DVX201 / Deverra Therapeutics, Coeptis - LARVOL DELTA

Off-the-shelf allogeneic natural killer cells for the treatment of COVID-19. (PubMed, Mol Ther Methods Clin Dev) - "We conducted a first-in-human, open-label, phase 1, dose-escalating (100 × 106, 300 × 106, or 900 × 106 cells) study of a single dose of DVX201, a cord-blood-derived allogeneic NK cell therapy, in hospitalized patients with COVID-19...The maximum allowed steroid dose for eligibility was up to 0.5 mg/kg prednisone (or equivalent) daily...This trial demonstrates the safety of allogeneic NK cell immunotherapy as a potential antiviral. Larger controlled trials are needed to establish efficacy."

Journal • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Novel Coronavirus Disease • Oncology • Respiratory Diseases

Safety and Efficacy of Allogeneic NK Cell Infusions in Patients With Relapsed/Refractory AML and High Risk MDS (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Coeptis Therapeutics | Recruiting ➔ Completed | N=18 ➔ 8 | Trial primary completion date: Jun 2024 ➔ Oct 2023

Enrollment change • Trial completion • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology

Allogeneic Natural Killer (NK) Cell Therapy in Subjects Hospitalized for COVID-19 (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Deverra Therapeutics, Inc. | Recruiting ➔ Completed | N=18 ➔ 12

Enrollment change • Trial completion • Infectious Disease • Novel Coronavirus Disease • Pneumonia • IL6

Safety and Efficacy of Allogeneic NK Cell Infusions in Patients With Relapsed/Refractory AML and High Risk MDS (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Deverra Therapeutics, Inc. | Trial completion date: Jun 2023 ➔ Jul 2024 | Trial primary completion date: Dec 2022 ➔ Jun 2024

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology

Coeptis Therapeutics President and CEO Issues Letter to Shareholders Highlighting 2023 Accomplishments and Outlook for 2024 (PRNewswire) - "DVX201 is a first-ever allogeneic, cord-blood derived NK cell therapy generated from pooled donor CD34+ hematopoietic stem and progenitor cells (HSPC) cells. This product is being investigated 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....the Phase 1 trial investigating DVX201 in relapsed/refractory AML or high-risk MDS has now safely dosed a total of eight subjects each receiving two infusions. The trial is expected to enroll two additional patients who will be infused at the highest dosing level, with completion of dosing expected to occur in Q1 2024."

Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Coeptis Therapeutics to Present at the 2023 Cell & Gene Meeting on the Mesa (PRNewswire) - "Coeptis Therapeutics Holdings, Inc...announced that Colleen Delaney, MD, MSc, Chief Scientific and Medical Officer, will present at the 2023 Cell & Gene Meeting on the Mesa being held October 10-12, 2023 in Carlsbad, CA at the Park Hyatt Aviara Resort. Dr. Delaney will provide an overview of Coeptis' clinical development programs including the recent Phase 1 safety and dosing update for DVX201 in relapsed/refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) and patients hospitalized with COVID-19 infection. "

P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

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 (PRNewswire) - P1 | N=18 | NCT04901416 | Sponsor: Deverra Therapeutics, Inc. | "Coeptis Therapeutics Holdings, Inc...today provided 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)...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)....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."

P1 data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Coeptis Therapeutics Completes Exclusive License for Allogeneic Immuno-Oncology Platform and Clinical Stage Assets from Deverra Therapeutics (PRNewswire) - "Coeptis Therapeutics Holdings, Inc...announced that it has completed the exclusive license of key assets from Deverra Therapeutics Inc. ('Deverra') related to its proprietary allogeneic stem cell expansion and directed differentiation platform for the generation of multiple distinct immune effector cell types, including natural killer (NK) and monocyte/macrophages....As a result of the transaction, Coeptis acquires exclusive rights to two Investigational New Drug (IND) applications and two assets in the Phase 1 clinical trial stage...investigating infusion of DVX201, an unmodified natural killer (NK) cell therapy generated from pooled donor CD34+ cells, in hematologic malignancies and viral infections."

Licensing / partnership • Acute Myelogenous Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Novel Coronavirus Disease • Oncology

Coeptis Therapeutics Signs Agreement to Acquire Allogeneic Immuno-Oncology NK Platform in Phase 1 Clinical Trials from Deverra Therapeutics (PRNewswire) - "Coeptis Therapeutics Holdings, Inc...announced it has entered into a binding term sheet with Deverra Therapeutics, Inc...pursuant to which it has obtained an exclusive right, until August 31, 2023, to negotiate towards the acquisition or license of assets from Deverra Therapeutics related to its proprietary allogeneic stem cell expansion and directed differentiation platform for the generation of multiple distinct immune effector cell types, including natural killer (NK) and monocyte/macrophages....The transaction, if finalized, would provide Coeptis with, among other assets, exclusive rights to two FDA approved Investigational New Drug (IND) applications and two Phase 1 clinical trials (NCT04901416, NCT04900454) investigating infusion of DVX201, an unmodified natural killer (NK) cell therapy generated from pooled donor CD34+ cells, in hematologic malignancies and viral infections...Deverra expects phase I clinical trial data from its AML study to be complete during 2H 2023."

Licensing / partnership • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Safety and Efficacy of Allogeneic NK Cell Infusions in Patients With Relapsed/Refractory AML and High Risk MDS (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: Deverra Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology

Safety and Efficacy of Allogeneic NK Cell Infusions in Patients With Relapsed/Refractory AML and High Risk MDS (clinicaltrials.gov) - P1; N=18; Not yet recruiting; Sponsor: Deverra Therapeutics, Inc.; Initiation date: Sep 2021 ➔ Dec 2021

Clinical • Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology

Allogeneic Natural Killer (NK) Cell Therapy in Subjects Hospitalized for COVID-19 (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: Deverra Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Pneumonia • IL6

Allogeneic Natural Killer (NK) Cell Therapy in Subjects Hospitalized for COVID-19 (clinicaltrials.gov) - P1; N=18; Not yet recruiting; Sponsor: Deverra Therapeutics, Inc.

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • Pneumonia • IL6

Safety and Efficacy of Allogeneic NK Cell Infusions in Patients With Relapsed/Refractory AML and High Risk MDS (clinicaltrials.gov) - P1; N=18; Not yet recruiting; Sponsor: Deverra Therapeutics, Inc.

Clinical • New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology