Transgene Provides Update on Phase II Trial of Therapeutic Cancer Vaccine TG4001 in Recurrent or Metastatic HPV16-Positive Cervical and Anogenital Cancers
14 Octobre 2024 - 7:30AM
Top line data show that the randomized Phase II
study of TG4001 in combination with avelumab versus avelumab alone
in patients with recurrent or metastatic HPV16-positive cervical
and anogenital tumors did not meet the primary objective of
improvement in progression-free survival
Pre-planned subgroup analysis showed a positive
efficacy trend in favor of the TG4001 containing regimen in
patients with cervical cancer
Transgene will complete full analysis of the data
before deciding on the best way forward for TG4001
Transgene will host a conference call today at
3:30 p.m. CET
Strasbourg, France, October 14, 2024,
7:30 a.m. CET – Transgene (Euronext Paris:
TNG), a biotech company that designs and develops
virus-based immunotherapies for the treatment of cancer, announces
that its randomized Phase II study to evaluate TG4001 in
combination with avelumab versus avelumab alone in patients with
recurrent or metastatic HPV16-positive cervical and anogenital
tumors has not met the primary objective of the study (improvement
in progression-free survival).
The pre-planned subgroup analysis showed a
positive efficacy trend in favor of the TG4001 containing regimen
in cervical cancer patients, which requires further confirmation
through additional analyses, including by PD-L1 status. These
patients account for approximately half of the patients enrolled in
the study.
The treatment has been well tolerated. Adverse
events are consistent with previous observations.
Transgene is currently evaluating the full study
results in detail to determine the best way forward for this
program and will communicate further once this is completed.
Dr. Alessandro Riva, Chairman and CEO of
Transgene, said: “Failure to meet the primary objective in
our Phase II study with TG4001 is disappointing. Nevertheless, we
are encouraged by the positive efficacy trend in favor of the
combination regimen in cervical cancer patients. We plan to
complete a full and rigorous analysis of the data before deciding
on any path forward for this asset, in particular in cervical
cancer, in the context of the evolving treatment landscape. The
complete study results will be presented at an upcoming scientific
conference. We would like to thank all the patients and
caregivers who have taken part in this study for their important
contribution. With a diversified portfolio of novel immunotherapies
targeting solid tumors, our strategy remains focused on advancing
our lead asset, TG4050, an individualized cancer vaccine for head
and neck cancers for use following surgery and adjuvant therapy. We
expect to report additional data on TG4050 from the 24-month median
follow-up of Phase I patients in our head and neck cancer trial in
November 2024 at the SITC conference.”
A conference
call in English is scheduled today, October 14,
2024, at 3:30 p.m. CET (9:30 p.m. ET).
Webcast link to English language
conference
call:https://edge.media-server.com/mmc/p/zh5cy2u9/
Please log in to the following link to obtain your
personal telephone IDs.
https://register.vevent.com/register/BIec45dd6245524e73b35d874459dedd5e
A replay of the call will be available on the
Transgene website (www.transgene.fr) following the live event.
***
Contacts
Transgene
Contacts: |
Transgene
Media Contact: |
Media: |
MEDiSTRAVA |
Caroline
Tosch |
Frazer
Hall/Sylvie Berrebi |
Corporate
Communications Manager |
+ 44 (0)
203 928 6900 |
+33 (0)3 68 33 27 38 |
transgene@medistrava.com |
communication@transgene.fr |
|
|
|
Lucie
Larguier |
|
Chief Financial
Officer |
|
Nadège
Bartoli |
|
IR Analyst &
Financial Communications Officer |
|
+33 (0)3 88 27 91 03 /00 |
|
investorrelations@transgene.fr |
|
About TG4001
TG4001 (tipapkinogen sovacivec) 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-prolonged 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. Its mechanism of action and good
safety profile make TG4001 an excellent candidate for combinations
with other therapies in HPV-mediated solid tumors.
About the trial
TG4001 was 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 recurrent or metastatic
HPV16-positive cervical and anogenital cancers who have disease
progression after a maximum of one line of systemic treatment, or
who are not eligible for first-line chemotherapy. The overall trial
enrolled 100 patients.
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
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.
- 20241014_TG4001_Phase_II_update_EN
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