[March 26, 2014] |
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Global Partners SillaJen, Transgene and Lee's Pharmaceutical Confirm Clinical Development Plan for Pexa-Vec
BUSAN, South Korea & SAN FRANCISCO & STRASBOURG, France & HONG KONG --(Business Wire)--
Regulatory News:
Transgene SA (Paris:TNG), Lee's Pharmaceutical (HKEx: 0950) and SillaJen
today unveiled their late-stage clinical development plan for Pexa-Vec
(JX-594/TG6006) oncolytic immunotherapy. The companies plan to initiate
a global Phase 3 study in the first-line treatment of advanced
hepatocellular carcinoma (HCC, liver cancer) patients, as well as
several additional Phase 1/2 trials in different cancers, both as a
single agent and in combination with a variety of other treatments,
including immunotherapies such as immune checkpoint inhibitors. In
addition, the partners plan to undertake several exploratory trials of
intravenous infusion therapy in various tumor types, including renal,
breast and soft tissue sarcoma.
Dr. Eun-Sang Moon, CEO of SillaJen, Inc. said: "With the recent
closing of our acquisition of Jennerex, Inc., we are very excited to
focus, together with Transgene and our other partners, on advancing and
broadening the clinical development for Pexa-Vec, our innovative
oncolytic immunotherapy. We believe that this emerging
multi-mechanistic therapeutic class holds great promise in treating
patients with cancers for which today there are very limited treatment
options. In a dose-finding Phase 2 study, Pexa-Vec has demonstrated
clinical activity with IV delivery. High-dose Pexa-Vec was associated
with longer survival benefit in first-line liver cancer patients in
Phase 2b, as published in Nature Medicine."
Philippe Archinard, Chairman and Chief Executive Officer of Transgene,
said: "Together with SillaJen and our other partners, we are pleased
to be moving forward our joint development plan for Pexa-Vec. Pexa-Vec
is an oncolytic immunotherapy with therapeutic potential, we believe, in
several hard-to-treat cancers. In addition to moving the program
into Phase 3 testing in liver cancer, for which today there is only one
approved product, we will be exploring its potential in other cancer
types and in combination with other therapies, such as immune checkpoint
inhibitors."
Dr. Benjamin Li, Chief Executive Officer of Lee's Pharmaceutical, said:
"China has the highest prevalence in liver cancer (HCC) in the world and
despite recent advancement in targeted therapy, significant medical need
remains unmet. Pexa-Vec's oncolytic immunotherapy approach has been
shown in a previous Phase 2 study as a promising first line treatment
option for advanced liver cancer patients. We look forward to starting
the Phase 3 clinical trial with our partners in 2015 to validate the
potential of this exciting agent and work towards a better management of
advanced HCC in China."
To date, over 300 patients have been treated with Pexa-Vec. Additional
data supporting the activity of Pexa-Vec across different tumor types is
expected to be presented at upcoming medical conferences later this year.
Lead Program - The planned Phase 3 trial will assess Pexa-Vec followed
by sorafenib in the first-line treatment of patients with advanced HCC.
This global study will be conducted in Europe, Asia and North America.
It is expected to enroll approximately 600 patients. Patients will be
randomized 1:1 to either receive Pexa-Vec immediately followed by
sorafenib or to receive sorafenib alone. Sorafenib (Nexavar®) is
currently considered the global standard of care and is the only product
approved for the first-line treatment of advanced HCC. The study is
expected to start recruitment by mid-2015.
Additional Studies - In addition and as previously announced, a study
evaluating Pexa-Vec and metronomic doses of cyclophosphamide in solid
tumors, mainly in breast cancer and soft tissue sarcoma, is planned to
be initiated this year. The study is being funded by the Institut
National du Cancer (INCa) and sponsored by the Bergonié Institute
(Bordeaux, France). Cyclophosphamide given at metronomic doses is used
classically in combination with immunotherapeutics to potentiate their
activity.
Other trials to complement and strengthen the program are also planned
and include:
-
A trial in the pre-surgery (neo-adjuvant) setting in solid tumors to
gain a better understanding of Pexa-Vec activity in the actual tumor
environment.
-
A trial evaluating Pexa-Vec in combination with an immune checkpoint
inhibitor, based on the rationale of gaining synergy and potency in
combining two immunotherapy classes. This type of combination approach
holds high promise in oncology.
The partners are also considering a Phase 1/2 study in combination with
sunitinib malate (Sutent®) for renal cell cancer.
Commented Dr. Tae-Ho Hwang, SillaJen co-founder and Chief Scientific
Officer: "We anticipate a number of these early exploratory studies
will be performed in collaboration with Pusan National University
Yangsan Hospital (PNUYH). The ecellent team at PNUYH has been very
supportive of the Pexa-Vec program and has demonstrated an ability to
enroll patients quickly and conduct studies efficiently. We believe open
collaboration and innovation by both the Company and Hospital is very
important to lead promising immunotherapeutics such as Pexa-Vec to the
clinic and we look forward to building on this progress as we move
forward."
About Pexa-Vec Pexa-Vec
(JX594/TG6006 pexastimogene devacirepvec) is an engineered oncolytic
vaccinia virus 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. Clinical
trials are ongoing or planned in hepatocellular carcinoma (liver
cancer), renal cell carcinoma (kidney cancer), as well as other tumor
types.
