Beckman Coulter to Develop aNK Assay for Pivotal Trial of Transgene’s NSCLC Drug

French company projects that Phase IIb/III study with TG4010 will start later this year.

Transgene is teaming up with Beckman Coulter for the development of a companion test to be used alongside clinical trials of Transgene’s Phase III-stage anticancer candidate TG4010. Under terms of the deal Beckman Coulter will develop a test measuring triple-positive (CD16+, CD56+, CD69+/CD45+ lymphocytes) activated NK (aNK) cells. This aNK assay will complement a test developed by Ventana Medical systems, which allows Transgene to identify patients with MUC1-positive tumor cells.

The MUC1 and aNK assays will be used in the forthcoming Phase IIb/III clinical trial with TG4010 in non-small cell lung cancer (NSCLC) patients, which is projected to start by mid-2011. Transgene says if the drug achieves regulatory clearance, the tests could also be used by physicians to identify patients who will benefit from TG4010 therapy.

TG4010 (MVA-MUC1-IL2) is an MVA vector-based immunotherapy candidate that expresses the entire MUC1 tumor antigen sequence along with the sequence for IL2 to stimulate specific T-cell responses, Transgene explains. The candidate is in development for the treatment of metatstatic NSCLC in combination with first-line chemotherapy.

A prior Phase IIb study evaluating TG4010 as an adjunct to standard chemotherapy in NSCLC identified a subpopulation of patients who particularly benefited from the treatment with TG4010. This subpopulation consisted of patients with normal levels of activated NK cells at baseline, and represented some 73% of the evaluable patient population (101 out of 138 patients), Transgene notes. For these patients, significant increases in median survival were achieved by adding TG4010 therapy on top of standard chemotherapy. Response rate, time to progression, and progression-free survival data also confirmed the identification of activated NK cells as an appropriate predictive biomarker associated with the positive clinical outcome for patients with NSCLC treated with TG4010 in combination with chemotherapy.

In March 2010 Novartis paid Transgene $10 million to secure an option to licence TG4010 worldwide. Under terms of the deal Transgene will initially fund and retain control over the global Phase IIb/III clinical trial. Results from the Phase IIb part of the study are expected to be available in the first quarter of 2012. Novartis will then have up to 90 days to exercise its option.

If the firm decides to take on TG4010, Transgene could receive up to about €700 million (about $939 million) in development, regulatory, and commercial milestones for different indications.