Transgene and BioInvent Present Preclinical Data Demonstrating BT-001’s Powerful Activity Against Solid Tumors

Regulatory News:

Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and BioInvent International AB (“BioInvent”) (OMXS: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announce new highly promising preclinical data demonstrating the broad therapeutic potential of BT-001, an anti-CTLA4 antibody-encoding oncolytic virus, against solid tumors. These data will be presented at the AACR 2020 Virtual Annual Meeting II.

BT-001 is a multifunctional oncolytic virus being co-developed by Transgene and BioInvent. It has been engineered to encode a Treg-depleting, anti-CTLA4 antibody generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms, and GM-CSF. It uses Transgene’s Vaccinia-based Invir.IO viral vector platform to deliver this powerful immunotherapy directly into the tumor.

Key results:

• The new data demonstrate a powerful therapeutic effect, indicated by curative potential as a single agent in multiple syngeneic mouse models spanning solid tumor models (CT26, EMT6, C38, and A20).
• An improved therapeutic window relative to systemic anti-CTLA4 blockade was indicated by higher, receptor-saturating, anti-CTLA4 antibody intratumoral concentrations versus much lower levels in the blood compartments.
• BT-001’s activity was further enhanced when combined with anti-PD-1 antibody therapy – opening up the potential for powerful dual checkpoint blockade treatment regimens.

These promising findings will be presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting II, taking place June 22-24. The abstract is posted online today.

The oncolytic virus, the anti-CTLA4 and the GM-CSF therapeutic strategies that underpin BT-001 have already demonstrated activity in humans based on their ability to induce a fundamental change in the tumor microenvironment and anti-tumor activity.

Looking at the clinical landscape, BioInvent and Transgene are confident that BT-001 could either be used as a monotherapy or be associated with standard of care immunotherapy options such as anti-PD1/anti-PD-L1 therapies in order to deliver improved clinical outcomes for patients with solid tumors.

Éric Quéméneur, Pharm.D., Ph.D., Executive VP, Chief Scientific Officer of Transgene, added: “The preclinical results generated with BT-001 have been remarkable and we remain extremely confident in its ability to change the treatment landscape for a significant number of solid tumors. We have submitted our first clinical trial application for BT-001 in March 2020 and are working hard to make sure we can take our first multifunctional Invir.IO oncolytic into the clinic before the end of 2020, despite uncertainties caused by the Covid-19 pandemic.”