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STRASBOURG, France

Regulatory News:

Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today announces that the Japan Patent Office has officially allowed the patent of Transgene’s oncolytic virus (OV) backbone VV_copTK^-RR^- that encodes one or more immune checkpoint inhibitor(s) (ICIs). This authorization in Japan follows similar patent grants obtained in several key other geographies including the US and Europe, providing broad protection of this technology in the key pharmaceutical markets globally. These patents protect Transgene’s VV_copTK^-RR^- backbone encoding one or several ICIs until 2035.

VV_copTK^-RR^- is a large capacity Vaccinia virus Copenhagen strain genetically modified with the double deletion TK^-RR^- which restricts the viral replication to tumor cells only. This proprietary backbone is the basis of Transgene’s Invir.IO™ platform. Candidates based on this viral design aim to stimulate an immune response locally in the tumor and to optimize the safety profile of the virus.

VV_copTK^-RR^- PATENTED BACKBONE IS THE BASIS OF TRANSGENE’S INVIR.IO™ PLATFORM TO DEVELOP MULTIPLE OVs

The new Japanese patent provides further IP by protecting this proprietary oncolytic virus when it encodes one or more ICI(s), a type of immunotherapy already approved and used in several cancer therapies.

Transgene has already obtained patent grants for this new technology in the US, Europe, Australia, Hong Kong, Israel, and Russia. In addition, applications are pending in Canada and in China.

Hedi Ben Brahim, Chairman and CEO of Transgene, said: “This new patent allowance in Japan is significant for Transgene’s Invir.IO™ platform as it further highlights our innovation-based strategy and strengthens the Company’s IP protection in another key geography. By protecting the vectorization of ICIs in our VV_copTK^-RR^- oncolytic viruses, we are extending our Invir.IO™ IP beyond the original viral backbone protection. As a result, we are in a position to protect oncolytic viruses coding for ICIs generated from our Invir.IO™ platform, securing the value of candidates such as BT-001, which is currently being evaluated in a Phase I/IIa trial, and several preclinical developments.”

Transgene’s patent portfolio includes approximately 150 granted patents and 100 pending patent applications as of June 2021.

About Transgene
Transgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.

The Company’s clinical-stage programs consist of two therapeutic vaccines (TG4001 for the treatment of HPV-positive cancers, and TG4050, the first individualized therapeutic vaccine based on the myvac® platform) as well as two oncolytic viruses (TG6002 for the treatment of solid tumors, and BT-001, the first oncolytic virus based on the Invir.IO™ platform).

With Transgene’s myvac® platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac® approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC.

With its proprietary platform Invir.IO™, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses. Transgene has an ongoing Invir.IO™ collaboration with AstraZeneca.

Additional information about Transgene is available at: www.transgene.fr
Follow us on Twitter: @TransgeneSA

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. 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 Universal Registration Document, 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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