MADRID, July 19 (EUROPA PRESS) –
Oryzon Genomics is up nearly 22% in the stock market at the end of the session after it announced it has signed a collaborative research and development agreement (CRADA) with the United States’ National Cancer Institute (NCI) to continue clinical development of the LSD1 – Clinical-stage inhibitor, iadademstat, in various types of solid and hematologic cancers.
Notably, the company’s shares are up 21.91% at the close, before exchanging at a price of €2,865.
“First and foremost, this research and development agreement with NCI is a strong endorsement of Iadademstat, probably the most potent and selective LSD1 inhibitor currently in clinical development, and will also allow us to significantly expand our clinical development program for this compound .” said Oryzon President and CEO Carlos Buesa.
Likewise, Oryzon’s global medical director, Douglas Faller, has assured that this collaboration with the NCI in the development of iadademstat will enable collaborations with some of the world’s most important oncology researchers to further expand its therapeutic potential.
“This collaboration also greatly expands our ability to conduct clinical trials across a broad range of indications and in combination with other novel or established therapies such as immuno-oncology and molecularly targeted therapies,” he commented.
CRADAs are formal agreements between one or more federal laboratories and a company under which the US government provides personnel, services, facilities, equipment, intellectual property, or other resources through its laboratories. It is a “very selective” process that will undergo a “rigorous” scientific evaluation beforehand by the experts of the different types of cancer considered in the agreement.
CRADA is an instrument of the National Cancer Institute (NCI), established in 1986 to facilitate government-industry collaboration and technology transfer. NCI receives its budget from the United States Congress as part of the federal budget process through funds from the Department of Health and the National Institutes of Health (NIH).
Iadademstat is an orally active, highly potent and selective inhibitor of the epigenetic enzyme LSD1 and has potent differentiating effects in hematological cancers. More than 100 cancer patients have been treated with iadademstat in various clinical trials.
In an ongoing Phase IIa study (“ALICE” study) in elderly patients with first-line acute myeloid leukemia (AML), iadademstat has shown encouraging safety and efficacy data in combination with azacitidine. Oryzon is now initiating a Phase Ib study of iadademstat in combination with gilteritinib in patients with relapsed or refractory FLT3-mutant AML, for which it recently received IND approval from the US Food and Drug Administration (FDA).
Beyond hematological cancers, LSD1 inhibition has been proposed as a valid therapeutic approach in some solid tumors such as small cell lung cancer (SCLC), neuroendocrine tumors, medulloblastoma, and others. Preliminary efficacy results were reported in a phase IIa study in combination with platinum/etoposide in second-line SCLC patients (CLEPSIDRA study, completed).
Iadademstat recently received orphan drug designation for SCLC from the FDA and now has orphan drug designation for SCLC and AML in the United States.