Transgene and PersonGen Announce Collaboration to Evaluate a New Combination Therapy Against Solid Tumors

STRASBOURG, France & SUZHOU, China--(BUSINESS WIRE)-- Regulatory News:

Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, and PersonGen BioTherapeutics, a Chinese biotech company at clinical trial stage, which is developing breakthrough and innovative CAR-T cell therapies for solid tumors and hematologic tumors, today announced a strategic collaboration to evaluate the feasibility and efficacy of combination therapy associating PersonGen’s TAA06 CAR-T cell injection with intravenous (IV) administration of an armed oncolytic virus, from Transgene’s Invir.IO™ platform, in solid tumors including pancreatic cancer and brain glioma. The collaboration aims to demonstrate the combination’s likely synergistic mechanisms to potentiate CAR-T cell therapy.

Under the terms of the collaboration agreement, Transgene will develop multiple new OV candidates, using its patented oncolytic virus backbone VV_copTK^-RR^- and its Invir.IO™ technology platform, specifically for IV administration in combination with PersonGen’s TAA06 CAR-T injection. PersonGen will evaluate the efficacy of the combination to eliminate solid tumors in preclinical models.

While CAR-T cell drugs have achieved great success in the treatment of hematological tumor therapies, there are many clinical challenges with the use of these novel therapies to treat solid tumors. One of the most critical obstacles is that the solid tumor microenvironment not only obstructs the homing of CAR-T cells, but also inhibits CAR-T cells’ function. In addition, the high heterogeneity of solid tumors also facilitates immune escape from CAR-T cell therapy.

TAA06, has been independently developed by PersonGen, which has filed an investigational new drug (IND) application for this novel CAR-T therapy in China and will initiate the IND in the US later this year. Preclinical studies with TAA06, including pharmacodynamic data have shown superior in vivo and in vitro therapeutic efficacy in solid tumors.

Patented VV_copTK^-RR^- oncolytic viruses developed with Transgene’s Invir.IO™ platform are able to:

• selectively replicate in cancer cells leading to tumor lysis;
• effectively release antitumor payloads into the tumor;
• stimulate an immune response locally in the tumor, thus optimizing the safety profile of the virus with the added potential to transform a “cold” tumor into a “hot” tumor.

Clinical and preclinical data has demonstrated that after IV administration, VV_copTK^-RR^- oncolytic viruses selectively replicate and persist in tumor cells leading to the local expression of its functional payload¹.

Based on these highly supportive data, Transgene and PersonGen believe that combining Transgene’s OV and PersonGen’s CAR-T therapies could overcome the challenges of solid tumor heterogeneity by improving the tumor microenvironment.

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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

About PersonGen
PersonGen’s vision and goal are to develop high-quality cellular therapeutics that cancer patients really need. Founded in 2010, PersonGen has turned into a state-level high-tech enterprise focusing on R&D of breakthrough and innovative cellular immunotherapy technology and drug products for cancers. The company is dedicated to developing first-in-class and best-in-class CAR-T cell drugs. The Headquarter and the R&D Center (PersonGen -Suzhou is located in SIP, Suzhou, Jiangsu Province; the Industrial Cell Manufacturing Center (PersonGen-Anke) is located in Hefei, Anhui Province; and a newly formed Center for Cell Preparation and Supply is located in Shijiazhuang, Hebai Province, which aims to have northern part of China covered under its service supply-chain.
Since its inception, the company has continuously gained the favor of investors. In 2012, PersonGen received angel round investment from Suzhou Industrial Park (SIP) Leading Venture Capital, Suzhou Industrial Park Venture Capital Guide Fund and other partners. In 2015 and 2016, it received strategic investment from Anhui Anke Biotechnology (Group) Co.,Ltd.. At the beginning of 2021, PersonGen (Suzhou) and PersonGen-Anke completed a major internal restructuring and followed by A round of investment of nearly 100 million yuan from YuanBio Venture Capital, Puenguoxin Equity Investment and Sangel Capital. At the end of 2021, the restructured PersonGen attracted B round financing of over 200 million yuan co-led by CCIC and Huatai Securities, and co-invested by Panyi Capital and Huatong Capital. This B round investment provides a greater impetus for the further development of PersonGen.
With its first-class R&D capabilities on cell therapy drugs, its automatic CAR-T cell preparation pipeline, and advanced lentiviral vector industrial process system, PersonGen has successfully developed several first-in-class and best-in-class therapeutic cell products, covering most hematological tumors and some solid tumors. Among them, first-in-class PA3-17 injection for T-lymphoblastic leukemia/lymphoma is the first autologous CD7-CAR-T cell drug candidate in the world that was approved for registered clinical trials, and it was designated as an orphan drug by the US FDA; the TAA06 CAR-T cell injection, developed for treating solid tumors in children and adults, has demonstrated outstanding tumor clearance efficacy in preclinical studies, and is now entering into the IND application phase in China.
For more information, please visit www.persongen.com.

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.

¹ Cassier et al. “Bioavailability and activity of oncolytic virus TG6002 after intravenous administration in patients with advanced gastrointestinal carcinomas” ESMO 2021, 16–21 September 2021, Poster presentation;
Bendjama et al. “Oncolytic virus TG6002 locates to tumors after intravenous infusion and induces tumor-specific expression of a functional pro-drug activating enzyme in patients with advanced gastrointestinal carcinomas” 2021 AACR Annual Meeting, April 9-14, 2021, Poster presentation

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