Transgene and NEC plan to start an extension of the
randomized Phase I trial into a randomized Phase I/II study in
2024 to further demonstrate the potential of
TG4050 as an adjuvant treatment of head and
neck cancers
Strasbourg, France & Tokyo, Japan, January
8, 2024, 5:45 p.m. CET/January 9,, 2024, 09:00 a.m. JST –
Transgene (Euronext Paris: TNG), a biotech company
that designs and develops virus-based immunotherapies for the
treatment of cancer, and NEC Corporation (NEC; TSE: 6701),
a leader in IT, network and AI technologies, have
announced the signing of a further development collaboration
agreement to continue the clinical evaluation of the individualized
neoantigen cancer vaccine TG4050.
TG4050 is currently being evaluated in a
randomized multicenter Phase I trial as a single agent in
the adjuvant treatment of HPV-negative head and neck
cancers. Based on promising data obtained in the Phase
I[*] trial (NCT04183166), Transgene and NEC are preparing a
randomized Phase I/II extension of this trial slated to start in
2024. This new trial builds on compelling first signs of efficacy
and induction of specific T-cell responses with the aim of
generating a comprehensive set of immunological and clinical data
to further demonstrate the potential of TG4050.
Transgene and NEC expect to present additional
immunological and clinical data from the Phase I trial at a
scientific conference in the first half of 2024.
TG4050 is based on Transgene’s viral vector
based myvac® platform and powered by NEC’s cutting-edge AI
capabilities for the identification and prediction of the most
immunogenic neoantigens.
Alessandro Riva, Chairman and CEO of
Transgene, commented: “We are pleased to announce the
extension of our agreement with NEC, which marks a significant
milestone in our collaboration. We are looking forward to
continuing to treat patients in our clinical studies with our
individualized cancer vaccine TG4050. The compelling initial Phase
I data presented with NEC at ASCO 2023 showed that all evaluable
patients treated with TG4050 monotherapy developed a specific
immune response and remained disease-free. Our joint clinical
development plan builds on these promising data in a setting where
there is no approved treatment to prevent patient relapse after
adjuvant chemoradiotherapy. We believe that TG4050, by combining a
powerful and immunogenic viral vector with an extremely
sophisticated neoantigen selection tool, has the potential to
address major medical needs in the adjuvant treatment of solid
tumors.”
Masamitsu Kitase, Corporate SVP, Head of
Healthcare and Life Sciences Division, NEC
Corporation, commented: “Transgene has been our
trusted partner in developing our joint neoantigen asset TG4050. I
am excited that the positive results from the Phase I study have
encouraged us to further collaborate on this very promising asset
for treating head and neck cancers. We are happy that our
state-of-the-art artificial intelligence (AI)/machine learning (ML)
models help in predicting clinically meaningful neoantigens, which
impact patient outcomes. NEC’s Healthcare and Life Sciences
Division is committed to bringing novel AI-based treatments to
patients across the globe and achieving meaningful advances in the
pharmaceutical industry.”
***
Contacts
Transgene:Lucie LarguierDirector
of Corporate Communications &
IR+33 (0)3 88 27 91 04investorrelations@transgene.fr |
Media: MEDiSTRAVA Consulting Frazer
Hall/Sylvie Berrebi+44
(0)203 928 6900transgene@medistrava.com |
NEC Corporation:AI
Drug Development Division contact@aidd.jp.nec.com
|
NEC Corporation:
Joseph Jasper
j-jasper@nec.com+81-3-3798-6511 |
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 to recognize and destroy tumors using their 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 TG4050TG4050 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) and machine learning (ML)
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 the clinical trialTG4050
is being evaluated in a Phase I clinical trial for patients with
HPV-negative head and neck cancers (NCT04183166). An individualized
treatment is created for each patient after they complete surgery
and while they receive adjuvant therapy. Half of the participants
received their vaccine immediately after completing adjuvant
treatment. The other half were given TG4050 as an additional
treatment at the time of recurrence of the disease as an additional
treatment to standard of care (SoC). This randomized study is
evaluating the treatment benefits of TG4050 in patients who are at
risk of relapse. Thirty-two patients have been included in this
trial under way in France, the UK, and 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 conducted at Institut
Curie 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, MD, PhD.
In the USA, the trial is being led by Yujie Zhao, MD, PhD, at the
Mayo Clinic. Endpoints of the trial include safety, feasibility,
and biological activity of the therapeutic vaccine. Initial
immunological and clinical data presented at AACR 2023 and ASCO
2023 are very encouraging.
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 a portfolio of therapeutic vaccines and
oncolytic viruses: TG4050, the first individualized therapeutic
vaccine based on the myvac® platform, TG4001 for the treatment of
HPV-positive cancers, as well as BT-001 and TG6050, two oncolytic
viruses based on the Invir.IO® viral backbone. 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.Additional information about
Transgene is available at: www.transgene.frFollow us on social
media: X (formerly Twitter): @TransgeneSA – LinkedIn:
@Transgene
About NEC’s Neoantigen Prediction System
NEC’s neoantigen prediction system utilizes its
proprietary AI, such as graph-based relational learning, trained on
multiple sources of biological data to discover candidate
neoantigen targets. These targets are carefully analyzed using
proprietary machine learning algorithms that include in-house HLA
binding and antigen presentation AI tools to evaluate the
likelihood of eliciting a robust and clinically relevant T-cell
response. With NEC OncoImmunity now on board, NEC continues to
strengthen its top-class neoantigen prediction pipelines with the
aim of maximizing the therapeutic benefits of personalized cancer
immunotherapy for patients worldwide. For more information, visit
NEC at www.nec.com. For additional information, please also visit
NEC OncoImmunity at https://www.oncoimmunity.com/
About NEC Corporation
NEC Corporation has established itself as a
leader in the integration of IT and network technologies while
promoting the brand statement of “Orchestrating a brighter world.”
NEC enables businesses and communities to adapt to rapid changes
taking place in both society and the market as it provides for the
social values of safety, security, fairness and efficiency to
promote a more sustainable world where everyone has the chance to
reach their full potential. For more information, visit NEC at
https://www.nec.com and NEC’s AI Drug Development Business at
https://www.nec.com/en/global/solutions/ai-drug/
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.
[*] Ottensmeier et al., “Safety and Immunogenicity of TG4050: a
personalized cancer vaccine in head and neck carcinoma” ASCO 2023,
June 6, 2023, Poster presentation
- 20240108_Transgene_NEC_continued_agreement_EN
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