Coeptis Therapeutics Holdings, Inc. announced plans to pursue DVX201, its proprietary allogeneic stem cell expansion and directed differentiation platform of unmodified natural killer (NK) cell therapy, as an antiviral treatment addressing various respiratory viral infections that lead to hospitalization, including the "tripledemic" of influenza, COVID-19 and respiratory syncytial virus (RSV). DVX201, the first-ever allogeneic, cord-blood derived NK cell therapy generated from pooled donor CD34+ hematopoietic stem and progenitor cells (HSPC) cells, is designed to supply a boost of healthy immune cells to potentially help fight the infection by directly infusing them into the patient's body. DVX201 NK cells are generated from cord blood cells (from birth tissue), a well understood and FDA regulated source of cells, that has been infused into patients for over 20 years.

DVX201 is produced by pooling CD34+ cells isolated from multiple cord blood donations to increase lot size and immune system diversity. Importantly, doses undergo stringent testing including a potency assay before treatment, to assess their ability to kill virally infected cells. Additionally, DVX201 does not contain T-cells, which significantly reduces the possibility for major rejection by patients, which is a major concern for some cell therapy products.

In two Phase 1 clinical trials for the treatment of relapsed/refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) and patients hospitalized with COVID-19 infection, 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 through the highest dose level. Since the COVID-19 pandemic, seasonal infections for the three viral infections have been elevated, and the CDC highlights last year's 2022-2023 "tripledemic" in which weekly hospitalization rates exceeded 20 per 100,000.

If this season follows with a severe flu and RSV, and with a moderate overlapping COVID-19 wave, the CDC warns that it expects similar impacts and hospitalizations placing a severe strain on the healthcare system. A truly global concern, The World Health Organization estimates that nearly 7 million people have died from COVID-19 worldwide since the 2020 pandemic. It also estimates the impact of seasonal flu, killing approximately 290,000 to 650,000 people per year, while RSV may be responsible for 29,000 deaths per year.