Transgene Confirms the Potential of the Intravenous Route of its Invir.IO™ Oncolytic Viruses against Solid Tumors with TG6002 Phase I Data Presented at ESMO Congress 2022
12 September 2022 - 8:00AM
Business Wire
Additional positive TG6002 Phase I data show that the oncolytic
virus is able to reach the tumor, replicate and express its payload
in all patients when administered intravenously
Regulatory News:
Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech
company that designs and develops virus-based immunotherapeutics
against cancer, today announces positive confirmatory data from
the Phase I trial evaluating TG6002 administered intravenously (IV)
in combination with oral 5-FC in patients with advanced
gastrointestinal carcinomas.
TG6002 is based on Transgene’s double deleted VVcopTK-RR-
patented virus backbone, which forms the basis of the company’s
Invir.IO™ platform, and is generating a pipeline of multi-armed
therapeutic OV drug candidates.
These updated data generated on 37 patients treated at the
highest dose levels of the Phase I demonstrated that the therapy is
well tolerated and confirmed the mechanism of action of TG6002
administered IV. They were presented on September 11, 2022, in
a poster presentation at the European Society for Medical Oncology
(ESMO) meeting taking place in Paris (France) from September 9-13,
2022.
The findings are as follows:
- TG6002 demonstrated good tolerability when administered
weekly or on days 1,3 and 5. No major toxicities limiting the dose
escalation process or the intensification of the schedule of
administration were observed. Transient fever is the most common
adverse event.
- TG6002 is able to reach the tumor, replicate, and express its
payload after IV administration.
- Onset of a neutralizing antibody response is not associated
with a decreased biological activity of the product.
- These data further confirm the mechanism of action of the
Invir.IO™-based oncolytic viruses in humans.
- The two IV administration schedules display different
characteristics, that can both be leveraged in upcoming clinical
trials. Three doses given once a week resulted in higher levels
of expression of the payload than the more intensive schedule (3
injections within 5 days). The intensive schedule allowed for a
longer lasting expression of the payload.
These findings support the potential of IV administration of
Invir.IO™-based oncolytic viruses, extending the use of these
therapies to a broad range of solid tumors.
The overall Phase I program with TG6002 was aimed at
establishing the tolerability and the potential different doses and
administration schedules for further development. Additional data
will be produced from the Phase I program and will be presented at
a scientific congress in H1 2023.
- Title of the poster: “Updated data of biodistribution
and activity of oncolytic virus TG6002 after intravenous
administration in patients with advanced gastrointestinal
carcinomas”
- Authors: Victor Moreno, Philippe Cassier, Bernard Doger,
Emiliano Calvo, Maria De Miguel, Rocio Garcia-Carbonero, Carlos
Gomez-Roca, Christiane Jungels, Sophie Sainte-Croix, Philippe Erbs,
Alain Sadoun and Kaïdre Bendjama
- Abstract Number: #4886
- Poster Number: 392P
The abstract and the e-poster are available on the ESMO congress
website here and the e-poster can be downloaded on the Transgene
website here as well.
***
About the trial (NCT03724071) This trial is
a single-arm open-label Phase I/II trial evaluating the safety and
tolerability of multiple ascending doses of TG6002 administered
intravenously in combination with oral 5-FC, a non-cytotoxic
pro-drug that can be converted in 5-FU, its active metabolite.
Based on the safety profile of TG6002, several dose levels and
administration schedules have been added to the initial Phase I
clinical protocol. The trial has safety as primary endpoint for the
Phase I. The trial also evaluates pharmacokinetic properties and
biodistribution of TG6002, along with immune modulation of the
tumor micro-environment. This European study enrolled patients
suffering from advanced gastrointestinal carcinomas who have failed
and/or are intolerant to standard therapeutic options in the Phase
I part. Dr. Philippe Cassier, M.D., Ph.D., head of the early-phase
trials unit at Centre Léon Bérard (Lyon, France), is the principal
investigator of the trial.
About TG6002 TG6002 has been engineered to directly kill
cancer cells (oncolysis), to enable the production of a
chemotherapy agent (5-FU) within the tumor, and to elicit an immune
response by the body against the tumor cells. Its satisfactory
safety profile after intravenous administration and its mechanism
of action has been shown in human in a Phase I trial. In
preclinical experiments, TG6002 has been shown to induce the
shrinkage of the primary tumor as well as the regression of distant
metastases (Foloppe, et al., Molecular Therapy Oncolytics,
https://doi.org/10.1016/j.omto.2019.03.005). The production of 5-FU
directly in the tumor aims to achieve a better anti-tumoral effect
with limited chemotherapy-induced side effects. TG6002 induces the
production of 5-FU in the cancer cells it has infected, by enabling
the local conversion of the pro-drug 5-FC (administered orally)
into 5-FU. 5-FU is a common chemotherapy agent for patients with
gastrointestinal cancers. This mechanism of action is based on the
in-tumor expression of the proprietary FCU1 gene that has been
encoded in the genome of TG6002, taking advantage of the virus
selective replication in the tumor cells. When administered
systemically, 5-FU is associated with side effects that can lead to
treatment discontinuation. With TG6002, 5-FU is produced within the
tumor where it is expected to be present at a high concentration
level in contrast to the very low levels anticipated in the rest of
the patient’s body.
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
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.
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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
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