All of Transgene’s Preclinical and Clinical
Assets Progressed in Line With Expectations in Q1 2022
TG4050 – New positive preliminary Phase I results
presented at AACR 2022; additional clinical data to be presented at
ASCO 2022
BT-001 – Preclinical data presented at AACR 2022. Phase
I clinical update to be released in Q2 2022
Dr. Alessandro Riva proposed as new independent Director
and non-executive Chairman of the Board, separating the roles
of Chairman and Chief Executive Officer
€46.8 million in cash and cash equivalents as of March 31,
2022 – Confirmed financial visibility until the end of 2023
Regulatory News:
Transgene (Euronext 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
ended March 31, 2022.
Over the first quarter of 2022, all of Transgene’s
preclinical and clinical assets progressed in line with
expectations. All clinical-stage immunotherapies are slated to
deliver data by the end of the year.
Key events of the period and upcoming news flow
TG4050
At the American Association for Cancer Research (AACR) 2022
annual meeting, held in New Orleans, LA, April 8-13,
Transgene discussed new preliminary positive data on TG4050, its
individualized cancer vaccine. These immunological and clinical
data highlight the potential of this highly innovative neoantigen
vaccine.
A poster on the progress of the two ongoing Phase I trials of
TG4050 has been accepted for presentation at the upcoming American
Society of Clinical Oncology (ASCO) annual meeting, taking
place in Chicago, IL, June 3-7, 2022. More information will be
provided on May 27, 2022, after the release of the abstracts by
ASCO.
An article on the two ongoing trials with TG4050 was also
published in the Journal for ImmunoTherapy of Cancer [1]. The
publication demonstrated that it is possible to develop a patient
specific vaccine within a few weeks for patients with a low to
moderate tumor mutational burden.
BT-001
Promising preclinical data with BT-001 were presented at AACR
2022 and published in the Journal for ImmunoTherapy of
Cancer [2] demonstrating the broad and robust antitumor
activity of this Invir.IO™ oncolytic virus.
Transgene and BioInvent will provide an update on the
progress of the clinical trial of BT-001 in Q2 2022. Initial Phase
I results will be presented at a scientific conference in H2
2022. These first results aim to establish the tolerability of
BT-001 and to determine the dose and administration schedule for
further development.
Invir.IO™ collaboration with PersonGen
BioTherapeutics
Transgene announced the launch of a preclinical collaboration
with PersonGen BioTherapeutics. This collaboration aims to
evaluate the feasibility and efficacy of a combination therapy
against solid tumors, combining PersonGen’s CAR-T cell injection
with an oncolytic virus from the Invir.IO™ platform.
Governance
Transgene plans to reinforce its corporate governance by
separating the roles of Chairman and CEO. Transgene’s Board of
Directors has proposed Dr. Alessandro Riva, MD, as the
Non-executive Chairman of the Company. If this nomination is
accepted at the upcoming General Shareholder Meeting (May 25,
2022), the roles of Chairman and CEO will be separated. With 30
years of experience in the Life Sciences industry, Dr. Riva will be
working closely with Transgene’s CEO Hedi Ben Brahim to realize the
potential of the Company’s technology platforms and products to
benefit cancer patients.
Transgene’s Board of Directors also proposed the appointment of
Prof. Jean‑Yves Blay (subject to the authorization of the public
authority to which he reports) and Laurence Espinasse as
directors.
Steven Bloom joined Transgene as Vice President, Chief
Business Officer (CBO). In this position, he has become a
member of the executive committee, leading global business
development strategy, alliance management and program management.
In particular, he is focused on building the profile of Transgene
in the US, where he is based, as part of establishing the Company
as a world leader in virus-based immunotherapies.
Transgene also announced that the date of the release of the
first half 2022 financial results and of the interim report has
been advanced to September 7, 2022.
