STRASBOURG, France--(BUSINESS WIRE)--Regulatory News:
Transgene (Paris:TNG), a company focused on designing and developing
viral-based immune-targeted therapies for the treatment of cancers and
infectious diseases, today announces that the 1st patient in
the ISI-JX trial has been treated at the Léon Bérard Cancer Center in
Lyon, France. ISI-JX is a Phase 1 clinical trial evaluating the
intra-tumoral co-administration of Pexa-Vec in combination with
ipilimumab in solid tumors (NCT02977156). This investigator initiated
trial promoted by the Leon Bérard Cancer Center will enroll patients
with metastatic and/or locally advanced solid tumors.
Pexa-Vec is a
GM-CSF expressing vaccinia derived oncolytic virus co-developed by
Transgene and SillaJen. Ipilimumab is a monoclonal antibody targeted
against the immune checkpoint CTLA-4 and is currently approved for the
treatment of melanoma (Yervoy®, Bristol-Myers Squibb).
The open-label trial that will recruit up to 60 patients in several clinical centers in France. First readouts could be expected towards the end of 2017. The trial will evaluate the safety of the combination and evaluate the first signals for efficacy.
Dr Aurélien Marabelle MD, PhD, from Gustave Roussy, a world expert in immunotherapy clinical research and coordinating investigator of the study commented: “We believe in the synergistic potential of the combination between oncolytic viruses and immune checkpoint-targeted antibodies. Also, we believe that the intra-tumoral co-delivery of these immunotherapies will trigger a better priming of the anti-tumor immune response while avoiding off-target toxicities. We hope this novel “in situ immunization” strategy will overcome the resistance to cancer immunotherapy that we observe in many patients.”
The combination of Pexa-Vec and ipilimumab aims at targeting two distinct steps in the immune response against cancer cells and is expected to be significantly more effective than either product alone. Pexa-Vec is an oncolytic virus designed to (i) selectively destroy cancer cells through the direct lysis (breakdown) of cancer cells via viral replication, (ii) reduce the blood supply to tumors through vascular disruption, and (iii) stimulate the body’s immune response against cancer cells. Its mechanism of action and its safety profile make it an appropriate candidate for combinations with immune checkpoint inhibitors (ICIs) such as ipilimumab, which acts as a brake on the body’s immune response to cancer cells thereby potentially improving Pexa-Vec’s anti-cancer effects.
Maud Brandely, Chief Medical Officer of Transgene, said: “This trial aims to first demonstrate that the regimen of our oncolytic virus Pexa-Vec plus ipilimumab is well tolerated. We expect that the intra-tumoral administration of ipilimumab will have less systemic toxicity thanks to its local administration. Another objective is to show the antitumor activity of the regimen in patients with advanced solid tumors which have exhausted all standard therapeutic options.”
About Transgene
Transgene S.A. (Euronext: TNG), part
of Institut Mérieux, 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 two lead
clinical-stage programs are: TG4010, a therapeutic vaccine against
non-small cell lung cancer and Pexa-Vec, an oncolytic virus against
liver cancer. The Company has several other programs in clinical and
preclinical development. Transgene is based in Strasbourg, France, and
has additional operations in Lyon, as well as a joint venture in China.
Additional information about Transgene is available at www.transgene.fr.
Follow us on Twitter: @TransgeneSA
About Pexa-Vec
Pexa-Vec (JX594/TG6006 - pexastimogene
devacirepvec) is an oncolytic immunotherapy armed with a GM-CSF gene
that promotes an anti-tumor immune response. Pexa-Vec is designed to
selectively target and destroy cancer cells through three different
mechanisms of action: the lysis (breakdown) of cancer cells through
viral replication, the reduction of the blood supply to tumors through
vascular disruption, and the stimulation of the body’s immune response
against cancer cells. The lead indication for Pexa-Vec is hepatocellular
carcinoma (HCC, liver cancer); trials in other cancer types are underway
or planned.
Transgene has exclusive rights to develop and
commercialize Pexa-Vec for the treatment of solid tumors in Europe. Its
partner SillaJen, Inc. is focused on developing Pexa-Vec for the north
American market and has also granted exclusive development and
commercial rights to Pexa-Vec in Hong Kong and The People’s Republic of
China to Lee’s Pharmaceutical.
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.
Yervoy® is a registered trademark of Bristol-Myers Squibb Company.
