?? Cytonics Announces Initiation Of First-In-Human Phase 1 Clinical Study For CYT-108 In Patients Suffering From Osteoarthritis Of The Knee

by Joey Bose and Gaetano Scuderi, MD

Jupiter, FL, January 15, 2024 (PRNewswire) – Cytonics Corporation, a private biotechnology company developing biologic therapies for musculoskeletal ailments, today announced initiation of enrollment for it Phase 1 clinical study of CYT-108, a recombinant variant of the alpha-2-macroglobulin blood serum protein, targeting proteases responsible for cartilage degradation in osteoarthritis (OA). CYT-108 was engineered for increased protease-inhibition activity against the major classes of proteases that are responsible for the majority of cartilage catabolism in arthritic joints, while maintaining its broad-spectrum anti-protease activity against serine and threonine proteases.

“Our first-in-human clinical trial is the culmination of 6 years of preclinical R&D, during which we overcame many technical challenges in developing our recombinant A2M variant, CYT-108,” said Joey Bose, President & CEO of Cytonics. “The massive size of the engineered protein (720kD) and complex folding structure made GMP production a scientific feat, and the ingenuity and experience of Lewis Hanna, PhD, our Chief Scientific Officer allowed us to surmount this incredible technical challenge. The preclinical data is compelling, demonstrating signs of CYT-108’s protective capabilities not only in the cartilage tissue, but in multiple other joint physiologies that are involved in the pathogenesis of osteoarthritis. Furthermore, we believe that the development of CYT-108 is de-risked by the clinical and commercial success of our first-generation OA therapy, the Autologous Protease Inhibitor Concentrate (APIC) medical device, which has treated over 8,000 patients using autologous A2M selectively concentrated from their own blood.”

~ Joey Bose, President & CEO of Cytonics

The Phase 1 study is designed to assess CYT-108’s tolerability and efficacy in patients suffering from primary osteoarthritis of the knee. A single dose of the drug will be administered intra-articularly at two timepoints, 90 days apart. Patients will be monitored every few weeks for an additional 90 days to evaluate safety, pharmacokinetics, and efficacy in reducing joint pain, stiffness, and mobility limitations.?

About CYT-108

CYT-108 is a recombinant variant of the endogenous alpha-2-macroglobulin (A2M) blood serum protein. The “bait” region of the protein, which serves as a substrate for proteases, was engineered to increase its affinity for specific proteases that are known to play a significant role in the molecular pathogenesis of osteoarthritis. The combination of both highly specific and broad-spectrum protease inhibition activity of CYT-108 differentiates this novel biologic from other attempts to develop small molecule inhibitors that target single proteases, positioning CYT-108 as an ideal disease-modifying candidate for osteoarthritis. The development of CYT-108 is predicated on the success of Cytonics’ first-generation therapy, the Autologous Protease Inhibitor Concentrate (APIC) system, which is a 510(k) medical device that selectively enriches autologous A2M for intra-articular injection into joints containing articular cartilage (knee, shoulder, spine, hip, etc.). The clinical and commercial success of APIC uniquely de-risks the development of CYT-108 because it is already understood that high concentrations of A2M can be introduced into arthritic joints without significant side effects, and the treatment has achieved clinical and commercial success since it was first cleared by the FDA as a 510(k) device and sold in 2015.

About Cytonics Corp.

Cytonics, founded in 2006, is a private research and development company focused on developing molecular diagnostics and therapeutics for chronic musculoskeletal diseases such as osteoarthritis. The company’s flagship product was a diagnostic test (the Fibronectin-Aggrecan Complex Test, FACT) which helps identify the source of joint pain and assists physicians in determining the most appropriate course of treatment. Cytonics then developed the Autologous Platelet-Integrated Concentrate (APIC) system which concentrates a therapeutic blood protein, A2M, from patients’ own blood and injects the A2M-rich concentrate into damaged joints. APIC has been used to treat over 8,000 patients nationwide, saving thousands of patients from invasive joint replacement surgeries. The company has raised over $25M in private funding and was awarded $1.8M in grants from the NIH to pursue their innovative research. The company is currently pursuing Phase 1 clinical studies for their lead drug candidate, CYT-108, a recombinant variant of the endogenous alpha-2-macroglobuling protease inhibitor. If approved, CYT-108 may be the first and only disease-modifying therapy for osteoarthritis.

Forward Looking Statements

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the progress of and plans related to the Company’s product candidates, clinical studies and preclinical research and development programs, the therapeutic and market potential of the Company’s research and development programs and product candidates, the Company’s clinical and product development strategy, and the Company’s expectations regarding progress and timelines. These and any other forward-looking statements in this release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s research and development programs and product candidates may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, and the risk that the Company may incur operating expenses in amounts greater than anticipated. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Cytonics Corporation is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Contact

Joey Bose, President and CEO

[email protected]

443-827-8135