Astria Therapeutics Announces Exclusive Worldwide License Agreement With Ichnos Sciences For OX40 Portfolio
Thursday, October 12, 2023
Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunological diseases, today announced that it has entered into a worldwide exclusive license agreement with Ichnos Sciences for an OX40 portfolio to be developed for the potential treatment of atopic dermatitis (AD) and potentially for other allergic and immunological diseases. Astria plans to develop the lead candidate, called STAR-0310, a monoclonal antibody OX40 antagonist that incorporates YTE half-life extension technology, for the treatment of AD. Astria believes STAR-0310, a preclinical-stage program, has the potential to have the best-in-class profile in AD with high affinity, reduced treatment burden with infrequent dosing, and favorably differentiated safety and tolerability. OX40 inhibition is a clinically validated mechanism for the treatment of AD. Astria also sees an opportunity with STAR-0310 for potential expansion into additional indications.
“We are very proud to add such a strong program to our company that supports our vision of strategic growth for the future,” said Jill C. Milne, Ph.D., Chief Executive Officer at Astria Therapeutics. “We are building a pipeline of potential first-choice products that can improve the health and outcomes for allergy and immunology patients. We believe STAR-0310 is a perfect complement to STAR-0215. The initial results from the Phase 1a trial support investigating STAR-0215 in hereditary angioedema (HAE) patients and also suggest that there could be an opportunity to dose STAR-0215 every three or six months. Additionally, the Phase 1b/2 trial in HAE patients is on-track and enrolling the third and final cohort, with initial proof-of-concept results expected mid-2024. We expect to initiate a pivotal Phase 3 trial in Q1 2025, assuming positive Phase 1b/2 results. We believe our pipeline has the potential to deliver significant benefit to patients with validated mechanisms and potential best-in-class profiles.”
“Our team worked hard to find a product that was the right fit for Astria’s mission, vision, goals, and plans for the future, and we believe we have found such a program with STAR-0310,” said Andrea Matthews, Chief Business Officer at Astria Therapeutics. “With our team’s expertise in antibody development, our understanding of the market, and our commitment to improving outcomes for patients, we are confident that we can become a leader in the development of first-choice allergy and immunology therapies.”
Ichnos Sciences developed a portfolio of monoclonal antibody antagonists of OX40, including STAR-0310 and telazorlimab, which Astria has exclusively in-licensed worldwide in all fields. STAR-0310 was developed by applying YTE half-life extension technology to an affinity-matured version of telazorlimab. By targeting OX40, STAR-0310 is designed to address a wide range of T cells involved in the heterogenous AD pathology, providing the potential for better efficacy and a broader addressable patient population. In addition, STAR-0310 has been engineered to minimize T cell depletion. As a potential long-acting OX40 inhibitor, STAR-0310 aims to address the need for a safe, effective, and infrequently administered AD treatment.
Astria expects to submit an Investigational New Drug (IND) application for STAR-0310 by year-end 2024 and, if the IND is cleared, plans to initiate a Phase 1a clinical trial in healthy subjects in the first quarter of 2025. Astria anticipates reporting initial results from the trial in the third quarter of 2025. Astria anticipates these initial results will be an important milestone for the program and that these initial results have the potential to establish early proof of concept of STAR-0310, including potentially demonstrating long half-life, initial PD, and safety and tolerability. Pending positive results from the Phase 1a clinical trial, Astria plans to initiate a Phase 1b clinical trial in patients with AD shortly thereafter, with initial results anticipated in second quarter of 2026, the goals of which are to demonstrate proof of concept of STAR-0310, initial efficacy in AD as well as show differentiation on safety and tolerability. Based on the inclusion of the YTE modification, Astria believes STAR-0310 has the potential to be dosed once every two to three months.
About Astria Therapeutics:
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema. STAR-0310 is a monoclonal antibody OX40 antagonist in preclinical development for the treatment of atopic dermatitis. Learn more about our company on our website, www.astriatx.com, or follow us on Twitter and Instagram @AstriaTx and on Facebook and LinkedIn.
Investor Relations and Media:
Elizabeth Higgins
investors@astriatx.com
