NASDAQ:DYAI
READ THE FULL DYAI RESEARCH REPORT
Since the report of third quarter results in early November, Dyadic International Inc. (NASDAQ:DYAI) has been active attending investor conferences, reading out clinical trial results and securing further partnerships. Some of the key partnership work that has been accomplished in the last three months includes an expansion of the work with Dyadic’s Africa licensee, Rubic One Health, to work with Afreximaxbank to fund the build of manufacturing capacity. A new agreement with a global biopharmaceutical company was signed and partnership with Cygnus Technologies was forged to provide testing for C1-produced product.
New Collaborations and Partnerships
Rubic and Afreximaxbank
Dyadic has generated a steady flow of collaborations and partnerships and has continued this progression into 2024. Last November, the company announced an expansion of development efforts with its African licensee, Rubic One Health with funding entity Afreximaxbank. Afreximaxbank has signed an agreement with Rubic that will fund the vaccine manufacturing facility using the C1 platform in South Africa. Production from this facility will supply the entire continent of Africa. The presence of a biologics manufacturing facility will provide a base for production of many therapeutic proteins that can be expressed using Dyadic’s C1 platform.
Global Biopharmaceutical Company
An unidentified global biopharmaceutical company signed a new research and development collaboration agreement with Dyadic, as shared on February 6th. The fully funded agreement includes a commercial option and will support the development and design of four recombinant proteins produced by C1.
Cygnus Technologies
On February 13th, Dyadic announced that it is working with Cygnus Technologies to develop an enzyme-linked immunosorbent assay (ELISA) test to evaluate C1 derived proteins for impurities and to quantify host cell proteins (HCPs). Cygnus, which was acquired by Maravai LifeSciences in 2016, develops a wide variety of assays, kits and other biologics testing products. It has been working with Dyadic to develop an ELISA test which is critical for evaluating monoclonal antibody outputs from C1 to determine if there are any contaminants that may produce an undesired immune response or impact drug stability. While this type of testing is not necessary for vaccines, it is required for other proteins such as monoclonal antibodies before they can be used in humans. Furthermore, biopharmaceutical manufacturers monitor HCPs to demonstrate reproducibility of their purification process, ensure HCP clearance and perform product lot release testing. The antibody deployed in the Cygnus C1 ELISA kit has been evaluated for over 1,000 HCPs that have appeared in C1-produced product, as determined by antibody affinity extraction and mass spectrometry methods. The availability of the test is an important tool for Dyadic collaborators and partners as it makes testing easier, faster and more accurate compared to other methods.
DYAI-100 Phase I Topline Results
Dyadic announced topline results from its Phase I DYAI-100 study evaluating a C1-derived antigen used in a vaccine to prevent COVID. Dyadic’s partner Rubic One Health ran the study in South Africa which enrolled 30 healthy adults who were administered the vaccine at two dose levels. The C1 SARS-CoV-2 RBD single booster vaccine achieved its primary endpoint and demonstrated safety and reactogenicity of the DYAI-100 recombinant protein. Both dose levels were considered safe and well tolerated. The final clinical study report has since been completed for this first-in-human clinical trial which is the first incidence of a vaccine antigen produced using a filamentous fungal cell line. In the press release, the CEO of partner Rubic noted that the C1-produced product is particularly well suited to Africa due to its relatively low cost and ability to produce product that does not require ultra-cold storage and that can be distributed throughout remote areas of Africa.
DYAI-100 Program
Dyadic achieved a pivotal point in its maturation as a provider of therapeutic proteins as it and partner Rubic One Health completed patient dosing with DYAI-100, a COVID-19 recombinant protein receptor binding domain (RBD) booster vaccine candidate.
The Phase I was designed as a randomized, double blind, placebo-controlled clinical trial conducted in South Africa. It measured the clinical safety and antibody response of DYAI-100, a C1-SARS-CoV-2 recombinant protein RBD vaccine, produced using the C1 platform, administered as a booster vaccine at two single dose levels in healthy volunteers. Patients aged 18 – 55 were randomized 4:1 for DYAI-100 and placebo, with 15 subjects per cohort. Following the screening period there were eight scheduled clinic visits. The first six visits occurred within the first 29 days following administration and two follow up visits will take place on Days 90 and 180. Safety data will be collected throughout the trial and immunogenicity assessments will be made. An interim analysis of the Day 29 data for both the low and high dose groups by the Data Safety Monitoring Board (DSMB) determined there were no major vaccine-related safety concerns.
On March 7th, 2023, an update informed stakeholders that dosing was complete and that no serious adverse events were reported. Initial safety and antibody response data was reported in late July that reiterated the absence of vaccine-related safety concerns and serious adverse events.
In September 2023, the last patient, last visit occurred and data lock was implemented on November 1, 2023. Top line is expected to be reported to stakeholders in December with a Phase I clinical study report (CSR) to follow.
A November 29th press release, discussed above, provided top-line results from the study.
SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR.
DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.
