Coeptis Therapeutics Announces Phase 1 Data on DVX201 for COVID-19 Treatment Has Been Accepted for Publication in Molecular Therapy Methods and Clinical Development
Coeptis Therapeutics announced the acceptance of Phase 1 study results for DVX201, an allogeneic natural killer (NK) cell therapy, in Molecular Therapy Methods and Clinical Development. The study evaluated DVX201 for treating hospitalized COVID-19 patients at high risk for disease progression. Key findings showed DVX201 was safe and well-tolerated in 9 patients, with no dose-limiting toxicities or cytokine release syndrome. The therapy, derived from pooled donor cord blood CD34+ cells, demonstrated rapid improvements in oxygenation, improved pulmonary radiographic findings, and led to hospital discharge within days of infusion.
Coeptis Therapeutics ha annunciato l'accettazione dei risultati dello studio di Fase 1 per DVX201, una terapia cellulare allogenica dei natural killer (NK), pubblicati su Molecular Therapy Methods and Clinical Development. Lo studio ha valutato DVX201 per il trattamento di pazienti COVID-19 ospedalizzati ad alto rischio di progressione della malattia. I risultati principali hanno mostrato che DVX201 era sicuro e ben tollerato in 9 pazienti, senza tossicità limitanti la dose o sindrome da rilascio di citochine. La terapia, derivata da cellule CD34+ di sangue cordonale di donatori selezionati, ha dimostrato rapidi miglioramenti nell'ossigenazione, miglioramenti nelle immagini radiografiche polmonari e ha portato alla dimissione ospedaliera entro pochi giorni dall'infusione.
Coeptis Therapeutics anunció la aceptación de los resultados del estudio de Fase 1 para DVX201, una terapia celular alogénica de células asesinas naturales (NK), en Molecular Therapy Methods and Clinical Development. El estudio evaluó DVX201 para el tratamiento de pacientes hospitalizados con COVID-19 que tienen un alto riesgo de progresión de la enfermedad. Los hallazgos clave mostraron que DVX201 fue seguro y bien tolerado en 9 pacientes, sin toxicidades limitantes de dosis ni síndrome de liberación de citoquinas. La terapia, derivada de células CD34+ de sangre de cordón umbilical de donantes agrupados, demostró mejoras rápidas en la oxigenación, mejoró los hallazgos radiográficos pulmonares y llevó al alta hospitalaria en unos pocos días después de la infusión.
Coeptis Therapeutics는 DVX201의 1상 연구 결과가 Molecular Therapy Methods and Clinical Development에 수록되었음을 발표했습니다. 연구는 고위험 코로나19 입원 환자를 치료하기 위해 DVX201을 평가했습니다. 주요 발견은 DVX201이 9명의 환자에서 안전하고 잘 견디어냈으며, 용량 제한 독성이나 사이토카인 방출 증후군이 없었다는 것입니다. 기증자 제대혈 CD34+ 세포에서 유래된 이 요법은 산소화의 신속한 개선, 호흡기 방사선 결과의 개선을 나타내었고, 주입 후 며칠 내에 병원에서 퇴원할 수 있게 했습니다.
Coeptis Therapeutics a annoncé l'acceptation des résultats de l'étude de Phase 1 pour DVX201, une thérapie par cellules tueuses naturelles (NK) allogéniques, dans Molecular Therapy Methods and Clinical Development. L'étude a évalué DVX201 pour traiter des patients COVID-19 hospitalisés à haut risque de progression de la maladie. Les résultats clés ont montré que DVX201 était sûr et bien toléré chez 9 patients, sans toxicités limitantes de dose ni syndrome de libération de cytokines. La thérapie, dérivée de cellules CD34+ de sang de cordon ombilical de donneurs groupés, a montré des améliorations rapides de l'oxygénation, une amélioration des résultats radiographiques pulmonaires et a conduit à une sortie de l'hôpital quelques jours après l'infusion.
Coeptis Therapeutics gab die Annahme der Ergebnisse der Phase-1-Studie für DVX201, eine allogene Therapie mit natürlichen Killerzellen (NK), in Molecular Therapy Methods and Clinical Development bekannt. Die Studie bewertete DVX201 zur Behandlung von hospitalisierten COVID-19-Patienten mit hohem Risiko für eine Krankheitsprogression. Wichtige Ergebnisse zeigten, dass DVX201 bei 9 Patienten sicher und gut verträglich war, ohne dosislimitierende Toxizitäten oder Syndrom der Zytokinfreisetzung. Die Therapie, abgeleitet aus pooled Spendernabelschnur-CD34+ Zellen, zeigte schnelle Verbesserungen der Sauerstoffversorgung, verbesserte pulmonale radiographische Befunde und führte zu einer Entlassung aus dem Krankenhaus innerhalb weniger Tage nach der Infusion.
- First successful demonstration of safety for allogeneic NK cell therapy in COVID-19 patients
- No treatment-related adverse events reported in Phase 1 trial
- Rapid clinical improvements observed in treated patients
- Scalable and cost-effective solution for allogeneic cell therapy
- Study was not designed to assess efficacy
- patient sample size (9 patients)
Insights
The Phase 1 trial results for DVX201 represent a significant milestone in cell therapy for viral infections. The study's key achievement lies in demonstrating the first successful safety profile for allogeneic NK cell therapy in COVID-19 patients, with zero dose-limiting toxicities across 9 patients. The absence of cytokine release syndrome, a common concern in cell therapies, is particularly noteworthy.
The therapy's derivation from pooled donor cord blood CD34+ cells offers substantial manufacturing advantages, potentially solving the scalability and cost challenges that typically plague cell therapies. Clinical observations showing rapid oxygenation improvements and expedited hospital discharges suggest promising therapeutic potential, though larger trials will be needed to confirm efficacy.
While COVID-19 serves as the initial proof-of-concept, the broader implication lies in establishing a platform for future viral pandemic responses. The stockpile-ready nature of this off-the-shelf therapy could revolutionize rapid response capabilities for emerging viral threats.
Study results demonstrate the safety and feasibility of adoptive immunotherapy using allogeneic off-the-shelf NK cells in hospitalized patients with COVID at high risk for progression of disease
DVX201, the first allogeneic NK cell therapy derived from pooled donor cord blood CD34+ cells, was administered to 9 patients with no dose limiting toxicities, cytokine release syndrome or infusion 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.
- No Adverse Events: DVX201 infusions were safe and well-tolerated, with no treatment-related adverse events, including no cytokine release syndrome (CRS).
- 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," said Joshua Hill, MD, associate professor and physician at Fred Hutch Cancer Center and 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," said Dave Mehalick, President and CEO of Coeptis Therapeutic. "These positive results, along with our recently announced expanded license agreement with Deverra, further strengthens Coeptis' role in the fight against infectious diseases."
To access the full publication in Molecular Therapy Methods and Clinical Development, please visit: https://www.cell.com/molecular-therapy-family/methods/fulltext/S2329-0501(24)00177-3
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, autoimmune, and infectious diseases 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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