Transgene - NEOVIVA Project Supporting the Development of myvac™ Awarded a €5.2 Million Grant from Bpifrance’s “Investments for the Future” Programme

Transgene (Euronext Paris:TNG), a biotech company that designs and develops virus-based immunotherapies against cancers and infectious diseases, announces that the NEOVIVA project was selected by the “Investments for the Future” (IFP) Programme (Programme d’Investissements d’Avenir) operated by Bpifrance for the development of an industrial sector focused on Transgene’s individualized immunotherapy platform myvac™. Under the agreement, the NEOVIVA project will receive €5.2 million over the five-year duration of the program from Bpifrance, of which Transgene will receive €2.6 million.

Transgene holds the intellectual property of the myvac™ platform and is actively working to further develop this innovative technology in collaboration with its three French partners participating in the NEOVIVA project: HalioDx in Marseille, Traaser in Evry and the Curie Institute in Paris. The NEOVIVA project complements the already existing collaboration between Transgene and the Japanese company NEC focused on the clinical validation of an individualized immunotherapy based on artificial intelligence.

The goal of the NEOVIVA project is to develop and validate a manufacturing approach that would provide all solutions needed for the development of individualized immunotherapies. These are designed to stimulate the patient’s immune system to recognize and kill cancer cells by using their own genetic mutations. Two proof of concept clinical trials are being prepared in Europe and US for the treatment of HPV-negative head and neck cancers and ovarian cancer. These are expected to start in H2 2019.

“We would like to thank Bpifrance for its financial support which will accelerate the development of myvac™. This funding is a further recognition of the myvac™ platform and reinforces our ambition to stand as a world leader in the development of individualized viral-vector (MVA) based immunotherapies. We believe the synergies among our partners and their respective teams are highly complementary and harness creativity which will lead to the success of our project. We are delighted to have access to our partners’ expertise through the NEOVIVA project,” said Philippe Archinard, CEO and Chairman of Transgene.

Aïcha Douhou, Leader of the Health sector at the innovation department, Bpifrance commented: “We are delighted to support Transgene and its partners HalioDX, Traaser and the Curie Institute in their innovative approach for the design and development of individualized immunotherapy against solid tumors. We expect this project to further boost the development of Transgene bioproduction manufacturing unit for this individualized immunotherapy.“

This consortium which combined bio-engineering, bioIT and a recognized know-how in viral vectorisation will be led by Transgene and each partner will contribute to the project as follows:

• Transgene will be responsible for the project’s strategy and the clinical development plan. The product design for each patient will be generated in collaboration with NEC which will provide bioIT predictions needed to finalise the immunotherapy. Transgene will also manufacture the myvac^TM clinical batches in its pilot manufacturing unit on the short timelines required for the treatment;
• Traaser will be in charge of the interpretation of the genomic profiles determined by DNA sequencing. This will be used to facilitate, guide and secure the study of the individualized virotherapy artificial intelligence algorithms results;
• HalioDx will study biomarkers to monitor and maximize the clinical efficacy of myvac^TM with Immunogram, a high-tech clinical research platform that includes a suite of proprietary tests including Immunosign® and the Immunoscore® assay suite;
• The Curie Institute (Immunotherapy Cancer Centre, led by Dr Amigorena) will contribute to the project in generating translational data and characterizing the therapy’s mechanism of action.

ABOUT TRANSGENE

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.IO™, Transgene builds on its expertise in viral vectors engineering to design a new generation of multifunctional oncolytic viruses.

myvac^TM, an individualized MVA-based immunotherapy platform designed to integrate neoantigens, completes this innovative research portfolio. TG4050 is the first candidate selected from the myvac™ platform.

Additional information about Transgene is available at www.transgene.fr.

Follow us on Twitter: @TransgeneSA

ABOUT THE PROGRAMME D’INVESTISSEMENTS D’AVENIR

With €57 billion, the Programme d’Investissements d’Avenir (PIA), led by the Secrétariat général pour l’investissement was founded by the government to finance innovative projects in France. Six national priorities were identified to allow the country to increase its growth and employment potential:

• Higher education, research and course program,
• Research appreciation and transfer to the economic world,
• Durable development,
• Industry and small-medium companies,
• Digital economy,
• Heatlh and biotechnology.

