SCOTTSDALE, Ariz., Oct. 06, 2026 (GLOBE NEWSWIRE) — Applied Biologics, LLC today announced the successful manufacture of the first recombinant reference protein for APPB-515, the Company’s investigational gene therapy program for osteoarthritis. The milestone establishes important manufacturing capabilities for the program and enables Applied Biologics to advance the next stage of its proprietary protein engineering and lead development efforts.
APPB-515 is being developed as a locally administered gene therapy designed to provide sustained expression of therapeutic proteins within the joint. The program combines computational protein engineering, molecular biology, gene delivery and functional characterization with the goal of developing a disease-modifying approach to osteoarthritis.
The successful manufacturing run establishes a reproducible process for expression, purification and production of the program’s reference protein. Applied Biologics intends to use the established process as the foundation for manufacturing a series of proprietary engineered protein candidates generated through the Company’s computational and protein engineering efforts.
“This is an important transition point for APPB-515,” said Edward Britt, Chief Executive Officer of Applied Biologics. “We have moved from computational design and protein engineering into manufacturing and experimental evaluation of physical drug candidates. Establishing the ability to reproducibly manufacture our reference protein gives us the foundation to produce and evaluate the proprietary engineered candidates that will ultimately drive lead selection for the program.”
In parallel with the manufacturing work, Applied Biologics has established analytical and functional capabilities to support comparative evaluation and continued optimization of APPB-515 candidates. Together, these capabilities provide an integrated development platform through which computationally designed candidates can be manufactured, characterized and experimentally evaluated before advancement into subsequent human-cell and in vivo studies.
“The ability to connect computational design with protein production and functional evaluation is an important part of building a disciplined therapeutic development program,” said Joydeep Basu, Ph.D., Director of Research and Development at Applied Biologics. “With the reference protein successfully manufactured and our evaluation capabilities coming online, we can begin systematically translating our engineering work into experimentally validated candidates and use those data to guide the next stages of APPB-515 development.”
Osteoarthritis is a progressive degenerative joint disease characterized by deterioration of articular cartilage, inflammation and changes throughout the joint. APPB-515 is designed to address multiple biological processes associated with disease progression through sustained, localized therapeutic activity. Applied Biologics expects to advance its engineered protein candidates through its established manufacturing and evaluation platform as it works toward lead selection.
“APPB-515 represents the type of program we are building Applied Biologics to pursue,” Britt added. “We are bringing together computational engineering, biologic development, manufacturing and gene delivery within a single development strategy. This milestone is meaningful because it demonstrates that the program is moving from design into execution.”
About Applied Biologics
Applied Biologics is a biopharmaceutical company advancing novel therapies for serious diseases with significant unmet medical needs.
The Company combines commercial-stage advanced wound care technologies with a growing pipeline of investigational biologic and gene therapy programs, including BIOxHEAL™, currently in Phase 3 clinical development for chronic wounds, and preclinical programs focused on degenerative diseases.
Applied Biologics continues to invest in rigorous clinical research, pharmaceutical-quality manufacturing, computational and protein engineering, gene delivery technologies, and scientific innovation.
Forward-Looking Statements
This press release contains forward-looking statements regarding APPB-515, protein engineering, gene therapy development, manufacturing activities, lead candidate selection, preclinical research, human-cell studies, in vivo studies, regulatory development and future business prospects. APPB-515 is an investigational preclinical program and has not been approved by the U.S. Food and Drug Administration. Forward-looking statements are subject to scientific, regulatory, operational and other risks and uncertainties, and actual results may differ materially from those expressed or implied.
MEDIA CONTACT: Molly Murphy Executive Assistant Applied Biologics, LLC molly.murphy@appliedbiologics.com
