25 April 2017 - - US-based pharmaceutical company Bristol-Myers Squibb Company (NYSE: BMY) and France-based Transgene (PAR: TNG) have forged a new clinical research collaboration to evaluate the safety, tolerability and efficacy of Transgene's investigational therapeutic vaccine TG4010 in combination with Bristol-Myers Squibb's Opdivo (nivolumab) + standard chemotherapy (CT) as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) in patients whose tumors have low or undetectable levels of PD-L1, the companies said.

The Phase 2 clinical trial will explore the potential of combining Transgene's TG4010, an investigational therapeutic vaccine designed to generate an immune response against MUC1 expressing tumors such as NSCLC, in conjunction with Bristol-Myers Squibb's immune checkpoint inhibitor, Opdivo, designed to alleviate immune suppression.

Both therapies will be combined with standard chemotherapy in first line NSCLC patients.

The Phase 2 trial will evaluate objective tumor responses, and disease control in patients provided the regimen of TG4010 + Opdivo + CT, whose tumors express low and undetectable levels of PD-L1.

In addition, the study will evaluate safety and tolerability of this regimen together with other efficacy metrics. This multi-center single-arm trial is expected to deliver first results in 2018.

Under the terms of the agreement, Transgene will be the sponsor of the trial. Bristol-Myers Squibb will provide Opdivo for use in the study.

Opdivo is a programmed death-1 immune checkpoint inhibitor that is designed to uniquely harness the body's own immune system to help restore anti-tumor immune response.

By harnessing the body's own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo's leading global development program is based on Bristol-Myers Squibb's scientific expertise in the field of Immuno-Oncology and includes a range of clinical trials across all phases, including Phase 3, in a variety of tumor types.

To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union and Japan.

In October 2015, the company's Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

TG4010 is an immunotherapy that has been designed to express the coding sequences of the MUC1 tumor-associated antigen and the cytokine, Interleukin-2. TG4010, which is based on a modified vaccinia virus, induces an immune response against MUC1 expressing tumors, such as non-small cell lung cancer (NSCLC).

The results from the Phase 2b TIME trial with TG4010 immunotherapy associated with chemotherapy in NSCLC have been published in the peer-reviewed medical journal, The Lancet Oncology in December 2015.