Acute myeloid leukemia (AML) is one of the most common types of leukemia in adults – with 20,800 new cases expected in the U.S. alone in 2024 – yet the treatments available today are insufficient. At the five-year mark, the survival rate for AML hovers around 28%. Meanwhile, the American Cancer Society predicts 11,220 people in the U.S. will die from AML this year. While AML is the second most common type of leukemia for adults and children, it is most prevalent in adults, accounting for 31% of all adult leukemia diagnoses.
Coeptis Therapeutics Holdings, Inc. COEP, the Wexford, Penn.-based clinical-stage biotechnology company is hoping to improve those odds by developing innovative cell therapy platforms for patients with cancer and other debilitating diseases.
Cell Therapy Breakthroughs Paving The Way
Coeptis was built on the idea that cell therapies should be safe, effective and available to everyone. While CAR-T cell therapies have been transformative and curative for some, challenges with starting materials, costs and accessibility continue to persist.
Coeptis is taking some of the costs out of the equation by integrating a proprietary, allogeneic immune cell generation platform with a pipeline of innovative cell engineering technologies, which the company believes could universalize the treatment of many debilitating diseases. Leveraging a proprietary hematopoietic stem cell expansion and directed differentiation platform, Coeptis has developed DVX201, an unmodified allogeneic natural killer or NK cell that is generated ex vivo from pooled donor CD34+ stem and progenitor cells. NK cells are a type of white blood cell that are the first line of defense against transformed cancer cells and virally infected cells. They can directly and quickly kill these transformed cells via a number of different mechanisms. Importantly, NK cell therapies can be derived from a healthy donor and used in an intended patient without matching and without the risk of graft versus host disease (GVHD) and cytokine release syndrome (CRS) that is associated with T cell therapies.
Coeptis’s Novel Approach May Prove Game-Changing
DVX201 NK cells are generated from umbilical cord blood cells (from birth tissue that is normally discarded as medical waste), which is a well-understood and FDA-regulated source of cells that have been infused into patients for over 20 years. DVX201 is produced by pooling CD34+ cells isolated from multiple cord blood units, which results in a highly scalable and consistent manufacturing process with a low cost of goods. Manufacturing lots undergo stringent testing including a potency assay before treatment, to assess their ability to kill target cells.
DVX201 is under investigation in two separate phase 1 clinical trials, one for the treatment of patients with relapsed/refractory AML or high-risk MDS and the other in the setting of patients hospitalized with COVID-19). DVX201 is designed to supply a boost of healthy immune cells to fight the infection or cancer cells by directly infusing them into the patient’s body.
In the two phase 1 clinical trials, interim data for a total of 17 patients and 25 infusions of DVX201 have indicated that the NK cell therapy is well tolerated with no dose-limiting toxicities (DLTs). Further, there have been no observed cytokine release syndrome (CRS) or infusion toxicities thus far, even at the highest dose level. Topline safety and efficacy data is expected soon.
Cell Therapy Is At A Major Inflection Point
Beyond treating AML and viral infections, the Coeptis cell therapy platform is being developed to fight multiple myeloma, which is a cancer of the bone marrow. Coeptis has signed an agreement with VyGen-Bio Inc. to develop autologous CD38-GEAR-NK, a natural killer cell therapy for the treatment of CD38+ cancers. The company has the exclusive rights to acquire the GEAR cell therapy and companion diagnostic platforms from VyGen. Coeptis shares that various immunotherapies for CD38+ tumors are designed to find and kill cells that express the CD38 antigen. As a result, healthy circulating CD38+ NK cells are likely to become collateral damage, and with their eradication, the overall anti-tumor response is suboptimal. Coeptis’ treatment engineers the NK cells to be resistant to elimination, enabling their co-existence with CD38 targeting therapies and thus allowing for complementary tumor killing and immune surveillance.
From treating cancer to inflammation, cell therapy is undergoing a major inflection point thanks to companies like Coeptis that are relying on advances in gene editing to churn out novel approaches to improving survival and outcomes with better therapy. It’s why the cell therapy market, which was valued at $17.4 billion in 2023 according to estimates compiled by Coeptis, is forecast to grow at a CAGR of 17.05% until 2029.
Coeptis may have an edge. Unlike traditional therapies that rely on the patient’s own cells to treat diseases, Coeptis utilizes cells from healthy donors and pools the starting material for manufacturing. The company says this approach overcomes the logistics of using a patient’s own cells or those from a single donor, resulting in a scalable and highly consistent manufacturing process that reduces costs and can all be done ahead of time to increase the availability of compatible cells. Put that all together, and it’s not surprising that Coeptis is optimistic about the future of its cell therapy platforms.
In addition to Coeptis, Bristol-Myers Squibb BMY and Actinium Pharmaceuticals ATNM are among a handful of other companies actively making strides to provide better patient outcomes for those diagnosed with AML.
Featured photo by CDC on Unsplash.
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