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Chinese NMPA CDE has accepted the NDA for opamtistomig (LBL-024) as monotx. for previously treated advanced extrapulmonary neuroendocrine carcinoma (EP-NEC)
The NDA is supported by a registrational study led by Professor Shen Lin of Peking University Cancer Hospital, conducted across 34 sites; the study enrolled 96 pts with EP-NEC and completed enrollment in Aug 2025,…
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Pelareorep is gaining regulatory momentum through multiple FDA interactions and Fast Track designations, providing greater clarity around potential registration pathways and shaping Oncolytics’ clinical development and partnership strategy.
REO-033 could mark a pivotal step toward registration as the randomized study in RAS-mutant MSS metastatic colorectal cancer builds on encouraging clinical data and has the potential to become…
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Oncolytics Biotech is advancing pelareorep beyond the traditional standalone therapy model, positioning the platform as a potential immune-priming backbone capable of enhancing immunotherapies, checkpoint inhibitors, chemotherapies, and other oncology treatments across multiple difficult-to-treat tumor settings.
The company continues generating growing survival and immune-engagement data across colorectal, pancreatic, and anal cancers, while emphasizing pelareorep’s potential to “turn cold tumors…
Roy Maute on Macrophage Checkpoint Inhibition: Pheast’s Vision for Advancing PHST001 in Solid Tumors
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Pheast Therapeutics is redefining innate immunity in oncology with PHST001, an anti-CD24 macrophage checkpoint inhibitor engineered to overcome the limitations of earlier macrophage-targeted therapies and unleash a powerful anti-tumor immune response.
At AACR 2026, PHST001 delivered encouraging early clinical signals with favorable tolerability, clear immune activation, and promising anti-tumor responses across heavily pretreated solid tumor…
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Agenus has completed its strategic collaboration with Zydus Lifesciences to accelerate global development and potential commercialization of the BOT+BAL immunotherapy program
As per the deal, Zydus gave $75M upfront payment to Agenus for US biologics manufacturing facilities, and Agenus is also eligible for Contingent Milestone Payments ~$50M in production-linked milestones. Zydus acquired common stock…
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Sun Pharma has reported Unloxcyt (cosibelimab-ipdl) is now available in the US for adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not eligible for curative surgery or radiation
Approval of label update was based on long-term pivotal CK-301-101 data, showing improved ORR, including higher CR, and DoR without new…
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The US FDA has granted IND clearance to HLX18 (nivolumab), a biosimilar version of Opdivo, for the treatment of certain resected solid tumors
Novolumab is an mAb targeting PD-1 to enhance anti-tumor immune responses and is approved worldwide for cancers, including melanoma, mesothelioma, head and neck, and urothelial carcinoma
HLX17 (pembrolizumab biosimilar) and HLX13 (ipilimumab biosimilar) have entered worldwide multicenter P-I…
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Evorpacept emerges as the only CD47-blocking therapy with strong clinical activity and a highly manageable safety profile, thanks to its unique inactive Fc design that enables targeted tumor destruction while sparing healthy cells
Updated ASPEN-06 data highlights CD47 overexpression as a powerful predictive biomarker, showing dramatic improvements in ORR, DOR, PFS, and OS for patients with…
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Teva & Fosun Pharma have partnered to advance the development of TEV-56278 in immuno-oncology & accelerate global clinical data generation
As per the deal, Fosun will receive an exclusive license to develop, manufacture & commercialize TEV-56278 in mainland China, Hong Kong SAR, Macau SAR & Taiwan as well as select Southeast Asian countries, while…
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AbTherx has entered into a multi-program antibody discovery partnership with Spice Biotechnologies to identify antibodies against targets selected by Spice Bio, using AbTherx’s Atlas Mouse technologies
As per the deal, Spice Bio will obtain rights to develop & commercialize antibodies from the collaboration in exchange for research payments, potential clinical & commercial milestones, plus…

