- Promising clinical data for TG4001 – late breaker abstract at
SITC 2020
- Advanced technological leadership with the myvac® platform:
two clinical trials in patients with solid tumors initiated in
January 2020
- Initial translational data confirm that I.V. TG6002 can induce
the production of a chemotherapy agent (5-FU) in the tumor
- Invir.IO™ -based BT-001 on track to enter the clinic before
the end of 2020
- €45.3 million in cash and cash equivalents as of September 30,
2020, following the partial sale of stake in Tasly
BioPharmaceuticals
Regulatory News:
Transgene (Paris:TNG), a biotech company that designs and
develops virus-based immunotherapies for the treatment of
cancer, today announces its business update for the quarter
ending September 30, 2020.
Promising data for TG4001 to be presented at SITC
2020
A late breaking abstract presenting the detailed results from
the Phase 1b/2 trial combining TG4001, a HPV16-targeted therapeutic
vaccine, with avelumab in advance HPV16-positive has been accepted
at the SITC 35th Anniversary Annual Meeting (SITC 2020).
The combination of TG4001 and avelumab demonstrated
anti-tumor activity (23.5% ORR) in patients with previously
treated recurrent and/or metastatic HPV-related cancers.
The trial showed that the presence of liver metastases has a
profound impact on outcome in terms of ORR and PFS. In
patients without liver metastases, an ORR of 34.8% and a median PFS
of 5.6 months were achieved. These results compare favorably
to single-agent immune checkpoint inhibitors.
The treatment induced HPV-specific T-cell responses and was
associated with increased levels of immune cell infiltration in the
tumors and expression of genes associated with activation of the
immune system.
A planned randomized controlled trial will allow for a larger
scale confirmation of these promising results.
The poster, as well as an audio commentary by Prof. Christophe
Le Tourneau, principal investigator of the trial, will be available
on the congress website from November 9, 2020.
Philippe Archinard, Chairman and CEO of Transgene, and
Dr. Maud Brandely, MD, PhD, Chief Medical Officer of
Transgene, will provide some further background to the data. An
investor and analyst conference call/webcast in English is
scheduled November 12, 2020, at 12:00 p.m. ET (6:00 p.m. CET). The
webcast will be accessible via the following link:
https://channel.royalcast.com/transgene/#!/transgene/20201112_1.
Advanced technological leadership with the myvac®
platform
Transgene is developing TG4050, an individualized
immunotherapy, together with NEC. This individualized cancer
vaccine is based on the myvac® platform, which integrates NEC’s
artificial intelligence capabilities.
Transgene’s myvac® platform brings together a series of highly
innovative technologies, to build an integrated framework for the
clinical use of this revolutionary viral-based immunotherapeutic
approach.
- Transgene, together with Hypertrust, has implemented the first
block chain solution dedicated to the traceability of personalized
treatment in clinical trials. This cloud-based solution monitors
and orchestrates all of the processes related to the design and
manufacturing of Transgene’s TG4050, a therapeutic vaccine created
for each individual patient
- BostonGene conducts genomic and transcriptomic analyses of
tumors collected from patients enrolled in the clinical trials to
identify predictors of response to TG4050. These include cancer
cell-intrinsic and cell-extrinsic factors that may mediate each
patient’s response to the vaccine. This novel way of analyzing
patient data is part of an ambitious translational program that
supports the development of our myvac® platform with the aim of
accelerating the development of TG4050 by identifying patients who
should achieve the best possible clinical outcomes.
The first Phase 1 clinical trials assessing TG4050 in patients
with ovarian and head and neck cancers started in January 2020 in
Europe and in the United States. NEC is financing 50% of these
studies.
The Company has set up an in-house production unit dedicated to
the manufacturing of the individualized clinical batches of TG4050
needed for each patient. This unit is operational and complies with
good manufacturing practice (GMP) norms. The manufacturing process
and unit have been validated and the first clinical batches have
been produced.
