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Today’s BioPharm Brief looks at an oncology trial discontinuation, an AI-designed glioblastoma vaccine, and an expanded biosimilars collaboration.

Outsourced cell and gene therapy manufacturing is set to grow nearly 6-fold by 2035 as biotech pipelines outpace in-house capacity.

The independent data monitoring committee's finding leaves clinicians without a new option for PD-L1-low NSCLC, a population historically underserved by current immunotherapies.

Evaxion has added EVX-05, an AI-designed, off-the-shelf therapeutic vaccine targeting glioblastoma, to its pipeline, discontinuing the EVX-03 program as part of a broader R&D refocus while maintaining its cash runway into the second half of 2027.

OncoC4 has dosed the first patient in a phase 1 trial of ONC-783, a T-cell engager targeting neoCD24, a cancer-specific glycoform of CD24, positioning the subcutaneously administered candidate as a potential treatment across multiple solid tumor types.

Shanghai Henlius Biotech has entered a strategic collaboration with Sandoz covering up to 10 proposed monoclonal antibody and antibody-drug conjugate biosimilar assets, deepening the companies' existing oncology biosimilars partnership with initial deals worth up to $322 million.

IASO Bio adds a fratricide-resistant CAR-T platform to its pipeline, aiming to speed novel T-cell malignancy therapies to patients.

The European Medicines Agency has validated the Marketing Authorization Application for PF-07307405, Pfizer and Valneva's six-valent OspA-based Lyme disease vaccine candidate, beginning formal review of what could become the first Lyme disease vaccine available in Europe.

Spevatamig's fast track status targets a cancer where 5-year survival is under 20%, pairing a novel mechanism with pembrolizumab.

Today’s BioPharm Brief covers NMPA approval of ivonescimab plus chemotherapy for first-line squamous NSCLC, a $175 million financing for Silence Therapeutics, and Infinimmune’s $75 million Series A for its human-derived antibody pipeline.

Infinimmune has closed a $75 million Series A financing co-led by Regeneron Ventures and Playground Global to advance its lead atopic dermatitis programs, IFX-101 (targeting IL-22) and IFX-201 (targeting IL-13), both derived from its Anthrobody platform for discovering fully human antibodies.

Cellex Life CEO Dr Eric von Hofe and Professor of Immunology at Mayo Clinic, Dr Keith L. Knutson, explain why individualized tumor profiling, not off-the-shelf targeting, is key to effective personalized cancer vaccines.

Fresh $175 million in funding follows Silence's 88% response rate in its divesiran polycythemia vera trials, positioning the company for a planned 2027 phase 3 push.