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Since Our Last Update
Dyadic's DYAI recent events include:
➢ Development of COVID-19 vaccine in India - May 2021
➢ C1 production platform utilized in ZAPI published in VACCINES - June 2021
➢ Technology transfer and licensing agreement with Rubic Consortium (S. Africa) - July 2021
➢ Sale of interest in VLP and BDI
Development of COVID-19 Vaccine in India
On May 26, 2021, Dyadic announced a collaboration with Syngene International Limited SYNGENE. Syngene is an India-based, integrated research, development and manufacturing services company which will develop a COVID-19 vaccine candidate using Dyadic's C1 expression system. Development efforts aim to produce a vaccine that can affordably protect against emerging variants of the coronavirus. India has an enormous population and much of it is in rural areas which lack the necessary infrastructure to efficiently distribute cold chain product. Successful vaccine distribution, especially in less developed areas, requires the ability to produce the vaccine rapidly, affordably, at sufficient scale and without the use of prohibitively specialized technologies and environments. India recently experienced a significant wave of infections, highlighting the need for local vaccine production to address the surge.
Dyadic will work with Syngene to develop a vaccine candidate for immunization against current and future variants of COVID-19, and continues to explore similar arrangements in other geographies.
Technology Transfer and Licensing Agreement with Rubic Consortium
Adding to recent geographical expansion throughout the Asian sphere, Dyadic announced on July 27, 2021 that it had entered into a technology transfer and licensing agreement with Rubic Consortium for research, development and commercialization of COVID-19 vaccine candidates throughout the African continent. Including recent successes with Syngene, Medytox and others, the deal expands C1's potential reach as a COVID-19 vaccine production solution to ~40% of the global population.
The Rubic Consortium comprises representatives from public health, medical, academia, vaccine technology, technology transfer and economics sectors. Development and implementation of vaccine technologies will be overseen by leading academics directed by the University of the Witwatersrand, Johannesburg (Wits) academic team with the support of Wits Health Consortium. Shabir Madhi, professor of vaccinology, Dean Faculty of Health Sciences at Wits stated, "The need to quickly acquire and commercialize technology and manufacturing capabilities, which addresses the infrastructure necessary to deploy vaccinations for broad populations affordably and timeously has never been a more strategic imperative of African nations than today," and expressed optimism regarding the high yields and low cost that Dyadic's C1 platform represents even beyond COVID-19.
Sale of Equity Interests in BDI and VLP
Dyadic has held a 3.3% interest in The Vaccine Company (VLP) and a 16.1% interest in Biotechnology Developments for Industry (BDI) which we have included on our summary of collaborations. In an 8-K filing, Dyadic announced the sale agreement of these two interests on July 26, 2021. Proceeds from the sale, after accounting for transaction costs and legal expenses were approximately €1.3 million. BDI and VLP are both subsidiaries of the company Spanish Biotechnology Developments for Industry, SL. The partners have provided research services and a service framework agreement that developed C1 for a variety of projects including the development of certolizumab.
Phase I Safety Study
On March 18, 2021, Dyadic announced its plans to launch clinical studies for a COVID vaccine. This candidate, designated DYAI-100, is an antigen that mimics the receptor binding domain of SARS-CoV-2 spike protein. This announcement follows successful animal trials conducted by the Israel Institute for Biological Research (IIBR) and work with the Zoonoses Anticipation and Preparedness Initiative (ZAPI) program. Dyadic entered into a master services agreement with contract research organization CR2O to manage preclinical and clinical development of DYAI-100. Dyadic has initiated toxicology studies. Other milestones include preparing and filing an investigational new drug application (IND) over the summer and obtaining clearance from the FDA to begin and launch its trial by the end of August 2021. The primary goal of the clinical trial is to validate the safety of C1-produced proteins in humans, which will be the first incidence of this use.
C1 expressed receptor binding domain (RBD) is being used in animal trials by 10 different research groups, government agencies and biopharma companies including IIBR, scientists from Oxford U, Utrecht U, Erasmus Medical Center, U of Veterinary Medicine Hannover, DE (TiHo) and others around the globe, testing RBD alone or with nanoparticles and adjuvants.
