Regulatory News:
Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech
company that designs and develops virus-based immunotherapeutics
against cancer, today announces that a first patient with head and
neck cancer has been dosed with the Company’s innovative
individualized immunotherapy, TG4050. This novel therapeutic
vaccine is based on Transgene’s myvac® technology platform, which
leverages cutting-edge Artificial Intelligence (AI) capabilities to
customize the treatment for each patient.
This innovative approach combines Transgene’s expertise in
virus-based immunotherapies, NEC’s longstanding AI technologies and
the commitment of prestigious cancer care centers.
THE FIRST PATIENT HAS BEEN DOSED AT THE IUCT ONCOPOLE IN
TOULOUSE, France, where the trial enrolling head and neck
cancer patients, is being conducted by Prof. Jean-Pierre Delord,
Director of the Claudius Regaud Institute and General Manager of
the IUCT Oncopole.
Prof. Jean-Pierre Delord added: “Each tumor has its own
very specific potential immune targets. The goal of TG4050 is to
provide the immune system with the information it needs to identify
cancer cells and trigger a targeted immune response to treat the
disease. Head & neck cancer patients currently have no
effective treatments to prevent recurrence of the disease and half
of these high-risk patients will relapse within the first year
after initial treatment. TG4050 can address the medical need of
these patients either as single agent or in combination with
standard of care. The IUCT Oncopole is an institution with a
state-of-the-art cancer research unit and can rely on highly
specialized teams to conduct this clinical trial and evaluate how
TG4050 has the potential to benefit cancer patients.”
TG4050 IS A CANCER VACCINE FULLY CUSTOMIZED FOR EACH PATIENT
COMBINING BEST-IN-CLASS THERAPEUTIC VACCINE RESEARCH
AND CUTTING-EDGE AI TECHNOLOGY
Transgene’s highly innovative technology platform, myvac®,
enables the generation of a virus-based immunotherapy, which
encodes patient-specific cancer cell mutations (neoantigens)
identified and selected by NEC’s Neoantigen Prediction System
(NPS), an advanced AI technology approach. TG4050 has been designed
to target up to 30 patient-specific neoantigens.
With more than 20 years of AI expertise, NEC’s NPS has been
trained using both proprietary and public immune databases.
Preclinical work with the myvac® technology platform has
demonstrated that NEC’s AI-based tumor mutanome profiling tool
accurately selects and prioritizes the most immunogenic neoantigens
from each unique tumor1.
Transgene is using its expertise in viral genome engineering to
incorporate the selected neoantigens into the DNA of the myvac®-MVA
viral vector.
The company has also set up a unique in-house Good Manufacturing
Practices (GMP) unit dedicated to the manufacturing of the
individualized batches of TG4050 that are needed for the ongoing
Phase I clinical studies with this novel therapeutic vaccine.
FIRST DATA FROM TWO ONGOING CLINICAL TRIALS
EXPECTED IN 2H 2021
In a first Phase I trial, TG4050 is being administered to
patients with HPV-negative head and neck cancer. A personalized
treatment is created for each patient after they complete surgery
and while they receive an adjuvant therapy. Half of the
participants receive their vaccine immediately after they complete
their adjuvant treatment. The other half will be given TG4050 as an
additional treatment at the time of recurrence of the disease. This
randomized study is evaluating the treatment benefits of TG4050 in
patients who have a high risk of relapse. Up to 30 patients will
receive TG4050 in France, in the UK and in the USA. The principal
investigator of the trial is Prof. Christian Ottensmeier,
Consultant Medical Oncologist at the Clatterbridge Cancer Centre
and Professor of Immuno-Oncology at the University of Liverpool. In
France, the clinical trial is being conducted, at Institut Curie,
Paris, by Prof. Christophe Le Tourneau, M.D., Ph.D., Head of the
Department of Drug Development and Innovation (D3i) and at the
IUCT-Oncopole, Toulouse, by Prof. Jean-Pierre Delord.
