Transgene and NEC Start Two Clinical Trials with TG4050, an Individualized AI-Powered Cancer Vaccine for Ovarian and Head & Neck Cancers

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Regulatory Information:

Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech firm that designs and develops virus-based immunotherapies for the therapy of most cancers, and NEC Company (NEC; TSE: 6701), a pacesetter in IT and community applied sciences, at this time introduced that the primary sufferers have been enrolled within the first-in-human trials evaluating TG4050, an individualized therapeutic vaccine primarily based on the myvac™ know-how and powered by NEC’s cutting-edge AI capabilities. In these Part 1 trials, TG4050 is being administered to sufferers with head and neck most cancers who’ve a excessive threat of relapse after surgical procedure and sufferers with ovarian most cancers after surgical procedure and adjuvant remedy.

Transgene’s extremely modern myvac™ know-how permits the era of a virus-based immunotherapy inside a really quick timeframe whereas encoding patient-specific mutations recognized and chosen by NEC’s Neoantigen Prediction System.

TG4050 has been designed to focus on as much as 30 patient-specific neoantigens (most cancers cell mutations). They’re chosen utilizing NEC’s Neoantigen Prediction System, a sophisticated AI know-how that has already been utilized within the area of oncology. The prediction system is predicated on greater than twenty years of experience in AI and has been educated on proprietary immune knowledge, permitting it to precisely prioritize and choose probably the most immunogenic sequences.

Transgene makes use of its experience in viral vectorization through myvac™ to include the chosen neoantigen sequences within the genome of the Modified Vaccinia virus Ankara (MVA) viral vector. The Firm has additionally arrange a novel in-house good manufacturing follow (GMP) unit devoted to the manufacturing of the individualized batches of TG4050 wanted for the medical growth of this novel therapeutic vaccine.

“As every affected person’s most cancers is exclusive, now we have developed a remedy that turns their stable tumor’s genetic signature into a strong extremely particular anticancer weapon. TG4050 is predicated on an MVA viral vector that has confirmed organic exercise and has the power to elicit an immune response in opposition to tumor antigens. Our partnership with NEC ensures that TG4050 is benefitting from its world-leading experience in synthetic intelligence and its distinctive algorithm that’s used to pick as much as 30 patient-specific antigens that permit this novel vaccine to induce a robust immune response. We’re satisfied that TG4050, which is on the crossroad of immunotherapy and massive knowledge sciences, will herald the beginning of a brand new period within the combat in opposition to most cancers,” defined Philippe Archinard, Chairman and Chief Govt Officer of Transgene.

“We’re excited to enroll our first sufferers in these trials and see TG4050 advance to the clinic. That is one other step nearer in direction of the conclusion of an AI-driven individualized immunotherapy for every affected person. Our distinctive partnership with Transgene allows us to leverage its important medical growth know-how and confirmed viral vector supply platform. We’re hopeful that TG4050 will make a major distinction for sufferers all through the world,” commented Osamu Fujikawa, Senior Vice President, NEC Company.

A Part 1 medical trial of TG4050 is enrolling sufferers with ovarian most cancers after surgical procedure and first-line chemotherapy. This multicenter, one-arm trial will recruit sufferers within the USA and in France. Endpoints of the trial embrace security, feasibility and organic exercise of the therapeutic vaccine. Dr. Matthew Block, immunologist and medical oncologist on the Mayo Clinic, is conducting the trial within the USA; in France, the trial will probably be performed by Dr. Martinez at Toulouse-Oncopole and by Pr. Le Tourneau at Institut Curie.

One other Part 1 medical trial of TG4050 is enrolling sufferers with newly identified, locoregionally superior, HPV unfavorable, squamous cell carcinoma of the top and neck (SCCHN) who’ve obtained an adjuvant remedy after surgical procedure. This multicenter, open label, randomized two arms trial will embrace sufferers within the UK and in France. Sufferers will obtain both TG4050 monotherapy after completion of the adjuvant remedy or together with the usual of care on the time of recurrence. Endpoints of the trial embrace security, feasibility and organic exercise of the therapeutic vaccine. In France, the trial is being performed by Pr. Delord at Toulouse-Oncopole and by Pr. Le Tourneau at Institut Curie; within the UK, the trial is coordinated by Pr. Ottensmeier from Southampton College.

