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Worldwide Clinical Trials - Oncology

Ajax Therapeutics Receives FDA Approval for AJ1-11095 IND Application, a Novel Type II JAK2 Inhibitor, for Myelofibrosis Treatment

Tuesday, May 14, 2024

Ajax Therapeutics, Inc., a biopharmaceutical company focused on developing next-generation JAK inhibitors for patients with myeloproliferative neoplasms (MPNs), has announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA). This clearance enables the initiation of a Phase 1 clinical study for AJ1-11095, a first-in-class Type II JAK2 inhibitor intended for the treatment of myelofibrosis.

Ajax Therapeutics, expressed excitement about advancing AJ1-11095 into clinical trials, emphasizing its potential to offer a new treatment option for myelofibrosis patients. He described this achievement as a significant milestone for the company, marking the launch of their first clinical program and the inaugural evaluation of a Type II JAK2 inhibitor in patients.

Ajax, highlighted AJ1-11095's unique mechanism as a Type II inhibitor of JAK2. He underscored its potential to provide improved efficacy and disease-modifying effects compared to existing therapies, offering hope for patients with myelofibrosis.

AJ1-11095, developed in collaboration with Schrödinger, utilizes advanced structure-based drug design and computational methods to selectively target the Type II conformation of the JAK2 kinase. Preclinical studies have shown its ability to reverse marrow fibrosis, reduce mutant allele burden, and maintain efficacy against MPN cells resistant to chronic Type I JAK2 inhibition.

Myelofibrosis is a rare blood cancer affecting approximately 20,000 patients in the United States. It is characterized by spleen enlargement, bone marrow scarring, and progressive anemia, leading to debilitating symptoms that impact patients' quality of life. Current treatments can alleviate symptoms but often do not address the underlying cause of the disease, leaving significant unmet needs in patient care. AJ1-11095 aims to address this gap by offering a potential breakthrough in myelofibrosis treatment.



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