By Claude Leguilloux Published on 09/09/2024 at 07:50
(Boursier.com) — Transgene a biotechnology company that designs and develops viral-based cancer immunotherapies, and BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotechnology company focused on discovering and developing innovative immunomodulatory antibodies for cancer, will present a poster on the first clinical results from the Phase I portion of the randomized Phase I/IIa trial evaluating BT-001 as monotherapy and in combination with KEYTRUDA (pembrolizumab), the anti-PD-1 therapy made available by MSD (Merck & Co. Inc. Rahway, NJ, USA).
Phase I data will be presented at the European Society for Medical Oncology (ESMO) Annual Conference to be held in Barcelona, Spain, September 13-17, 2024.
Key points of the abstract include:
In monotherapy, in terms of overall response, disease stabilization was observed in 4 of 18 patients with advanced solid tumors receiving BT-001. Tumor reduction was also observed in 2 of 20 injected lesions.
In combination, partial responses were observed in 2 out of 6 patients with advanced solid tumors receiving BT-001 in combination with pembrolizumab. This includes one patient with PD(L)-1-resistant melanoma and one patient with leiomyosarcoma after five lines of treatment. Patient response profiles and updated results will be presented at ESMO.
BT-001 is well tolerated, with no dose-limiting toxicity (DLT) observed. Two grade 3 adverse events related to BT-001 were observed (one skin ulcer and one decreased lymphocyte count). No DLT was observed despite repeated intratumoral injections of BT-001 alone (in 18 patients) or in combination with pembrolizumab (in 6 patients).
The oncolytic virus BT-001 replicates in tumors and expresses its anti-CTLA-4 antibody (mAb) payload with rare and sporadic dissemination, in line with translational data.
Dr. Stéphane Champiat, Medical Oncologist at Gustave Roussy, Head of the Hospitalization Unit, Department of Drug Development (DITEP) and clinical investigator of the study, adds: “Many cancer patients do not respond to existing treatments, which underlines the significant need for new approaches. BT-001 is a potentially very promising new immunotherapy that elicits a strong immune response, enhanced by the local expression of the anti-immune checkpoint inhibitor antibody CTLA-4 and the cytokine GM-CSF. The first clinical data from this study provide an important proof of principle and demonstrate the relevance of this oncolytic virus approach. Alone or in combination with pembrolizumab, BT-001 offers the possibility of improving treatment options with a better safety profile for patients in many types of cancer.”
Dr. Alessandro Riva, Chairman and Chief Executive Officer of Transgene, commented: “The promising initial clinical results from the ongoing Phase I/IIa clinical study evaluating BT-001 demonstrate its full potential. Within Transgene’s portfolio of oncolytic viruses, it further confirms the ability of our invir.IO(R) platform to generate tumor-specific targeted immunotherapies. BT-001 shows preliminary efficacy without dose-limiting toxicity, both as a monotherapy and in combination with pembrolizumab, while modulating the tumor microenvironment. We look forward to presenting further results as this study progresses.”
©2024 Boursier.com
