Transgene to Present Updated Positive Preliminary Data from the Phase I Clinical Trials with TG4050 (myvac® platform) at ASCO 2022
27 Mai 2022 - 08:00AM
Business Wire
Regulatory News:
Transgene (Euronext Paris: TNG), a biotech company that
designs and develops virus-based immunotherapies for the treatment
of cancer, announces that an abstract reporting preliminary data
from the two Phase I trials assessing TG4050, its individualized
neoantigen cancer vaccine, has been selected for a poster
presentation at the American Society of Clinical Oncology (ASCO)
annual meeting. The conference will be held online and
in-person in Chicago, IL, USA, from June 3 to 7, 2022.
The abstract reports positive immunogenicity and clinical data
generated from the two ongoing Phase I trials in patients with
ovarian cancer and HPV-negative head and neck cancer (NCT03839524
and NCT04183166). The detailed data will be presented during a
poster session on June 5, 2022, at the ASCO conference.
Poster title: Phase 1 studies of personalized neoantigen
vaccine TG4050 in ovarian carcinoma (OC) and head and neck
carcinoma (HNSCC)
- Abstract number: 2637
- Session title: Developmental
Therapeutics—Immunotherapy
- Session date and time: Sunday,
June 5, 2022, 8:00 am-11:00 am CDT
- Authors: J.P. Delord, M. Block, C.
Ottensmeier, G. Colon-Otero, C. Le Tourneau, A. Lalanne, O. Lantz,
KL. Knutson, G. Lacoste, A. Tavernaro, M. Brandely, N. Silvestre,
B. Grellier, Y. Yamashita, O. Kousuke, N. Yamagata, Y. Tanaka, B.
Malone, E. Quemeneur, K. Bendjama
The abstract can be accessed on the ASCO and Transgene
websites.
***
About the clinical trials TG4050 is being evaluated in
two Phase I clinical trials for patients with ovarian cancer
(NCT03839524) and HPV-negative head and neck cancers (NCT04183166).
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 is 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, MD, PhD,
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, MD, PhD, Head of the
Department of Drug Development and Innovation (D3i), and at the
IUCT-Oncopole, Toulouse by Prof. Jean-Pierre Delord. In the USA,
the trial is being led by Dr. Yujie Zhao, MD, PhD, at the Mayo
Clinic. Endpoints of the trial include safety, feasibility and
biological activity of the therapeutic vaccine. In parallel, a
Phase I clinical trial of TG4050 is enrolling patients with ovarian
cancer. This second trial is including patients at the time of
asymptomatic relapse after surgery and first-line chemotherapy. Dr.
Matthew Block, MD, PhD, 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, MD, PhD, at Institut
Curie and by Dr. Alexandra Martinez, MD, Associate Head of Surgical
Department, at IUCT-Oncopole. Endpoints of the trial include
safety, feasibility and biological activity of the therapeutic
vaccine. The first preliminary clinical data generated from the
first patients treated with TG4050 were very encouraging.
About myvac® myvac® is a viral vector (MVA – Modified
Vaccinia Ankara) 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 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.
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
Transgene 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220526005054/en/
Transgene: Lucie Larguier Director Corporate
Communications & IR +33 (0)3 88 27 91 04
investorrelations@transgene.fr
Media Transgene: MEDiSTRAVA Consulting David
Dible/Sylvie Berrebi +44 (0)203 928 6900
transgene@medistrava.com
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