STRASBOURG, France--(BUSINESS WIRE)--Regulatory News:
Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies against cancers and infectious diseases, announces its decision to initiate clinical developments of its lead myvacTM candidate, TG4050, and the finalization of its collaboration agreement with NEC. This product is designed and manufactured by Transgene using its proprietary platform myvacTM (*1) and integrating neoantigens selected by NEC’s Neoantigen Prediction System (*2).
TG4050 capitalizes on the tremendous progress in the field of artificial intelligence (AI) and on advances in genome sequencing to create an individualized immunotherapy, targeted to mutated antigens identified by sequencing and predicted to be relevant target by the NEC’s algorithm.
Transgene will be responsible for the clinical development and will sponsor two clinical studies starting in H2 2019:
- A study in ovarian cancer patients after first line surgery and chemotherapy
- A study in head and neck cancer patient after surgery and radiation therapy.
These studies, which will be co-financed by Transgene and NEC, will evaluate safety and immunogenicity of TG4050 and, pave the way for combination studies with different classes of therapies.
“Individualized vaccination is being increasingly perceived as a promising therapeutic modality to specifically activate the immune system to attack tumor cells. We are pleased, together with NEC, to be advancing in the clinic TG4050 in H2 2019. We are confident that this approach has the potential to transform the treatment of a broad range of solid tumors,” said Éric Quéméneur, Pharm.D., Ph.D., Executive VP, Chief Scientific Officer of Transgene.
“Individualized immunotherapy is a breakthrough science which holds great promises to achieve clinical benefits for cancer patients. We are honored to partner with Transgene in the initiation of these clinical trials this year. The success of this product would create immense impact that could improve the quality of life for many cancer patients”, commented Osamu Fujikawa, Senior Vice President, Business Innovation Unit, of NEC Corporation.
myvacTM is a viral vector (MVA) based, individualized immunotherapy platform that has been developed by Transgene to target solid tumors. The 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.
*2) NEC’s Neoantigen Prediction System
NEC’s neoantigen prediction utilizes its proprietary 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.
Transgene (Euronext: TNG) is a publicly traded French biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing infected or cancerous cells. The Company’s lead clinical-stage programs are: TG4010, a therapeutic vaccine against non-small cell lung cancer, Pexa-Vec, an oncolytic virus against liver cancer, and TG4001, a therapeutic vaccine against HPV-positive head and neck cancers. The Company has several other programs in clinical development, including TG1050 (a therapeutic vaccine for the treatment of chronic hepatitis B) and TG6002 (an oncolytic virus for the treatment of solid tumors).
With its proprietary Invir.IOTM, Transgene builds on its expertise in viral vectors engineering to design a new generation of multifunctional oncolytic viruses.
myvacTM, an individualized MVA-based immunotherapy platform designed to integrate neoantigens, completes this innovative research portfolio. TG4050, the first candidate selected from the myvacTM platform, will enter the clinic for the treatment of ovarian cancer and head and neck cancer.
Additional information about Transgene is available at www.transgene.fr
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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 any of these risks could have a significant negative outcome for the Company’s activities, perspectives, financial situation, results, regulatory authorities’ agreement with development phases, and development. The Company’s ability to commercialize its products depends on but is not limited to the following factors: positive pre-clinical 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 commercialization, and marketing approval by government regulatory authorities. For a discussion of risks and uncertainties which 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 (“Facteurs de Risque”) section of the Document de Référence, available on the AMF website (http://www.amf-france.org) or on Transgene’s website (www.transgene.fr). Forward-looking statements speak only as of the date on which they are made and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.