Transgene - Preclinical Results Showing TG6050, a Novel Oncolytic Virus, induces Tumor Regression by Activating Innate and Adaptive immune responses presented at AACR
April 17 2023 - 12:30AM
Business Wire
Invir.IO® based oncolytic virus TG6050, is armed with IL-12 and
an anti-CTLA4 antibody. A Phase I trial (Delivir) recently started
enrolling patients with advanced non-small cell lung cancer
(NSCLC)
Regulatory News:
Transgene (Euronext Paris: TNG), a biotech company that
designs and develops virus-based immunotherapies for the treatment
of cancer, presented promising preclinical data on its novel
oncolytic virus TG6050, at the American Association for Cancer
Research (AACR) Annual Meeting, April 14-19, 2023.
These data demonstrate the ability of TG6050 to induce strong
antitumor responses through the production of IL-12 and anti-CTLA4
antibody in the tumor and the induction of innate and adaptive
immune responses.
TG6050 is a clinical-stage oncolytic virus that has been
engineered to encode human IL-12 and a full length anti-CTLA4
antibody. It is derived from the Invir.IO® platform and its
patented VVCOPTK-RR- viral vector which was shown to be well
tolerated in humans and to replicate and express payloads in tumor
tissues.
Key results of the poster are as follows:
✓ Sustained expression of IL-12 has been
detected in tumors after intravenous and intratumoral
administration of the murine version of TG6050 (mTG6050). The
levels of functional IL-12 found in the tumor reach active
concentrations. They are associated with low systemic exposure. ✓
mTG6050 treatment increased T cell responses capable of killing
cancer cells. ✓ Transcriptomic and immunological analyses clearly
show a remodeling of the tumor micro-environment and the activation
of numerous innate and adaptive immune pathways. ✓ In several mice
models, mTG6050 displayed a very strong anti-tumor activity.
Hedi Ben Brahim, Transgene’s CEO said, “We have designed
TG6050, a novel oncolytic virus encoding the IL-12 and an
anti-CTLA4, to generate both innate and adaptive immune responses.
These outstanding pre-clinical findings clearly support the
clinical development of TG6050, which has recently started the
Phase I Delivir trial in patients with non-small cell lung cancer.
We are confident that by generating similar effects in humans,
TG6050 could become a new standard of care in patients with solid
tumors.”
The Phase I Delivir trial has been initiated in 2023 and is
currently enrolling patients with metastatic and recurring
NSCLC.
Transgene will present a total of eight posters at AACR 2023
which all demonstrate the potential of the Company’s viral vectors
in the treatment of solid tumors.
About TG6050 TG6050 is an oncolytic virus developed with
Transgene’s Invir.IO® platform for intravenous administration.
Invir.IO®’s viruses are based on the patented large capacity
Vaccinia virus Copenhagen strain genetically modified with the
double deletion TK-RR- (VVCOPTK-RR-). TG6050 has been engineered to
encode human IL-12, a cytokine that triggers a powerful antitumor
immune response and a full length anti-CTLA4 antibody. It has also
been optimized with the deletion of the gene encoding for the M2L
viral protein that targets CD80 and CD86, two ligands of CTLA4
[source: Kleinpeter et al., J Virol. 2019 Jun 1; 93(11):
e00207-19]. The use of an oncolytic virus to deliver these
immunotherapies locally and selectively in the tumor
microenvironment allows high intratumoral concentrations of both
therapeutic proteins 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 IL-12 and the
anti-CTLA4 antibody. It will be evaluated in the Delivir trial, a
Phase I trial conducted in advanced NSCLC patients. A short video
detailing TG6050’s mechanism of action can be found here.
About the Delivir trial (NCT: 05788926) The Delivir trial
is a multicenter, open label, dose-escalation Phase I trial
evaluating TG6050 as a single agent. The trial will enroll up to 36
patients with metastatic/advanced non-small cell lung cancer
(NSCLC), who have failed standard therapeutic options including
immunotherapies such as immune checkpoint inhibitors. Patients will
receive single and repeated escalating doses of TG6050 administered
intravenously, to determine the recommended dose and best schedule
of administration for subsequent clinical development.
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. 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230416005012/en/
Transgene: Lucie Larguier Director Corporate
Communications & IR +33 (0)3 88 27 91 04
investorrelations@transgene.fr
Media: MEDiSTRAVA Consulting David Dible/Sylvie
Berrebi/Evelyn McCormack+44 (0)203 928 6900
transgene@medistrava.com
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