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Transgene Receives MHRA Approval for Lead myvac™ Individualized Immunotherapy, TG4050, to Commence Clinical Development in HPV Negative Head and Neck Cancers in the UK

Phase 1 clinical trial, expected to start in H2 2019, will be co-funded by Transgene and its collaboration partner NEC

Strasbourg, France, July 10, 2019, 5:45 p.m. CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of solid tumors, today announces it has received the approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to proceed with a Phase 1 clinical trial of its lead myvacTM candidate TG4050. TG4050 is being developed as a potential treatment for patients with newly diagnosed, locoregionally advanced, HPV negative, squamous cell carcinoma of the head and neck (SCCHN).

TG4050 is an individualized MVA-based immunotherapy derived from the myvacTM platform. It has been designed to stimulate and educate the patient’s immune system to recognize and destroy tumor cells. Tumor cells accumulate mutations and each patient has a set of mutations that are unique to their tumor. TG4050 has been designed to target a panel of these patient specific mutations, which have been selected using NEC’s Neoantigen Prediction System.

 “This trial builds upon a long-term research collaboration in the field of immunology of cancer between Transgene and the University of Southampton. It will allow us to bring a very innovative individualized approach to patients. I expect the study to provide us with data demonstrating the safety and immunogenicity of TG4050. I believe such personalized vaccine approaches are the next paradigm in cancer care and could redefine the way patients with H&N cancer and other solid tumors will be treated” said lead investigator Pr. Christian Ottensmeier, MD, PhD, FRCP, Professor of Experimental Medicine within Medicine at the University of Southampton.

 The Phase 1 clinical trial of TG4050 will be carried out in patients with SCCHN that have received an adjuvant (first line) therapy. Antitumor activity of TG4050 as monotherapy will also be measured. This multi-center, open label, two arms trial will include patients in the UK and in France.

 The study, sponsored by Transgene, will be co-financed by Transgene and its partner NEC, which will also support the trial by contributing to the therapeutic vaccine design and the selection of target neoantigens (see press release dated March 5, 2019).

 Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene commented, “This approval from MHRA follows our recent IND from the FDA in ovarian cancer, allowing us to conduct Phase 1 clinical trials with TG4050 in both the US and Europe. With our partner NEC, we look forward to updating you on the progress on both of these clinical trials. These studies will also provide us with important insights into the optimal way to manufacture this novel individualized immunotherapy which is made specifically for each cancer patient.”

TG4050 has also been granted an IND from the US FDA to evaluate TG4050 as a potential treatment for ovarian cancer patients (see press release dated May 13, 2019).

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Last Updated: 11-Jul-2019