Telazorlimab

Astria Therapeutics is years behind the front-runners in the eczema race. Ichnos Sciences has finally found a buyer for its OX40 eczema program. Astria Therapeutics has taken the other side of the deal, paying $15 million upfront to secure a spot at the back of a race led by Amgen and Sanofi. New Jersey-based Ichnos has been talking about partnering its OX40 work for almost as long as it has existed, having made the program available (PDF) for out-licensing the year after it spun out of Glenmark in 2019. Over the years it has sought a partner, Ichnos has seen Sanofi acquire an OX40 candidate in its $1.1 billion takeover of Kymab and Amgen pay Kyowa Kirin $400 million upfront to enter the space.  Now, Ichnos has landed a deal—but failed to command the sort of prices paid by those Big Pharmas. The structure of the agreement, which is worth $15 million upfront, $20 million in clinical milestones and $285 million in regulatory and commercial paydays, reflects Astria’s preferred asset.  While Ichnos wrapped up a phase 2 trial of its lead OX40-targeting candidate telazorlimab in 2021, that candidate barely gets a mention in Astria’s statement to disclose the deal. Astria is licensing the full OX40 portfolio, but its focus is on STAR-0310, a preclinical program that is forecast to enter human testing early in 2025.  The timeline puts Astria years behind the front-runners. Amgen has started seven phase 3 clinical trials of its candidate, rocatinlimab, over the past 16 months, while Sanofi top-lined positive phase 2b data in June. In contrast, the first clinical data on STAR-0310 in healthy volunteers aren't expected until the third quarter of 2025, by which time Amgen could have phase 3 data on rocatinlimab. Astria’s decision to focus on a preclinical program, rather than push telazorlimab into late-phase studies, could give it a differentiated candidate. The biotech sees STAR-0310 as a best-in-class prospect, pointing to its use of half-life extension technology, which could reduce dosing frequency, and early evidence of affinity, safety and tolerability to make its case.

[11-October-2023] Astria Therapeutics is granted global rights to develop and commercialize OX40 portfolio, comprised of Telazorlimab and its follow-on molecules, for use in inflammatory and immune diseases. NEW YORK, Oct. 11, 2023 /PRNewswire/ -- Ichnos Sciences, a global clinical-stage biotechnology company developing innovative multispecific antibodies for oncology, today announced that the company has entered into an exclusive worldwide licensing agreement for its OX40 antagonist monoclonal antibody portfolio with Astria Therapeutics, a biopharmaceutical company developing therapies for rare allergic and immunological diseases. With the execution of this agreement, Ichnos has successfully licensed its two assets for inflammatory and immunological diseases, a key milestone in the company's prioritization of its pipeline of oncology drug candidates. Within the terms of the agreement, Astria will assume full cost and responsibility for the global development and commercialization of the licensed therapeutic program for all indications. In exchange, Ichnos will receive up to $320 million in upfront, development, regulatory and sales milestone payments in addition to up to low double-digit royalties. Ichnos has also agreed to allow Astria to draw down on its existing investigational drug substance and drug product stocks at normalized costs to facilitate development. Telazorlimab is a novel, humanized IgG1 monoclonal antibody that targets OX40 on T cells responsible for inflammation and immunity diseases. Excessive OX40 signaling, expressed on activated T cells, is the feature of several inflammatory diseases, including atopic dermatitis (AD). Astria plans to develop an affinity-matured version of telazorlimab and apply YTE half-life extension technology to create a product that aims to address the need for a safe, effective, and infrequently administered AD treatment. "As Ichnos continues to grow as a biotechnology company, this agreement enables our team to focus on advancing our robust pipeline of clinical-stage multispecific antibodies in oncology generated by our proprietary BEAT® platform1, as well as continue the discovery and development of our NK-cell engaging programs for solid tumors," said Cyril Konto, M.D., President and CEO of Ichnos. "I am proud of the work achieved by the Ichnos team in successfully completing the Phase 2b with telazorlimab in atopic dermatitis and potentially opening up a new therapeutic class for this disease. Ichnos is confident in Astria Therapeutics' capabilities and vision for pursuing the development of its OX40 program and delivering a potentially life-changing treatment to patients with inflammatory and immune diseases." "We are looking forward to building on the foundational work that Ichnos has done with their OX40 portfolio," said Jill Milne, Ph.D., co-founder and CEO of Astria Therapeutics. "We believe that by using Ichnos' affinity-matured next generation monoclonal antibody OX40 antagonist and applying YTE half-life extension technology, we have the potential to deliver a best-in-class pro atopic dermatitis patients; one that we think can be safe, effective, and long-acting. In addition to OX40 antagonism already being a clinically validated mechanism in atopic dermatitis, we also are excited about the opportunity for potential expansion into additional indications." About Ichnos Sciences Inc. A fully integrated, global biotech with the spirit of a start-up, Ichnos is shifting the way the world thinks about innovation in medicine through its research and development of transformative, disease-centric treatments in oncology. The company, with headquarters in New York, N.Y., is rapidly advancing a clinical-stage pipeline of novel, first-in-class candidates designed to address complex diseases and to treat patients holistically. With its patented BEAT® technology platform and pioneering teams, Ichnos Sciences has a mission to provide breakthrough, curative therapies that will extend and improve lives, writing a new chapter in healthcare. For more information, visit Ichnos.com. CONTACT Hill+Knowlton Strategies HKIchnos@hkstrategies.com 1 BEAT®: Bispecific Engagement by Antibodies based on the TCR