The BioPharm Brief: A Bispecific Approval in Head and Neck Cancer, TCR Bispecifics Head to the Clinic, and a New Antibody Target in Essential Thrombocythemia

Welcome to the BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry. Today: a bispecific antibody approval in head and neck cancer and two financings backing early-stage antibody platforms.

First, FDA has granted accelerated approval to Johnson & Johnson’s Rybrevant Faspro, the subcutaneous form of the EGFR/MET bispecific amivantamab. It is approved for recurrent or metastatic head and neck squamous cell carcinoma that progressed after platinum chemotherapy and a PD-1 or PD-L1 inhibitor. HPV-associated oropharyngeal cancer is excluded. In the OrigAMI-4 trial, 42% of 102 patients responded, including 15% with complete responses. It is the drug’s first approval outside lung cancer, and continued approval may depend on the phase 3 OrigAMI-5 trial.

Next, T-Therapeutics has raised a $133 million Series B to take its TCR bispecifics into the clinic. The approach pairs fully human T-cell receptors with a CD3 T-cell engager, which could reach targets inside cells that conventional antibodies cannot. Its lead programs, TTX-008 in solid tumors and TTX-018 in immunology, have not yet entered human testing.

And finally, Oxford spinout Alethio Therapeutics has raised a $90 million Series A for ATX-011, an antibody against G6B. It is being developed for essential thrombocythemia, a blood cancer in which the body makes too many platelets. Alethio says G6B is found on the cells that drive the disease but not on healthy stem cells. ATX-011 is in IND-enabling studies, and trial enrollment is expected to begin in the first half of 2028.

That’s today’s BioPharm Brief. For analysis and expert insights, please visit BioPharmInternational.com.

Key takeaways

• Label expansion: Rybrevant Faspro’s accelerated approval gives patients with previously treated head and neck cancer a subcutaneous bispecific option, with confirmation of benefit still to come.
• Intracellular targets: T-Therapeutics’ financing is a bet that TCR bispecifics can bring T-cell engagers into solid tumors and autoimmune disease.
• Disease-modifying ambitions: Alethio wants to go beyond controlling blood counts by targeting the cells that drive essential thrombocythemia, though its data so far are preclinical.