Hepatocellular carcinoma, the lead indication for Pexa-Vec, is the fifth
most common cancer worldwide and the third leading cause of cancer
death, with over 600,000 new cases diagnosed annually resulting in more
than 90 percent mortality.1 The annual incidence rate in the
U.S., Europe, Japan and China are estimated to be 20,000, 55,000, 40,000
and 350,000 patients, respectively.2 Currently, there are few
approved treatment options for advanced HCC patients.
Jennerex, Inc. has partnered with Transgene and Lee's Pharmaceutical to
develop and commercialize Pexa-Vec in major markets outside of the
United States. Under existing agreements, Transgene has exclusive rights
to develop and commercialize Pexa-Vec for the treatment of solid tumors
in Europe, the Commonwealth of Independent States and the Middle East,
while Lee's Pharmaceutical retains exclusive development and commercial
rights in Hong Kong and The People's Republic of China.
About SillaJen, Inc. SillaJen,
Inc., headquartered and with research laboratories in Busan, South Korea
with offices in San Francisco, California, is an R&D company
specializing in the translational and clinical development of complex
biologics. Headquartered on the campus of Pusan National University, the
company is comprised of dedicated in-house pre-clinical, bioanalytic,
and clinical research teams that collaborate closely with a network of
local hospitals (including PNUYH) and USA-based world-class scientists
and physicians. Born from a desire to revolutionize therapeutic
approaches for patients with serious unmet medical needs and honed
through years of pioneering experience guiding oncolytic vaccinia
through clinical trials in Korea, the SillaJen operations are uniquely
poised for rapid and efficient development of similar cutting-edge gene
and viral therapies. Additional information about SillaJen can be found
at www.sillajen.com.
About Transgene Transgene
(NYSE-Euronext: TNG), a member of the Institut Mérieux Group, is a
publicly traded French biopharmaceutical company focused on discovering,
developing and manufacturing targeted immunotherapies for the treatment
of cancer and infectious diseases. Transgene's programs utilize
well-tolerated viruses with the goal of indirectly or directly killing
infected or cancerous cells. The Company's four clinical-stage programs
are: TG4010 for non-small cell lung cancer; Pexa-Vec for liver cancer;
TG4001 for oropharyngeal cancer (under a collaboration agreement with
the EORTC) and TG4040 for chronic Hepatitis C. Transgene has concluded
corporate strategic agreements for the development of two of its
immunotherapy products: an exclusive option agreement with Novartis for
the development and commercialization of TG4010 and an in-licensing
agreement with U.S.-based Jennerex, Inc. for the development and
commercialization of Pexa-Vec in certain territories. The Company also
has several programs in research and pre-clinical development that are
based on its core viral vector technology. Transgene is based in
Strasbourg, France, and has additional operations in Lyon, as well as
satellite offices in China and the U.S. Additional information about
Transgene is available at www.transgene.fr.
Transgene Disclaimer This press release contains
forward-looking statements about the future development of the Pexa-Vec
program. Although the Company believes its expectations are based on
reasonable assumptions, these forward-looking statements are subject to
numerous risks and uncertainties, which could cause actual results to
differ materially from those anticipated. 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 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, which is available on
the AMF website (http://www.amf-france.org)
or on Transgene's website (www.transgene.fr).
About Lee's Pharmaceutical Lee's
Pharmaceutical Holdings Limited is a research-based Hong Kong
biopharmaceutical company with 20 years operation in China's
pharmaceutical industry. It is fully integrated with strong
infrastructures in drug development, manufacturing, sales and marketing.
It has established extensive partnership with over 20 international
companies and currently has 14 products in the market place. Lee's
focuses on several key disease areas such as cardiovascular, oncology,
gynecology, dermatology and ophthalmology. Lee's development program is
lauded with 30 products stemming from both internal R&D efforts and
collaborations with US, European and Japanese companies and aspiring to
combat diseases such as liver cancer and pulmonary hypertension. The
mission of Lee's is to become a successful biopharmaceutical group in
Asia providing innovative products to fight diseases and improve health
and quality of life. Additional information about Lee's Pharmaceutical
is available at www.leespharm.com.
Lee's Pharmaceutical Safe Harbor Statement The
performance and the results of operation of Lee's during the past years
are historical in nature and past performance can be no guarantee of
future results of the Lee's. This news release may contain
forward-looking statements and opinions that involve risks and
uncertainties. Actual results may differ materially from expectations
discussed in such forward-looking statements and opinions. Neither Lee's
nor the Directors, employees or agents of Lee's assume (a) any
obligation to correct or update the forward-looking statements or
opinions contained in this news release; and (b) any liability in the
event that any of the forward-looking statements or opinions does not
materialize or turns out to be incorrect.
1 http://www.who.int/mediacentre/factsheets/fs297/en/ 2
Ferlay J, Shin HR, Bray F, Forman D, Mathers C and Parkin DM.GLOBOCAN
2008 v2.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No.
10 [Internet]. Lyon, France: International Agency for Research on
Cancer; 2010. Available from: http://globocan.iarc.fr
Nexavar® is a registered trademark of Bayer HealthCare Pharmaceuticals,
Inc. Sutent® is a registered trademark of Pfizer.
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