Treatment of all Phase Ia cohorts in monotherapy completed with
no safety concerns
Stabilization of injected lesions in 11/18 patients
An independent Safety Review Committee has approved initiation
of the combination trial with pembrolizumab
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 positive
Phase Ia data on the oncolytic virus BT-001 for the treatment of
solid tumors.
Treatment with single agent BT-001 in 18 patients has now been
completed with no safety concerns reported. Patients had at least
one accessible superficial lesion and were studied in three
dose-escalating cohorts. BT-001 stabilized the injected lesions in
eleven patients in total: two at the 106 pfu dose (n=6), five at
107 pfu (n=6) and four at 108 pfu (n=6). Furthermore, objective
antitumor activity, defined as decrease of injected lesion size of
50% or more, was observed in one patient in the 106 pfu cohort
(n=6) and one patient in the 107 pfu cohort (n=6).
Transgene and BioInvent are co-developing BT-001, an oncolytic
virus developed using Transgene’s Invir.IO® platform encoding
BioInvent’s anti-CTLA-4 antibody to elicit a strong and effective
anti-tumoral response. The drug is currently being evaluated in a
Phase I/IIa clinical trial as a single agent and in combination
with the PD-1 checkpoint inhibitor KEYTRUDA® (pembrolizumab)
against solid tumors.
Previously reported Phase I data confirmed the mechanism of
action of BT-001 as a single agent and demonstrated first signs of
anti-tumor activity.
Based on these results, the independent Safety Review Committee
(SRC) has now approved initiation of the combination part of the
trial with pembrolizumab. The first patient in this Phase I part B
is expected to be enrolled in H2 2023.
“These data are a further positive indication of the efficacy of
BT-001 against solid tumors. While the advanced disease setting of
this first in human trial did not allow long-term monitoring of
patients, the effect on injected lesions has the potential to
translate into the induction of a systemic immune response,
antitumor effect and ultimately clinical benefit in combination
with pembrolizumab. There were no safety concerns and antitumor
activity was observed even at the lowest dose. We are looking
forward to investigating BT-001 further in combination with
pembrolizumab,” commented Martin Welschof, CEO of BioInvent and Dr.
Alessandro Riva, Chairman of Transgene.
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 receive single agent, intra-tumoral
administrations of BT-001. Part B will explore the combination of
intra-tumoral injections of BT-001 with pembrolizumab. In this
part, KEYTRUDA® (pembrolizumab) will be provided to the trial by
MSD (Merck & Co).
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 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 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 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
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 on Twitter: @BioInvent.
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/20230524005747/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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