Tolododekin Alfa

ANK-203 is a first-in-class anchored immunotherapy designed to unlock the full therapeutic potential of monoclonal antibody CD137 through localized delivery and retention In preclinical studies, ANK-203 activated the CD137 (4-1BB) immune pathway and showed strong anti-tumor activity with no observed systemic toxicity; additional studies are underway Ankyra’s pipeline also includes tolododekin alfa, an IL-12 anchored immunotherapy with promising Phase 1 clinical activity and favorable tolerability as monotherapy in advanced solid tumors CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ankyra Therapeutics, a clinical-stage biotechnology company pioneering anchored immunotherapy to deliver better outcomes for people with cancer and other serious diseases, announced preclinical data on ANK-203, a first-in-class anchored immunotherapy using monoclonal antibody CD137 (4-1BB). The data were presented today in an oral session, “Agonistic CD137 (4-1BB) anchored immunotherapy (ANK-203) elicits potent 4-1BBL signaling in vitro and therapeutic responses against established tumors without systemic toxicity in vivo” (abstract # 64034) at the American Association of Cancer Research (AACR) Immuno-Oncology Conference in Los Angeles, CA. 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. “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, MD, and Chief Executive Officer at 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.” ANK-203 is designed to activate the CD137 (4-1BB) immune pathway through localized delivery and retention at the tumor site. In preclinical studies, ANK-203 demonstrated robust activation of the CD137 (4-1BB) immune pathway and regression of established tumors following localized administration. Treatment was well tolerated, with no significant safety signals observed. In addition to local tumor control, ANK-203 induced anti-tumor responses in distant, untreated tumors, suggesting the induction of a systemic immune response. “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, PhD, Chief Scientific Officer at 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 these findings, Ankyra plans to advance ANK-203 through additional preclinical studies to further characterize immune mechanisms and support potential clinical development. About Ankyra Therapeutics Ankyra Therapeutics is a clinical-stage biotechnology company pioneering anchored immunotherapy to deliver better outcomes for people with cancer and other serious immune-mediated diseases. Powered by its novel anchoring platform, Ankyra engineers therapies that unlock the full therapeutic potential of immune-modulating drugs once limited by toxicity. Anchored immunotherapies are designed to stay precisely at the disease site, allowing higher doses for greater therapeutic impact while limiting systemic exposure. Ankyra is advancing a robust pipeline of first-in-class therapies and strategic collaborations to shape the next generation of immunotherapy. For more information, please visit www.ankyratx.com.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ankyra Therapeutics, a clinical-stage biotechnology company pioneering anchored drug conjugate technology for cancer and other diseases, today announced that the first patient has been dosed in its ANK-101-004 clinical trial (NCT07027514). This study will evaluate the combination of Ankyra’s tolododekin alfa (ANK-101), an anchored IL-12 drug conjugate with the anti-PD1 agent, cetrelimab, in patients who have progressed after initial treatment of metastatic, non-mutated non-small cell lung cancer (NSCLC). In addition, the study will evaluate tolododekin alfa in combination with standard of care immune checkpoint blockade in first-line treatment of patients with metastatic, non-mutated NSCLC and a tumor proportion score (TPS) of ≥ 50%. “The potential use of anchored IL-12 to drive better responses without adding appreciable toxicity could be an important advance for patients.” “While there has been considerable progress in the treatment of lung cancer many patients do not respond to current approaches”, said Thomas Marron, MD, PhD, Director of the Early Phase Trials Unit at the Tisch Cancer Institute at Mount Sinai and Chief Medical Officer of OCCAM Immune and the 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”, stated Howard L. Kaufman, MD. CEO at Ankyra Therapeutics, “and now we have an opportunity to test tolododekin in patients with advanced lung cancer.” Ankyra is working with OCCAM Immune at Mount Sinai in support of Ankyra the LANTERN clinical trial, which is evaluating ANK-101 in combination with PD-1 blockade in patients with first- and second-line NSCLC. Through state-of-the-art immune profiling, OCCAM Immune aims to generate a comprehensive immune atlas to correlate immune modulation with therapeutic efficacy and disease progression, advance biomarker discovery and deepen mechanistic insights into Ankyra’s novel therapeutic approach. The ANK-101-004 (LANTERN) trial will be conducted at several institutions, including, 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 as well. About Tolododekin alfa (ANK-101) Tolododekin alfa (ANK-101) is an anchored drug conjugate composed of interleukin-12 (IL-12) linked to aluminum hydroxide. ANK-101 enables local delivery of functional IL-12 to the tumor microenvironment where it remains biologically active for several weeks with transient exposure to the systemic circulation, thereby avoiding systemic toxicity. Treatment with ANK-101 in animal models has been associated with immune activation and rapid tumor regression. ANK-101 is being evaluated for the treatment of advanced solid tumors alone and in combination with anti-PD-1 agents. The first-in-human clinical trial of ANK-101 (NCT06171750) consists of monotherapy dose escalation, dose expansion in combination with cemiplimab, and dose optimization cohorts. The ANK-101-004 clinical trial (NCT07027514) will focus on non-mutated metastatic non-small cell lung cancer. About Ankyra Therapeutics Ankyra Therapeutics is a biotechnology company that has developed a highly differentiated technology platform that expands the therapeutic window of therapeutic drugs by forming a stable depot after local administration leading to prolonged immune activation and potent local and systemic immunity with reduced systemic toxicity. Ankyra is headquartered in Cambridge, Massachusetts. For more information, please visit www.ankyratx.com.