The Phase I Part B will evaluate the combination of BT-001 and
pembrolizumab in solid tumors, including melanoma
Regulatory News:
Transgene (Euronext Paris: TNG), a biotech company that
designs and develops virus-based immunotherapeutics against cancer,
and BioInvent International AB (“BioInvent”) (Nasdaq Stockholm:
BINV), a biotech company focused on the discovery and
development of novel and first-in-class immune-modulatory
antibodies for cancer immunotherapy, today announce that the
first patient of the Phase I part B clinical trial evaluating the
combination of BT-001 and MSD’s anti-PD-1 therapy, KEYTRUDA®
(pembrolizumab) has been dosed.
The Phase I Part B of the trial explores repeated intra-tumoral
injections of BT-001 in combination with intravenous infusions of
KEYTRUDA. Transgene and BioInvent plan to enroll a minimum of 12
patients with metastatic or advanced solid tumors, including
melanoma. In accordance with our clinical trial and supply
agreement, KEYTRUDA is being supplied by MSD (a tradename of Merck
& Co., Inc., Rahway, NJ, USA). Trial endpoints include safety,
evaluation of efficacy, and assessment of immune changes in the
tumor microenvironment.
Transgene and BioInvent are co-developing BT-001, an oncolytic
virus designed using Transgene’s Invir.IO® platform encoding
BioInvent’s differentiated anti-CTLA-4 antibody and human GM-CSF
cytokine to elicit a strong and effective anti-tumoral response.
The drug is currently being evaluated against solid tumors in a
Phase I/IIa clinical trial as a single agent and in combination
with the PD-1 checkpoint inhibitor KEYTRUDA.
The inclusion of the last patient in Part B of the study is
expected in H1 2024.
Previously reported Phase I data confirmed the mechanism of
action of BT-001 as a single agent and demonstrated first signs of
anti-tumoral activity.
Dr. Martin Welschof, CEO of BioInvent and Dr. Alessandro Riva,
Chairman and CEO of Transgene, added: “By combining BT-001 with
pembrolizumab, we are building upon the promising data generated by
BT-001 as a single agent. Targeting the PD1/PD-L1 pathway in
addition to BT-001’s mechanism of action is expected to further
stimulate and restore the patient’s immune system, which should
result in improved antitumoral activity and patient outcome. We are
thrilled to enter this new phase of the development of the novel
oncolytic virus BT-001 and further demonstrate its potential in
combination with a reference treatment.”
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
***
About the trial The ongoing Phase I/IIa (NCT: 04725331)
study is a multicenter, open label, dose-escalation trial
evaluating BT-001 as a single agent and in combination with
pembrolizumab (anti-PD-1 treatment). Patient inclusions are ongoing
in Europe (France, Belgium) and the trial has been authorized in
the US. This Phase I is divided into two parts. In part A, patients
with metastatic/advanced tumors received single agent,
intra-tumoral administrations of BT-001. Part B is exploring
intra-tumoral injections of BT-001 in combination with KEYTRUDA. In
this part, KEYTRUDA is being provided to the trial by MSD (a
tradename of Merck & Co., Inc., Rahway, NJ, USA). The Phase IIa
will evaluate the combination regimen in several patient cohorts
with selected tumor 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 an oncolytic virus generated using
Transgene’s Invir.IO® platform and its patented large-capacity
VVcopTK-RR- oncolytic virus, which has been engineered to encode
both a Treg-depleting recombinant human anti-CTLA-4 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. Therefore, by reducing
systemic exposure, the safety and tolerability profile of the
anti-CTLA-4 antibody may be greatly improved. BT-001 is being
co-developed as part of a 50/50 collaboration on oncolytic viruses
between Transgene and BioInvent. To know more on BT-001, watch our
video here.
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.fr Follow us on social
media: X (ex-Twitter): @TransgeneSA – LinkedIn: @Transgene
About BioInvent BioInvent International AB (Nasdaq
Stockholm: BINV) is a clinical-stage biotech company that discovers
and develops novel and first-in-class immuno-modulatory antibodies
for cancer therapy, with currently four drug candidates in five
ongoing clinical programs in Phase 1/2 trials for the treatment of
hematological cancer and solid tumors, respectively. The Company’s
validated, proprietary F.I.R.S.T™ technology platform identifies
both targets and the antibodies that bind to them, generating many
promising new drug candidates to fuel the Company’s own clinical
development pipeline and providing licensing and partnering
opportunities. The Company generates revenues from research
collaborations and license agreements with multiple top-tier
pharmaceutical companies, as well as from producing antibodies for
third parties in the Company’s fully integrated manufacturing unit.
More information is available at www.bioinvent.com. Follow us on
social media platform X: @BioInvent
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.
BioInvent disclaimer The press release contains
statements about the future, consisting of subjective assumptions
and forecasts for future scenarios. Predictions for the future only
apply as the date they are made and are, by their very nature, in
the same way as research and development work in the biotech
segment, associated with risk and uncertainty. With this in mind,
the actual outcome may deviate significantly from the scenarios
described in this press release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231009505229/en/
Transgene: Lucie Larguier Director Corporate
Communications & IR +33 (0)3 88 27 91 04
investorrelations@transgene.fr
Media Transgene: MEDiSTRAVA Consulting Frazer
Hall/Sylvie Berrebi +44 (0)203 928 6900
transgene@medistrava.com
BioInvent: Cecilia Hofvander Senior Director Investor
Relations +46 (0)46 286 85 50 cecilia.hofvander@bioinvent.com
BioInvent International AB (publ): Co. Reg. No. Org nr:
556537-7263 Visiting address: Ideongatan 1 Mailing address: 223 70
LUND Phone: +46 (0)46 286 85 50 www.bioinvent.com
Transgene (EU:TNG)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Transgene (EU:TNG)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024