Transgene Presents Immunological Data Demonstrating that TG4001, a Novel Therapeutic Cancer Vaccine, Can Induce T-cell Responses Against HPV16 Antigens in the Ongoing Phase II Trial at ASCO 2023
05 Juin 2023 - 7:30AM
Business Wire
TG4001 can induce de novo immune responses against HPV16
antigens E6 and E7 in patients with advanced HPV16-positive
anogenital cancers
Patients with complete objective response showed strong
vaccine-induced immunoreactivity
Transgene is preparing for a potentially registrational
study
Regulatory News:
Transgene (Euronext Paris: TNG), a biotech company that
designs and develops virus-based immunotherapies for the treatment
of cancer, announced that new data will be presented today on
TG4001. These data confirm the ability of this novel
investigational therapeutic cancer vaccine to induce immune
responses against HPV16 antigens, that are associated with
anti-tumor response. These results have been presented in a poster
at the ongoing American Society of Clinical Oncology (ASCO) Annual
Meeting in Chicago, IL.
TG4001 is an investigational viral vector based therapeutic
cancer vaccine. It is being evaluated in a randomized controlled
Phase II clinical study comparing TG4001 in combination with
avelumab to avelumab alone in patients with HPV16-positive
anogenital tumors (NCT: 03260023). The data presented at ASCO were
generated from 46 patients included in both arms of the trial.
TG4001 induced the priming of adaptive immunity
58% of patients receiving TG4001 + avelumab showed an
increase of immune responses against HPV antigens versus 9% in
the avelumab arm. At baseline, immune responses against HPV
antigens were limited to 4/46 patients. The occurrence of an immune
response was detected at day 43 and tended to gain in intensity at
day 85.
These data clearly demonstrate that Transgene’s TG4001 could
induce a specific immune response against the antigens vectorized
within this vaccine.
11 of the 13 patients with an immune response had either
stable disease, partial or complete tumor response according to
RECIST criteria.
Remarkably, two case studies are presented, with patients
exhibiting a strong E6 and E7 immune response while showing a
complete clinical response.
Preparing for a planned potentially registrational trial in
an HPV-positive indication
Transgene anticipates that the last patient will be randomized
in the current Phase II clinical study in the first half of 2024.
Final results will be communicated in 2024.
Transgene is working on the design of a potentially
registrational trial to further confirm the benefit of this novel
investigational therapeutic cancer vaccine.
Dr Alessandro Riva, MD, Chairman and CEO of Transgene,
added: “We are very excited by the immunological data that we are
presenting at ASCO. These data further confirm that our therapeutic
vaccine TG4001 can induce clinically meaningful immune responses,
that are associated with antitumor response. We look forward to the
final analysis of the ongoing randomized phase 2 study and the
potential next steps for TG4001 in patients with HPV positive
cancers”.
The abstract and poster can be accessed on the ASCO and
Transgene websites.
About TG4001 TG4001 is an investigational therapeutic
vaccine based on a non-propagative, highly attenuated Vaccinia
vector (MVA), which is engineered to express HPV16 antigens (E6
& E7) and an adjuvant (IL-2). TG4001 is designed to have a
two-pronged antiviral approach: to alert the immune system
specifically to cells presenting the HPV16 E6 and E7 antigens, that
can be found in HPV16-related tumors, and to further stimulate the
infection-clearing activity of the immune system through
interleukin 2 (IL-2). TG4001 has been administered to more than 350
individuals, demonstrating good safety and promising efficacy
results [1]. Its mechanism of action and good safety profile make
TG4001 an excellent candidate for combinations with other therapies
in HPV-mediated solid tumors.
It is currently evaluated in a multi-center, open label,
randomized Phase II trial (NCT03260023) designed to compare the
efficacy of the combination of TG4001 and avelumab versus avelumab
alone in patients with advanced, recurrent and/or metastatic
HPV16-positive anogenital cancers who have disease progression
after a maximum of one line of systemic treatment, or who are not
eligible for first-line chemotherapy.
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
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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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
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