The trial will assess BT-001, an oncolytic virus co-developed by Transgene and BioInvent, in combination with anti-PD-1 therapy, Keytruda.
“We are very pleased to be signing another collaboration with MSD, supporting the expansion of the clinical trial program of BT-001. 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,” said Martin Welschof, CEO of BioInvent International.
Since 2017, Sweden’s BioInvent and French biotech, Transgene, have been collaborating on the development of oncolytic virus (OV) drug candidates aimed at treating solid tumors, with the potential to be significantly more effective than the combination of a virus and an antibody as single agents.
BT-001 is based on Transgene’s patented OV and is encoding BioInvent’s proprietary anti CTLA 4 antibody.
The research and development costs, as well as revenue and royalties from drug candidates generated from the collaboration, are shared 50:50 by both entities.
Transgene also has an ongoing partnership with AstraZeneca aimed at exploring virus-based immunotherapies.
Progress and safety data
Yesterday saw Transgene and BioInvent also jointly announce positive progress and safety data from the ongoing Phase I/2a trial evaluating BT-001 in patients with solid tumors.
They said the initial data generated in Phase I part A demonstrated that BT-001 alone is well tolerated, with first signs of anti-tumor activity in a hard-to-treat population, and the findings also confirmed the mechanism of action of BT 001 as a single agent. “The oncolytic virus BT-001 replicates in the tumor for several days and expresses the anti-CTLA-4 monoclonal antibody.”
The companies added that no spreading in blood or biological fluids was detected, suggesting “high tumor specificity” while reporting that tumor shrinkage was observed in one patient in the first cohort.
The part A of the Phase I trial aims to establish the tolerability of BT-001 and to determine the dose and administration schedule for further development. Repeated and ascending doses of intratumoral administration of BT 001, as a single agent, will be administered to up to 18 patients with metastatic/advanced tumors, said the developers.
The first two dose levels have been successfully completed, with 12 patients dosed to date. The Safety Review Committee (SRC) has stated that the safety profile supports escalation to the highest dose level of Phase I part A.
The Phase I part B is planned to start in the second half of 2022, said the companies. It will assess the combination of intratumoral injections of BT-001 with intravenous administrations of Keytruda.
According to a review last year in the World Journal of Virology oncolytic viruses are organisms able to infect and lyse the tumor cells beyond stimulating the immune system to combat the disease. “The clinical use of oncolytic viruses has shown to have positive results in the treatment of some types of cancers, contributing to reducing the tumor. Furthermore, the combined use of these viruses and other antitumor therapies have contributed to better prognosis in the patient’s clinical condition.”