Transgene announces License Option Exercise by AstraZeneca for an Oncolytic Virus Generated by Transgene’s Invir.IO™ Platform

Regulatory News:

Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, announces that AstraZeneca (LSE/STO/Nasdaq: AZN) has exercised its first license option for an Invir.IO™ oncolytic virus (OV) developed from their on-going OV collaboration. The exercise of this option for an OV, integrating an undisclosed transgene, will result in Transgene receiving an $8 million payment from AstraZeneca. Transgene is also eligible to receive development, regulatory and sales-based milestones payments as well as a royalty based on future commercial sales.

Hedi Ben Brahim, Chairman and CEO of Transgene, commenting on today’s news said, “We are delighted that AstraZeneca has decided to exercise its first license option for an oncolytic virus generated from our on-going Invir.IO™ collaboration. We have developed a very productive working relationship with the AstraZeneca team and based on long standing expertise developing Vaccinia based viruses capable of carrying payloads that enhance the OV’s antitumoral properties. We are looking forward to seeing this exciting OV candidate progress into clinical development.”

Transgene’s Invir.IO™ collaboration agreement with AstraZeneca started in 2019. Under the terms of the agreement Transgene is contributing its OV expertise, including viral design, and engineering, to the collaboration. It is also providing access to its novel and improved Vaccinia Virus double-deleted (TK- RR-) backbone, which forms the basis for its Invir.IO™ platform, and is responsible for in vitro preclinical development of the OV candidates generated from the collaboration. AstraZeneca has selected several transgenes to be integrated within candidates generated with the Invir.IO™ viral backbone and is responsible for further in vivo preclinical development. Under the terms of the agreement, up to five novel oncolytic immunotherapies can be co-developed.

Transgene has an in-house pilot manufacturing capability that allows it to produce GMP batches of Invir.IO™ drug candidates for clinical development.

Recent clinical data, presented by Transgene in September 2021 at the European Society for Medical Oncology (ESMO) virtual meeting confirmed that OVs based on Transgene’s proprietary double deleted VVcopTK-RR- virus backbone can be administered intravenously (see press release here). Transgene believes that Invir.IO™ OVs delivered via the intravenous route could greatly expand the number of solid tumors that could be treated with this therapy, significantly increasing the commercial potential of Transgene’s OV candidates.

A conference call in English is scheduled today on December 15, 2021, at 6:00 p.m. CET (12:00 p.m. ET).

Webcast link to English language conference call:
https://channel.royalcast.com/landingpage/transgene/20211215_1/
Participant telephone numbers:

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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

Transgene 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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