumor microenvironment, minimizing off-target toxicity [4] - Adagene's Dynamic Precision Library (DPL) platform includes NEObody™, SAFEbody, and POWERbody™ technologies, contributing to a differentiated pipeline of immunotherapy programs [4] Company Overview: Third Arc Bio - Third Arc Bio is a clinical-stage biotech company developing multifunctional antibodies aimed at precisely activating or inhibiting T cells [7] - The lead program, ARC101, is a bispecific T cell engager currently in Phase 1 trials for solid tumors expressing CLDN6 [8] - Third Arc Bio's platforms include the ARCStim Platform for solid tumors and the ARCTag Platform for precision immune regulation [7]

Core Insights - Anixa Biosciences has received a patent for its breast cancer vaccine technology, which targets the -lactalbumin protein, a promising approach for immunoprevention strategies against breast cancer [1][2][3] Company Overview - Anixa Biosciences is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a strong emphasis on developing next-generation preventive immunotherapies [2][5] - The company has a collaboration with Cleveland Clinic for the development of its breast cancer vaccine, which is part of a broader portfolio that includes ovarian cancer immunotherapy [5] Patent and Intellectual Property - The U.S. Patent Number 12,472,205 will be issued on November 18, 2025, extending the intellectual property protection for Anixa's breast cancer vaccine technology into the mid-2040s [1][2] - This patent reinforces the company's commitment to addressing breast cancer, which is projected to affect nearly 300,000 women in the U.S. by 2026 [1][3] Market Need - Breast cancer remains the most commonly diagnosed cancer among women globally, with over 297,000 new cases expected in the U.S. in 2025 and approximately 43,000 deaths anticipated [3] - There is currently no FDA-approved vaccine for breast cancer prevention, highlighting a significant unmet need in preventive oncology [3] Vaccine Mechanism - Anixa's investigational vaccine aims to stimulate the immune system to recognize and eliminate cells expressing -lactalbumin while sparing normal tissue, potentially minimizing off-target effects [4]

Accessibility StatementSkip Navigation SAN JOSE, Calif., Nov. 10, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that its Chairman and CEO, Dr. Amit Kumar, will participate in the upcoming Water Tower Research Fireside Chat Series taking place on Tuesday, November 11, 2025, at 11:00am PT. The Fireside Chat wil be hosted by Robert Sassoon, Managing Director – Healthcare at Wat ...

Core Insights - IO Biotech announced new pre-clinical data for its cancer vaccine candidates IO112 and IO170 at the Society for Immunotherapy of Cancer's 40th Annual Meeting [1][6] - The company plans to file an Investigational New Drug Application for IO112 in 2026, indicating a commitment to advancing its cancer immunotherapy pipeline [2] Group 1: Vaccine Candidates - IO112, targeting arginase 1 (Arg1), shows robust expansion of Arg1-specific T cells that inhibit tumor growth by reprogramming immune suppressive myeloid cells [3][5] - IO170, targeting Transforming Growth Factor (TGF)-β, activates TGF-β-specific T cells to promote anti-tumor activities, demonstrating significant tumor growth inhibition and reduced lung metastasis [4][5] Group 2: Research and Development - The data presented highlight the unique approach of IO Biotech's T-win® platform, which targets both tumor cells and immune-suppressive cells in the tumor microenvironment [5][8] - The company is advancing its lead cancer vaccine candidate, Cylembio®, in clinical trials while developing additional candidates through preclinical stages [8]

