BioInvent and Transgene’s Oncolytic Virus BT-001 Shows Promising Antitumor Activity in Ongoing Phase 1/2a Trial in Solid Tumors that Failed Previous Treatments

LUND, SWEDEN / ACCESSWIRE / September 14, 2024 / BioInvent International (STO:BINV)

• Preliminary data presented at ESMO 2024 demonstrate BT-001 induces tumor regression in patients who failed previous anti-PD(L)-1 treatment

• In a patient with a heavily pretreated leiomyosarcoma, BT-001 was able to modulate the tumor microenvironment, turning a "cold" tumor to "hot", enhancing the potential of T cell infiltration and a shift to PD(L)-1 positivity

Early signs of efficacy with clinical responses observed with BT-001 in combination with KEYTRUDA (pembrolizumab), in 2 of 6 patients who failed previous treatment

Lund, Sweden, and Strasbourg, France, September 14, 2024, 9:05 a.m. CEST -BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, and Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today announce new initial data from their ongoing Phase 2/2a study on the multifunctional oncolytic virus BT-001, demonstrating antitumor activity in patients with refractory solid tumors.

The data presented today at the2024European Society for Medical Oncology (ESMO) Annual Meeting, showed that BT-001 induced tumor regression in patients unresponsive to prior anti PD(L)-1 treatment, both as a monotherapy and in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab).
Preliminary translational data suggest that BT-001 replicates in the tumor where the payloads are expressed with undetectable systemic exposure. BT-001 alone or in combination with pembrolizumab was well tolerated and showed first signs of efficacy with clinical responses in 2 of 6 refractory patients when given in combination with pembrolizumab. BT-001 treatment turned "cold" tumors to "hot" inducing T cell infiltration, a higher M1/M2 ratio, and a shift toPD(L)-1 positivity in the tumor microenvironment.

Dr. S. Champiat, Medical Oncologist, Head of the Inpatient Unit, Drug Development Department (DITEP) at Institut Gustave Roussy, commented:"The immunological data generated by BT-001 suggest that, as hoped, BT-001 is replicating in the tumor and its payload of transgenes is expressed, with very limited exposure outside of the tumor thereby limiting systemic toxicity. I look forward to additional results from this ongoing study which will provide further evidence of the safety and clinical activity of BT-001 and its potential role as a new therapy for cancer patients with solid tumors."