On September 14, 2023 Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, reported a safety and patient dosing update from two Phase 1 clinical trials investigating DVX201 for the treatment of relapsed/refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) and patients hospitalized with COVID-19 infection (Press release, Coeptis Pharmaceuticals, SEP 14, 2023, View Source [SID1234635169]). DVX201 is a novel allogeneic, unmodified natural killer (NK) cell therapy generated from pooled donor CD34+ hematopoietic stem and progenitor cells (HSPC) cells.
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Interim data from both trials involving 16 patients and 23 infusions of DVX201 indicate that the NK cell therapy is well-tolerated with no dose limiting toxicities (DLTs), cytokine release syndrome (CRS) or infusion toxicities observed thus far through the highest dose level. The Phase 1 clinical trial investigating DVX201 in patients with hospitalized COVID-19 infection (NCT04900454) has completed the three dosing cohorts (3+3 design), enrolling a total of nine patients each receiving a single infusion. DVX201 was tolerated at all dosing levels.
The Phase 1 trial investigating DVX201 in relapsed/refractory AML or high-risk MDS (NCT04901416) has safely dosed a total of seven subjects each receiving two infusions (14 total). The trial is expected to enroll three to five additional patients who will be infused at the highest dosing level. Coeptis expects to report topline safety and efficacy data from the full patient population in the first quarter of 2024.
"The excellent safety results to date for DVX201 across two trials with distinct patient populations, including 16 patients and 23 infusions, is extremely encouraging and represents a major step for this first in-human use of an allogeneic NK cell therapy derived from pooled donor CD34+ HSPCs," said Colleen Delaney, MD, Chief Scientific and Medical Officer. "DVX201, a pooled donor product, represents a truly novel manufacturing platform, and these preliminary safety results give us confidence as we continue enrolling the highest dose cohort, which should total seven subjects for 14 infusions for the remaining portion of the Phase 1 trial in relapsed/refractory AML and high risk MDS. We anticipate receiving top line data for this trial in 1Q24."