Candidate: DYAI-100

Category: VAX

Type: SARS-CoV-2-S-RBD vaccine candidate produced via Dyadic’s C1 technology platform

2021 Status: Dyadic said March 18 that it will begin a toxicology study of DYAI-100 in the second quarter, then advance the vaccine candidate into a first-in-humans Phase I trial in the second half of this year. The plans for the vaccine follow positive preclinical results generated one of Dyadic’s nine research collaboration partners, the Israel Institute for Biological Research (IIBR), in challenge studies using human ACE2 transgenic mice vaccinated with the company’s SARS-CoV-2-S-RBD vaccine candidate manufactured from C1-cells. DYAI-100 generated high levels of neutralizing antibodies in preclinical studies in mice, supporting its potential to promote excellent immunogenicity responses, according to Dyadic.

Dyadic has engaged CR2O, a contract research organization, to manage and support further preclinical and clinical development of DYAI-100. As of March 18, DYAI-100 had been evaluated in 10 animal trials by academic, industrial, and governmental R&D groups worldwide.

DYAI-100 is the company’s initial SARS-CoV-2-S-RBD vaccine candidate produced via Dyadic’s C1 technology platform. In parallel with advancing DYAI-100, Dyadic said, it is engineering additional C1-cells to manufacture SARS-CoV-2 variant antigens for monovalent and multivalent vaccine candidates.

2020 Status: In an announcement of COVID-19-related activity, Dyadic said October 12 that its C1 Rapid Recombinant Protein Manufacturing Platform had shown that it can manufacture monoclonal antibodies (mAbs) more efficiently and faster—with potential to generate three to four times greater quantities of mAbs in the same timeframe—compared to current production methods using Chinese hamster ovary (CHO) cells, potentially broadening access to the treatment. A COVID-19 vaccine antigen has been developed from Dyadic’s proprietary and patented C1 cell line capable of being produced at 3 grams/liter in five days. Dyadic also said it had expressed a SARS-CoV-2 monoclonal antibody in collaboration with an undisclosed biotech company that is developing antibody cocktails to treat COVID-19 patients.

Dyadic noted that its C1 expressed RBD of the SARS-CoV-2 spike protein was being used in animal trials by seven different research groups, governmental agencies and biopharma companies, including IIBR and a collaboration of European Union scientists that participated with Dyadic in the ZAPI program. The partners were testing the C1 expressed RBD vaccine candidate(s) in animal trials on a stand-alone basis as well as testing the C1 RBD with nanoparticles and adjuvants.. The programs were in addition to the previously announced activities with the Frederick National Laboratory, Jiangsu Hengrui Medicine, and other third-party collaborations which are working with Dyadic’s C1 expression platform to express their own COVID-19 and other vaccine and antibody candidates for a number of animal and human health applications.

COVID-19: 300 Candidates and Counting

To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.

KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types: