The first results of the randomized Phase II trial evaluating the combination of TG4001 with avelumab versus avelumab alone in patients with HPV16-positive, recurrent or metastatic cervical and anogenital tumors show that the primary objective ( improvement in progression-free survival) was not achieved
A subgroup analysis, planned in the protocol, showed a positive trend in terms of effectiveness in favor of the treatment containing TG4001, in patients with cervical cancer
Transgene will conduct a comprehensive data analysis before defining the next steps in clinical development for TG4001
Transgene will hold a conference call on Monday October 14 at 3:30 p.m.
Strasbourg, France, October 14, 2024, 7:30 a.m. – Transgene (Euronext Paris : TNG)a biotechnology company that designs and develops cancer immunotherapies based on viral vectors, announces that in the randomized Phase II study which evaluated TG4001 in combination with avelumab versus avelumab alone in patients with cervical cancer uterus and HPV16-positive, recurrent or metastatic anogenital cancers, the main objective (improved progression-free survival) was not achieved.
The subgroup analysis, as planned in the protocol, showed a positive trend in terms of effectiveness in favor of the combination treatment containing TG4001 in patients with cervical cancer. These results require additional analyzes including by PD-L1 status. These patients represent approximately half of the patients recruited in the study.
The treatment was well tolerated. Adverse effects are consistent with previous observations.
Transgene is currently carrying out a full analysis of the study results to determine the next steps in clinical development for this program and will communicate on this subject at a later date.
Dr. Alessandro Riva, President and CEO of Transgene, comments : “We are disappointed that the objective The primary objective of the Phase II study with TG4001 has not been achieved. Nevertheless, in the subgroup of patients with cervical cancer, the positive trend in effectiveness in favor of the TG4001-containing treatment is encouraging. We plan to perform a comprehensive and rigorous analysis of the data before determining the next steps in the clinical development of this asset, particularly in cervical cancer, taking into account the evolving therapeutic landscape. The full results of the study will be presented at an upcoming scientific conference. We would like to thank all patients and caregivers who participated and contributed to this study. Transgene relies on a portfolio of diversified products targeting solid tumors. Our strategy remains focused on the continued development of our main asset, TG4050, an individualized therapeutic vaccine evaluated in the adjuvant treatment of head and neck cancers after surgery. Additional data, relating to the median 24-month follow-up of patients in Phase I of our study in this indication, will be presented in November 2024 at the SITC conference. »
A conference call in English will take place today, October 14, 2024, at 3:30 p.m. (Paris time).
Webcast link to the conference:
Link to obtain a telephone number for participants:
An audio recording will also be available on the company’s website: www.transgene.fr after the conference.
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Contacts
About TG4001
TG4001 (tipapkinogen sovacivec) is a therapeutic vaccine candidate based on a highly attenuated, non-replicating Vaccinia virus (MVA) that expresses the E6 and E7 antigens of the HPV16 virus (human papillomavirus type 16) and an adjuvant, interleukin 2 (IL-2). TG4001 was developed to act against the HPV virus using a dual approach: alerting the immune system specifically against cells infected by HPV16 presenting the E6 and E7 antigens, which are located in tumors induced by this papillomavirus and, thanks to the interleukin 2 (IL-2), stimulate the viral clearance activity of the immune system. TG4001 has already been administered to more than 350 individuals. Its mechanism of action and excellent safety profile make TG4001 a relevant candidate for combinations with other therapies against solid tumors.
About the trial
This multicenter, open-label, randomized Phase II trial (NCT03260023) is designed to evaluate the efficacy of the combination of immunotherapies TG4001 plus avelumab versus avelumab alone in patients with advanced, recurrent or metastatic HPV16-positive anogenital cancer that has failed. after a maximum of one line of systemic treatment, or who cannot receive a first line of chemotherapy. The entire study included 100 patients.
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 several immunotherapies in clinical development: TG4050, the first individualized treatment from the platform myvac®, TG4001, a therapeutic vaccine developed in HPV-positive cancers, as well as TG6002, BT-001, and TG6050, three oncolytic viruses based on the patented virus of the Invir.IO® platform.
With myvac®, therapeutic vaccination enters precision medicine with innovative immunotherapy specific to each patient. This immunotherapy makes it possible to integrate, into a viral vector, tumor mutations identified and selected using artificial intelligence provided by its partner NEC.
Invir.IO®, a platform resulting from Transgene’s expertise in viral vector engineering, makes it possible to design a new generation of multifunctional oncolytic viruses.
More information on www.transgene.fr.
Follow us on social media: Twitter: @TransgeneSA and LinkedIn: @Transgene
Transgene forward-looking statements
This press release contains forward-looking information and/or statements that may be affected by a number of hazards and uncertainties, such that actual results could differ significantly from those anticipated. There is no guarantee (i) that the results of prior preclinical work and 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 market its therapies within reasonable time frames and under satisfactory conditions. The occurrence of these risks could have a significant negative impact on the Company’s activities, its prospects, its financial situation, its results or its developments. For a description of the risks and uncertainties likely to affect the results, financial situation, performance or achievements of the Company and thus cause a variation from the forward-looking statements, please refer to the “Risk Factors” section. of the Universal Registration Document filed with the AMF and available on the websites of the AMF (www.amf-france.org) and the Company (www.transgene.fr). Forward-looking statements speak only as of the date hereof and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.
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