Summary of key ongoing clinical trials and expected
milestones
myvac®
TG4050
Phase I
NCT03839524
Targets: tumor neoantigens
- Codeveloped with NEC
- New positive data in first patients demonstrating the
immunogenicity of the vaccine as well as first signs of clinical
activity presented at AACR 2022
Ovarian cancer – after surgery and
first-line chemotherapy
- Trial ongoing in the USA and in France
- Patient enrollment progressing in line with forecast
TG4050
Phase I
NCT04183166
HPV-negative head and neck cancer – after
surgery and adjuvant therapy
- Trial ongoing in the UK and in France
- Patient enrollment progressing in line with forecast
TG4001
+ avelumab Phase II
NCT03260023
Targets: HPV16 E6 and E7 oncoproteins
Recurrent/metastatic anogenital
HPV-positive – 1st (patients ineligible for chemotherapy) and 2nd
lines
- Randomized Phase II trial comparing the combination of TG4001
with avelumab versus avelumab alone
- Active patient enrollment in Europe (France and Spain), trial
initiated in the USA
Invir.IO™
BT-001
Phase I/IIa
NCT04725331
Payload: anti-CTLA4 antibody and GM-CSF cytokine
Solid tumors
- Co-development with BioInvent
- Very encouraging preclinical results presented at AACR
2022
- Trial ongoing in France, Belgium and approved in the USA
TG6002
Phase I/IIa
NCT03724071
Payload: FCU1 for the local production of a 5-FU
chemotherapy
Gastro-intestinal cancer (colorectal
cancer for Phase II) – Intravenous (IV) administration
- Multicenter trial ongoing in Belgium, France and Spain
- Proof-of-concept data of the IV administration presented in
2021 (ESMO & AACR)
- Dose escalation completed to the maximum projected dose (3x109
pfu), confirming the good safety profile. Assessment of this
intensified administration schedule ongoing
- End of Phase I expected mid-2022
TG6002
Phase I/IIa
NCT04194034
Colorectal cancer with liver metastasis –
Intrahepatic artery (IHA) administration
- Multicenter trial ongoing in the UK and in France
- Ongoing enrollment of patients from the latest dose escalation
cohort (109 pfu)
- First data expected mid-2022
Operating revenue
Q1
In millions of euros
2022
2021
Revenue from collaborative and licensing agreements
0.4
0.9
Government financing for research expenditures
1.7
1.5
Other income
0.1
-
Operating revenue
2.2
2.4
During the first quarter of 2022, revenue from collaborative and
licensing agreements was mainly composed of revenue from the
collaboration with AstraZeneca.
As of March 31, 2022, government financing for research
expenditures mainly consisted of accrual of 25% of the research tax
credit expected for 2022 (€1.7 million in the first quarter of 2022
compared to €1.5 million for the same period in 2021).
Cash, cash equivalents and other financial assets
Cash, cash equivalents and other financial assets stood at
€46.8 million as of March 31, 2022, compared to €49.6 million
as of December 31, 2021. In the first quarter of 2022, Transgene’s
net cash burn was €2.8 million, compared to €7.2 million for the
same period in 2021. This decrease is notably linked to the receipt
in January 2022 of the $8 million payment from AstraZeneca
following the exercise of a first license option in December 2021
for an oncolytic virus developed by Transgene.
The Company holds shares of Tasly BioPharmaceuticals valued at
€18.9 million at the end of December 2021.
The Company has a financial visibility through the end of
2023.
Next planned financial communication September
7, 2022 - First Half 2022 Financial Results
***
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
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.
[1] McCann K, von Witzleben A, Thomas J, et al, Targeting the
tumor mutanome for personalized vaccination in a TMB low non-small
cell lung cancer, Journal for ImmunoTherapy of Cancer
2022;10:e003821. doi:
10.1136/jitc-2021-003821
[2] Semmrich M, Marchand J, Fend L, et al. Vectorized
Treg-depleting αCTLA-4 elicits antigen cross-presentation and CD8+
T cell immunity to reject ‘cold’ tumors. Journal for ImmunoTherapy
of Cancer 2022;10:e003488. doi:
10.1136/jitc-2021-003488
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version on businesswire.com: https://www.businesswire.com/news/home/20220510006075/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
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