NEW YORK, August 23, 2022 (Newswire.com) - After successfully completing in vitro and in vivo (mice) experiments, which support the notion that its lead drug candidate OM-301 breaks down cancer cells and significantly increases survival rates, Oncolyze now has its sights set on advancing OM-301 into clinical trials.
Oncolyze has launched a Regulation A+ ("Reg A") funding campaign to spread awareness of OM-301 among cancer patients, healthcare professionals, and the investment community. Reg A is a type of offering that allows anyone to invest in Oncolyze and receive shares in the company. The investment opportunity is being hosted by SeedInvest and investments may be made in Oncolyze directly by visiting the SeedInvest website. Potential investors can also learn more about the investment opportunity at the Oncolyze website.
Cancer is the second-leading cause of death globally, killing 10 million cancer patients yearly worldwide. The estimated total annual economic impact of cancer is more than $1 trillion globally. There are many types of cancer, but one of the deadliest is acute myelogenous leukemia (AML). Patients with this blood cancer have only a 1 in 4 chance of living for five years after diagnosis.
Current treatments include chemotherapies, targeted therapies, and bone marrow transplants. All these options carry significant side effects and are physically taxing to the patient, as well as being mostly ineffective given the high recurrence rate. As a result, there remains a huge unmet medical need for more efficacious treatments. Oncolyze sees this tremendous challenge as a significant opportunity to make a positive impact on patients' lives, with the potential to both increase their chance of survival and improve their quality of life.
Oncolyze has designed a novel anti-cancer drug (OM-301) that targets a particular cell surface protein. This protein, HDM2, is well known to exist at high levels inside cancer cells and is thought to be an important driver of cancer growth and metastasis. More recently, though, it was discovered that HDM2 is found as well on the cell surface of many types of cancer cells, but not normal cells. OM-301 has two components. The first, a targeting segment, finds the HDM2 residing on the external surface of the cancer cell. Once OM-301 finds HDM2 and anchors, the second segment pokes holes in the surface and kills the cancer cell almost instantly by cell lysis and necrosis.
"Our mission is to bring a new drug to market which gives renewed hope to patients that there can be a cure for their terrible disease, or at the very least an improvement in their survival without a myriad of side effects. We are passionate in our quest to add a new type of anticancer therapy with a novel mechanism of action to the armamentarium in the war against cancer," said Dr. Steven Evans, Co-Founder and CEO of Oncolyze.
"Because OM-301 acts on the outside of a cancer cell, we think that its efficacy may be independent of cancer genetics. What that means is that it could potentially work in cancer patients regardless of mutation type. This is important because AML can be caused by a variety of mutations in multiple proteins in leukemic blood cells. Some recently approved drugs only work for a subset of patients with a specific mutation, whereas we believe that OM-301 could help most if not all AML patients, especially those with hard-to-treat mutations."
Earlier this year, Oncolyze announced that the FDA had granted OM-301 an Orphan Drug designation for the treatment of AML. The FDA's Office of Orphan Drug Products grants orphan status to drugs and biologics that demonstrate promise for the treatment of diseases or conditions affecting fewer than 200,000 people in the United States. This designation provides Oncolyze with certain development incentives, including tax credits for qualified clinical testing, exemptions from certain FDA application fees, and potential market exclusivity, if approved.
Dr. Alex Stojanovic, COO of Oncolyze, added that "AML is our immediate focus. We have preclinical evidence supporting the potential use of OM-301 in other types of cancers, including multiple myeloma (another blood cancer) and solid tumors such as colon, ovarian, pancreatic and sarcoma cancer. We know that our target exists on the cell surface of over 25 types of cancer. If approved by the FDA, as far as we are aware of, OM-301 would be the only therapeutic that treats cancer by targeting this cell-surface HDM2 protein."
The management team at Oncolyze brings over 100 years of experience across healthcare and leading institutions such as Pfizer, Johnson & Johnson, and Medimmune. Dr. Evans holds a MD from the New York University School of Medicine and completed a fellowship in Cardiovascular Disease and Electrophysiology at Cedars-Sinai Hospital. He is an experienced entrepreneur with a 25-year career in the life sciences. Dr. Stojanovic holds a PhD from Dartmouth College, and he was a NIH Postdoctoral Fellow at Northwestern University. He brings 17 years of global consulting and operational experience in the life sciences. In addition to a well-rounded management team, the company's collaborators and advisors include globally renowned medical experts such as the former Chief of Leukemia at Memorial Sloan Kettering Cancer Center, the Chief of Molecular Hematology at MD Anderson, and the Chief of Leukemia at City of Hope Medical Center.
The current financing campaign is expected to provide Oncolyze with the necessary funds to advance OM-301 through the final preclinical testing phase and into a Phase 1/2a clinical trial in AML patients. The company plans to start that clinical trial approximately one year post-financing. Oncolyze began accepting investments on Aug. 4, after receiving qualification by the Securities and Exchange Commission. The company has already received more than $825,000 in investments in the first 2+ weeks.
Oncolyze is developing a disruptive technology for the treatment of cancer. The drug's novel approach uses a simple mechanism of action to selectively kill cancer cells and cancer stem cells while sparing normal cells. This provides a highly effective treatment with potentially little to no side effects. The lead drug candidate, OM-301, targets the cancer cell membrane and causes lysis/necrosis; many antibiotics, such as penicillin, kill bacteria in a similar way. The initial therapeutic target is acute myeloid leukemia (AML). Most AML patients relapse within one year of treatment, as standard therapy does not destroy cancer stem cells. As a result, AML has only a 25% five-year survival rate. In contrast, OM-301 has been shown to destroy leukemic cancer stem cells, and therefore has the potential to disrupt current medical treatment. Following proof of concept in AML patients, the company expects to pursue development for patients with other hematologic and solid cancers.
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Oncolyze is offering securities through the use of an Offering Statement that has been qualified by the Securities and Exchange Commission under Tier II of Regulation A. A copy of the Final Offering Circular that forms a part of the Offering Statement may be obtained at https://seedinvest.com/oncolyze. This press release may contain forward-looking statements and information relating to, among other things, the company, its business plan and strategy, and its industry. These statements reflect management's current views with respect to future events based on information currently available and are subject to risks and uncertainties that could cause the company's actual results to differ materially. Investors are cautioned not to place undue reliance on these forward-looking statements as they are meant for illustrative purposes and they do not represent guarantees of future results, levels of activity, performance, or achievements, all of which cannot be made. Moreover, no person nor any other person or entity assumes responsibility for the accuracy and completeness of forward-looking statements, and is under no duty to update any such statements to conform them to actual results.
Source: Oncolyze, Inc.