PIPELINE

Human Health

Dyadic International, Inc. (NASDAQ: DYAI)

We are a global biotechnology company committed to building disruptive microbial platforms to address the growing demand for global protein bioproduction and unmet clinical needs for effective, affordable, and accessible biopharmaceutical products for human and animal health.

With a passion to enable our partners and collaborators to develop effective preventative and therapeutic treatments in both developed and emerging countries, Dyadic is building an active pipeline by advancing its proprietary filamentous fungal based

We are building an active pipeline of products for human health by applying our proprietary and patented C1 technology to develop vaccines and antibodies for infectious and other diseases.

Vaccine and Antibody Development: The C1 platform is ready for full commercialization opportunities in recombinant protein vaccines.

Animal Trials

  • Data from vaccines and antibodies produced from C1 proteins have repeatedly demonstrated safety and efficacy comparable to mammalian cell lines in hamsters and non-human primates as well as in a range of infectious diseases in animal trials with cattle, lambs, chicken, rabbits, hamsters, and mice.

Human Trials

  • In the first quarter of 2023, Dyadic initiated dosing in a Phase 1 clinical trial of DYAI-100, a recombinant protein COVID-19 booster vaccine candidate.
  • In November 2023, Dyadic announced successful top-line results for this 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.  These results from this first in human clinical trial are expected to accelerate the adoption of the C1-cell protein production platform for both vaccine and therapeutic candidates.
  • A COVID-19 monoclonal antibody produced using the C1 protein production platform is being developed in partnership with leading academic and pharmaceutical partners.

Pipeline

  • In addition to COVID-19 we are developing several other vaccines for infectious disease such as influenza as part of our internal pipeline and in partnerships and collaborations with academia, industry and government agencies globally

Technology Transfer

Dyadic has cGMP experience with validated up and downstream processes and an established Tech Transfer process in compliance with ICH 11 guidelines.

Human Health Products Currently in Development