CAMBRIDGE, Mass. — Ankyra Therapeutics on Monday presented its first preclinical data on ANK-203, a novel anchored immunotherapy designed to activate the CD137 immune pathway while avoiding systemic toxicity, during an oral session at the American Association of Cancer Research Immuno-Oncology Conference in Los Angeles.
The clinical-stage biotechnology company said ANK-203 is a first-in-class anchored immunotherapy that uses a monoclonal antibody targeting CD137, also known as 4-1BB, and is designed for localized delivery and retention at the tumor site. The approach aims to unlock the therapeutic potential of CD137, a well-established immune costimulatory target whose clinical development has historically been limited by safety concerns.
According to Ankyra, preclinical studies showed that ANK-203 robustly activated the CD137 immune pathway and produced strong anti-tumor responses following localized administration. The treatment was well tolerated, with no significant systemic toxicity observed. In addition to controlling treated tumors, ANK-203 also induced anti-tumor effects in distant, untreated tumors, suggesting activation of a broader systemic immune response.
“Our anchored immunotherapy platform has already demonstrated promising clinical activity with tolododekin alfa, validating our approach to improving the therapeutic index of potent immune modulators, like IL-12,” said Howard Kaufman, M.D., chief executive officer of Ankyra Therapeutics. “ANK-203 extends our platform’s application beyond cytokines to monoclonal antibodies and expands our pipeline, reinforcing its versatility and underscoring the potential to realize the promise of therapeutics that have been shelved due to toxicity.”
Ankyra said ANK-203 builds on the same anchored immunotherapy platform used in tolododekin alfa, an interleukin-12–based anchored therapy that has shown encouraging Phase 1 clinical activity and favorable tolerability as a monotherapy in patients with advanced solid tumors.
“CD137 has long been recognized as a powerful immune costimulatory molecule with a high potential for cancer immunotherapy, but safety challenges have constrained its clinical potential,” said Sailaja Battula, Ph.D., chief scientific officer of Ankyra Therapeutics. “By anchoring CD137 locally, ANK-203 enables focused immune activation where it matters most, at the tumor site, while minimizing systemic exposure, offering a differentiated approach to maximize clinical benefit.”
Based on the preclinical results, Ankyra said it plans to continue advancing ANK-203 through additional studies to further characterize its immune mechanisms and support potential clinical development.
