- New Phase I data confirm promising immunogenicity and efficacy
profile of TG4050, an individualized neoantigen cancer vaccine
developed by Transgene in collaboration with NEC Corporation
- In the head and neck cancer trial to date, all patients
treated with TG4050 have remained disease-free, despite unfavorable
systemic immunity and tumor micro-environment before treatment
- Transgene and NEC are considering the most appropriate path
towards registration in head and neck, with a Phase II trial to be
initiated in H2 2023
Regulatory News:
Transgene (Euronext Paris: TNG) (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 will be presented today on TG4050, an individualized
neoantigen cancer vaccine, at the American Association for
Cancer Research (AACR) Annual Meeting in Orlando,
Florida. 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 and with ovarian cancer, who have
been enrolled in two ongoing Phase I trials assessing TG4050.
TG4050 has demonstrated the ability to induce strong immune
responses against targeted antigens in patients, which are expected
to result in extended remission periods.
Hedi Ben Brahim, CEO of Transgene, added: “Our
individualized neoantigen vaccine TG4050 continues to deliver very
encouraging clinical and immune response data, combined with an
excellent safety profile. These results suggest that TG4050 has the
potential to extend the remission period for cancer patients who
have undergone surgery, giving new hope to a patient population who
currently have no treatment options available except a watchful
follow up. We are continuing to build a strong and compelling
clinical data set to support the benefits of this novel
personalized immunotherapy. In parallel, we, along with NEC, are
preparing for a Phase II trial as part of the registration path,
which could start as early as the second half of 2023 for head and
neck cancer, which represents a $1 billion+ market opportunity for
the program. TG4050 also has the potential to be developed for
preventing relapses in other solid tumor indications.”
Masamitsu Kitase, Corporate Senior VP, and Managing Director
of Healthcare Life Sciences Business, NEC Corporation,
commented: “It is very encouraging to see such promising clinical
and immune response data contributing to the momentum of TG4050’s
development. We look forward to working closely with Transgene to
maintain this advancement, and we are confident that our
personalized therapy will benefit the health of individual patients
across the globe."
New immune data confirm the ability of TG4050 to effectively
prime the immune system in patients with poor immune status
The new set of comprehensive immunological data presented at
AACR 2023 show that all evaluable patients developed a specific
immune response after treatment with TG4050 against multiple cancer
neoantigens and remained disease-free, in spite of having
challenging immune contextures comprised of both unfavorable
systemic immunity and tumor micro-environment at baseline. These
are normally associated with limited responses to treatments, and
in particular resistance to immune checkpoint blockades.
This suggests that TG4050 can boost the immune system of
patients with a tumor micro-environment usually characterized as an
immune desert or involving the presence of non-functional immune
cells, or with low or negative levels of PD-L1 expression.
In addition, these data confirm that all evaluable patients
developed robust T-cell responses against multiple targeted
neoantigens (median of 9 positive responses per patient out of
approximately 30 targets). T-cell responses were observed for class
I and class II epitopes, consisting of both de novo responses and
amplifications of preexisting responses.
Vaccination was well tolerated and associated with
encouraging preliminary signs of anti-tumor efficacy
As of March 2023, 32 patients were randomized in the head and
neck cancer trial. All 16 patients who received TG4050 remained
disease-free, with a median follow-up time of 9.2 months. This
compares favorably to the control arm, in which two patients with
similar characteristics experienced relapse. These patients are
still followed in the ongoing trial.
Transgene expects the last patient to be treated in the coming
weeks. Final results from this trial are expected in mid-2024.
To date, the vaccine has been well tolerated and no related
Serious Adverse Events have been reported.
Phase II trial to start in H2 2023
Transgene and NEC are preparing for a Phase II trial in head and
neck cancers which could be initiated in H2 2023.
An abstract and poster can be accessed on the AACR and Transgene
websites.
Dr Christian Ottensmeier, MD, PhD, FRCP (University of
Liverpool, La Jolla Institute for Immunology) will discuss the
unmet medical need and current treatment landscape for patients
suffering from head and neck cancers in a live virtual event taking
place on April 19, 2023 (12:00 pm ET; 6:00 pm CET). Click here to
register or listen to the replay.
***
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 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 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. Transgene has an ongoing
Invir.IO® collaboration with AstraZeneca. 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/20230417005605/en/
Transgene: Lucie Larguier Director Corporate
Communications & IR +33 (0)3 88 27 91 04
investorrelations@transgene.fr
Media: MEDiSTRAVA Consulting David Dible/Sylvie
Berrebi +44 (0)203 928 6900 transgene@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
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