Each research are sponsored by Transgene and are co-financed by Transgene and NEC.

About TG4050

TG4050 is an individualized immunotherapy primarily based on Transgene’s myvac™ know-how and powered by NEC’s synthetic intelligence. This virus-based therapeutic vaccine encodes neoantigens (patient-specific mutations) recognized and chosen by NEC’s Neoantigen Prediction System. The prediction system is predicated on greater than twenty years of experience in AI and has been educated on proprietary knowledge permitting it to precisely prioritize and choose probably the most immunogenic sequences.

TG4050 is designed to stimulate the immune system of sufferers as a way to induce a T-cell response that is ready to acknowledge and destroy tumor cells primarily based on their very own neoantigens. This individualized immunotherapy is developed for every affected person and might be produced in a really quick timeframe.

About myvac

myvac™ is a viral vector (MVA) primarily based, individualized immunotherapy platform that has been developed by Transgene to focus on stable tumors. myvac™-derived merchandise are designed to stimulate the affected person’s immune system, acknowledge and destroy tumors utilizing the affected person’s personal most cancers particular genetic mutations. Transgene has arrange an modern community that mixes bioengineering, digital transformation, established vectorization know-how and distinctive manufacturing capabilities. Transgene has been awarded an “Funding for the Future” funding from Bpifrance for the event of its platform myvac™. TG4050 is the primary myvac™-derived product being evaluated in medical trials.

About NEC’s Neoantigen Prediction System

NEC’s neoantigen prediction makes use of its proprietary synthetic intelligence (AI), corresponding to graph-based relational studying, which is mixed with different sources of knowledge to find candidate neoantigen targets. NEC comprehensively evaluates the candidate neoantigens with a major focus positioned on its in-house main histocompatibility complicated (MHC) binding affinity prediction educated on public and proprietary datasets. These permit NEC to successfully prioritize the quite a few candidate neoantigens recognized in a single affected person.

About Transgene

Transgene (Euronext: TNG) is a publicly traded French biotechnology firm targeted on designing and growing focused immunotherapies for the therapy of most cancers and infectious illnesses. Transgene’s applications make the most of viral vector know-how with the purpose of not directly or straight killing contaminated or cancerous cells. The Firm’s clinical-stage applications are TG4001, a therapeutic vaccine in opposition to HPV-positive cancers, TG6002, an oncolytic virus for the therapy of stable tumors, and TG4050, the primary individualized therapeutic vaccine primarily based on the myvac™ platform.

With its proprietary platform Invir.IO®, Transgene additionally builds on its experience in viral vectors engineering to design a brand new era of multifunctional oncolytic viruses.

Further details about Transgene is obtainable at: www.transgene.fr.

Comply with us on Twitter: @TransgeneSA

About NEC Company

NEC Company is a pacesetter within the integration of IT and community applied sciences that profit companies and folks world wide. The NEC Group globally offers “Options for Society” that promote the protection, safety, effectivity and equality of society. Below the corporate’s company message of “Orchestrating a brighter world,” NEC goals to assist resolve a variety of difficult points and to create new social worth for the altering world of tomorrow. For extra data, go to NEC at www.nec.com.

Disclaimer

This press launch comprises forward-looking statements, that are topic to quite a few dangers and uncertainties, which might trigger precise outcomes to vary materially from these anticipated. The incidence of any of those dangers might have a major unfavorable consequence for the Firm’s actions, views, monetary state of affairs, outcomes, regulatory authorities’ settlement with growth phases, and growth. The Firm’s potential to commercialize its merchandise depends upon however is just not restricted to the next components: optimistic pre-clinical knowledge is probably not predictive of human medical outcomes, the success of medical research, the power to acquire financing and/or partnerships for product manufacturing, growth and commercialization, and advertising approval by authorities regulatory authorities. For a dialogue of dangers and uncertainties which might trigger the Firm’s precise outcomes, monetary situation, efficiency or achievements to vary from these contained within the forward-looking statements, please confer with the Danger Components (“Facteurs de Risque”) part of the Doc de Référence, obtainable on the AMF web site (http://www.amf-france.org) or on Transgene’s web site (www.transgene.fr). Ahead-looking statements communicate solely as of the date on which they’re made and Transgene undertakes no obligation to replace these forward-looking statements, even when new data turns into obtainable sooner or later.



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