CAMBRIDGE, Mass. — Ankyra Therapeutics presented encouraging preliminary results from its ongoing Phase 1 clinical trial of tolododekin alfa (ANK-101), an anchored interleukin-12 (IL-12) drug conjugate, during the 2025 American Association for Cancer Research (AACR) Annual Meeting in Chicago. The company also announced that it has dosed the first patient in an expansion cohort combining tolododekin alfa with the PD-1 inhibitor cemiplimab (Libtayo®) for the treatment of advanced cutaneous squamous cell carcinoma.
The initial results, drawn from Part 1 of the first-in-human ANCHOR trial, demonstrated that tolododekin alfa was well-tolerated as a monotherapy in patients with advanced solid tumors, including melanoma, head and neck cancer, and breast cancer. According to Ankyra, the therapy showed no dose-limiting toxicities (DLTs) or severe treatment-related adverse events at doses up to 250 micrograms per milliliter.
Dr. Howard Kaufman, Ankyra’s president and CEO, said the data supports the company’s anchored drug conjugate platform. “This study demonstrates for the first time that IL-12 can be delivered to tumors at therapeutic doses higher than previously achievable without systemic toxicity,” he said. Traditional systemic IL-12 delivery has been limited due to toxicity at doses exceeding 500 nanograms per kilogram.
Dr. Joe Elassal, Ankyra’s chief medical officer, added that anchoring IL-12 to the tumor site resulted in six times higher local IL-12 concentrations compared to systemic administration, with minimal systemic exposure. Biomarker analyses of tumor biopsies indicated increased infiltration of CD8+ T cells and elevated PD-L1 expression, suggesting robust immune activation.
These findings laid the groundwork for expanding the trial to explore the combination of tolododekin alfa with cemiplimab, a PD-1 checkpoint inhibitor developed by Regeneron. The first patient in this expansion cohort was treated on March 25, 2025.
The Phase 1 results, presented as a poster at AACR on April 28, included data from 15 patients with metastatic solid tumors across four sites in the U.S. and Canada. Tumor types included melanoma (7 patients), head and neck cancer (4), breast cancer (2), bladder cancer (1), and apocrine adenocarcinoma (1). The study reported a disease control rate of 80%, including two partial responses, according to modified RECIST v1.1 criteria.
Ankyra’s poster, titled Results of a first-in-human phase 1 trial of anchored IL-12 drug conjugate (ANK-101), was presented during the AACR’s Phase 0 and Phase I Clinical Trials session and will be available on the company’s website.
The ANCHOR study continues to evaluate tolododekin alfa, both as a monotherapy and in combination with immune checkpoint inhibitors, to assess its potential in enhancing anti-tumor immune responses across various cancers.
