STRASBOURG, France--(BUSINESS WIRE)--Regulatory News:
Transgene (Paris:TNG) (Euronext Paris: TNG), a biotechnology company
focused on designing and developing viral-based immune-targeted
therapies for the treatment of cancers and infectious diseases, today
announced its financial results for the fiscal year ended December 31,
2016, and provided its outlook for 2017.
In 2016, Transgene has focused its efforts on implementing its strategy,
which looks to combine Transgene’s immunotherapies (therapeutic vaccines
and oncolytic viruses, which boost the immune system), with immune
checkpoint inhibitors (ICIs). Over the last twelve months, additional
data from clinical studies combining active immunotherapies with ICIs
have confirmed the strong rationale behind this strategy.
During the second half of 2016, Transgene signed two clinical
collaboration agreements that allow clinical studies with:
TG4010 in combination with Bristol Myers-Squibb’s ICI nivolumab in
lung cancer patients receiving a 2nd line of treatment and;
TG4001 with Merck KGaA’s and Pfizer’s ICI avelumab in patients with
HPV-positive head and neck cancer.
Several clinical trials have recently started or are being initiated to
confirm the potential of Transgene’s immunotherapeutics in combination
with ICIs. The first results from these studies are expected around the
end of 2017.
During the 2016 fiscal year, the Company strengthened its financial
structure which will provide it with the funding to execute its clinical
development plan through the end of 2018. This improved financial
situation was the result of:
a loan of €20 million from the European Investment Bank (EIB), €10
million of which was drawn down in June 2016 ;
a €46.4 million rights issue that was completed in November 2016;
as well as the significant reduction of our net loss €25.2 million
compared to €46.4 million in 2015.
In parallel with strengthening its financial position, Transgene
completed its reorganization with the result it is now focused on
research and clinical development (R&D). As part of the restructuring,
Transgene sold its production facility to ABL Europe, a Mérieux Group
Company, for €3.5 million.
Philippe Archinard, Chairman and Chief Executive Officer of Transgene
said: “Our achievements in 2016 have reinforced our position as a
major player in immunotherapy. Our portfolio of immunotherapies, our
clinical collaborations and our much-improved financial position have
put us in a strong position to execute our clinical plan which is
designed to deliver a rich news flow over the coming months. Positive
results from these studies would allow us to conclude partnership
agreements with pharmaceutical companies. We are looking forward to
demonstrating the important clinical benefits that our immunotherapies
in combination with ICIs can offer to patients with severe diseases.”
Product pipeline review
1. Therapeutic Vaccines
TG4010 in advanced non-squamous non-small cell
TG4010 is a therapeutic vaccine that induces an immune response
against MUC1 expressing cells. TG4010 is being developed in non-squamous
non-small cell lung cancer (NSCLC). TG4010’s mechanism of action and
excellent safety profile make it a very suitable candidate for
combinations with other therapies.
TG4010’s development plan is focused on Phase 2 studies that can
generate a comprehensive data package for TG4010 in 1st-
and 2nd-line treatment of advanced NSCLC over
the next 9 to 18 months.
The clinical trials aim to confirm the synergies that are expected to
result from the combination of a therapeutic vaccine and an ICI. The
expected clinical benefits are an increase in the response rate, in the
quality and in the duration of the response to current and future
standards of care.