Compelling 24.1-month median follow-up data presented at
SITC 2024 showed that all patients treated with TG4050 after
completion of an adjuvant standard of care remain
disease-free
TG4050 induced specific and sustained immune responses.
A Phase II part is now enrolling patients internationally to
build on this promising outcome
Strasbourg, France & Tokyo, Japan,
November 7, 2024, 5:45 p.m. CET — 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, today announced 24.1-month median
follow-up data from the ongoing randomized Phase I trial of TG4050
in the adjuvant treatment of head and neck cancers. The data will
be presented in a poster at the Society for ImmunoTherapy of Cancer
(SITC) 2024 Annual Meeting on November 9 in Houston, TX.
TG4050 is an individualized
immunotherapy being developed for solid tumors that is
based on Transgene’s myvac® platform and powered by NEC’s
cutting-edge AI capabilities designed to optimize antigen
selection.
After a median follow up of 24.1 months,
all 16 patients who received TG4050 as adjuvant immunotherapy after
completion of adjuvant standard of care remain disease-free and
have not relapsed. Out of the 16 patients in the control
observation arm, 3 patients have relapsed. There remains a high
medical need for these head and neck cancer patients, as
approximately 30% of them are expected to experience a relapse
within 24 months after standard surgery and adjuvant
chemoradiotherapy.
Immune responses targeting selected neoantigens
were identified in 100% of patients who received TG4050,
demonstrating the strong immunogenicity of the cancer vaccine, with
both de novo and amplified responses. An analysis over 7 months
also shows that immune responses are sustained, during the
induction and boost periods.
All treatment-related adverse events continue to
be mild to moderate.
Building on these promising data, the randomized
Phase I trial has been expanded to a randomized
Phase I/II trial in the adjuvant setting of head and
neck cancer (NCT04183166), which is currently enrolling patients in
the Phase II part.Pr. Le Tourneau, MD, PhD, Head of
the Department of Drug Development and Innovation (D3i) at Institut
Curie, and Principal Investigator, said:
“There remains a significant unmet medical need in head and neck
cancer patients in the adjuvant setting. It is therefore highly
encouraging to see confirmation of TG4050’s clinical and immune
response data after a median follow-up of 24.1-months. TG4050 has
demonstrated its potential to prime an adaptive immune response
against tumor antigens and prevent relapse in patients with locally
advanced resected head and neck squamous cell carcinoma
(HNSCC).”
Dr. Emmanuelle Dochy, MD, Chief
Medical Officer of Transgene, added: “We are very
encouraged to observe that all the patients treated with our
neoantigen cancer vaccine TG4050 remain disease-free after a
median follow-up of 24.1 months. Looking at these results and at
the long-lasting immune response, we are confident that TG4050 has
the potential to benefit these patients, who still face a
significant risk of relapse with current therapies. The
Phase II part of our trial is currently enrolling patients
internationally, with the aim of further confirming these promising
findings.”
Motoo Nishihara, Corporate EVP and CTO,
at NEC, added: “These results illustrate the power of our
collaboration with Transgene and our ability to develop a
personalized approach to cancer patient treatment using our
proprietary artificial intelligence and machine learning models. We
have built a strong and compelling clinical data set to support the
benefits of TG4050 as an individualized immunotherapy, and we
remain committed to bringing novel AI-based treatments to patients
across the globe.”
Poster details:
Title: Randomized phase I trial of
adjuvant individualized TG4050 vaccine in patients with locally
advanced resected HPV-negative head and neck squamous cell
carcinoma (HNSCC)
- Abstract Number: 650
- Session: Clinical Trial In Progress
- Date: Saturday, Novembre 9, 2024
- Presenting Author: Prof. C. Le Tourneau, MD, PhD—Institut
Curie
The SITC poster can be viewed in-person during
the poster presentation at the SITC 2024 meeting and can be
accessed on Transgene’s website.
***
Contacts
Transgene Contacts: |
Transgene Media Contact: |
Media: |
MEDiSTRAVA |
Caroline Tosch |
Frazer Hall/Sylvie Berrebi |
Corporate Communication Manager |
+ 44 (0)203 928 6900 |
+33 (0)3 68 33 27 38 |
transgene@medistrava.com |
communication@transgene.fr |
|
|
|
Lucie Larguier |
|
Chief Financial Officer |
|
Nadege Bartoli |
|
IR Analyst and Financial Communications Officer |
|
+33 (0)3 88 27 91 03/00 |
|
investorrelations@transgene.fr |
|
|
|
NEC Corporation: |
NEC Corporation: |
AI Drug Development Division |
Joseph Jasper |
contact@aidd.jp.nec.com |
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 Phase I/II clinical
trialTG4050 is being evaluated in a Phase I/II 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. In the
Phase I part, thirty-two evaluable patients have been included. The
Phase II part is currently enrolling patients
internationally.
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.
- 20241107_TG4050_PosterSITC2024_EN
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