KANSAS CITY, Mo. — October 7, 2025 — Leads & Copy — Biomed Valley Discoveries (BVD) today announced the publication of results from a Phase 1b study, which investigated the safety and synergistic effects of intratumoral injection of Clostridium novyi-NT in combination with pembrolizumab in patients with advanced solid tumors. The findings were recently published in Clinical Cancer Research, a journal of the American Association for Cancer Research. The study, conducted with researchers at The University of Texas MD Anderson Cancer Center, showed an overall objective response rate (ORR) of 25% (n=4) among patients with various advanced solid tumor malignancies, building on earlier Phase 1 study results that demonstrated encouraging safety, tolerability, and anti-tumor results with CNV-NT monotherapy.
BVD is researching Clostridium novyi-NT (non-toxic) (CNV-NT/BVD-550), an attenuated form of the Clostridium novyi bacteria, as a modality to target the necrotic cores of tumors and unleash a tumor-destroying attack. The consequence of germination and growth of CNV-NT results in direct tumor destruction and activation of the host immune system.
According to Brent Kreider, Ph.D., President of BVD, CNV-NT can uniquely target and destroy difficult-to-access necrotic cores in tumors. Sarina Piha-Paul, M.D., professor, of Investigational Cancer Therapeutics at MD Anderson, stated that the encouraging early data support the hypothesis that pairing CNV-NT with an immunotherapy could amplify and enhance the durability of its cancer-fighting attack.
A total of 16 patients with advanced solid tumors were enrolled in the Phase 1b study. The combination therapy was generally well tolerated. The confirmed ORR of 25% was observed among four patients with various tumor types, with a median duration of response of 10.93 months. Stable disease was observed in 69% of patients.
BVD is evaluating possible partnerships for the next stage of development.
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Source: Biomed Valley Discoveries