Dyadic's COVID-19 vaccine milestones include:
➢ C1 expression of SARS-CoV-2 mAb achieved - 2H:20
➢ Record expression of SARS-CoV-2 RBD antigen - 2H:20
➢ VTT C1 engineering of full spike protein & RBD antigen of SARS-CoV-2 – 2H:20
➢ Non-exclusive technology usage agreement with Epygen Biotech - 2H:20
➢ 10 ongoing animal trials of SARS-CoV-2-S-RBD – 2020/2021
➢ CR2O master services agreement - March 2021
➢ ZAPI Update - March 2021
➢ Medytox collaboration - March 2021
➢ CR2O antibody research collaboration - April 2021
➢ DYAI-100 toxicology study - April 2021
➢ Syngene collaboration for development of COVID-19 vaccine in India - May 2021
➢ Technology Transfer and Licensing Agreement with Rubic Consortium - July 2021
➢ DYAI-100 Phase I initiation – 2H:21
VACCINES Publication
Based on work done with the Zoonotic Anticipation and Preparedness Initiative (ZAPI), Dyadic published findings from its participation in the initiative in VACCINES, a leading peer-reviewed journal. The publication was entitled "Development of a Modular Vaccine Platform for Multimeric Antigen Display Using an Orthobunyavirus Model", and described the development of a robust and versatile self-assembling multimeric protein scaffold particle vaccine platform using lumazine synthase from Aquifex aeolicus. Among the production platforms used to produce the multimers was Dyadic's C1.
The goal of the ZAPI initiative was to identify the best subunit vaccines and neutralizing antibodies against potential new zoonotic diseases and strains, define optimal manufacturing technologies and processes to produce the vaccines and antibodies in high volumes and facilitate public sector adoption of the leading solutions. The peer-reviewed study demonstrated the successful use of Dyadic's C1 platform to facilitate rapid and high yield protein production.
Summary
Dyadic continues to add partnerships and research collaborations and advance its COVID-19 candidate, DYAI-100. Since our last update, Dyadic has added representatives from India and Africa to its list of COVID-19 development partners, expanding C1's geographical reach to ~40% of the world's population. Through these partnerships C1 should demonstrate the platform's ability to produce vaccines affordably, rapidly and at high yield.
We expect to see future agreements that provide upfronts, milestones and royalties based on a successful candidate in animal health, human health or as a vaccine for SARS-CoV-2. The most important recent announcement is the move into clinical trials to test the safety and later, efficacy, of a COVID vaccine. The company has guided towards a second half start for the Phase I in-human safety study and has a plan to move into Phase II and beyond if results are supportive.
The pandemic may catalyze the pathway forward for C1 to be used as an expression system for producing vaccines and other therapeutic proteins. Advancing a C1-expressed protein in human trials would be a tremendous achievement and the effort is now underway with contract research organization CR2O. C1 may be able to provide much higher output with improved characteristics compared to current approaches which addresses one of the primary bottlenecks when manufacturing sufficient quantities of vaccine for global populations.
Dyadic's balance sheet is strong with numerous fully funded collaborations and multiple years' worth of cash at 2021 anticipated burn rates. Cash burn guidance of ($10) to ($12) million for 2021 includes amounts necessary to fund the clinical trial and should improve somewhat with the €1.3 million addition due to the VLP/BDI sale.
There is substantial value in Dyadic's broad portfolio of options and in its exciting technology that can revolutionize the protein expression industry. Future favorable catalysts include the addition of more collaborators, achieving output milestones and launching the planned clinical trial.
Research Collaboration Summary
Dyadic has continued to announce new collaborations. Below we summarize Dyadic's relationships since 2015.
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2. Source: Dyadic March 2021 Corporate Presentation
3. Source: Zacks Research and Dyadic corporate filings. Green highlight indicates animal health collaboration. Blue highlight indicates academic collaborator, orange indicates a follow-on project with a previous partner.
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