Tessa Therapeutics, a clinical-stage immunotherapy company focused on autologous and off-the-shelf, allogeneic therapies targeting solid tumors, has announced that it has entered into an agreement with MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA), through a subsidiary, to evaluate Tessa's armored human papillomavirus-specific T cell (HPVST) therapy, or TT12, in combination with KEYTRUDA^® (pembrolizumab), MSD's anti-PD-1 (programmed death receptor-1) therapy, in patients with recurrent or metastatic HPV 16 and 18-positive cervical cancer.

Under the agreement, Tessa will conduct a multi-center Phase 1b/2 trial to evaluate the safety and efficacy of the combination. The trial is planned for initiation in the United States, Singapore and South Korea.

Tessa's TT12 is an autologous cell therapy product composed of HPVSTs that have been trained to target HPV 16/18 antigens and genetically modified with a decoy TGF-β receptor to overcome the suppressive tumor microenvironment.

The safety and optimal dose selection of armored HPVSTs in combination with another anti-PD-1 antibody is currently being evaluated in a separate, ongoing investigator-sponsored Phase 1 trial in the United States, in patients with relapsed HPV-associated cancers. Preliminary results from this trial show that armored HPVSTs and its combination with anti-PD-1 are well-tolerated, have minimal toxicities and early signs of efficacy.