On July 10, 2019 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of solid tumors, reported 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 (Press release, Transgene, JUL 10, 2019, View Source [SID1234537466]). 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).
About TG4050
TG4050 is an immunotherapy designed to stimulate the immune system of patients in order to induce a response that is able to recognize and destroy tumor cells in a specific manner.
This personalized immunotherapy is developed for each patient, on the basis of mutations identified through sequencing of tumor tissue, prioritized using NEC’s Neoantigen Prediction System and delivered using the myvacTM technological platform which allows development and manufacture of a product that is specific to each patient and that is within time frames compatible with clinical management.
About myvacTM
myvacTM is a viral vector (MVA) based, individualized immunotherapy platform that has been developed by Transgene to target solid tumors. myvacTM-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, established vectorization know-how and unique manufacturing capabilities. Transgene has been awarded an "Investments for the Future" funding from Bpifrance for the development of its platform myvacTM.
About NEC’s Neoantigen Prediction System
NEC’s neoantigen prediction utilizes its proprietary artificial intelligence (AI), such as graph-based relational learning, which is combined with other sources of data to discover candidate neoantigen targets. NEC comprehensively evaluates the candidate neoantigens with a primary focus placed on its in-house MHC-binding affinity prediction. These allow NEC to effectively prioritize the numerous candidate neoantigens identified in a single patient.