Coeptis Therapeutics Holdings, Inc. has announced that its Phase 1 clinical trial data on DVX201, a novel treatment aimed at combating COVID-19, has gained acceptance for publication in the esteemed journal, Molecular Therapy Methods and Clinical Development.
The study’s findings illustrate the safety and feasibility of implementing adoptive immunotherapy through the use of allogeneic off-the-shelf natural killer (NK) cells among hospitalized patients diagnosed with COVID-19, particularly those at an elevated risk of disease progression.
DVX201 represents a groundbreaking advancement as the first allogeneic NK cell therapy clinically utilized that is derived from pooled donor cord blood CD34+ cells. In a cohort of 9 patients, the therapy was well tolerated, exhibiting no dose-limiting toxicities, cytokine release syndrome, or infusion-related toxicities.
Results from the clinical trial demonstrated the safety and feasibility of DVX201 as a potential treatment for patients with active SARS-CoV-2 infections. The following key findings are highlighted in the accepted manuscript:
- First Demonstration of Safety: This is the first known study to demonstrate the safety of adoptive immunotherapy with allogeneic, off-the-shelf NK cells in patients with active COVID-19, especially those at high risk for disease progression.
- Innovative NK Cell Therapy: DVX201 is the first allogeneic NK cell adoptive immunotherapy used clinically that is derived from pooled donor cord blood CD34+ cells, offering a scalable, consistent, and cost-effective solution to barriers in the allogeneic cell therapy space.
- Study Observations: Observations included rapid improvements in oxygenation, improved pulmonary radiographic findings, and hospital discharge within days of infusion.
- Future Potential for Viral Therapies: This study supports the potential of allogeneic NK cell therapy as a scalable, stockpile-ready antiviral treatment for future viral pandemics.
“Despite advances in treatment and prevention strategies for SARS-CoV-2, COVID-19 still results in substantial morbidity in certain patient populations, underscoring the ongoing need for additional therapeutic options, particularly among immune-compromised individuals,” stated Joshua Hill, MD, an associate professor and physician at Fred Hutch Cancer Center, who is the corresponding author of the study. “Although the study was not designed to assess efficacy, our findings demonstrate the safety and potential utility of NK cell therapy as a complementary therapeutic strategy for viral infections in high-risk patients.”
“We are very excited by these results and look forward to sharing the full findings in Molecular Therapy Methods and Clinical Development,” remarked Dave Mehalick, President and CEO of Coeptis Therapeutics. “These positive results, combined with our recently announced expanded license agreement with Deverra, further bolster Coeptis’ position in the fight against infectious diseases.”
About Coeptis Therapeutics Holdings, Inc.
Coeptis Therapeutics Holdings, Inc. is dedicated to groundbreaking advancements in the biopharmaceutical sector, focusing on innovative cell therapy platforms for cancer, autoimmune, and infectious diseases. The company strives to disrupt conventional treatment paradigms while enhancing patient outcomes significantly. Their product portfolio features unique assets licensed from Deverra Therapeutics, including an allogeneic cellular immunotherapy platform and DVX201, which is a clinical-stage, unmodified natural killer cell therapy technology. Coeptis is also developing various other innovative therapies in collaboration with esteemed institutions such as the University of Pittsburgh and leading medical researchers at the Karolinska Institutet.
Contacts
Coeptis Therapeutics, Inc.
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SOURCE Coeptis Pharmaceuticals, Inc.
**Interview with Dr. Joshua Hill, Corresponding Author of the DVX201 Clinical Trial Study**
**Editor:** Welcome, Dr. Hill. Thank you for joining us today to discuss the recent findings from your Phase 1 trial of DVX201. Can you start by explaining what DVX201 is and its significance in treating COVID-19?
**Dr. Hill:** Thank you for having me. DVX201 is an innovative immune cell therapy utilizing allogeneic off-the-shelf natural killer (NK) cells derived from pooled donor cord blood CD34+ cells. Its significance lies in its potential as a scalable and consistent treatment option for hospitalized patients with COVID-19, particularly those at high risk for severe disease. This study is a groundbreaking step in demonstrating the safety and feasibility of this therapy in such patients.
**Editor:** The study results showed no dose-limiting toxicities or serious adverse effects. How important is this finding, and what does it mean for future research and patient care?
**Dr. Hill:** It’s an incredibly important finding. The fact that we observed no dose-limiting toxicities or infusion-related complications indicates that DVX201 can be safely administered to patients. This not only sets the foundation for further research into its efficacy, but it also provides hope for the immediate treatment of high-risk populations who still face significant morbidity due to COVID-19.
**Editor:** You mentioned observations such as rapid improvements in oxygenation and hospital discharge within days. How do these results correlate with the safety profile you observed?
**Dr. Hill:** The rapid improvements in patients’ conditions suggest a potential therapeutic benefit, even though our study wasn’t designed to specifically assess efficacy. These outcomes, combined with the safety profile we documented, imply that DVX201 could play an important role as a supportive treatment in managing COVID-19 for vulnerable populations.
**Editor:** Looking ahead, what is your vision for the clinical application of allogeneic NK cell therapies beyond COVID-19?
**Dr. Hill:** Our findings suggest a promising potential for allogeneic NK cell therapy as a scalable and readily available treatment for other viral infections, particularly in situations similar to the COVID-19 pandemic. The ability to stockpile these therapies could enable more robust responses to future viral threats, enhancing preparedness for potential pandemics.
**Editor:** Thank you, Dr. Hill, for sharing your insights and the importance of your work with DVX201. We look forward to seeing the complete findings published in *Molecular Therapy Methods and Clinical Development*.
**Dr. Hill:** Thank you for the opportunity. We are excited to share more details and contribute to the fight against COVID-19 and other viral infections.