Oncolyze is an explosive biotech startup.
It’s aiming to treat cancer by literally exploding cancer cells. Its lead drug candidate — OM-301 — selectively attacks cancer cells and pokes holes in their membrane, causing them to explode and die, while leaving normal cells intact.
OM-301 has proven effective in early-stage pre-clinical testing. And Oncolyze has pre-clinical evidence that its novel therapy could potentially target more than twenty five types of cancer.
The company is seeking capital to progress toward Phase 1 and 2 FDA trials, and finalize a commercialization date of 2027.
Oncolyze is led by an experienced team. Management has more than 100 combined years in healthcare experience, including at Pfizer, Johnson & Johnson, and Medimmune. Notable advisors include the Chief of Leukemia at Memorial Sloan Kettering, the Chief of Molecular Hematology at MD Andersen, and the Chief of Leukemia at City of Hope National Medical Center.
Like most biotech companies focused on cancer, Oncolyze’s goal is to eliminate the disease, which kills ten million people annually.
One of the deadliest forms of cancer is called Acute Myelogenous Leukemia, or AML. Patients with this blood cancer have just a twenty-five percent chance of survival five years after diagnosis.
Treatments like chemotherapy target cancerous cells, but they also target normal, healthy cells. That’s why targeted therapies have become increasingly popular.
Oncolyze’s anti-cancer drug targets a cell surface protein — HDM2 — which is unique to cancer cells. Here’s how it works:
OM-301 has two components. First is a targeting segment that finds HDM2 and anchors to it. The second segment pokes holes in the surface of the protein and kills the cell almost instantly.
Because it acts on the outside of the cancer cell, Oncolyze believes its efficacy will be independent of cancer genetics. In other words, it’ll work in cancer patients regardless of mutation type.
This is important because AML can be caused by a variety of mutations in a number of protein blood cells. Some recently approved drugs only work for a subset of patients, whereas OM-301 could help most, if not all, AML patients.
As mentioned, OM-301 could potentially treat additional cancers, too. Evidence supports its potential use in treating Multiple Myeloma (another blood cancer), and solid tumors such as colon, pancreatic, and sarcoma.
By targeting AML alone, Oncolyze’s drug could be used to treat as many as 10,000 patients a year. The current cost for AML treatments ranges from $40,000 to $100,000 in the U.S., presenting a total available market of one billion dollars.
Oncolyze could also look to license its drug once available. In 2020, there were more than 300 licensing deals in Oncology, including twenty-one that were for more than one billion dollars in value.
Research on OM-301 began in 2010. Since then, Oncolyze has completed two in-vitro and in-vivo experiments. It also has three patents pending.
Additionally, the company’s drug received Orphan Drug Designation from the FDA in January 2022. This is for drugs designed to treat conditions that are so rare, they wouldn’t be profitable to produce without government assistance.