Transgene, BioInvent dose first patient in part B of phase I clinical trial assessing Oncolytic virus, BT-001 in combination with pembrolizumab

Transgene, a biotech company that designs and develops virus-based immunotherapeutics against cancer, and BioInvent International AB (BioInvent), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, announced that the first patient of the Phase I part B clinical trial evaluating the combination of BT-001 and MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) has been dosed.

The Phase I Part B of the trial explores repeated intra-tumoral injections of BT-001 in combination with intravenous infusions of KEYTRUDA. Transgene and BioInvent plan to enroll a minimum of 12 patients with metastatic or advanced solid tumors, including melanoma. In accordance with our clinical trial and supply agreement, KEYTRUDA is being supplied by MSD (a tradename of Merck & Co., Inc., Rahway, NJ, USA). Trial endpoints include safety, evaluation of efficacy, and assessment of immune changes in the tumour microenvironment.

Transgene and BioInvent are co-developing BT-001, an oncolytic virus designed using Transgene’s Invir.IO platform encoding BioInvent’s differentiated anti-CTLA-4 antibody and human GM-CSF cytokine to elicit a strong and effective anti-tumoral response. The drug is currently being evaluated against solid tumors in a Phase I/IIa clinical trial as a single agent and in combination with the PD-1 checkpoint inhibitor KEYTRUDA.

The inclusion of the last patient in Part B of the study is expected in H1 2024.

Previously reported Phase I data confirmed the mechanism of action of BT-001 as a single agent and demonstrated first signs of anti-tumoral activity.

Dr. Martin Welschof, CEO of BioInvent and Dr. Alessandro Riva, Chairman and CEO of Transgene, added: “By combining BT-001 with pembrolizumab, we are building upon the promising data generated by BT-001 as a single agent. Targeting the PD1/PD-L1 pathway in addition to BT-001’s mechanism of action is expected to further stimulate and restore the patient’s immune system, which should result in improved antitumoral activity and patient outcome. We are thrilled to enter this new phase of the development of the novel oncolytic virus BT-001 and further demonstrate its potential in combination with a reference treatment.”

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

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