Company finalizing preparations for end of January 2026 U.S. FDA Biologics License Application (BLA) submission for OST-HER2 program in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma (Metastatic Osteosarcoma Program) under Accelerated Approval ProgramBiomarker data from Phase 2b Metastatic Osteosarcoma Program human clinical trial expected to be released during week of J.P. Morgan Healthcare Conference 2026UK and EU Marketing Authorisation Application (MAA) submissi ...

Core Insights - Anixa Biosciences has completed the transfer of the Investigational New Drug application for its breast cancer vaccine from Cleveland Clinic, becoming the trial sponsor for its future development [1][2] - The company plans to advance the vaccine into a Phase 2 clinical trial after completing enrollment and observing encouraging immune response and safety data in the Phase 1 trial [2][4] - The breast cancer vaccine targets -lactalbumin, a protein that re-emerges in many forms of breast cancer, potentially offering therapeutic and preventive benefits [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 [5] - The company’s vaccine portfolio includes vaccines for breast and ovarian cancer, developed in collaboration with Cleveland Clinic, and aims to address various cancers by immunizing against "retired" proteins expressed in certain cancer forms [5] - Anixa's business model involves partnering with renowned research institutions to explore emerging technologies for further development and commercialization [5]

TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA has initiated a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma. In addition to its innate immune agonist product candidates, TuHURA acquired TBS-2025 in its merger with Kineta Inc. on Jun ...

®Combination of Keytruda and the vaccine generated T cell responses and showed no major additional side effects, supporting plans for a Phase 2 neoadjuvant combination study in newly diagnosed breast cancer patients Vaccine Was Safe and Well Tolerated at the Maximum Tolerated Dose Results Support Advancement of the Program into Phase 2 Development In Cohort Ic, a key objective was to assess whether administration of the investigational vaccine in combination with pembrolizumab could create intolerable side ...

OS Therapies Announces Successful pre-Marketing Authorisation Application Meeting with UK MHRA Regarding the Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic OsteosarcomaDecember 09, 2025 7:40 AM EST | Source: OS TherapiesAlignment achieved on all key points surrounding non-clinical, CMC and post-market authorization confirmatory study designBiomarker data advanced as key pre-specified surrogate clinical efficacy endpoint, with p ...

OS Therapies Announces FDA PDUFA Waiver & EMA Grants Union Marketing Authorisation EligibilityDecember 05, 2025 8:01 AM EST | Source: OS TherapiesU.S. FDA grants waiver of application fee for BLA Filing of OST-HER2Scheduled pre-Marketing Authorisation Application meeting with United Kingdom's Medicines and Healthcare products Regulatory Agency on December 8, 2025Scheduled Type C Meeting with United States Food & Drug Administration on December 11, 2025New York, New York--(Newsfile Corp. - Dece ...

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 ...

Core Viewpoint - Anaptysbio and GSK are engaged in a legal dispute over alleged breaches of contract related to the marketing of the cancer immunotherapy Jemperli, with both companies filing lawsuits against each other [1][2]. Group 1: Legal Dispute - Anaptysbio claims GSK violated their decade-old agreement by testing its experimental cancer drugs alongside competitors of Jemperli, such as Merck's Keytruda [2]. - GSK initiated the lawsuit first, asserting that Anaptysbio's actions constituted a material breach of the license agreement, seeking to terminate the agreement and reduce royalties owed to Anaptysbio [4]. - Anaptysbio's countersuit alleges that GSK's testing of other PD-1 drugs before Jemperli breached the terms of their license [4]. Group 2: Background of the Agreement - The lawsuits stem from a 2014 deal between Anaptysbio and Tesaro, which licensed Jemperli, a PD-1 inhibitor similar to Keytruda and Opdivo [3]. - GSK acquired Tesaro in 2019 for $5.1 billion, primarily for the ovarian cancer drug Zejula, but also recognized the potential of Jemperli [3]. Group 3: Financial Implications - Jemperli generated sales of approximately $785 million through the first nine months of 2025, with projections to reach $1 billion by year-end [6]. - Anaptysbio stands to receive a $75 million milestone payment and royalties of 8% on sales up to $1 billion, increasing to 12% on sales between $1 billion and $1.5 billion [6].

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]