The third part of the PIA, the PIA 3, is part of the Grand Plan d’Investissement (GPI) that was presented by the Prime Minister in September 25, 2017.

Additional information is available at www.gouvernement.fr/secretariat-general-pour-l-investissement-sgpi.

Twitter : @SGPI_avenir.

ABOUT BPIFRANCE

Bpifrance is the French national investment bank: it finances businesses – at every stage of their development –through loans, guarantees, equity investments and export insurances.

Bpifrance also provides extrafinancialservices (training, consultancy..). to help entrepreneurs meet their challenges (innovation, export…).

For more information, please visit: www.bpifrance.fr and presse.bpifrance.fr

Follow us on Twitter: @Bpifrance -@BpifrancePresse

ABOUT TRAASER

Traaser (www.traaser.com ) is an innovative digital health company, specialized in the development of software services for personalized medicine. Traaser, located at Genopole in Evry (France) and winner of the 2016 World Innovation Contest, uses artificial intelligence (AI) tools for the collection, management and interpretation of sequencing data in their clinical and therapeutic context in order to meet crucial needs of modern genomic analysis. Diagen™, its comprehensive, scalable, medical-grade expert system based on an industry-leading proprietary methodology, provides a rapid access to patient’s genome information, improving diagnosis and patient care. Data organized by the system lead to the improvement and potential discovery of new therapeutic options for patients.

Please contact: Célia Ringeval, Amalthea : 01 76 21 67 55, cringeval@amalthea.fr or contact@traaser.com

ABOUT HALIODX

HalioDx is an immuno-oncology diagnostic company providing oncologists with first-in-class Immune-based diagnostic products and services to guide cancer care and contribute to precision medicine in the era of immuno- oncology and combination therapies. Immunoscore® proprietary technology, pioneered by Jeìrôme Galon at the Cordeliers Research Center, Paris, France, integrates immunohistochemistry combined with sophisticated algorithm and advanced imaging analysis enabling extraction of spatially-organized tissue molecular information.

Immunoscore® is a platform for many cancers, as immune response to tumor is a key hallmark of disease progression. HalioDx collaborates with renowned international clinical groups to support clinical utility and ensure rigorous performance validation of its assays in selected cancer indications.

HalioDx has an experienced team of more than 135 employees, CLIA-certified laboratories and compliant facilities in Europe and in the US to develop, manufacture, register and market in vitro diagnostic (IVD) products. HalioDx executes biomarker studies and companion diagnostic assay development in conformity with regulations and in partnership with biopharmaceutical companies. The company co-founded the European immunology cluster Marseille Immunopôle (MI).

For more information, please visit our websites www.haliodx.com and www.immunoscore-colon.com and follow the company on Twitter @HalioDx.

ABOUT INSTITUT CURIE & CARNOT CURIE CANCER

Institut Curie, a leading player in the fight against cancer, combines a leading French research center in oncology and a state-of-the-art hospital group that treat all types of cancer, including the rarest. Founded in 1909 by Marie Curie, the Institut Curie brings together more than 3,500 researchers, physicians and healthcare professionals around its three missions: care, research and teaching. As a private foundation recognized for public utility, Institut Curie is authorized to receive donations and bequests and can, thanks to the support of its donors, accelerate discoveries and thus improve the treatment and the quality of life of the patients. For more information: www.institut-curie.org

Since 2011, Institut Curie is certified “Institut Carnot Curie Cancer”. The Carnot label is a label of excellence granted to academic research structures with proven high quality and involvement in partnership research. Curie Cancer offers industrial partners the opportunity to set up research collaborations, benefiting from the expertise of the Institut Curie teams, for the development of innovative therapeutic solutions against cancers from the therapeutic target to clinical validation.

For more information: www.instituts-carnot.eu/fr/institut-carnot/curie-cancer

Disclaimer

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. There can be no guarantee that (i) the results of preclinical work and prior clinical trials will be predictive of the results of the clinical trials currently underway, (ii) regulatory authorities will agree with the Company’s further development plans for its therapies, or (iii) the Company will find development and commercialization partners for its therapies in a timely manner and on satisfactory terms and conditions, if at all. The occurrence of any of these risks could have a significant negative outcome for the Company’s activities, perspectives, financial situation, results and development.

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 Risques”) section of the Document de Reìfeìrence, 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.

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