By Godson Umejiego, USA and Ron Chen, ASEAN Region

Entos Pharmaceuticals (Entos), a clinical-stage biotechnology company developing genetic medicines with its Fusogenix proteolipid vehicle (PLV) nucleic acid delivery platform, and Centre National de Recherche et de Formation sur le Paludisme (CNRFP), the Burkina Faso site team lead by Dr. GansaneAdama, have announced that enrollment is now complete into the single and two-dose cohorts of the Phase 2 clinical trial of Covigenix VAX-001-1b (Covigenix), its COVID-19 DNA vaccine. A total of 268 participants are enrolled in the study at two sites in Burkina Faso. The phase 2 trial in Burkina Faso is managed by Clinical Pharma Solutions Inc. based in Ontario, Canada.

“We’re thrilled that recruitment for our Phase 2 trial of our COVID-19 DNA vaccine was completed so quickly by Dr. Adama’s team in Burkina Faso. We’d like to extend our deepest gratitude to all the study participants, without whom, this milestone would not be possible,” said founder, and CEO of Entos Pharmaceuticals, John D. Lewis, Ph.D.,. “The continued progress of our Covigenix vaccine clinical development programme brings us closer towards providing a potentially effective and safe fridge-stable, single-dose vaccine against COVID-19 to under-vaccinated regions of the world.”

Formulated using Entos’ Fusogenix PLV delivery platform, Covigenix is a DNA vaccine encoding SARS-CoV-2 Spike protein and two genetic adjuvants engineered to stimulate the adaptive and innate immune systems. By stimulating both arms of the immune system, the vaccine is designed to provide effective and durable protection against COVID-19. Preclinical studies of Covigenix demonstrated potent immunogenicity, conferring protection from infection with SARS-CoV-2 in animal models. Given the high stability of DNA, Covigenix has the key advantage of stability for more than a year at normal refrigerated temperatures, making it more cost-effective to store, transport, and deploy to developing countries compared to approved vaccines.

The ongoing Phase 2 trial was preceded by a first-in-human Phase 1 study conducted in Canada. In Phase 1, Entos’ Fusogenix PLV platform was determined to be safe and well-tolerated for the intracellular delivery of DNA, with the potential to promote positive immunological outcomes in a single vaccine dose. The ongoing Phase 2 randomized, observer-blind clinical trial in Burkina Faso is further evaluating the safety, tolerability, and immunogenicity of Entos’ single-dose and double-dose regimens of the intramuscularly administered Covigenix DNA vaccine candidate in healthy adults 18 or older.

“Despite the availability of mRNA-based vaccines, COVID-19 is still a major problem in Burkina Faso and other countries with vulnerable populations,” said Principal Investigator with CNRFP, Dr. GansaneAdama. “We need vaccines that are safe, effective, and easy to transport, store, and administer. With the study now fully enrolled, we look forward to generating data that can inform the potential utility of this important investigational vaccine.”