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BT-001 - Partnership with Transgene – developing next generation oncolytic viruses expressing an anti-CTLA-4 antibody to treat solid tumors

MABS + Oncolytic virus to target solid tumors

BioInvent and Transgene announced in December 2020 that regulatory approval had been received in Belgium for a clinical trial application for a Phase l/lla study of BT-001 in solid tumors.

Promising findings was presented both at AACR Virtual Annual Meeting II in June 2020 and at the SITC 35th Anniversary Annual Meeting in November 2020. Cure rates exceeding 70% were seen in multiple mouse models, demonstrating the powerful therapeutic effect of BT-001 when used as a single agent, providing a solid basis for BT-001’s upcoming clinical development. BT-001 has been designed to combine the killing of cancer cells (oncolysis mediated by the virus), with the production of the anti-CTLA4 antibody and GM-CSF directly in the tumor site to enhance the generation of an efficacious immune response against tumor cells. It was shown that while the anti-CTLA-4 antibody and GM-CSF accumulate in tumors, the systemic exposure is very low. It was shown that a strong tumor-specific response and long-lasting immune memory were developed by BT-001 surrogate treated mice, which prevented establishment of re-implanted tumor cells in mice that had been cured. These data indicate that BT-001 has the potential to make a significant difference in the treatment of solid tumors.

Background
BioInvent and Transgene collaborate to co-develop oncolytic virus (OV) candidates encoding a validated anti-CTLA-4 antibody sequence – potentially with additional transgenes – 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.

Transgene is contributing both engineering expertise, as well as its proprietary Vaccinia viruses, designed to directly and selectively destroy cancer cells by intracellular replication of the virus in the cancer cell (oncolysis). Oncolysis induces an immune response against tumors, while the “weaponized” virus allows the expression of genes carried by the viral genome, here an immune modulatory anti-CTLA-4 antibody, which will further boost immune response against the tumor. BioInvent is providing its cancer biology and antibody expertise to the collaboration, as well as anti-CTLA-4 antibody sequences generated through its proprietary n-CoDeR®/F.I.R.S.TTM platforms.

In March 2019 BioInvent and Transgene announced an extension of their collaboration to co-develop multifunctional oncolytic viruses encoding antibodies targeting an undisclosed target, which can be used in the treatment of a broad range of solid tumors.

The research and development costs, as well as revenue and royalties from candidates generated from the collaboration, are shared 50:50.