Initial translational data of TG6002 highlight the potential
of the IV route – Invir.IO™ -based BT-001 on track to enter
the clinic before the end of 2020
Initial data from the Phase 1 trial confirm the good
tolerability of TG6002 in humans. The study also demonstrated that
this Vaccinia Virus can reach the tumor and replicate within these
cancer cells when administered intravenously. These data also
showed that 5-FU (a chemotherapeutic agent) can be produced at
therapeutic doses, resulting from the expression of the FCU1 gene,
integrated into the TG6002 genome, as the virus replicates
selectively in the tumor cells. In addition, these results support
the development of the Invir.IO™ platform, which uses the same
patented viral backbone.
BT-001 is the first oncolytic virus from the Invir.IO™ platform.
A first-in-human trial is being prepared; the trial protocol has
been filed in France and in Belgium. Transgene and its partner
BioInvent expect to initiate a Phase I clinical trial with BT-001
before the end of 2020. Promising preclinical results for BT-001
will be presented at the SITC annual congress.
The collaboration with AstraZeneca continues, as planned, with
the development of new innovative oncolytic viruses. AstraZeneca
can exercise options to further develop each of these novel drug
candidates.
Operating revenue
Q3
First Nine Months
In millions of euros
2020
2019
2020
2019
Revenue from collaborative and licensing
agreements
0.4
2.0
2.7
3.4
Government financing for research
expenditures
1.5
1.5
4.5
4.6
Other revenue
0.1
0.1
0.6
0.4
Operating revenue
2.0
3.6
7.8
8.4
During the first nine months of 2020, operating revenues
amounted to €7.8 million compared to €8.4 million in the same
period in 2019.
Revenue from collaborative and licensing agreements, amounted
to €2.7 million in the first nine months of 2020, compared with
€3.4 million in the same period in 2019. These revenues are
mainly derived from Transgene’s collaboration agreement with
AstraZeneca on the Invir.IO™ program. This amount corresponds to
€2.1 million recognized as the initial payment of €8.9 million ($10
million) received in 2019 and reflects the progress of the related
activities; the remaining corresponds to the payment of
contract-defined preclinical milestones. During the first nine
months of 2020, government financing for research expenditures
mainly in the form of a research tax credit remained stable at €4.5
million.
Cash, cash equivalents and other financial assets
Cash, cash equivalents, and other current financial assets
stood at €45.3 million as of September 30, 2020, compared to €43.3
million as of December 31, 2019. In the first nine months of
2020, Transgene’s cash position increased by €2.0 million. This
compares to a cash burn of €10.1 million (excluding the net
proceeds from a rights issue) for the same period in 2019. This
increase is due to the receipt of a net amount of €18.2 million in
July 2020, following the partial sale of Transgene’s stake in Tasly
BioPharmaceuticals. Following this share sale, Transgene holds 17.1
million shares in Tasly BioPharmaceuticals, equivalent to 1.58% of
the Chinese company’s capital. Transgene’s remaining shareholding
in Tasly BioPharmaceuticals is valued at approximately $36.9
million based on the price of the current share sale. In addition,
on October 20, 2020, the Company made an early repayment of the €10
million loan granted by the European Investment Bank (EIB). The
loan was due to be repaid in June 2021. This early repayment
resulted in interest savings of approximately €0.6 million.
Planned succession of the Chairman and Chief Executive
Officer
In September 2020, Philippe Archinard, Chairman and Chief
Executive Officer of Transgene, has informed the Board of Directors
of his intention to leave his position at the end of 2020 and to
take up new responsibilities within Institut Mérieux. His successor
will be Hedi Ben Brahim, who will take office on January 1, 2021.
Hedi Ben Brahim has been a Board member of Transgene since May
2019
Outlook
The Company confirms its financial visibility until
2022.
***
About Transgene Transgene (Euronext: TNG) is a
publicly traded French 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
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201105005801/en/
Transgene: Lucie Larguier Director Corporate
Communications & IR +33 (0)3 88 27 91 04
investorrelations@transgene.fr
Media: Citigate Dewe Rogerson David Dible/Sylvie
Berrebi + 44 (0)20 7638 9571
transgene@citigatedewerogerson.com
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