Transgene looks to partner cancer vaccine after positive Phase IIb

Partnership opportunity

Transgene SA of Strasbourg, France, is looking for a development partner for its lung cancer vaccine after the successful completion of the Phase IIb trial of the drug, TG4010 as an adjunct to first-line chemotherapy in patients with advanced non-small cell lung cancer.

“We are very pleased that the data accumulated from the Phase IIb trial of our therapeutic vaccine TG4010 confirm the results we have previously observed in this indication and establish that the trial has met its primary endpoint,” said Philippe Archinard, Chief Executive Officer of Transgene. “These results clearly warrant pursuing development into a Phase III programme and we will be seeking to establish a partnership in order to complete the last stages of clinical development and bring TG4010 to the market.”

The Phase IIb trial was a randomised, open-label and controlled study designed to assess the efficacy of TG4010 in combination with cisplatin and gemcitabine compared to the chemotherapy alone.

The trial enrolled of 148 patients at 27 centres in France, Poland, Germany, and Hungary. The trial met its primary endpoint, with a progression-free survival at six months of 44 per cent (33 out of 74 patients) in the treatment arm. In the control arm, progression-free survival at six months was 33 per cent (26 out of 74 patients).

A biomarker programme is in progress to further characterise TG4010’s mode of action and contribute to the design of Phase III trials.

The trial confirmed the favourable safety profile of TG4010 when associated with chemotherapy, with most adverse events related to chemotherapy, or to the disease.

TG4010 uses the modified vaccinia Ankara virus vector to deliver MUC1, a major tumor-associated antigen. TG4010 expresses the entire MUC1 gene sequence and has the potential to generate an immune response to all antigenic epitopes of MUC1.