Preclinical proof-of-concept data published in the January
20, 2022 edition of the Journal for ImmunoTherapy of Cancer
(JITC).
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 jointly announced the
publication of extensive preclinical proof-of-concept data for
BT-001 in the Journal for ImmunoTherapy of Cancer (JITC). This
peer-reviewed article demonstrates that their co-developed clinical
stage product, based on Transgene’s patented oncolytic vector and
encoding BioInvent’s proprietary anti-CTLA-4 antibody, has the
potential to provide greater therapeutic benefit than systemically
administered anti-CTLA-4 antibodies.
Systemically administered anti-CTLA-4 antibodies, such as the
approved ipilimumab, have demonstrated substantial efficacy but
also clinically-limiting toxicity.
The JITC paper provides in vivo evidence that vectorized
anti-CTLA-4 antibodies delivered intratumorally (i.t.) can improve
safety by reducing their systemic exposure. Efficacy may also be
improved, with evidence from the immunocompetent murine model
showing that vectorized anti-CTLA-4 antibodies have anti-tumoral
activity even against ‘cold tumors’ that are resistant to
systemically-delivered checkpoint inhibitors. Furthermore, the
precise targeting of the antibody to a unique functional epitope of
CTLA-4 provides a higher level of regulatory T cells (Treg)
depletion than ipilimumab.
“This strong preclinical data supports the development of our
oncolytic virus BT-001 as an effective agent to treat solid tumors.
We have vectorized a uniquely targeted anti-CTLA-4 antibody for
intratumoral delivery and shown in vivo evidence that this reduces
systemic toxicity, addresses ‘cold tumors’ and provides excellent
tumor-selective Treg depletion. We are keenly anticipating progress
in our ongoing Phase 1/2a clinical study with BT-001,” said
Bjorn Frendéus, Chief Scientific Officer of BioInvent.
“These data demonstrate the relevance of the approach which is
based on combining our respective technologies to fully exploit the
synergy between oncolytic vector, targeted delivery of a potent
payload targeting immunosuppressive cells, and recruitment of
effector T cells. The antitumor properties showed in this JITC
publication give us great confidence in the results we expect from
the further clinical development of BT-001,” added Éric
Quéméneur, Executive VP & Chief Scientific Officer of
Transgene.
The safety-relevant data, published in JITC, show that a murine
vector version of BT-001 delivered sustained levels of
CTLA-4-receptor-saturating antibodies within tumors but low,
sub-saturating exposure in blood and the non-tumor tissue. These
antibody levels were associated with high depletion of Tregs in the
tumor but the absence of systemic Treg depletion, notably in the
spleen.
The study also provides several key insights into likely
mechanisms underlying the efficacy of BT-001. Vectorized
anti-CTLA-4:
- triggered both Fcγ-receptor-dependent Treg depletion and
antigen cross-presentation, mechanisms known to trigger and promote
long-lasting, systemic, CD8+ T cell antitumor immunity;
- showed broad antitumor activity, including activity against
murine ‘cold tumor’ models which are resistant to systemic
checkpoint inhibitors;
- showed additive or synergistic anti-tumor activity when
combined with anti-PD-1.
The JITC paper is titled “Vectorized Treg-depleting αCTLA-4
elicits antigen cross-presentation and CD8+ T cell immunity to
reject ‘cold’ tumors” and can be accessed here.
Recruitment in the ongoing Phase I/IIa clinical study of BT-001
(NCT04725331) in Europe is progressing steadily. The trial assesses
BT-001 as a single agent and in combination with the PD-1
checkpoint inhibitor pembrolizumab against solid tumors. Initial
Phase I data are expected in the first half of 2022.
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/20220119005975/en/
Transgene: Jean-Philippe Del Chief Financial Officer +33
(0)3 88 27 91 00 investorrelations@transgene.fr
Media: MEDiSTRAVA Consulting David Dible/Sylvie Berrebi +44
(0)7714 306525 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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