BioInvent and Transgene Announce First Patient Enrolled in Phase I/IIa Trial of BT-001 Oncolytic Virotherapy

Strategic Insights -

The first patient in a Phase I/IIa clinical trial of BT-001, a novel dual mechanism-of-action oncolytic vaccinia virus, has been enrolled at the Institut Bergonie in Bordeaux, France. BT-001 is being co-developed by BioInvent and Transgene through a 50/50 collaboration and combines multiple mechanisms-of-action to target the tumor microenvironment. This approach aims to elicit a stronger and more effective antitumoral response, while reducing systemic exposure to improve the safety and tolerability profile of the anti-CTLA-4 antibody.

Key Takeaways:

  • BioInvent and Transgene have announced the enrollment of the first patient in a Phase I/IIa clinical trial of BT-001, an oncolytic vaccinia virus designed to target the tumor microenvironment.
  • BT-001 combines a Treg-depleting human recombinant anti-CTLA-4 antibody and the human GM-CSF cytokine, selectively targeting the tumor microenvironment to induce a stronger and more effective antitumoral response.
  • The trial will evaluate the safety and efficacy of BT-001 as a single agent and in combination with pembrolizumab (anti-PD-1 treatment) in patients with metastatic/advanced solid tumors.
  • The Phase I part of the trial will enroll up to 36 patients in two parts, with Part A evaluating single-agent BT-001 and Part B exploring the combination of intra-tumoral injections of BT-001 with pembrolizumab.
  • The Phase IIa part of the trial will evaluate the combination regimen in several patient cohorts with different tumor types, offering the possibility of exploring the activity of this approach to treat other malignancies.
  • BioInvent and Transgeneplan to submit an IND in the USA following the clinical trial's progression and completion of the necessary regulatory submissions.

Statistics:

  • 36 patients will be enrolled in the Phase I part of the trial, with up to 12 patients in the combination cohort.
  • 12 patients will be enrolled in the Phase IIa part of the trial, with multiple expansion cohorts evaluating the combination regimen in different tumor types.
  • The trial will be conducted at five sites in Europe: UCL Saint Luc (Brussels, Belgium), the Bergonie Institute (Bordeaux, France), the Gustave Roussy Institute (Paris area, France), the Centre Leon Berard (Lyon, France), and the Hopital Saint-Louis (Paris, France).

Sources:

  • NewsRx: "BioInvent International AB and Transgene Announce First Patient Enrolled in Phase I/IIa Clinical Trial of BT-001 Oncolytic Virotherapy"
  • BioInvent International AB: Press Release, March 2021
  • Transgene: Press Release, March 2021