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Ajax Therapeutics Receives FDA Clearance to Initiate Phase 1 Clinical Study of AJ1-11095 for Myelofibrosis
Biopharmaceutical company Ajax Therapeutics received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to begin a phase 1 clinical study of AJ1-11095, a first-in-class type 2 JAK2 inhibitor, to treat patients with myelofibrosis.
The most common treatment for patients with myelofibrosis are type 1 JAK2 inhibitors, which can reduce spleen size and provide symptomatic improvement. However, they have minor impact on the underlying cause of the disease, and over time patients with myelofibrosis discontinue the use of these inhibitors due to a lack of benefit or loss of response, adverse events, and disease progression.
“As a first-in-class therapy with a unique mechanism as a type II inhibitor of JAK2, AJ1-11095 was developed to provide a much-needed new treatment for patients with myelofibrosis by offering the potential for improved efficacy with disease modifying effects compared to existing therapies,” said David Steensma, MD, FACP, chief medical officer at Ajax.
Ajax describes AJ1-11095 as a “next-generation JAK2 inhibitor” that uses structure-based drug design and computational methods at scale to selectively bind the type 2 conformation of the JAK2 kinase. According to Ajax Therapeutics, the therapy provides greater efficacy with disease modification compared to all currently approved JAK2 inhibitors, which bind the type 1 conformation of JAK2. The company also states that AJ1-11095 can reverse marrow fibrosis, reduce mutant allele burden, and maintain efficacy against MPN cells that become resistant to chronic type 1 JAK2 inhibition, according to results from preclinical studies.
The company will begin their phase 1 dose escalation study, AJX-101, later in 2024.
Reference
Ajax Therapeutics announces FDA clearance of IND application for AJ1-11095, a first-in-class type II JAK2 inhibitor, for the treatment of myelofibrosis. News release. Business Wire. May 13, 2024. Accessed May 22, 2024. https://www.businesswire.com/news/home/20240513313466/en