Core Insights - AlphaTON Capital Corp and its subsidiary Cyncado Therapeutics presented preclinical findings at the Society for Immunotherapy of Cancer Annual Meeting, highlighting the potential of combining selective adenosine A2B and A2A antagonists with cancer vaccines to enhance immune response against tumors [1][2][3] Company Overview - AlphaTON Capital is focused on building a strategic reserve of TON tokens and developing the Telegram ecosystem, providing institutional-grade exposure to the TON ecosystem while maintaining governance standards of a Nasdaq-listed company [7][8] - Cyncado Therapeutics is developing small molecule adenosine receptor antagonists targeting A2B and A2A receptors to overcome immune suppression in oncology, with a lead program TT-4 aimed at mesothelioma [10] Clinical Development - The clinical program for TT-4 (A2B receptor antagonist) is preparing for first-patient dosing in Q1 2026, while TT-10 (A2A receptor antagonist) is currently in Phase 1 dose escalation for advanced solid tumors [6] - Preclinical studies demonstrated that the combination of TT-4 and TT-10 with therapeutic vaccines resulted in significant tumor growth suppression and improved survival in mouse models [2][3] Research Collaboration - The collaboration with the National Cancer Institute reflects a multi-year effort to explore the synergistic effects of adenosine receptor antagonists and cancer vaccines, aiming to translate these findings into human applications [3][4]

Core Insights - Exelixis, Inc. (EXEL) reported better-than-expected results for Q3 2025, with adjusted earnings of 78 cents per share, surpassing the Zacks Consensus Estimate of 68 cents and up from 47 cents in the same quarter last year [1][8] - Net revenues reached $598 million, exceeding the Zacks Consensus Estimate of $589 million and reflecting a year-over-year increase of 10.8% [2][8] - The company's stock has increased by 13.9% year-to-date, outperforming the industry gain of 10.9% [4] Financial Performance - The year-over-year revenue growth was driven by higher product sales, with net product revenues of $542.9 million, up 13.5% year over year [5][8] - Cabometyx (cabozantinib) generated revenues of $540 million, slightly above the Zacks Consensus Estimate of $539 million [6][8] - Collaboration revenues totaled $54.8 million, down 10.8% from $61.5 million in the previous year, primarily due to lower milestone-related revenues [10] Expense Management - Research and development expenses amounted to $199.2 million, down 10.5% year over year, attributed to decreased clinical trial costs [11] - Selling, general, and administrative expenses increased to $123.7 million, up 10.6% year over year, mainly due to higher stock-based compensation [11] Stock Repurchase Program - Exelixis has repurchased $895.3 million of its common stock as of September 30, 2025, under its stock repurchase programs [12][13] - The board authorized an additional $750 million for repurchase before December 31, 2026 [13] Updated Guidance - The company narrowed its 2025 revenue outlook to $2.30-$2.35 billion, with net product revenues estimated between $2.10-$2.15 billion [14] - Research and development expenses are now expected to be in the range of $850-$900 million, while selling, general, and administrative expenses are anticipated to be $500-$525 million [15] Pipeline Developments - Exelixis is developing zanzalintinib, a next-generation oral investigational tyrosine kinase inhibitor, with positive results from the STELLAR-303 study [16][17] - The company plans to submit a new drug application for zanzalintinib in combination with atezolizumab for metastatic colorectal cancer by the end of 2025 [19] - Exelixis has initiated several ongoing phase I studies for its pipeline programs, including XB371, a next-generation tissue factor-targeting antibody-drug conjugate [22] Market Position - Overall performance in the quarter was encouraging, with a beat in both earnings and sales, and initial demand for Cabometyx in the newly approved indication is promising [23]

Core Insights - Anixa Biosciences has executed a data transfer agreement with Cleveland Clinic, marking a significant step in transferring the breast cancer vaccine clinical trial data and sponsorship to Anixa for future clinical development [1][2][4] Group 1: Clinical Development - Enrollment for the Phase 1 trial has been completed, showing encouraging immune response data, leading Anixa to advance the vaccine into a Phase 2 clinical trial [2] - The IND, currently sponsored by Cleveland Clinic, is in the process of being transferred to Anixa, allowing the company to assume full sponsorship [2][4] Group 2: Vaccine Technology - The breast cancer vaccine targets -lactalbumin, a protein typically expressed in breast tissue during lactation, which re-emerges in various forms of breast cancer [3] - By establishing an immune response against -lactalbumin-expressing cells, the vaccine may provide both therapeutic and preventive benefits for patients with tumors expressing this protein [3] Group 3: Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a portfolio that includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center [4] - The company’s vaccine portfolio includes vaccines for breast and ovarian cancer, as well as additional vaccines targeting other cancers, developed in collaboration with Cleveland Clinic [4]