CAMBRIDGE, Mass. — Ankyra Therapeutics, a clinical-stage biotechnology company developing anchored drug conjugate therapies for cancer and other diseases, has dosed the first patient in its Phase 1b ANK-101-004 clinical trial (NCT07027514). The study, known as LANTERN, is evaluating tolododekin alfa (ANK-101), an anchored IL-12 drug conjugate, in combination with the anti-PD1 agent cetrelimab, in patients with metastatic, non-mutated non-small cell lung cancer (NSCLC) who have progressed following initial treatment.
The trial will also assess tolododekin alfa combined with standard-of-care immune checkpoint blockade as a first-line treatment for patients with metastatic, non-mutated NSCLC and a tumor proportion score of 50 percent or higher.
“While there has been considerable progress in the treatment of lung cancer, many patients do not respond to current approaches,” said Thomas Marron, M.D., Ph.D., Director of the Early Phase Trials Unit at the Tisch Cancer Institute at Mount Sinai, Chief Medical Officer of OCCAM Immune, and principal investigator of the study. “The potential use of anchored IL-12 to drive better responses without adding appreciable toxicity could be an important advance for patients.”
“Tolododekin alfa has already demonstrated objective responses as a single agent in patients with anti-PD-1-refractory cancers in phase 1 trials,” said Howard L. Kaufman, M.D., CEO of Ankyra Therapeutics. “Now we have an opportunity to test tolododekin in patients with advanced lung cancer.”
Ankyra is collaborating with OCCAM Immune at Mount Sinai to support the LANTERN clinical trial, which is evaluating ANK-101 in combination with PD-1 blockade in both first- and second-line NSCLC. Using advanced immune profiling, OCCAM Immune aims to generate a detailed immune atlas to correlate immune modulation with therapeutic benefit, enable biomarker discovery and provide deeper insight into Ankyra’s novel therapeutic approach.
The ANK-101-004 trial is being conducted at multiple institutions, including the Icahn School of Medicine at Mount Sinai, Roswell Park Cancer Institute, Mayo Clinic, Moffitt Cancer Center, The University of Chicago, Community Health Network, The University of Miami Sylvester Comprehensive Cancer Center, Karmanos Cancer Institute, FirstHealth of the Carolinas, and OSF Saint Francis Medical Center, with additional sites expected.
