First clinical data presented at ESMO 2024 show that BT-001 induces tumor size reduction in patients with treatment failure
In a patient with heavily pretreated sarcoma, BT-001 has the ability to reheat tumors, increasing T cell infiltration and PD(L)-1 expression in tumors
In combination with KEYTRUDA® (pembrolizumab), the first signs of efficacy with clinical responses in 2 out of 6 patients with treatment failure are observed
Strasbourg, France, and Lund, Sweden, on September 14, 2024, 9:05 a.m. — Transgene (Euronext Paris : TNG)a biotechnology company that designs and develops cancer immunotherapies based on viral vectors, and BioInvent International AB (« BioInvent ») (Nasdaq Stockholm : BINV)a biotechnology company dedicated to the discovery and development of innovative immunomodulatory antibodies against cancer, announce today that New clinical data from ongoing Phase I/IIa study of multifunctional oncolytic virus BT-001demonstrating antitumor activity in patients with treatment failure.
The data presented at the congress of the European Society of Medical Oncology (ESMO), show that BT-001 induces antitumor activity in resistant tumors to PD(L)1, both as monotherapy and in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab).
Preliminary translational data suggest that BT-001 replicates in the tumor and transgenes are expressed without observed systemic toxicity. BT-001, alone or in combination with pembrolizumab, is well tolerated and has shown the first signs of effectiveness with clinical responses in 2/6 patients with treatment failure when administered in combination with pembrolizumab. Treatment with BT-001 warms the tumor microenvironment, induces positive tumor remodeling, and results in T cell infiltration, higher M1/M2 ratio, and PD(L)-1 expression in tumors.
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Dr. Stéphane Champiat, Medical Oncologist, Head of the Hospitalization Unit, Department of Therapeutic Innovation and Early Trials of the Gustave Roussy Cancer Center (DITEP)add: “The immunological data generated by BT-001 suggest that, as expected, BT-001 replicates within the tumor and expresses its transgenes within the tumor, thereby limiting systemic toxicity. I look forward to additional results from this ongoing study, which will provide further evidence of the safety and clinical activity of BT-001 and its potential as a novel therapy for patients with solid tumors.”
Transgene and BioInvent are co-developing BT-001, an oncolytic virus from Transgene’s Invir.IO® platform, armed with GM-CSF and BioInvent’s anti-CTLA-4 monoclonal antibody with the potential to induce a strong and effective anti-tumor response in solid tumors.
Dr. Alessandro Riva, Chairman and CEO of Transgenecomments: “We are pleased to present promising first clinical data on BT-001 at ESMO 2024, confirming its mechanism of action as an intratumoral monotherapy and showing early signs of anti-tumor activity. In addition to its favorable safety profile as monotherapy or in combination with pembrolizumab, BT-001 has the potential to shrink lesions and induce disease stabilization in patients who have failed treatment and have limited treatment options. We will continue to explore the safety profile and efficacy of BT-001 in the development program with our partner BioInvent and will report additional data as they become available.”
Andres McAllister, MD, PhD, Chief Medical Officer at BioInvent International ABconclu : “The first clinical results of BT-001 presented at ESMO, which encodes both a recombinant human anti-CTLA-4 antibody, generated by our proprietary n-CoDeR®/FIRST™ platforms, and the human cytokine GM-CSF are very encouraging. This clinical proof of concept confirms our ability to identify antibodies that bind to a selected target, enabling the development of promising new drug candidates such as BT-001.”
Title of the poster and abstract: “ Initial clinical results of BT-001, an oncolytic virus expressing an anti-CTLA4 mAb administered as single agent and in combination with pembrolizumab in patients with advanced solid tumors. » are available on the websites of theSMO and of Transgene.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
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About the trial
The Phase I/IIa trial (NCT : 04725331) is an ongoing, multicenter, open-label study evaluating ascending doses of BT-001 alone and in combination with pembrolizumab (anti-PD-1 therapy). This trial is active in Europe (France and Belgium) and has been authorized in the United States.
