Coeptis Therapeutics Provides Safety and Dosing Update from Phase 1 Trials Investigating DVX201 in Relapsed/Refractory AML or High Risk MDS and Hospitalized COVID-19 Infection
- DVX201 shows no dose limiting toxicities, cytokine release syndrome, or infusion toxicities in 16 patients and 23 infusions.
- DVX201 is well-tolerated at all dose levels and is expected to report topline safety and efficacy data in Q1 2024.
- None.
DVX201, a first-ever allogeneic, cord-blood derived, natural killer (NK) cell therapy, has been administered to 16 patients with no dose limiting toxicities, cytokine release syndrome or infusion toxicities to date at all dose levels
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."
About Coeptis Therapeutics Holdings, Inc.
Coeptis Therapeutics Holdings, Inc., together with its subsidiaries including Coeptis Therapeutics, Inc. and Coeptis Pharmaceuticals, Inc., (collectively "Coeptis"), is a biopharmaceutical company developing innovative cell therapy platforms for cancer that have the potential to disrupt conventional treatment paradigms and improve patient outcomes. Coeptis' product portfolio and rights are highlighted by assets licensed from Deverra Therapeutics, including an allogeneic cellular immunotherapy platform and DVX201, a clinical-stage, unmodified natural killer cell therapy technology. Additionally, Coeptis is developing a universal, multi-antigen CAR T technology licensed from the University of
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