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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–(BUSINESS WIRE)–#TG4001–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
[email protected]

Media: Citigate Dewe Rogerson
EU: David Dible/Sylvie Berrebi
US:
Marine Perrier-Barthez
+ 44 (0)20 7638 9571/+1 424 341 9140
[email protected]

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