Sorrento Therapeutics (NSDQ: SRNE), a San Diego-Suzhou biopharma, signed a binding term sheet to license and develop vaccines, therapeutics and diagnostics using a proprietary C1-cell protein production platform developed by Florida's Dyadic International. The agreement includes rights to Dyadic's lead COVID-19 vaccine, which is already in  pre-clinical testing being conducted by Sorrento. Sorrento will pay $10 million upfront, with up to $33 million in milestones plus royalty payments. Dyadic says exclusive access to its platform is dependent on Sorrento's achieving specific milestones on time.

Sorrento will also reimburse up to $4 million of Dyadic's preclinical and clinical expenses of the COVID vaccine and be responsible for all further development costs.

Dyadic expects its proprietary C1-cell protein production platform will accelerate development and lower production costs of biologic vaccines and drugs. The C1 program is a biopharmaceutical gene expression platform based on the fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila), named C1.

Dyadic's lead COVID-19 vaccine candidate, DYAI-100, was produced by its proprietary C1-cell protein production platform. Sorrento will have rights to use the platform to discover additional COVID-19 candidates. Sorrento said the COVID-19 program offers a protein-based vaccine that can be rapidly manufactured in large quantities in its existing cGMP facilities, and stored and transported at room temperature, in order to increase access and affordability to underserved populations globally.”

If it meets timelines, Sorrento will have exclusive rights to develop the vaccines and other products in North and South America, Europe, major Asian countries (including Greater China and Japan) and certain other countries.

Sorrento’s Chairman and CEO, Dr. Henry Ji, said, “We look forward to continuing our collaboration with Dyadic, which began last year, initially with a goal of developing and commercializing a protein-based COVID-19 vaccine. “Over the past six months we have carried out several promising preclinical animal trials using the C1 produced RBD antigen in Dyadic’s lead COVID-19 vaccine candidate, DYAI-100. Our goal is to manufacture a COVID-19 vaccine that will provide protection across the variants of concern, including Delta, and in addition, apply the C1 protein production platform broadly across our current and future coronavirus programs.”

Mark Emalfarb, Dyadic’s President and CEO added, “We are delighted to have executed a binding term-sheet with Sorrento Therapeutics to license the C1 technology for the development and commercialization of coronavirus vaccines, therapeutics, and diagnostics, including COVID-19. This marks a significant milestone in our corporate development efforts as we expect the license agreement we will enter into to enable us to monetize our internal COVID-19 development efforts with a partner that has the resources and expertise to advance vaccines, therapeutics, and diagnostics both clinically and commercially.”

Sorrento, an antibody biopharma, focuses on therapies for cancer, infectious diseases and pain. Its immuno-oncology platforms include fully human antibodies (G-MAB library), clinical stage immuno-cellular therapies such as CAR-T and DAR-T, intracellular targeting antibodies (iTAbs), antibody-drug conjugates (ADC) and a clinical stage oncolytic virus, Seprehvir. Its antiviral therapies include COVIDTRAP, ACE-MAB, COVI-MAB, COVI-SHIELD and COVI-CELL.

In pain, the company is developing a first-in-class non-opioid TRPV1 small molecule agonist for pain management, resiniferatoxin (RTX), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, and to commercialize ZTlido® (lidocaine topical system) 1.8% to treat post-herpetic neuralgia. RTX has completed a Phase IB trial for intractable pain associated with cancer and a Phase IB trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase III trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido® was approved by the FDA in 2018.

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Disclosure: None.