GAITHERSBURG, Md.--(BUSINESS WIRE)--Adaptive Phage Therapeutics, Inc. (“APT”), a clinical-stage biotechnology company dedicated to providing therapies to treat infectious diseases, today announced a newly-formed research collaboration with Oyster Point Pharma, Inc. (Nasdaq: OYST) for developing therapies, using APT’s PhageBank™ technology, potentially targeting multiple ophthalmic diseases.
APT’s PhageBank™ technology is an ever-expanding library of bactericidal agents, commonly referred to as bacteriophages (“phages”), that collectively provide poly-microbial coverage for bacterial infections. By continually adding phages to PhageBank™ for relevant bacterial threats, PhageBank™ addresses the emergence of resistance – the core issue that leads to the obsolescence of antimicrobials and the cause of the current crisis of anti-microbial resistance (AMR).
Under the terms of the collaboration agreement, Oyster Point Pharma has the option and certain rights to obtain an exclusive license for ophthalmic indications to PhageBank™ technology. Under the first license, if such option is exercised, Oyster Point Pharma has agreed to pay APT potential development and regulatory milestones, as well as the potential for sales-based milestones and tiered royalties of net sales, if a licensed phage therapy is approved by the U.S. Food and Drug Administration (FDA). APT retains production rights to PhageBank™ and will supply Oyster Point Pharma product on a cost-plus basis.
“We are excited to be partnering with Oyster Point Pharma, an innovation leader in therapeutics for the treatment of ocular surface disease, and working together to potentially bring new, much-needed therapies to a variety of unmet medical needs in the ophthalmic area,” said Greg Merril, APT’s CEO and co-founder. “The plan is to design these ophthalmic therapies as the first evergreen antimicrobials to potentially enter the ophthalmic market. As targeted bacterial pathogens develop resistance, APT plans to leverage its PhageBank™ technology to dynamically optimize each product for a given ophthalmic indication. Conceptually, this PhageBank™-based approach is similar to the advanced surveillance and antigen selection of annual flu vaccine. PhageBank™-based products also combine bacterial surveillance providing an ability to update product composition to better ensure continuing and optimized efficacy.”
“Antibiotic resistance of bacterial pathogens and antibiotic-resistant biofilm formation in the eye are serious and growing problems, made more acute by the possibility of blindness when patient infections cannot be effectively treated using conventional treatments,” said Jeffrey Nau, Ph.D. M.M.S., president and chief executive officer of Oyster Point. “By partnering with APT, we plan to utilize the innovative PhageBank™ technology to develop potential novel treatments for ophthalmic indications. Effective treatments are needed for bacterial infections today as well as antibiotic resistant eye disease that may develop in the future.”
Adaptive Phage Therapeutics, Inc.
Adaptive Phage Therapeutics (APT) is a clinical-stage company advancing therapies to treat antimicrobial resistant (AMR) infections. Prior antimicrobial therapeutic formulations have failed to adapt to evolving bacterial resistance, leading to product obsolesce and the clinical practice of antibiotic stewardship. APT’s PhageBank™ technology is engineered as an ever-expanding library of bactericidal agents, called bacteriophages (“phages”), to provide increasingly broad spectrum of bacterial coverage. PhageBank™ phages are matched through a proprietary PhageBank Susceptibility Test (PST) that APT has teamed with Mayo Clinic Laboratories to commercialize on a global scale. APT’s technology was originally developed by the biodefense program of U.S. Department of Defense. APT acquired the world-wide exclusive commercial rights in 2017. Under FDA emergency Investigational New Drug allowance, APT has provided investigational PhageBank™ therapy to treat more than 40 critically ill patients in which standard-of-care antibiotics had failed. For more information, visit http://www.aphage.com.
About Oyster Point Pharma
Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies to treat ophthalmic diseases. Oyster Point’s lead clinical program is focused on the development of OC-01 (varenicline) nasal spray, a highly selective cholinergic agonist being developed as a multidose preservative-free nasal spray to treat the signs and symptoms of dry eye disease and neurotrophic keratopathy. In December 2020, Oyster Point submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease. The Prescription Drug User Fee Act (PDUFA) target action date is October 17, 2021, with a planned U.S. launch of OC-01 (varenicline) nasal spray in the fourth quarter of 2021, if approved by the FDA. OC-01 (varenicline) nasal spray is an investigational new drug and has not been approved for any use in any country. The safety and efficacy of OC-01 (varenicline) nasal spray have not been established. In addition, Oyster Point is developing its proprietary Enriched Tear Film (ETF™) Gene Therapy. ETF™ is an adeno-associated virus (AAV)-based gene therapy approach where a target gene is delivered to human lacrimal gland cells via intralacrimal gland injection for the potential treatment of select ocular surface diseases. Rather than replacing a gene that is defective or missing, a new target gene is delivered that potentially may produce a selected naturally occurring protein, enzyme, or other therapeutic gene product. The goal for this target gene is to produce a selected gene product to change cell behavior and function on the ocular surface.
Forward-Looking Statements
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