Major Achievements In 2016 Validate TRANSGENE’s Strategy And Provide Promising Outlook For 2017

Published: Mar 20, 2017

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 lung cancer

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.

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