Date: 2014-11-11
Type of information: Development agreement
Compound: ARQ 092
Company: Arqule Therapeutics (USA - MA) National Human Genome Research Institute (NHGRI) (USA)
Therapeutic area: Rare diseases
Type agreement: development
Action mechanism: AKT inhibitor/kinase inhibitor. ARQ 092 is an orally bioavailable inhibitor of the serine/threonine protein kinase AKT (protein kinase B) with potential antineoplastic activity. AKT inhibitor ARQ 092 binds to and inhibits the activity of AKT in a non-ATP competitive manner, which may result in the inhibition of the PI3K/AKT signaling pathway. This may lead to the reduction in tumor cell proliferation and the induction of tumor cell apoptosis.
Disease: Proteus syndrome
Details: * On November 11, 2014, ArQule announced an agreement with the National Human Genome Research Institute (NHGRI) of the National Institutes of Health (NIH) providing for the clinical development of ARQ 092, an orally available, selective small molecule inhibitor of AKT, in Proteus syndrome, a rare disease characterized by overgrowth of the skeleton, skin, adipose tissue and central nervous system. The NIH Proteus syndrome team is led by researchers who originally discovered the somatic single mutation in the AKT 1 oncogene that causes Proteus syndrome. On that basis, the NIH entered into a collaboration with ArQule focused on pre-clinical testing of ARQ 092. Results from that pre-clinical research recently presented by the NIH team at the 2014 meeting of the American Society of Human Genetics (ASHG, Abstract # 2180M2) demonstrate that treatment with ARQ 092 caused a rapid shutdown of AKT signaling and a reduction in the viability of Proteus syndrome cells taken from patients compared to untreated diseased cells. These findings represent pre-clinical proof-of-concept for advancement of ARQ 092 into clinical testing in this indication. The NIH is currently developing a protocol for a Phase 1 trial with ARQ 092 in this indication, with input from ArQule. The Company will also be providing compound for the planned NIH clinical trial, which is currently expected to begin in 2015.
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