|[March 13, 2017]
First Patient Dosed in Phase 2 Trial Evaluating Transgene's TG4010 in Combination With Opdivo® (Nivolumab) for 2nd Line Treatment of Metastatic Non-Small Cell Lung Cancer (NSCLC)
Transgene (Paris:TNG) (Euronext Paris: TNG), a biotechnology company
focused on designing and developing viral-based immune-targeted
therapies for the treatment of cancers and infectious diseases, today
announced the dosing of the first patient of the Phase 2 trial
evaluating TG4010 in combination with Opdivo® (nivolumab) for the
treatment of metastatic non-small cell lung cancer (NSCLC) after failure
of one line of platinum-based chemotherapy.
Karen Kelly, MD, a world-renowned expert of lung cancer and Associate
Director for Clinical Research at UC Davis Comprehensive Cancer Center
(USA, California), is the Principal Investigator of this Phase 2 study.
The trial is being conducted via a collaborative arrangement with UC
Davis. The investigator-initiated study led by UC Davis Medical Center
is financially supported by Transgene. Bristol-Myers Squibb is supplying
Maud Brandely, Chief Medical Officer of Transgene, said: "We are
convinced that the complementary mechanisms of action of TG4010 and
Opdivo® can enhance response rates, increase the duration of response
and extend overall survival in patients. Today, advanced lung cancer
remains a severe disease with a poor prognosis. Major improvements are
needed in the therapeutic options available to physicians."
This study is a multi-center Phase 2 trial. Its primary objective is to
evaluate the efficacy (overall response rate) of the TG4010 plus Opdivo®
regimen in patients with stage IV non-squamous NSCLC who have progressed
after one line of platinum-based chemotherapy. Secondary endpoints
include progression-free survival (PFS), overall survival (OS), duration
of response and safety. The trial will enroll up to 33 patients. First
results could be expected from the end of 2017.
TG4010 is an active immunotherapy that has been designed by Transgene to
express the coding sequences of the MUC1 tumor-associated antigen and
the cytokine, Interleukin-2 (IL2). TG4010, which is based on a modified
vaccinia virus (MVA), induces an immune response against MUC1 expressing
tumors, such as non-squamous NSCLC. Its mechanism of action and
excellent safety profile make TG4010 a very suitable candidate for
combinations with other therapies, such as Opdivo®, a PD-1 immune
checkpoint inhibitor that is designed to prevent the PD-1 pathway from
suppressing the immune system's response against tumors. Opdivo® is
approved in the USA for the 2nd line treatment of advanced
non-small cell lung cancer.
About non-small cell lung cancer
Lung cancer is one
of the most common malignancies worldwide with an estimated 1.8 million
new cases annually. It is also a leading cause of cancer-related deaths,
accounting for an estimated nearly 1.6 million deaths in 2012 (Source (News - Alert):
Advancd lung cancer remains one of the cancer
types with the worst prognosis (five-year survival rate for advanced
NSCLC of less than 5%), underlining the unmet need in this disease.
TG4010 is a novel MUC1 targeting
immunotherapy. This therapeutic vaccine is in development for the
treatment of metastatic NSCLC. TG4010 is a recombinant vaccinia virus of
the Ankara strain (MVA) expressing the coding sequences of the MUC1
antigen and of the cytokine, Interleukin-2 (IL2). In healthy cells, the
MUC1 protein is normally found on the surface of epithelial cells in
many types of tissue and works to protect these cells. In tumor cells,
several modifications of MUC1 can occur: over expression,
hypo-glycosylation and changes in cellular localization. These changes
transform the MUC1 protein into a highly immunogenic tumor associated
antigen (TAA) and make it an attractive target for cancer immunotherapy.
Thus, the strategy is to induce MUC1 antigen expression in a non-tumor
environment, i.e., where the immune system is fully functional, in order
to induce both innate and MUC1 specific adaptive immunity. In addition
to NSCLC, the MUC1 TAA is expressed in many other solid tumor types,
such as lung, breast, colorectal, kidney and prostate cancers. The
results from the Phase 2b TIME trial with TG4010 immunotherapy in
non-small cell lung cancer (NSCLC) have been published in the
peer-reviewed medical journal, The
Lancet Oncology in December 2015.
Transgene S.A. (Euronext: TNG), part
of Institut Mérieux, is a publicly traded French biotechnology company
focused on designing and developing immune-targeted viral-based
therapies for the treatment of cancers 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 for non-small cell lung cancer, and Pexa-Vec, an oncolytic virus
for liver cancer. The Company has several other programs, including
TG4001, 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.
us on Twitter (News - Alert): @TransgeneSA
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
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
Opdivo® is a registered trademark of Bristol-Myers Squibb Company.
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