The Phase I trial is organized in two parts. In Part A, BT-001 was administered as monotherapy via intratumoral injections in patients with advanced/metastatic solid tumors. Part B is designed to evaluate intratumoral injections of BT-001 in combination with KEYTRUDA. In this part of the trial, KEYTRUDA is made available by MSD (a registered trademark of Merck & Co, Inc., Rahway, NJ, USA).
Phase IIa is dedicated to the evaluation of this therapeutic combination in multiple cohorts of patients with selected solid tumor types. The expansion of the cohorts will provide the opportunity to explore the potential of this approach for other cancers that are not traditionally treated with this type of treatment.
About BT-001
BT-001 is a patented oncolytic virus based on the proprietary Invir.IO® platform (VVcopTK-RR—). This drug candidate has been designed to express an anti-human CTLA-4 monoclonal antibody that eliminates immunosuppressive cells (Tregs) from BioInvent’s n-CoDeR®/FIRST™ technology and the human cytokine GM-CSF. By selectively targeting the tumor microenvironment, BT-001 aims to induce a strong and effective anti-tumor response. Therefore, by limiting systemic exposure, this approach aims to significantly improve the safety and tolerability profile of the anti-human CTLA-4 antibody. BT-001 is co-developed by Transgene and BioInvent on a 50/50 basis. To learn more about BT-001, watch the video ici.
About Transgene
Transgene (Euronext: TNG) is a biotechnology company that designs and develops immunotherapy products against cancer. These products use viral vectors to directly or indirectly destroy cancer cells.
Transgene’s portfolio consists of therapeutic vaccines and oncolytic viruses: TG4050, the first individualized treatment from the platform myvac®, TG4001, developed in HPV-positive cancers and BT-001 and TG6050, two oncolytic viruses from the Invir.IO® platform.
With myvac®, therapeutic vaccination enters precision medicine with an innovative immunotherapy specific to each patient. This immunotherapy makes it possible to integrate, into a viral vector, tumor mutations identified and selected thanks to artificial intelligence provided by its partner NEC.
Invir.IO®, a platform resulting from Transgene’s expertise in viral vector engineering, enables the design of a new generation of multifunctional oncolytic viruses.
More information on www.transgene.fr
Follow us on social media: Twitter: @TransgeneSA — LinkedIn : @Transgene
About BioInvent
BioInvent International AB (Nasdaq Stockholm: BINV) is a biotechnology company focused on the discovery and development of innovative immunomodulatory antibodies in oncology, with three products in clinical development in four Phase I and II trials targeting hematological cancers and solid tumors. BioInvent’s patented and validated FIRST™ technology platform simultaneously identifies targets and the antibodies that bind to them to generate numerous promising drug candidates; these will expand the company’s portfolio of proprietary products, or may be the subject of partnership and licensing agreements.
The Company generates revenues from research collaborations and licensing agreements with leading pharmaceutical companies, as well as from the production of antibodies on behalf of third parties in the Company’s fully integrated manufacturing facility.
For more information: www.bioinvent.com.
Follow us on X (ex-Twitter): @BioInvent
Transgene Forward-Looking Statements
This press release contains forward-looking information and/or statements that are subject to a number of risks and uncertainties, such that actual results could differ materially from those anticipated. There can be no assurance that (i) the results of preclinical work and prior clinical trials are predictive of the results of clinical trials currently underway, (ii) that regulatory approvals for Transgene’s therapies will be obtained or (iii) that the Company will find partners to develop and commercialize its therapies within a reasonable time frame and under satisfactory conditions. The occurrence of these risks could have a significant negative impact on the Company’s activities, prospects, financial position, results or developments.
For a description of risks and uncertainties that could affect the Company’s results, financial position, performance or achievements and thus cause a variation in relation to the forward-looking statements, please refer to the “Risk Factors” section of the Universal Registration Document filed with the AMF and available on the AMF (www.amf-france.org) and Company (www.transgene.fr).
Forward-looking statements speak only as of the date of this document, and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.
BioInvent Forward-Looking Statements
This press release contains forward-looking statements that are subjective assumptions and predictions of future scenarios. Forward-looking statements speak only as of the date they are made and, by their very nature, like research and development in the biotechnology sector, are subject to risks and uncertainties. As such, actual results may differ materially from the scenarios described in this press release.
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