Transgene and BioInvent’s Armed Oncolytic Virus BT-001 Shows Positive Local, Abscopal, and Sustained Antitumoral Activity in Advanced Refractory Tumors

BT-001 in combination with pembrolizumab is well tolerated and shows sustained antitumoral activity in both injected and non-injected lesionsData support further development of BT-001 in solid tumors to improve response to cancer immunotherapyStrasbourg, France, and Lund, Sweden, October 20, 2025, 08:30 a.m. CEST –Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer,andBioInvent International AB...

Illkirch Graffenstaden, 20/10/2025 (informazione.news - comunicati stampa - economia)

BT-001 in combination with pembrolizumab is well tolerated and shows sustained antitumoral activity in both injected and non-injected lesions

Data support further development of BT-001 in solid tumors to improve response to cancer immunotherapy

Strasbourg, France, and Lund, Sweden, October 20, 2025, 08:30 a.m. CEST – and a biotech company focused on the discovery and development of novel and first-in-class antibodies for cancer immunotherapy, at the 2025 European Society for Medical Oncology (ESMO) Annual Meeting

The data show that intra-tumoral (IT) injection in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) intravenous (IV) anti-PD-1 therapy KEYTRUDA® (pembrolizumab ), was

Translational analyses reveal  after treatment with BT-001 in combination with pembrolizumab. Significant tumor shrinkage (≥30% decrease in longest diameter) was observed in five of 16 injected lesions (in three patients with melanoma and one patient with sarcoma). Four patients had

(PRs) were observed in a patient with melanoma resistant to anti-PD-1/anti-CTLA-4 combination therapy and in a heavily pre-treated, PD-L1 negative leiomyosarcoma patient.

The overall data support further development of BT-001 across a range of solid tumors to improve responses to cancer immunotherapies.

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Transgene and BioInvent are co-developing BT-001, an oncolytic virus developed using Transgene’s Invir.IO® platform armed to express GM-CSF and BioInvent’s full-length anti-CTLA-4 monoclonal antibody, to elicit a strong and effective anti-tumoral response in solid tumors.

, can be accessed at the websites for the ESMO conference, Transgene and BioInvent.

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Transgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. The Company’s clinical-stage programs consist of a portfolio of viral vector-based immunotherapeutics. TG4050, the first individualized therapeutic vaccine based on the platform is the Company’s lead asset, with demonstrated proof of principle in patients in the adjuvant treatment of head and neck cancers. The Company has other viral vector-based assets, including BT-001, an oncolytic virus based on the Invir. IO® viral backbone, which is in clinical development. The Company also conducts innovative discovery and preclinical work, aimed at developing novel viral vector-based modalities.
With Transgene’s platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The 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.
Additional information about Transgene is available at: www.transgene.com
Follow us on social media: X (formerly Twitter): @TransgeneSA — LinkedIn: @Transgene — Bluesky: @Transgene

BT-001 is an oncolytic virus, from Transgene’s invir.IO® platform, with enhanced replication selectivity in tumor cells and recombinantly armed to express an anti-CTLA4 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 designed to induce a strong and effective anti-tumor response and by limiting systemic exposure, this approach aims to significantly improve the safety and tolerability profile of the human anti-CTLA-4 antibody. The ongoing Phase I/IIa trial (NCT04725331) is a multi-center, open-label study, and aims to evaluate safety and antitumor activity of intratumoral BT-001 alone and in combination with pembrolizumab in patients with advanced solid tumors.

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 several drug candidates in ongoing clinical programs in Phase 1/2 studies for the treatment of hematological cancer and solid tumors, respectively. The Company’s validated, proprietary F.I.R.S.T.™ technology platform 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 and providing licensing and partnering opportunities.
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

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