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 immuno-modulatory
antibodies for cancer immunotherapy, today announced a clinical
trial collaboration and supply agreement with MSD, a tradename of
Merck & Co., Inc., Rahway, NJ., USA, to evaluate the oncolytic
virus BT-001 in combination with MSD’s anti-PD-1 therapy KEYTRUDA®
(pembrolizumab) in a Phase I/IIa clinical trial for the treatment
of patients with solid tumors.
Under the terms of the supply agreement, MSD will provide
pembrolizumab to be used in combination with BT-001 in the ongoing
Phase I/IIa clinical trial.
“By combining BT-001 with the anti-PD-1 drug KEYTRUDA® we expect
to optimize the patient’s immune response to induce a strong and
effective anti-tumor response. This agreement will allow us to move
further on the clinical development of our promising co-developed
oncolytic candidate BT-001” said Hedi Ben Brahim, CEO of
Transgene.
“We are very pleased to be signing another collaboration with
MSD, supporting the expansion of the clinical trial program of
BT-001, the oncolytic virus expressing our proprietary anti-CTLA-4
antibody, jointly developed by Transgene and BioInvent. It marks a
further validation of our expanding and promising clinical pipeline
of anti-cancer treatments, which currently encompasses three
compounds in four ongoing clinical trials” added Martin
Welschof, CEO of BioInvent.
Recruitment in the clinical study (NCT04725331) is ongoing. The
trial is a Phase I/IIa of BT-001, which is being co-developed as
part of a 50/50 collaboration between Transgene and BioInvent, as a
single agent and in combination with KEYTRUDA® for the treatment of
solid tumors.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
***
About the trial
The ongoing Phase I/IIa (NCT04725331) 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 receive single agent, intra-tumoral
administrations of BT-001. Part B will explore the combination of
intra-tumoral injections of BT-001 with pembrolizumab. The Phase
IIa will evaluate the combination regimen in several patient
cohorts with different 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 human recombinant 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. As a consequence, by reducing
systemic exposure, the safety and tolerability profile of the
anti-CTLA-4 antibody will 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 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
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 three drug candidates in four ongoing clinical
programs in Phase l/ll trials for the treatment of hematological
cancer and solid tumors, respectively. The Company’s validated,
proprietary F.I.R.S.T™ technology platform simultaneously
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 or for additional licensing and
partnering.
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 Twitter: @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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220627005554/en/
Transgene: Lucie Larguier Director Corporate
Communications & IR +33 (0)3 88 27 91 04
investorrelations@transgene.fr
Media Transgene: MEDiSTRAVA Consulting David
Dible/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
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