Drug development based on Janus kinase (JAK) inhibitors hasn’t progressed as far as other biopharma specialties since the first such treatment won approval more than a decade ago. Ajax Therapeutics, a drug developer created to develop JAK inhibitors for people with rare blood cancers called myeloproliferative neoplasms (MPNs), hopes to change that through its recent financing and clinical development plans. Earlier this month Ajax completed an oversubscribed $95 million Series C financing, with proceeds set to advance clinical development of Ajax’s lead candidate AJ1‐11095—a first-in-class Type II JAK2 inhibitor—as a treatment for myelofibrosis, as well as further develop the company’s pipeline.
The FDA on May 13 cleared Ajax’s investigational new drug (IND) application for a Phase I dose escalation study ( ) of AJ1-11095. The study is expected to begin in the second half of this year. When that happens, AJ1-11095 will become the first Type II JAK2 inhibitor to enter the clinic.
Ajax aims to disrupt the JAK inhibitor space long dominated by the first such drug to reach the market, ruxolitinib, marketed in the U.S. as Jakafi® by Incyte and outside the U.
S. as Jakavi® by Novartis. Jakafi/Jakavi is a selective inhibitor of JAK1 and JAK2 indicated for forms of myelofibrosis, polycythemia vera, and graft-versus-host disease.
Last year Jakafi generated $2.594 billion in U.S.
net product revenues (up 8% year-over-year) and another $1.72 billion in rest-of-world net s.
