On March 3, 2020 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, and Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported that they will be presenting preclinical data on BT-001 at several upcoming scientific congresses in March and April 2020 (Press release, BioInvent, MAR 3, 2020, View Source [SID1234555137]).

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Transgene and BioInvent have submitted the first clinical trial application for BT-001, and the first-in-human trial is expected to start before the end of 2020 in Europe and the USA.

BT-001 is a multifunctional oncolytic virus being co-developed by Transgene and BioInvent. It is based on Transgene’s Invir.IO platform and patented, large-capacity VVcopTK-RR- oncolytic virus. BT-001 has been engineered to encode a Treg-depleting, anti-CTLA4 antibody derived from BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms, as well as the cytokine GM-CSF.

Both the oncolytic and the anti-CTLA4 therapeutic strategies that underpin BT-001 have demonstrated activity in humans based on their ability to induce a fundamental change in the tumor microenvironment and anti-tumoral activity. Looking at the clinical landscape, 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 preclinical models, BT-001 has demonstrated the benefits of its multiple mechanisms of action as well as the potential to deliver significantly improved tolerability when compared to the anti-PD-1/anti-CTLA4 combination therapies currently available," said Björn Frendéus, Ph.D., Chief Scientific Officer of BioInvent. "We believe that the potential to combine anti-CTLA4, anti-PD-1/PD-L1 and oncolytic immunotherapy could change the treatment paradigm for multiple solid tumors, and we are very much looking forward to investigate BT-001 in its first-in-human study, which is planned to start before the end of 2020."

"With BT-001, we are looking to combine Transgene’s potent oncolytic virus with the local production of a high concentration of an anti-CTLA4 antibody. We believe that BT-001 will have an improved tolerability due to its ability to generate high concentrations of the antibody in the tumor and very low systemic concentrations. With this next-generation oncolytic virus, we hope to demonstrate that we can increase the antitumor activity without exposing patients to unnecessary adverse events," added Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene.

Upcoming presentations on BT-001 include:

1. Poster presentation at the Immuno-Oncology (IO) Summit Europe, March 9-12, 2020, London (UK)

– "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" presented by Jean-Baptiste Marchand (Transgene).

– Date: March 11 and 12, 2020

– Location: Poster Session C

2. Poster presentation at the Keystone Advances in Cancer Immunotherapy Symposium, March 22 – 26, 2020, Whistler (Canada)

– "BT-001, an oncolytic vaccinia virus armed with a Treg-depleting anti-CTLA4 antibody and GM-CSF to target the tumor microenvironment" presented by Monika Semmrich (BioInvent). Poster No. 3028.

– Date: March 25, 2020

– Location: Poster Session 3

3. Poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 24-29, 2020, San Diego (USA)

– A poster has been accepted. The name and abstract of the poster will be available on the AACR (Free AACR Whitepaper) website on March 24, 2020.

4. Oral presentation at the ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies (TAT) Congress, March 2-4, 2020, Paris (France)

– "Antibody armed oncolytic viruses" (ID 42) presented by Eric Quéméneur (Transgene) during the session entitled "Where next with Oncolytics".

– Date: March 3, 2020

– The congress has been cancelled due to the coronavirus outbreak.