On July 28, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and 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, reported it will jointly present a poster on updated data from the Phase I part of the Phase I/IIa study of BT-001 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting (Press release, Transgene, JUL 28, 2025, View Source [SID1234654577]). ESMO (Free ESMO Whitepaper) will take place in Berlin, Germany, from October 17 to 21, 2025.
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Poster details
Title: "Updated clinical results of BT-001, an oncolytic virus expressing an anti-CTLA4 mAb, administered in combination with pembrolizumab in patients with advanced solid tumors."
Abstract number: 2828
Authors: C. Lebbe, R. Bahleda, E. Ezine, B. Baroudjian, M. Sakkal, E. Rowinski, A. Vinceneux, S. Champiat, K. Bidet Huang, N. Stojkowitz, H. Makhloufi, A. Sadoun, A. Ropenga, M. Semmrich, A. McAllister, M. Chisamore, P. Cassier
The abstract will be available on ESMO (Free ESMO Whitepaper)’s website on October 13, 2025, at 00:05 CEST.
BT-001 is an oncolytic virus generated using Transgene’s Invir.IO platform and its patented large-capacity VVcopTK-RR- oncolytic virus, which has been engineered to encode both a Treg-depleting recombinant human anti-CTLA-4 antibody generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms, and the human GM-CSF cytokine. BT-001 is being co-developed as part of a 50/50 collaboration on oncolytic viruses between Transgene and BioInvent. In the Phase I part of this study, as monotherapy and in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), BT-001 has been shown to be well tolerated. BT-001 also showed the first signs of efficacy with clinical response in two out of six refractory patients, thirteen patients evaluated in total, when given in combination with pembrolizumab, with shrinkage of injected and non-injected lesions. Treatment with BT-001 converted "cold" tumors into "hot" ones, and induced T-cell infiltration, as well as PD(L)-1 expression in the tumor microenvironment (See press release from September 14, 2024 here).
The ongoing Phase I/IIa study (NCT04725331) is a multicenter, open label, dose-escalation study evaluating BT-001 as a single agent and in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab). The last patient in the Phase I part was enrolled in August 2024.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.