Purple Biotech Advances NT219 into Phase 2 Head and Neck Cancer Trial, Feb. 18, 2025
Purple Biotech has announced the advancement of its first-in-class drug NT219 into a Phase 2 clinical trial for patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). NT219 targets key resistance mechanisms by degrading IRS1/2 and blocking IGF1R/STAT3 pathways, aiming to overcome tumor resistance to standard therapies like pembrolizumab (Keytruda) and cetuximab (Erbitux). The trial, led by Dr. Antonio Jimeno at the University of Colorado Anschutz Medical Campus, will assess the combination therapies in two arms, with promising preclinical data showing NT219’s potential to enhance tumor response and reverse immune resistance.
Full Article: Purple Biotech Update
Ona Therapeutics Strengthens Leadership Team to Accelerate ADC Development, Feb. 19, 2025
Ona Therapeutics, a global biotech company pioneering first-in-class antibody-drug conjugates (ADCs), announced key leadership appointments to support its rapid growth and pipeline advancement. Dr. Aleix Prat, a global leader in drug and biomarker development, has been appointed Chair of the Advisory Board. Dr. Jutta Amersdorffer has joined as Chief Medical Officer, and Stéphane Durant des Aulnois as Chief Financial Officer. These appointments come as Ona accelerates the development of ADC therapeutics targeting novel tumor-specific markers to eliminate resistant cancer cells.
Full Article: Ona Therapeutics Update
Merck’s Welireg Secures First Approvals in Europe for VHL Disease and RCC, Feb. 19, 2025
Merck’s Welireg received its first two approvals in Europe, covering certain patients with von Hippel-Lindau (VHL) disease and advanced clear renal cell carcinoma (RCC). The European Commission approved Welireg for VHL patients with localized RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, where localized treatments are unsuitable. This makes Welireg the first available treatment for VHL-associated tumors in Europe.
Full Article: Merck Welireg Approval
Merck Partners with Epitopea in $300M Antigen Discovery Collaboration, Feb. 19, 2025
Merck & Co. has entered a collaboration with Epitopea, a biotech focused on Cryptigen tumor-specific antigens (TSAs), in a deal worth up to $300 million per product. Epitopea’s CryptoMap platform identifies hidden TSAs derived from "junk DNA" to enhance immunotherapy targeting cold tumors. Merck will have exclusive rights to develop and commercialize therapies for a specified tumor type. This partnership supports Epitopea’s clinical-stage transition and highlights its antigen discovery approach in immuno-oncology.
Full Article: Merck & Epitopea Collaboration
ImmunityBio Receives FDA Approval to Support BCG Supply for Bladder Cancer, Feb. 19, 2025
ImmunityBio has received FDA authorization for an expanded access program (EAP) to provide an alternative source of Bacillus Calmette-Guérin (BCG) for bladder cancer treatment. With Merck & Co. being the primary supplier in the U.S., ImmunityBio's approval will help address BCG shortages and enhance its new immunotherapy Anktiva. BCG, used since 1921, is crucial for treating non-muscle invasive bladder cancer (NMIBC), which accounts for about 80% of new bladder cancer diagnoses in the U.S.
Full Article: ImmunityBio FDA Approval
Phanes Therapeutics Doses First Patient in Clinical Study of PT217 for SCLC and NEC, Feb. 19, 2025
Phanes Therapeutics has dosed the first patient in its clinical study of peluntamig (PT217), a bispecific antibody targeting DLL3 and CD47, in combination with chemotherapy for small cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC), including neuroendocrine prostate cancer (NEPC). The Phase I/II SKYBRIDGE trial (NCT05652686) is evaluating the safety and efficacy of PT217 in DLL3-expressing cancers. Phanes also has a clinical supply agreement with Roche to study PT217 alongside atezolizumab.
Full Article: Phanes Therapeutics Trial
Bantam Pharmaceutical Activates First Phase 1 Clinical Trial Site at MD Anderson Cancer Center, Feb. 20, 2025
Bantam Pharmaceutical has activated its first clinical trial site at MD Anderson Cancer Center for a Phase 1 study evaluating BTM-3566 in relapsed/refractory mature B-cell lymphomas. BTM-3566 is a first-in-class small molecule targeting mitochondrial homeostasis via the ATF4-Integrated Stress Response (ISR) pathway. This milestone marks Bantam’s transition into clinical development, with initial data expected in late 2025. The company plans to expand the trial to additional North American sites.
Full Article: Bantam Pharmaceutical Trial
Akeso Enrolls First Patient in Phase III Trial of Ivonescimab in Triple-Negative Breast Cancer, Feb. 20, 2025
Akeso, Inc. has enrolled the first patient in its Phase III trial (HARMONi-BC1/AK112-308) evaluating ivonescimab in combination with chemotherapy for first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). Ivonescimab, a first-in-class PD-1/VEGF bispecific antibody, has shown promising efficacy and safety in preliminary data presented at ESMO 2024. Akeso continues to advance multiple Phase III trials globally, positioning ivonescimab as a potential new
standard in cancer immunotherapy.
Full Article: Akeso Trial
UroGen Pharma Acquires Oncolytic Virus ICVB-1042 and Announces Strategic Collaborations, Feb. 20, 2025
UroGen Pharma has expanded its oncology pipeline with the acquisition of next-generation oncolytic virus ICVB-1042 from IconOVir Bio, Inc. and entered multiple research collaborations to enhance immunotherapy effectiveness using its RTGel technology. ICVB-1042, designed to selectively destroy cancer cells while triggering a robust immune response, represents a significant step in advancing locally administered therapies for bladder and specialty cancers. This strategic move reinforces UroGen’s commitment to innovation and high-impact treatments in uro-oncology.
Full Article: UroGen Acquisition
FibroGen Announces Sale of China Subsidiary to AstraZeneca, Feb. 20, 2025
FibroGen has announced the sale of its China subsidiary to AstraZeneca for approximately $160 million, strengthening its financial position and extending its cash runway into 2027. The transaction enables FibroGen to focus on advancing its clinical pipeline, including FG-3246, a first-in-class CD46-targeting ADC, and FG-3180, a companion PET imaging agent for mCRPC. Upon closing, AstraZeneca will obtain all rights to roxadustat in China, while FibroGen retains rights in the U.S. and other markets. The transaction is expected to close by mid-2025, pending regulatory review.
Full Article: FibroGen Sale
