New immunological data assessed by tetramer staining confirms
the induction of T cell responses in treated patients
All trial patients treated with TG4050 monotherapy continue to
remain in remission to date
Transgene and NEC are preparing a Phase II trial to further
demonstrate the potential of TG4050 as an adjuvant treatment of
head and neck cancer
Regulatory News:
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, announced that new data have
been presented on TG4050, an individualized neoantigen cancer
vaccine, at the American Society of Clinical Oncology (ASCO)
Annual Meeting in Chicago, IL. TG4050 is based on Transgene’s
myvac® platform and powered by NEC’s cutting-edge AI
capabilities.
The new positive data have been generated from patients with
HPV-negative head and neck cancer who have been enrolled in an
ongoing randomized Phase I trial assessing TG4050 (NCT04183166).
All patients treated with TG4050 in the trial have developed a
specific immune response, as demonstrated by the results of
additional immunological testing, and remained disease-free to
date.
Alessandro Riva, Chairman and CEO of Transgene, added:
“TG4050 is showing its potential to extend patient remission after
surgery and firmly establishes Transgene among the leading pioneers
in the emerging field of individualized cancer vaccines. The
monotherapy data we are presenting at ASCO are a solid basis to
accelerate the clinical development of this innovative therapy as
an adjuvant treatment to HPV-negative head and neck carcinoma and
potentially in other indications.”
Masamitsu Kitase, Corporate Senior VP, Head of Healthcare and
Life Science Division, NEC Corporation, commented: “We are
excited by the additional data from immunological testing that is
being presented in the poster at ASCO. It is certainly an
encouraging outcome for NEC’s AI prediction for neoantigens that
are able to effectuate an immunological response. These are early
results that underpin NEC’s AI capability of making predictions
that help in making TG4050 an efficacious product for patients
across the globe. We look forward to working with Transgene to
develop on this asset further."
TG4050 has demonstrated the ability to induce strong immune
responses against targeted antigens
The data presented at ASCO 2023 show that all evaluable
patients developed a specific immune response after treatment with
TG4050 against multiple cancer neoantigens. These immune
responses were developed in spite of patients having unfavorable
systemic immunity and tumor micro-environment at baseline (with
the presence of non-functional immune cells or with low or negative
levels of PD-L1 expression). These challenging characteristics are
normally associated with limited responses to treatments, including
immune checkpoint blockers.
Two patient case studies are also being reported. In
these patients who are disease-free following treatment with
TG4050, immunoreactive T cell response against targeted antigens
was assessed by tetramer staining. The results confirm a large
amplification of the frequency of immunoreactive T cells. These T
cells were characterized as effector cytotoxic T cells, a cell
population with potential anti-tumor activity. These data further
demonstrate that TG4050 is able to induce an anti-tumor cellular
immune response.
All patients in the trial who received TG4050 remain
disease-free to date
As of May 2023, 32 patients were randomized in the head and neck
cancer Phase I trial. All 16 patients who received TG4050
remained disease-free, with a median follow-up time of 10.4
months. This compares favorably to the control arm, in which
two patients with similar characteristics experienced relapse. Two
other patients also showed biochemical signs of relapse, as seen in
the poster. These patients are still being followed in the ongoing
trial.
To date, the vaccine has been well tolerated and no related
Serious Adverse Events have been reported.
The abstract and poster can be accessed on the ASCO and
Transgene websites.
Final results from randomized Phase I trial expected in mid-2024
– Phase II trial to start in H2 2023
The last patient has recently been randomized in the head and
neck cancer trial. Transgene and NEC plan to achieve a median
follow up of 18 months in mid-2024.
Transgene and NEC are preparing for a Phase II trial in head and
neck cancer, in an adjuvant setting, which could be initiated in H2
2023.
***
About the clinical trials TG4050 is being evaluated in
two Phase I clinical trials for patients with HPV-negative head and
neck cancers (NCT04183166) and ovarian cancer (NCT03839524).
In a first Phase I trial, TG4050 is being administered to
patients with HPV-negative head and neck cancer. An
individualized 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
as an additional treatment to standard of care (SoC). 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 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.
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. 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 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 with TG4050 are
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 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 TG6002, BT-001 and TG6050, three 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.fr
Follow us on social media: 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 onboard, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230605005619/en/
Transgene: Lucie Larguier Director Corporate
Communications & IR +33 (0)3 88 27 91 04
investorrelations@transgene.fr
NEC Corporation: AI Drug Development Division
contact@aidd.jp.nec.com
Media: MEDiSTRAVA Consulting David Dible/Sylvie
Berrebi +44 (0)203 928 6900 transgene@medistrava.com
NEC Corporation: Joseph Jasper j-jasper@nec.com
+81-3-3798-6511
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