Abeona Therapeutics Provides Update on SDF(TM) (Salt Diafiltration) Plasma Fractionation Products

Abeona Therapeutics, Inc.

, a biopharmaceutical company focused on developing and delivering gene therapy and plasma-based products for severe and life-threatening rare diseases, today provided an update on the development of its proprietary SDFâ„¢ (salt diafiltration) process of extracting and purifying plasma proteins from human plasma. Through the first of two planned contract manufacturers, Abeona has run multiple batches of its two-step salt precipitation process and confirmed that resultant SDF fractions contain significantly enhanced levels of alpha-1 protease inhibitor and immunoglobulins (IVIG) when compared with the industry-standard Cohn process. The Company is also analyzing the process to identify ultra-orphan proteins for which the SDF process can be further optimized, and has initiated a program to finalize the downstream purification process for SDF IVIG. Preliminary analysis of SDF starting fractions indicates the process should be beneficial for the isolation of a number of ultra-orphan proteins, including plasminogen, fibrinogen, Factor H and von Willebrand's factor, among others. Additionally the Company confirmed that it will be seeking a meeting with the FDA to discuss further development and a clinical pathway for its SDF protein products. "We are pleased with the progress to date on the development of the SDF plasma process, and can confirm that the process is very efficient at fractioning plasma to provide high levels of PTB-101 SDF Alphaâ„¢ (alpha1-proteinase inhibitor) for inherited COPD; and PTB-201 SDF IVIGâ„¢ (intravenous immunoglobulin) for autoimmune, infectious, and idiopathic diseases," stated Jeffrey Davis, Chief Operating Officer. "While continuing to optimize downstream steps, we have initiated a program to confirm chromatography steps for our IVIG product, and continue to analyze the SDF fractions to identify ultra-orphan protein products for which our process is particularly well-suited." "With continued expansion of clinical indications for these proteins, and the potential for new proteins to be extracted and purified, the human plasma protein market remains a high growth opportunity both here and abroad," stated David Nowotnik, Ph.D., Senior Vice President, Research and Development. "We are excited about the opportunity to continue development of our SDF process, and continue to work with our consultants and contract manufacturing partner to evaluate opportunities in this dynamic market." About Plasma Proteins: The global market for drugs derived from human blood plasma fractionation is currently greater than US$15 billion, and is growing at a rate close to 10% annually. ABEO has developed and patented a new extraction process for plasma biologics that may fundamentally change the economics of blood plasma fractionation, and may make possible the extraction of several additional therapeutically useful plasma proteins. The Company believes that Abeona's proprietary fractionation process is expected to significantly enhance yields of key value blood proteins, including alpha-1 antitrypsin, expanding market opportunities while enhancing margins. The Company obtained rights to utilize and sub license to other pharmaceuticals firms, the recently patented improved methods for the extraction of therapeutic biologics from human plasma. The ability to extract several additional therapeutically useful and important proteins, due to the process being less destructive than historical fractionation processes, may enable the Company to seek new therapeutic applications and address ultra-orphan indications.