In parallel, a Phase I clinical trial of TG4050 is enrolling
patients with ovarian cancer. The first patient has been dosed in
the USA. This second trial is including patients after surgery and
first-line chemotherapy. Dr. Matthew Block, Consultant Medical
Oncology, Consultant Immunology and Associate Professor of Oncology
at the Mayo Clinic (USA) is the principal investigator of the
trial; in France, the trial is being conducted by Prof. Le Tourneau
at Institut Curie and by Dr. Alexandra Martinez, Associate Head of
Surgical Department, at Toulouse-Oncopole.
The first data from the two trials evaluating TG4050 are
expected in 2H 2021.
***
TG4050
TG4050 is an individualized immunotherapy being developed for
solid tumors that is based on Transgene’s myvac® technology and
powered by NEC’s longstanding artificial intelligence (AI)
expertise. This virus-based therapeutic vaccine encodes neoantigens
(patient-specific mutations) identified and selected by NEC’s
Neoantigen Prediction System. The prediction system is based on
more than two decades of expertise in AI and has been trained on
proprietary data allowing it to accurately prioritize and select
the most immunogenic sequences.
TG4050 is designed to stimulate the immune system of patients in
order to induce a T-cell response that is able to recognize and
destroy tumor cells based on their own neoantigens. This
individualized immunotherapy is developed and produced for each
patient.
This best-in-class candidate is being evaluated in two Phase I
clinical trials for patients with ovarian cancers (NCT03839524) and
HPV-negative head and neck cancers (NCT04183166).
About myvac®
myvac® is a viral vector (MVA) based, individualized
immunotherapy platform that has been developed by Transgene to
target solid tumors. myvac®-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 “Investment for the Future” funding from Bpifrance for the
development of its platform myvac®. TG4050 is the first
myvac®-derived product being evaluated in clinical trials.
Click here to watch a short
video on myvac®.
About Transgene
Transgene (Euronext: TNG) is a biotechnology company focused on
designing and developing targeted immunotherapies for the treatment
of cancer. Transgene’s programs utilize viral vector technology
with the goal of indirectly or directly killing cancer cells.
The Company’s clinical-stage programs consist of two therapeutic
vaccines (TG4001 for the treatment of HPV-positive cancers, and
TG4050, the first individualized therapeutic vaccine based on the
myvac® platform) as well as two oncolytic viruses (TG6002 for the
treatment of solid tumors, and BT-001, the first oncolytic virus
based on the Invir.IO™ platform).
With Transgene’s myvac® platform, therapeutic vaccination enters
the field of precision medicine with a novel immunotherapy that is
fully tailored to each individual. The myvac® approach allows the
generation of a virus-based immunotherapy that encodes
patient-specific mutations identified and selected by Artificial
Intelligence capabilities provided by its partner NEC.
With its proprietary platform Invir.IO™, Transgene is building
on its viral vector engineering expertise to design a new
generation of multifunctional oncolytic viruses. Transgene has an
ongoing Invir.IO™ collaboration with AstraZeneca.
Additional information about Transgene is available at:
www.transgene.fr.// Follow us on Twitter: @TransgeneSA
About IUCT-Oncopole
Located in the heart of Future Health Campus, the IUCT-Oncopole
gathers the Institut Claudius Regaud, a cancer center, and several
teams from Toulouse University Hospital Center. Both group together
1 600 professionals specialized in onco-hematology. The
IUCT-Oncopole carries out 3 missions to fight against cancer: care,
research and training. Stand against its building, the Toulouse
Cancer Research Center (CRCT) includes 21 basic and transfer
research team, i. e. 430 researchers, clinicians and staff.
www.iuct-oncopole.fr
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
Universal Registration Document, 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 Mallone et al., “Performance of neoantigen prediction for the
design of TG4050, a patient specific neoantigen cancer vaccine”,
AACR, June 2020
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version on businesswire.com: https://www.businesswire.com/news/home/20210120005466/en/
Transgene: Lucie Larguier Director Corporate
Communications & IR +33 (0)3 88 27 91 04
investorrelations@transgene.fr
Media: Citigate Dewe Rogerson David Dible/Sylvie
Berrebi + 44 (0)20 7638 9571 transgene@citigatedewerogerson.com
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