Transgene: Peer-Reviewed Publications Confirm the Potential of Transgene’s TG4001 and TG6002

  • Therapeutic vaccine TG4001, administered as a single agent, demonstrated statistically significant curative activity at 30 months in randomized Phase 2b trial in HPV-associated CIN 2/3
  • Oncolytic virus TG6002 shows increased tumor selectivity and strong antitumor activity in several preclinical models

STRASBOURG, France--()--Regulatory News:

Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of solid tumors, announces the publication of two articles highlighting the potential of TG4001 and TG6002, two clinical-stage products, that are expected to generate new clinical data in H2 2019.

TG4001 in Gynecologic Oncology
 

The data confirm the potential of TG4001 (Tipapkinogen Sovacivec), administered as a monotherapy, to treat precancerous HPV-induced lesions (cervical intraepithelial neoplasia - CIN2/3).

These clinical results, with a 30-month follow up, are highly supportive of the ongoing development of TG4001 in combination with avelumab in HPV-positive cancers, including head and neck carcinomas (NCT

03260023), for which efficacy data are expected in H2 2019.

  • Of the 129 women randomized to TG4001 and 63 to placebo, complete resolution1 was significantly higher in the vaccine group than placebo for CIN 2/3 regardless of the 13 high-risk HPV types assayed (24% vs. 10%, p < 0.05).
  • Irrespective of baseline HPV infection, viral DNA clearance2 was higher in the vaccine group compared to placebo (p < 0.01).
  • TG4001 was well tolerated with the most common adverse events being injection site reactions.

Ref: The efficacy and safety of Tipapkinogen Sovacivec therapeutic HPV vaccine in cervical intraepithelial neoplasia grades 2 and 3: Randomized controlled phase II trial with 2.5 years of follow-up, D.M. Harper, et al., Gynecologic Oncology -

https://doi.org/10.1016/j.ygyno.2019.03.250

TG6002 in Molecular Therapy Oncolytics
 

Transgene provides detailed preclinical data on its oncolytic virus TG6002. Based on an optimized Copenhagen strain of vaccinia virus, TG6002 displays a proprietary double gene deletion (TK-RR-) and a patented FCU1 gene, that allows the production of chemotherapy (5-FU) directly in the tumor.

TG6002 is currently being evaluated in a Phase 1/2 study patients with colorectal cancer (NCT

03724071).

  • TG6002 has an improved safety and efficacy profile and has shown to selectively replicate in tumor cells.
  • Several models highlight the promising activity of the oncolytic virus, particularly in colorectal carcinoma models.

Ref: The Enhanced Tumor Specificity of TG6002, an Armed Oncolytic Vaccinia Virus Deleted in Two Genes Involved in Nucleotide Metabolism, J. Foloppe, et al., Molecular Therapy Oncolytics -

https://doi.org/10.1016/j.omto.2019.03.005

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.IOTM, Transgene builds on its expertise in viral vectors engineering to design a new generation of multifunctional oncolytic viruses.
myvacTM, an individualized MVA-based immunotherapy platform designed to integrate neoantigens, completes this innovative research portfolio. TG4050, the first candidate selected from the myvacTM platform, will enter the clinic for the treatment of ovarian cancer and head and neck cancer.
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 Document de Référence, 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 Resolution: complete disappearance of CIN lesions.
2 Viral clearance: disappearance of the high-risk HPV genotypes present at baseline.

Contacts

Transgene:
Lucie Larguier
Director Corporate Communications & IR
+33 (0)3 88 27 91 04
investorrelations@transgene.fr

Media: Citigate Dewe Rogerson
EU: David Dible/Sylvie Berrebi
US: Marine Perrier-Barthez
+ 44 (0)20 7638 9571/+1 424 341 9140
transgene@citigatedewerogerson.com

Contacts

Transgene:
Lucie Larguier
Director Corporate Communications & IR
+33 (0)3 88 27 91 04
investorrelations@transgene.fr

Media: Citigate Dewe Rogerson
EU: David Dible/Sylvie Berrebi
US: Marine Perrier-Barthez
+ 44 (0)20 7638 9571/+1 424 341 9140
transgene@citigatedewerogerson.com