Biotechnology companies Transgene (Euronext Paris: TNG) and BioInvent International AB (Nasdaq Stockholm: BINV) on Tuesday announced the initiation of a Phase I Part B of a clinical trial evaluating the oncolytic virus BT-001 in combination with KEYTRUDA (pembrolizumab) for treating solid tumours, including melanoma.

MSD (Merck & Co Inc, Rahway, NJ, USA) is suppling KEYTRUDA.

The trial aims to enroll a minimum of 12 patients with advanced solid tumours, assessing safety, efficacy and immune changes in the tumor microenvironment.

BT-001, co-developed by Transgene and BioInvent, utilises Transgene's Invir.IO platform, encoding BioInvent's anti-CTLA-4 antibody and human GM-CSF cytokine. The drug is currently undergoing Phase I/IIa clinical trials as a single agent and in combination with KEYTRUDA, with completion of Phase B expected in H1 2024. Previous Phase I data indicated BT-001's mechanism of action and initial anti-tumoural activity.

The ongoing multicentre trial (NCT: 04725331) is open-label and dose-escalation, divided into Part A (evaluating BT-001 as a single agent) and Part B (exploring combination therapy with KEYTRUDA). Patient inclusions are ongoing in Europe (France, Belgium) and the trial is authorised in the US. Phase IIa will evaluate the combination in various patient cohorts with selected tumour types.

BT-001, an oncolytic virus from Transgene, utilises the Invir.IO platform, engineered to encode a Treg-depleting anti-CTLA-4 antibody and GM-CSF cytokine. The goal is to elicit a potent anti-tumoural response with improved safety by targeting the tumour microenvironment.

Transgene focuses on designing targeted immunotherapies using viral vector technology. Clinical-stage programs include therapeutic vaccines and oncolytic viruses.

BioInvent International AB is a clinical-stage biotech discovering and developing immuno-modulatory antibodies for cancer therapy. The F.I.R.S.T technology platform drives the development of drug candidates for hematological cancer and solid tumours.

Both companies generate revenues through research collaborations, license agreements and antibody production for third parties.