A Biotech Company that Explodes Cancer Cells
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.
Steven has spent twenty-five years in the life sciences industry.
Prior to starting Oncolyze, he was CEO of Althera, a pharmaceutical manufacturing business developing therapies to improve patient health. Before that, he was co-founder & CEO of ImaCor Medical Technologies, a biotech company, where he led the business through clinical trials and FDA clearance.
In addition to his entrepreneurial experience, Steven has been a strategic advisor to companies including Johnson & Johnson, Biosense, Medtronic, and Guidant.
He earned an MD from the New York University of School of Medicine and completed a fellowship in Cardiovascular Disease and Electrophysiology at Cedars-Sinai Hospital.
Larry began his career as a neurologist at the Mount Sinai Alzheimer’s Disease Research Center. From there, he joined Eli Lilly, a pharmaceutical company, where he spent five years as a group leader.
He then joined Pfizer, another pharmaceutical company, serving as Vice President of Neuroscience Clinical Development. He was responsible for all early-phase clinical research. After that, he became CEO of Provectra Therapeutics, a biotech company developing gene therapies for neurodegenerative diseases.
Most recently, Larry was Chief Medical Officer and Executive Vice President of vTv Therapeutics, a biotech company. He holds a Bachelor’s degree in Chemistry and Physics from the University of Illinois, a Ph.D. in Cell Biology from The Rockefeller University, and an MD from The University of Miami Miller School of Medicine.
Barbara has been Oncolyze’s CFO since 2021, working through Danforth Advisors. She’s worked with Danforth since 2020 as a consultant for life sciences companies.
Previously, she held finance leadership roles at pharmaceutical companies Egalet Corporation, Topaz Pharmaceuticals, Genaera Corporation, and Vicuron Pharmaceuticals.
Barbara began her career as an auditor with Deloitte, a professional services firm. She is a certified public accountant and holds a Bachelor’s degree in Accounting, as well as an MBA in Pharmaceutical and Healthcare Marketing from St. Joseph’s University.
John is General Partner at Northlea Partners, a family office through which he has founded multiple early-stage biotech companies. Several of these companies have achieved successful exits.
Earlier in his career, he became the first full-time Wall Street healthcare analyst with MD qualifications. He also held senior medical positions with Pfizer and Sterling Drug.
During his career, he has served on the advisory board of the College of Chemistry at the University of California, Berkeley, and the Higuchi BioSciences Institute at the University of Kansas.
John is a Fellow of the Royal Society of Medicine in London, and received his MD, as well as a degree in Physiology and Pharmacology, from the University of Birmingham, England.
In addition to his role with Oncolyze, Alexander is Chief Medical Officer of CASI Pharmaceuticals.
Most recently, he was CEO and Chief Medical Officer of Arno Therapeutics, a biotech company, and before that was Chief Medical Officer and Executive Vice President of Clinical Research at MedImmune, a pharmaceutical company acquired for more than fifteen billion dollars.
Earlier in his career, Alexander held key clinical roles at Johnson & Johnson, Ortho Biotech, Hoffmann-LaRoche, and Rhone-Poulenc Rorer. He has served as a member of the Medical Advisory Board at Gem Pharmaceuticals and a Director of Ambit Biosciences.
He holds a Bachelor’s degree in Pharmacy from the University of Alberta and an MD from the University of Calgary. He conducted post-graduate training at the University of Texas MD Anderson Cancer Center.
Alex has fifteen years of global consulting experience in the life sciences industry, and has guided more than fifty public and private companies.
Most recently, he was Vice President of Business Development and Commercial Operations at Phosphagenics, a pharmaceutical manufacturing company. He focused on R&D efforts and led the company’s partnership with medical device business Terumo.
Before that, he was Head of New Products Marketing at Grunenthal, a Germany-based pharmaceutical company. While there, he led the commercial development of novel pain therapeutics.
Alex earned Bachelor’s degrees in Chemistry and Cell Biology from the University of Illinois, a Ph.D. in Pharmacology and Toxicology from Dartmouth, and was an NIH Postdoctoral Fellow at Northwestern.