Transgene & BioInvent Receive Approval From ANSM to Proceed With Phase I/IIa Trial of Anti-CTLA4-armed Oncolytic Virus BT-001...
19 Gennaio 2021 - 07:30AM
Business Wire
Regulatory News:
Transgene (Euronext Paris: TNG), a biotech company that designs
and develops virus-based immunotherapies for the treatment of
cancer, today announced it has received approval from the French
National Agency for the Safety of Medicines and Health Products
(ANSM) to proceed with a Phase I/IIa study of the novel oncolytic
Vaccinia virus BT-001. This announcement follows the approval
received in December 2020 from the Belgian health authorities. The
first patient is expected to be enrolled in this trial in the
upcoming weeks.
BT-001 IS AN ONCOLYTIC VIRUS GENERATED WITH TRANSGENE’S
INNOVATIVE INVIR.IO™ PLATFORM
BT-001 is based on the patented Invir.IO™ oncolytic virus
(VVcopTK-RR-), and has been engineered to encode both a
Treg-depleting human recombinant anti-CTLA4 antibody generated by
BioInvent’s proprietary n-CoDeR®/F.I.R.S.T™ platforms, and the
human GM-CSF cytokine. By selectively targeting the tumor
microenvironment, BT-001 is expected to elicit a much stronger and
more effective antitumoral response and greatly increase the safety
and tolerability profile of the anti-CTLA4 antibody. BT-001 is
being co-developed through a 50/50 collaboration between Transgene
and BioInvent.
IN FRANCE, FOUR CLINICAL CENTERS WILL ENROLL PATIENTS
“The development of BT-001 is progressing well and we are
pleased to start this clinical trial in France with patients being
enrolled across the country in four reference clinical centers, and
in other hospitals in Europe. BT-001 is a highly innovative
oncolytic virus, that has been designed to achieve a strong
anti-tumor response by combining multiple mechanisms of action. We
would like to thank the investigators and the clinical teams for
their support and look forward to treating the first patients with
this first Invir.IO™ generated oncolytic virus candidate to enter
clinical development” said Dr. Maud Brandely, MD, PhD, Chief
Medical Officer of Transgene.
In France, the BT-001 Phase I/IIa trial will be conducted in
four clinical centers: the Bergonié Institute (Bordeaux), the
Gustave Roussy Institute (Paris area), the Centre Léon Bérard
(Lyon) and the Hôpital Saint-Louis (Paris).
This international study will enroll up to 48 patients with
metastatic/advanced solid tumors in its Phase I part followed by
expansion cohorts in its Phase IIa part. The trial will evaluate
the administration of BT-001 as a single agent and in combination
with pembrolizumab, an anti-PD1.
***
About the trial The trial is a multicenter, open-label,
dose-escalation Phase I/IIa trial evaluating BT-001 alone or in
combination with pembrolizumab. The trial has been approved in
Europe (France and Belgium) and will be next conducted in the USA.
The Phase I will be divided into two parts. Part A will enroll up
to 36 patients with metastatic/advanced solid tumors, who have
already been pretreated, including with immunotherapies. Patients
will receive single agent, intra-tumoral administrations of BT-001,
in cutaneous or palpable subcutaneous lesions or easily injectable
lymph nodes, to select the recommended dose and best regimen. Part
B will explore the combination of intra-tumoral injections of
BT-001 with pembrolizumab, an anti-PD1 targeting agent in 12
patients. The Phase IIa will evaluate the combination regimen in
several patient cohorts with different tumors types. These
expansion cohorts will offer the possibility of exploring the
activity of this approach to treat other malignancies not
traditionally addressed with this type of treatment.
About BT-001 BT-001 is a best-in-class oncolytic virus
developed with Transgene’s Invir.IO™ platform. Invir.IO™’s viruses
are based on the patented large capacity Vaccinia virus Copenhagen
strain genetically modified with the double deletion TK-RR-. This
optimization enhances the safety profile of the virus. From this,
BT-001 is engineered to encode both a highly differentiated Treg
depleting anti-CTLA4 antibody and the human GM-CSF cytokine. The
recombinant antibody recognizing human CTLA4 was generated by
BioInvent’s proprietary n-CoDeR®/F.I.R.S.T™ platforms. The use of
an oncolytic virus to deliver the anti-CTLA4 locally and
selectively in the tumor microenvironment allows high intratumoral
concentrations of both transgenes eliciting a stronger and more
effective antitumor response. By reducing systemic exposure to a
very low level, this local therapeutic activity furthermore allows
to increase the safety and tolerability profile of the anti-CTLA4
antibody. Preclinical data have shown that BT-001 has potential for
broad single agent activity, and that selective tumor-localized
delivery of anti-CTLA4 may allow for a better tolerated, sustained
and more effective combination therapy with antibodies targeting
the PD-1/PDL1 axis. A multicenter, open-label, dose-escalation
Phase I/IIa trial evaluating BT-001 alone or in combination with
pembrolizumab has been approved in Europe (France and Belgium) and
should be next conducted in the USA. The scientific and clinical
development of the oncolytic virus candidate BT-001 is a 50/50
collaboration between BioInvent and Transgene.
About Transgene Transgene (Euronext: TNG) is a publicly
traded French 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 two therapeutic vaccines (TG4001
for the treatment of HPV-positive cancers, and TG4050, the first
individualized therapeutic vaccine based on the myvac® platform) as
well as two oncolytic viruses (TG6002 for the treatment of solid
tumors, and BT-001, the first oncolytic virus based on the
Invir.IO™ platform). 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
Twitter: @TransgeneSA
Disclaimer Transgene 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. There can be no guarantee that
(i) the results of pre-clinical work and prior clinical trials will
be predictive of the results of the clinical trials currently
underway, (ii) regulatory authorities will agree with the Company’s
further development plans for its therapies, or (iii) the Company
will find development and commercialization partners for its
therapies in a timely manner and on satisfactory terms and
conditions, if at all. The occurrence of any of these risks could
have a significant negative outcome for the Company’s activities,
perspectives, financial situation, results and development. 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
Risques”) 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: Citigate Dewe Rogerson David Dible/Sylvie Berrebi
+ 44 (0)20 7638 9571 transgene@citigatedewerogerson.com
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