STRASBOURG, France & LUND, Sweden--(BUSINESS WIRE)--

Regulatory News:

Transgene (Paris:TNG) (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 that they will be presenting preclinical data on BT-001 at several upcoming scientific congresses in March and April 2020.

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.

“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.

“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.”

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) 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 website on March 24, 2020.

4. Oral presentation at the ESMO 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 COVID-19 coronavirus outbreak.

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About Transgene

Transgene (Euronext: TNG) is a publicly traded French biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.

The Company’s clinical-stage programs consist in two therapeutic vaccines (TG4001 for the treatment of HPV-positive cancers, and TG4050, the first individualized therapeutic vaccine based on the myvac® platform) and two oncolytic viruses (TG6002 for the treatment of solid tumors, and BT-001, the first oncolytic virus based on the Invir.IO™ platform).

With myvac®, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. This immunotherapy allows the generation of a virus-based therapeutic vaccine that encodes patient-specific mutations identified and selected by an Artificial Intelligence.

With its proprietary platform Invir.IO™, Transgene also builds on its expertise in viral vector engineering to design a new generation of multifunctional oncolytic viruses.

Additional information about Transgene is available at: .

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About BioInvent

BioInvent International AB (OMXS: BINV) is a clinical stage company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapies, with two ongoing Phase l/ll clinical trials for the treatment of hematological cancer and solid tumors, respectively. Two preclinical programs in solid tumors are expected to have entered clinical trials by the end of 2020. The Company’s validated, proprietary F.I.R.S.T™ technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company’s fully integrated manufacturing unit. More information is available at .

Disclaimer

This press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. The occurrence of any of these risks could have a significant negative outcome for the Company’s activities, perspectives, financial situation, results, regulatory authorities’ agreement with development phases, and development. The Company’s ability to commercialize its products depends on but is not limited to the following factors: positive pre-clinical data may not be predictive of human clinical results, the success of clinical studies, the ability to obtain financing and/or partnerships for product manufacturing, development and commercialization, and marketing approval by government regulatory authorities. For a discussion of risks and uncertainties which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Document de Référence, available on the AMF website () or on Transgene’s website (). Forward-looking statements speak only as of the date on which they are made and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.

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