Transgene and BioInvent – First Patient Treated in Part B of Phase I Trial Assessing the Novel Oncolytic Virus BT-001 in Combination With KEYTRUDA® (pembrolizumab)

Transgene and BioInvent International have announced the dosing of the first patient in the Phase I Part B clinical trial evaluating the combination of BT-001 and pembrolizumab (KEYTRUDA®) in solid tumors, including melanoma. BT-001 is an oncolytic virus designed to elicit a strong anti-tumoral response, while pembrolizumab is an anti-PD-1 therapy that stimulates the patient’s immune system. The trial aims to enroll a minimum of 12 patients with metastatic or advanced solid tumors.

The Phase I Part B trial will explore repeated intra-tumoral injections of BT-001 in combination with intravenous infusions of pembrolizumab. The trial endpoints include safety, evaluation of efficacy, and assessment of immune changes in the tumor microenvironment. The inclusion of the last patient in Part B is expected in the first half of 2024.

BT-001 is being co-developed by Transgene and BioInvent as part of a collaboration on oncolytic viruses. It is currently being evaluated in a Phase I/IIa clinical trial as a single agent and in combination with pembrolizumab. Previous Phase I data has demonstrated the mechanism of action of BT-001 as a single agent and showed initial signs of anti-tumoral activity.

Dr. Martin Welschof, CEO of BioInvent, and Dr. Alessandro Riva, Chairman and CEO of Transgene, expressed their excitement about the potential of combining BT-001 with pembrolizumab. They believe that targeting the PD1/PD-L1 pathway in addition to BT-001’s mechanism of action will further stimulate and restore the patient’s immune system, leading to improved anti-tumoral activity and patient outcomes.

The ongoing Phase I/IIa study is a multicenter, open-label, dose-escalation trial evaluating BT-001 as a single agent and in combination with pembrolizumab. The trial has been authorized in the US and is currently enrolling patients in Europe. The Phase IIa will evaluate the combination regimen in several patient cohorts with selected tumor types.

BT-001 is an oncolytic virus generated using Transgene’s Invir.IO® platform and BioInvent’s anti-CTLA-4 antibody and human GM-CSF cytokine. By selectively targeting the tumor microenvironment, BT-001 aims to elicit a stronger and more effective anti-tumoral response. The collaboration between Transgene and BioInvent on oncolytic viruses is expected to pave the way for novel immunotherapies in cancer treatment.

Both Transgene and BioInvent are dedicated to developing innovative therapies for cancer. Transgene focuses on designing targeted immunotherapies using viral vector technology, while BioInvent discovers and develops immuno-modulatory antibodies for cancer therapy. The companies have ongoing clinical programs and collaborations with top-tier pharmaceutical companies.

The progress made in the Phase I Part B trial marks an important milestone in the development of BT-001 and its potential to improve patient outcomes in solid tumors, including melanoma. The combination of BT-001 and pembrolizumab holds promise in stimulating the immune system and enhancing the anti-tumoral response. As the trial progresses, further data will be generated to evaluate the safety and efficacy of this novel treatment approach.