Next Stop: Phase 1/2a Clinical Trial for H5N1 Vaccine Candidate
Greffex is preparing to enter Phase 1 clinical trials after successfully completing pre-clinical trials on its H5N1 Avian Flu vaccine. The company is working with a team at Washington University in St. Louis to manufacture the cGMP. Greffex expects to begin the trials in the fourth quarter of 2024, once the IND is approved.
This marks the initial clinical trial for Greffex and will provide the human proof the company has been eagerly awaiting. Greffex believes its platform has several advantages over mRNA and other legacy technologies. For example, mRNA’s short duration requires frequent boosters and Greffex is much easier to transport globally. The cost to deliver a dose of mRNA can be 3-times more expensive than the cost of a Greffex dose. The lifetime savings could be enormous. Greffex expects this Phase 1/2a trial to propel its technology to the forefront of the vaccine world as a better, cheaper, and more patient-friendly vaccine.
Due to the nature of H5N1, there will only be Phase 1 and 2 trials conducted before offering the doses to the US stockpile for prevention. There will not be a Phase 3 trial conducted due to the extremely deadly nature of the virus.
Greffex plans to closely followup this clinical trial with a Phase 1 trial for its other advanced vaccine candidate, a Universal Flu vaccine, which is also being sponsored by the NIH.