Transgene and BioInvent Present Preclinical Data Highlighting the Robust Anti-Tumoral Activity of BT-001 Oncolytic Virus at SITC 2021

Rhea-AI Summary

BioInvent (BINV) and Transgene announced promising preclinical data for their oncolytic virus BT-001, designed to combat solid tumors. The findings indicate significant intratumoral expression of an immune checkpoint inhibitor and strong anti-tumoral activity across various models. Currently in a Phase I/IIa trial, BT-001 aims to enhance treatment efficacy while minimizing systemic exposure. Initial results are expected in the first half of 2022, showcasing BT-001's potential role in cancer immunotherapy.

Positive

• Preclinical data demonstrate high antitumoral activity and immune checkpoint inhibition.
• BT-001 shows potential for improved safety by reducing systemic exposure.
• Successful patient inclusion in ongoing Phase I/IIa clinical trial.

Negative

• None.

Data support BT-001’s unique dual mode of action

STRASBOURG, France & LUND, Sweden--(BUSINESS WIRE)-- Regulatory News:

Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, and BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announce preclinical data supporting the mode of action of BT-001, their novel dual mechanism-of-action oncolytic Vaccinia virus. The data demonstrate high intratumoral expression of an immune checkpoint-inhibiting antibody and robust anti-tumoral activity in several tumor models.

BT-001, developed by BioInvent and Transgene, is a clinical phase oncolytic virus engineered to deliver an anti-CTLA-4 antibody and human GM-CSF in a tumor-specific vehicle (the VV_copTK^-RR^- virus backbone) for the treatment of solid tumors.

The companies’ poster at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2021) shows that BT-001 selectively replicates in tumor cells. The murine surrogate of BT-001 delivered sustained and high intratumoral levels of antibody accompanied by low systemic exposure. These differential expression levels were associated with high depletion of intratumoral regulatory T cells (T_reg) but the absence of systemic T_reg depletion. Similar effects in humans would allow BT-001 to deliver powerful antitumor immunity.

Patient inclusion into the ongoing Phase I/IIa clinical study of BT-001 (NCT04725331) is progressing well. The multicenter trial, authorized in Europe and in the U.S., is assessing BT-001 as single agent and in combination with the PD-1 checkpoint inhibitor pembrolizumab for the treatment of solid tumors. Initial Phase I data are expected in the first half of 2022.

Other data highlighted in the SITC poster show improved survival in several syngeneic tumor models following treatment with a murine version of BT-001. There is also evidence of a positive synergistic effect between the murine ‘BT-001’ oncolytic virus expressing the CTLA-4 antibody and a systemic PD-1 checkpoint inhibitor.

“These impressive data, demonstrating the multiple mechanisms of action and anti-cancer properties of BT-001, played a key role in our decision to take this unique oncolytic virus into the clinic. We are pleased to be able to share them with our scientific and clinical peers at SITC” said Martin Welschof, CEO of BioInvent and Hedi Ben Brahim, Chairman and CEO of Transgene.

SITC 2021 will take place on November 10–14, 2021, at the Walter E. Washington Convention Center in Washington, D.C. and virtually. The poster, entitled “Vectorized Treg-depleting aCTLA-4 elicits antigen cross-presentation and CD8+ T cell immunity to reject “cold” tumors”, will be presented on the Virtual ePoster Hall and presented in the Poster Hall (Hall E) on Saturday, November 13, 2021.

Authors: Monika Semmrich, Jean-Baptiste Marchand, Matilda Rehn, Laetitia Fend, Christelle Remy, Petra Holmkvist, Nathalie Silvestre, Carolin Svensson, Patricia Kleinpeter, Jules Deforges, Fred Junghus, Linda Mårtensson, Johann Foloppe, Ingrid Teige, Eric Quéméneur and Björn Frendéus.

Abstract and poster number: 746

About BT-001
BT-001 is an oncolytic virus generated using Transgene’s Invir.IO™ platform and its patented large-capacity VV_copTK^-RR^- oncolytic virus, which has been engineered to encode both a Treg-depleting human recombinant anti-CTLA-4 antibody generated by BioInvent’s proprietary n-CoDeR^®/F.I.R.S.T™ platforms, and the human GM-CSF cytokine. By selectively targeting the tumor microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoral response. As a consequence, by reducing systemic exposure, the safety and tolerability profile of the anti-CTLA-4 antibody will be greatly improved.

BT-001 is being co-developed as part of a 50/50 collaboration on oncolytic viruses between Transgene and BioInvent. To know more on BT-001, watch our video here.

About Transgene
Transgene (Euronext: TNG) is a 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 of two therapeutic vaccines (TG4001 for the treatment of HPV-positive cancers, and TG4050, the first individualized therapeutic vaccine based on the myvac® platform) as well as two oncolytic viruses (TG6002 for the treatment of solid tumors, and BT-001, the first oncolytic virus based on the Invir.IO™ platform).
With Transgene’s myvac® platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac® approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC.
With its proprietary platform Invir.IO™, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses. Transgene has an ongoing Invir.IO™ collaboration with AstraZeneca.
Additional information about Transgene is available at: www.transgene.fr.
Follow us on Twitter: @TransgeneSA

About BioInvent
BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently three drug candidates in four ongoing clinical programs in Phase l/ll trials for the treatment of hematological cancer and solid tumors, respectively. 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 www.bioinvent.com.
Follow us on Twitter: @BioInvent

Transgene 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 Universal Registration Document, available on the AMF website (http://www.amf-france.org) or on Transgene’s website (www.transgene.fr). 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.

BioInvent disclaimer
The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211109005892/en/

Transgene:

Lucie Larguier

Director Corporate Communications & IR

+33 (0)3 88 27 91 04

investorrelations@transgene.fr

Media: MEDiSTRAVA Consulting

David Dible/Sylvie Berrebi

+44 (0)7714 306525

transgene@medistrava.com

BioInvent:

Cecilia Hofvander

Senior Director Investor Relations

+46 (0)46 286 85 50

cecilia.hofvander@bioinvent.com

BioInvent International AB (publ):

Co. Reg. No. Org nr: 556537-7263

Visiting address: Ideongatan 1

Mailing address: 223 70 LUND

Phone: +46 (0)46 286 85 50

www.bioinvent.com

Source: Transgene

FAQ

What is BT-001 and its purpose in cancer treatment?

BT-001 is an oncolytic virus designed to treat solid tumors by delivering an anti-CTLA-4 antibody and GM-CSF, aiming to enhance immune response against cancer.

What are the main findings from the recent BT-001 preclinical data?

The preclinical data indicate high intratumoral expression of an immune checkpoint inhibitor and significant anti-tumoral effects across multiple tumor models.

What phase is the BT-001 clinical trial currently in?

BT-001 is currently in a Phase I/IIa clinical trial, assessing its efficacy as a single agent and in combination with the PD-1 inhibitor pembrolizumab.

When can we expect initial results from the BT-001 trial?

Initial results from the Phase I trial of BT-001 are anticipated in the first half of 2022.

How does BT-001 enhance cancer treatment compared to traditional therapies?

BT-001 uniquely targets the tumor microenvironment, potentially eliciting a stronger antitumor response while minimizing systemic side effects.