On June 28, 2022 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immuno-modulatory antibodies for cancer immunotherapy, reported a clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Rahway, NJ., USA, to evaluate the oncolytic virus BT-001 in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in a Phase I/IIa clinical trial for the treatment of patients with solid tumors (Press release, Transgene, JUN 28, 2022, View Source [SID1234616332]).
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Under the terms of the supply agreement, MSD will provide pembrolizumab to be used in combination with BT-001 in the ongoing Phase I/IIa clinical trial.
"By combining BT-001 with the anti-PD-1 drug KEYTRUDA we expect to optimize the patient’s immune response to induce a strong and effective anti-tumor response. This agreement will allow us to move further on the clinical development of our promising co-developed oncolytic candidate BT-001" said Hedi Ben Brahim, CEO of Transgene.
"We are very pleased to be signing another collaboration with MSD, supporting the expansion of the clinical trial program of BT-001, the oncolytic virus expressing our proprietary anti-CTLA-4 antibody, jointly developed by Transgene and BioInvent. It marks a further validation of our expanding and promising clinical pipeline of anti-cancer treatments, which currently encompasses three compounds in four ongoing clinical trials" added Martin Welschof, CEO of BioInvent.
Recruitment in the clinical study (NCT04725331) is ongoing. The trial is a Phase I/IIa of BT-001, which is being co-developed as part of a 50/50 collaboration between Transgene and BioInvent, as a single agent and in combination with KEYTRUDA for the treatment of solid tumors.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About the trial
The ongoing Phase I/IIa (NCT04725331) study is a multicenter, open label, dose-escalation trial evaluating BT-001 as a single agent and in combination with pembrolizumab (anti-PD-1 treatment). Patient inclusions are ongoing in Europe (France, Belgium) and the trial has been authorized in the US.
This Phase I is divided into two parts. In part A, patients with metastatic/advanced tumors receive single agent, intra-tumoral administrations of BT-001. Part B will explore the combination of intra-tumoral injections of BT-001 with pembrolizumab. The Phase IIa will evaluate the combination regimen in several patient cohorts with different tumor types. These expansion cohorts will offer the possibility of exploring the activity of this approach to treat other malignancies not traditionally addressed with this type of treatment.
About BT-001
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 human recombinant anti-CTLA-4 antibody generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms, and the human GM-CSF cytokine. By selectively targeting the tumor microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoral response. As a consequence, by reducing systemic exposure, the safety and tolerability profile of the anti-CTLA-4 antibody will be greatly improved.
BT-001 is being co-developed as part of a 50/50 collaboration on oncolytic viruses between Transgene and BioInvent. To know more on BT-001, watch our video here.