We are advancing OM-301 for the treatment of other blood cancers and solid tumors.
At the same time, we are exploring other similar peptides as well as novel immune-oncology approaches to deliver more effective therapeutics leveraging our unique mechanism of action for cancer treatment.
In early 2022, Oncolyze announced that the U.S. Food and Drug Administration (FDA) granted the company orphan drug designation for OM-301 for the treatment of acute myeloid leukemia (AML).
OM-301 is an investigational drug candidate that we are evaluating in multiple hematologic and solid cancer indications. We envision OM-301 being delivered to patients as an intravenous infusion (potentially over a one-hour period) once daily for a certain number of days that we will determine in upcoming clinical trials.
OM-301 is a fusion peptide that binds to HDM2 located on the cell surface of cancer cells and selectively creates pores in those cells, thereby inducing cell death. We have shown activity of OM-301 against a panel of cancer cell types in vitro, and most recently excellent efficacy in human AML transplanted directly into mice. At Oncolyze, we are now advancing OM-301 through GMP toxicology and expect to open an IND (investigational new drug application) with the U.S. Food and Drug Administration (FDA) and initiate our first Phase 1/2 clinical trial in 2023.