Transgene to present new positive preliminary Phase I data on TG4050 (myvac® platform), its individualized therapeutic cancer vaccine, at AACR 2022

STRASBOURG, France–(BUSINESS WIRE)–Regulatory news:

Transgene (Euronext Paris: TNG) (Paris: TNG), a biotechnology company that designs and develops virus-based immunotherapies for the treatment of cancer will present a poster with promising new preliminary Phase I data on TG4050, its individualized neo-antigen cancer vaccine, at the 2022 Annual Meeting of the American Association for Cancer Research (AACR). The AACR will take place in New Orleans, Louisiana, USA, April 8 – 13.

The abstract has been accepted for a last-minute session and will be available on the AACR’s online itinerary planner and meeting app on April 8, 2022.

TG4050 is the first candidate based on Transgene’s technology monvac® platform. Powered by NEC’s cutting-edge AI capabilities, TG4050 is being evaluated in two ongoing multicenter Phase I trials in patients with ovarian cancer and head cancer and by the neck.

Poster title: Phase I trials of TG4050 personalized cancer vaccine in patients with high-risk head and neck squamous cell carcinoma (HNSCC) and recurrent ovarian cancer (OvC) treated surgically

  • Session title: Phase I 2 clinical trials
  • Poster and abstract number: CT182
  • Date, time, place: Tuesday April 12, 2022 9:00 – 12:30 CDT, Board 7, Section 33
  • Authors: M. Block, JP Delord, C. Ottensmeier, C. Le Tourneau, A. Lalanne, O. Lantz, K. Knutson, G. Lacoste, A. Tavernaro, M. Brandely, N. Silvestre, B. Grellier, Y Yamashita, O. Kousuke, N. Yamagata, E. Quemeneur, K. Bendjama

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About Clinical Trials

TG4050 is being evaluated in two Phase I clinical trials for patients with ovarian cancer (NCT03839524) and HPV-negative head and neck cancer (NCT04183166).

In first phase I trial, TG4050 is given to patients with HPV negative head and neck cancer. A personalized treatment is created for each patient after surgery and while receiving adjuvant therapy. Half of the participants receive their vaccine immediately after completing their adjuvant therapy. The other half receive TG4050 as an add-on therapy when the disease relapses. This randomized study evaluates the benefits of TG4050 treatment in patients who are at high risk of relapse. Up to 30 patients will receive TG4050 in France, the UK and the US. The principal investigator of the trial is Professor Christian Ottensmeier, MD, PhD, Consultant Medical Oncologist at Clatterbridge Cancer Center and Professor of Immuno-Oncology at the University of Liverpool. In France, the clinical trial is conducted at the Institut Curie, Paris, by Prof. Christophe Le Tourneau, MD, PhD, Head of the Department of Drug Development and Innovation (D3i) and at the IUCT-Oncopole, Toulouse, by Professor Jean-Pierre Delord. In the United States, the trial is led by Dr. Yujie Zhao, MD, PhD, at Mayo Clinic. The endpoints of the trial include the safety, feasibility and biological activity of the therapeutic vaccine.

In parallel, a phase I clinical trial of TG4050 is recruiting patients with ovarian cancer. The first patient was dosed in the United States. This second trial includes patients after surgery and first-line chemotherapy. Dr. Matthew Block, MD, PhD, consultant in medical oncology, consultant in immunology and associate professor of oncology at Mayo Clinic (USA) is the principal investigator of the trial; in France, the trial is led by Pr Le Tourneau, MD, PhD, at the Institut Curie and by Dr Alexandra Martinez, MD, associate head of surgery, at the IUCT-Oncopole. The endpoints of the trial include the safety, feasibility and biological activity of the therapeutic vaccine.

The first positive preliminary data on these two phase I trials were communicated in November 2021.

More information can be found here, or in a short video here.

On myvac®

monvac® is a viral vector (MVA – Modified Vaccinia Ankara) individualized immunotherapy platform developed by Transgene to target solid tumors. monvac®-derived products are designed to stimulate the patient’s immune system, recognize and destroy tumors using the patient’s own cancer-specific genetic mutations. Transgene has set up an innovative network that combines bioengineering, digital transformation, recognized know-how in vectorization and unique manufacturing capabilities. Transgene wins “Investment for the Future” funding from Bpifrance for the development of its platform monvac®. TG4050 is the first monvac®-derived product being evaluated in clinical trials.

Click on here to watch a short video on monvac®.

About TG4050

TG4050 is an individualized immunotherapy in development for solid tumors based on the monvac® and drawing on NEC’s longstanding expertise in artificial intelligence (AI). This therapeutic virus-based vaccine encodes neo-antigens (patient-specific mutations) identified and selected by NEC’s neo-antigen prediction system. The prediction system is based on more than two decades of AI expertise and was trained on proprietary data allowing it to prioritize and accurately select the most immunogenic sequences.

TG4050 is designed to stimulate the patient’s immune system to induce a T cell response capable of recognizing and destroying tumor cells based on their own neo-antigens. This individualized immunotherapy is developed and produced for each patient.

About Transgene

Transgene (Euronext: TNG) is a biotechnology company specializing in the design and development of targeted immunotherapies for the treatment of cancer. Transgene’s programs use viral vector technology to indirectly or directly kill 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 monvac®) 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 monvac®, therapeutic vaccination enters the field of precision medicine with a new immunotherapy fully adapted to each individual. the monvac® enables the generation of virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC.

With its proprietary Invir.IO™ platform, Transgene relies on its expertise in viral vector engineering to design a new generation of multifunctional oncolytic viruses. Transgene has an ongoing Invir.IO™ collaboration with AstraZeneca.

Additional information on Transgene is available at: www.transgene.fr

Follow us on twitter: @TransgeneSA

Warning

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 one of these risks could have a significant negative impact on the Company’s activities, prospects, financial situation, results, approval of the regulatory authorities on the development phases and development. The Company’s ability to market its products depends, but is not limited to, the following factors: positive preclinical 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 marketing, and marketing approval by governmental regulatory authorities. For a discussion of the risks and uncertainties that 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 section (” Risk Factors”) of the Universal Registration Document, available on the AMF website (http://www.amf-france.org) or on the Transgene website (www.transgene.fr). Forward-looking statements speak only as of the date 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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