Transgene Receives FDA IND Approval to Begin a Clinical Trial with TG4010 + Nivolumab + Chemotherapy in the First-Line Treatment of Lung Cancer (NSCLC)

information fournie par Boursorama •11/09/2017 à 17:45

- Phase 2 Clinical Trial in Collaboration with Bristol-Myers Squibb
- First patient expected to be enrolled at the end of 2017

Strasbourg, France, September 11, 2017, 5:45 p.m. CET - Transgene (Euronext Paris: TNG), a biotech company that designs and develops viral-based immunotherapies, today announces that the US Food and Drug Administration (FDA) has granted Transgene Investigational New Drug (IND) clearance to proceed with a Phase 2 clinical trial of TG4010 in combination with Opdivo® (nivolumab) and chemotherapy as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) in the USA.

The Phase 2 clinical trial will explore the potential of combining Transgene’s TG4010, an investigational therapeutic vaccine, in association with Bristol-Myers Squibb’s immune checkpoint inhibitor, nivolumab, which acts by overcoming immune suppression. Both therapies will be combined with standard chemotherapy in first-line NSCLC patients, whose tumors express low and undetectable levels of PD-L1.

Transgene is the sponsor of this international trial. Transgene has signed a clinical collaboration agreement with Bristol-Myers Squibb, which will provide nivolumab for the study (see press release dated April 25, 2017).
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