Transgene gets FDA IND clearance to start clinical trial of myvac for ovarian cancer treatment

May 13, 2019 Off By BusinessWire

Phase 1 clinical trial, expected to start in H2 2019, will be
co-funded by Transgene and its collaboration partner NEC

STRASBOURG, France–(BUSINESS WIRE)—Regulatory News:

Transgene (Euronext Paris: TNG), a biotech company that designs and
develops virus-based immunotherapies for the treatment of solid tumors,
today announces that it has received Investigational New Drug (IND)
clearance from the US Food and Drug Administration (FDA) to proceed with
a Phase 1 clinical trial of its lead myvac™ candidate TG4050
as a potential treatment for ovarian cancer patients after first-line
surgery and chemotherapy.

TG4050 is an individualized MVA-based immunotherapy derived from the myvac™
platform. It has been designed to stimulate and educate the immune
system of patients to recognize and destroy tumor cells. Tumor cells
accumulate mutations and each patient has a set of mutations that are
unique to his tumor. TG4050 is designed to target a panel of patient
specific mutations selected using a NEC’s Neoantigen Prediction System

“We are very pleased to have been granted an IND for TG4050 by the
FDA allowing us to commence the first trial with our lead myvac™
candidate in ovarian cancer patients who have already received
first-line treatment” said Maud Brandely, Chief Medical Officer
of Transgene. “We believe individualized vaccination is a
promising solution with significant potential to transform treatment
outcomes for a wide range of solid tumors. With TG4050, we are confident
that we can show that this therapeutic modality will improve patient
outcome. We look forward to updating you on the progress of this
clinical trial, which is expected to start later this year.”

The Phase 1 clinical trial will evaluate the safety and the tolerability
of TG4050 in patients with ovarian, fallopian or peritoneal serous cell
carcinoma. Antitumor activity will also be measured. This multi-center,
one-arm trial will recruit patients in the United States and Europe.

The study, sponsored by Transgene, will be co-financed by Transgene and
its partner NEC, which will also support the trial by contributing to
the therapeutic vaccine design and the selection of target neoantigens
(see press release dated March 5, 2019).

About TG4050
TG4050 is an immunotherapy designed to
stimulate the immune system of patients in order to induce a response
that is able to recognize and destroy tumor cells in a specific manner.
This
personalized immunotherapy is developed for each patient, on the basis
of mutations identified through sequencing of tumor tissue, prioritized
using NEC’s Neoantigen Prediction System and delivered using the myvac^TM
technological platform which allows development and manufacture of a
product that is specific to the patient within time frames compatible
with clinical management.

About myvac^TM
myvac^TM
is a viral vector (MVA) based, individualized immunotherapy platform
that has been developed by Transgene to target solid tumors. The myvac^TM-derived
products are designed to stimulate the patient’s immune system,
recognize and destroy tumors using the patient’s own cancer specific
genetic mutations. Transgene has set up an innovative network that
combines bioengineering, digital transformation, established
vectorization know-how and unique manufacturing capabilities. Transgene
has been awarded an “Investments for the Future” funding from Bpifrance
for the development of its platform myvac^TM.

About NEC’s Neoantigen Prediction System
NEC’s
neoantigen prediction utilizes its proprietary AI, such as graph-based
relational learning, which is combined with other sources of data to
discover candidate neoantigen targets. NEC comprehensively evaluates the
candidate neoantigens with a primary focus placed on its in-house
MHC-binding affinity prediction. These allow NEC to effectively
prioritize the numerous candidate neoantigens identified in a single
patient.

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.IO^TM, Transgene builds on its expertise in
viral vectors engineering to design a new generation of multifunctional
oncolytic viruses.
myvac^TM, an individualized
MVA-based immunotherapy platform designed to integrate neoantigens,
completes this innovative research portfolio. TG4050, the first
candidate selected from the myvac^TM 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

About NEC Corporation
NEC Corporation is a leader in
the integration of IT and network technologies that benefit businesses
and people around the world. The NEC Group globally provides “Solutions
for Society” that promote the safety, security, efficiency and equality
of society. Under the company’s corporate message of “Orchestrating a
brighter world,” NEC aims to help solve a wide range of challenging
issues and to create new social value for the changing world of
tomorrow. For more information, visit NEC at http://www.nec.com.

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.