The BioPharm Brief: Breakthroughs, Bispecifics, and the Brain

Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry.

Here’s what’s making headlines today.

AbbVie is reporting encouraging early data for its investigational bispecific antibody ABBV-1480 in frontline non-small cell lung cancer. In a Phase 1b study, ABBV-1480, which targets PD-1 and VEGF, was combined with platinum-based chemotherapy and produced a 90% objective response rate in squamous NSCLC, with responses in 27 of 30 patients at the recommended Phase 3 dose of 10 milligrams per kilogram. The combination also produced a 75.9% response rate in non-squamous NSCLC, with 22 of 29 patients responding. The most common treatment-related adverse events were hematologic, and no grade 3 or higher hemorrhages were reported at the 10 milligram per kilogram dose. The data are from an early-stage, uncontrolled study, and AbbVie is continuing development into Phase 3.

In China, Leads Biolabs has reached a regulatory milestone for opamtistomig, its PD-L1/4-1BB bispecific antibody. The NMPA has accepted the company's NDA for the treatment of previously treated advanced extrapulmonary neuroendocrine carcinoma, or EP-NEC. The application is supported by a 96-patient registrational trial, although detailed efficacy and safety results have not yet been publicly presented. If approved, opamtistomig would be the first approved therapy specifically targeting 4-1BB and would address a cancer for which there are currently no approved therapies worldwide. The bispecific is designed to combine PD-L1 blockade with 4-1BB activation, with the goal of reactivating exhausted T cells and generating an antitumor response.

And in glioblastoma, Adaptin Bio has opened a phase 1 trial of APTN-101, a bispecific T-cell engager designed to cross the blood-brain barrier and target EGFRvIII-positive tumor cells. The therapy is built on Adaptin's BRiTE platform, which uses immune cell hitchhiking to help transport the treatment into the brain before redirecting T cells toward tumor cells. In preclinical studies, APTN-101 showed more than a seven-fold increase in brain distribution compared with the T-cell engager component alone, while completely eliminating EGFRvIII-positive tumors in 70% to 80% of treated mice across several aggressive models. The first-in-human trial, being conducted with Duke University, plans to enroll up to 15 adults with WHO Grade IV malignant glioma.

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

Key takeaways:

• AbbVie’s ABBV-1480 generated a 90% response rate in a Phase 1b frontline squamous NSCLC study.
• Leads Biolabs’ opamtistomig is moving into NMPA review for a rare neuroendocrine cancer with no approved therapies.
• Adaptin Bio has begun first-in-human testing of a bispecific designed to cross the blood-brain barrier in glioblastoma.