BioInvent and Transgene has enrolled first patient in Phase I/IIa trial of novel oncolytic virus BT-001 in solid tumors

BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, and Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today announced that the first patient in a Phase I/IIa clinical trial of the novel dual mechanism-of-action oncolytic vaccinia virus BT-001 has been enrolled at Institut Bergonié (Bordeaux, France).

BT-001 has been generated using Transgene’s Invir.IO™ platform and its patented large-capacity VVcopTK-RR- oncolytic virus, which has been engineered to encode both a Treg-depleting human recombinant anti-CTLA-4 antibody generated by BioInvent’s proprietary n-CoDeR^®/F.I.R.S.T™ platforms, and the human GM-CSF cytokine.

By selectively targeting the tumor microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoral response. In addition, delivering the anti-CTLA-4 antibody directly to the tumor microenvironment aims to induce local Treg depletion and strong therapeutic activity. As a consequence, by reducing systemic exposure, the safety and tolerability profile of the anti-CTLA-4 antibody will be greatly improved. BT-001 is being co-developed through a 50/50 collaboration between BioInvent and Transgene.

“The inclusion of the first patient in this Phase I/IIa trial marks a further broadening of our clinical pipeline, which now comprises three candidate products and four clinical studies. BT-001 is a unique oncolytic virus, combining multiple mechanisms-of-action, and has outstanding potential in a wide range of indications thanks to its combination of multiple anti-cancer properties,” said Martin Welschof, CEO of BioInvent.

Hedi Ben Brahim, Chairman and CEO of Transgene, said: “We are excited to start this clinical trial with BT-001, which is the result of a very productive collaboration between Transgene and BioInvent. This first Invir.IO™ based oncolytic virus entering the clinic has been shown to induce long-lasting antitumor immune responses and abscopal effects in several preclinical tumor models; in these experiments, the activity of BT-001 was further enhanced through combination with an anti-PD-1 antibody treatment. It has a unique mode of action and the outstanding results so far indicate it could make a significant difference to cancer patients.”

This multicenter, open-label, dose-escalation Phase l/lla trial evaluating BT-001 as a single agent and in combination with pembrolizumab (anti-PD-1 treatment) will first be including patients in several countries in Europe. An IND submission will follow in the USA.

The Phase I will be divided into two parts. Part A will enroll up to 36 patients with metastatic/advanced solid tumors. Patients will receive single agent, intra-tumoral administrations of BT-001, in cutaneous or palpable subcutaneous lesions or easily injectable lymph nodes. Part B will explore the combination of intra-tumoral injections of BT-001 with pembrolizumab in 12 patients. The Phase lla will evaluate the combination regimen in several patient cohorts with different tumor types. These expansion cohorts will offer the possibility of exploring the activity of this approach to treat other malignancies not traditionally addressed with this type of treatment.

The trial (NCT04725331) will first be conducted at the UCL Saint Luc (Brussels, Belgium), the Bergonié Institute (Bordeaux, France), the Gustave Roussy Institute (Paris area, France), the Centre Léon Bérard (Lyon, France) and the Hôpital Saint-Louis (Paris, France).