Transgene gains on NSCLC data for TG4010

Transgene S.A. (Euronext:TNG) gained EUR 1.74 (19%) to EUR 10.98 on Thursday after reporting data from the Phase IIb portion of the Phase IIb/III TIME trial evaluating subcutaneous TG4010 for first-line non-small cell lung cancer (NSCLC). Transgene said the Phase IIb portion was aimed at assessing the predictive value of the triple-positive activated lymphocyte (TrPAL) biomarker. Based on the results, the company said it plans to start the Phase III portion of the trial early this summer with a "refined" biomarker threshold for selecting patients, which it plans to discuss with regulatory authorities. TG4010 is a recombinant Modified Vaccinia Ankara (MVA) virus vector encoding the mucin 1 ( MUC1; CD227) tumor-associated antigen and IL-2.

In the Phase IIb portion of the trial, subcutaneous TG4010 plus chemotherapy did not improve progression-free survival (PFS) in MUC1-positive stage IV NSCLC patients with normal baseline TrPAL levels compared to patients with high baseline TrPAL levels. However, in a second pre-planned PFS analysis, TG4010 led to a greater than 25% improvement in PFS compared to placebo in patients in the three lowest quartiles of TrPAL levels. TG4010 did not improve PFS vs. placebo in the patients in the highest quartile. ...