On May 15, 2020 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, reported new highly promising preclinical data demonstrating the broad therapeutic potential of BT-001, an anti-CTLA4 antibody-encoding oncolytic virus, against solid tumors (Press release, Transgene, MAY 15, 2020, View Source [SID1234558160]). These data will be presented at the AACR (Free AACR Whitepaper) 2020 Virtual Annual Meeting II.

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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) (Free AACR Whitepaper) 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."

Martin Welschof, CEO of BioInvent, says: "We are very pleased with these data on BT-001, which indicate the oncolytic virus has the potential to treat a broad range of cancers. This is a further demonstration of the power of BioInvent’s technology platform, multiplied by our strong cooperation with Transgene, and we look forward to further investigating the capabilities of this promising therapeutic option."

Title of the poster: "BT-001, an oncolytic Vaccinia virus armed with a Treg-depletion-optimized recombinant human anti-CTLA4 antibody and GM-CSF to target the tumor microenvironment."
Authors: Jean-Baptiste Marchand, Monika Semmrich, Laetitia Fend, Matilda Rehn, Nathalie Silvestre, Ingrid Teige, Johann Foloppe, Linda Mårtensson, Eric Quéméneur, Björn Frendeus
Abstract Number: 2902
Session Date: June 22-24, 2020
Poster Session Title: Inflammation, Immunity, and Cancer / Modifiers of the Tumor Microenvironment 2
Poster number: 5602
The abstract can be downloaded on the AACR (Free AACR Whitepaper) website.