First-in-Human Filamentous Fungal-Based Vaccine Candidate Completes Successful Phase 1 Clinical Study

Dyadic International, Inc. today announced successful top-line results for the Phase 1 clinical trial of its recombinant protein RBD vaccine candidate, DYAI-100.

This marks the first-in-human use of a recombinant protein vaccine expressed by Dyadic's C1-cell expression platform.

"We are excited to share the top-line results from what we believe marks the first-in-human clinical trial for a vaccine antigen produced using a filamentous fungal cell line, such as our C1 platform," said Mark Emalfarb, CEO of Dyadic, in a press release on November 29, 2023.

"While vaccines and antibodies produced from our C1-cell protein production platform have previously demonstrated safety and efficacy in animal studies, this trial represents the initial evaluation of a C1-cell produced protein in humans and is a key milestone for the Company."

"Notably, no Serious Adverse Events were reported, and the clinical study successfully met its primary endpoint demonstrating that a C1-produced antigen was both safe and well-tolerated in both the low and high dose groups."

DYAI-100, also known as the C1-SARS-CoV-2 RBD vaccine, is a novel receptor-binding domain (RBD) recombinant protein booster vaccine candidate, highly expressed in Dyadic's proprietary C1-cell protein production platform for the prevention of COVID-19.

The C1-SARS-CoV-2 RBD vaccine candidate consists of the SARS-CoV-2 RBD adjuvanted with Alhydrogel 85® 2%.

Dyadic's gene expression and protein production platforms are based on the highly productive and scalable fungus  Thermothelomyces heterothallica (formerly Myceliophthora thermophila). 

Previously, the U.S. FDA conducted a digital workshop, "Next-Gen Vaccines without the right platform limit pandemic effectiveness," posted on YouTube.