Monday, March 06, 2023
Selagine, Inc., a spin-out company from the University of Illinois at Chicago (UIC), announced today that it has entered into a research, development and sublicense agreement with Grifols (Nasdaq: GRFS), a global leader in plasma-derived medicines, for the development and commercialization of immunoglobulin eye drops for dry eye disease.
An immunoglobulin eye drop is a biologic drug that contains naturally occurring functional antibodies generated from human plasma collected from thousands of healthy donors. These antibodies can neutralize inflammatory proteins such as Interferon-gamma, Interlukin-17 and matrix metalloproteinase-9 that are implicated in producing ocular surface disease in dry eyes. In a first-in-human pilot clinical trial, immunoglobulin eye drops twice a day for eight weeks caused significant reduction in signs and symptoms of dry eyes with no difference in tolerability or adverse events as compared to placebo. Initial developmental work for these antibody-based biologic eye drops was performed in the Department of Ophthalmology and Visual Sciences at the University of Illinois College of Medicine, supported by UI Health Pharmacy, and is the outcome of over a decade of research and development efforts, with grant funding from the National Eye Institute (NEI)/National Institutes of Health (NIH), Research to Prevent Blindness and UIC's Office of Technology Management.
Inflammatory proteins (cytokines or chemokines), cells (neutrophils, T-cells and dendritic cells), complement system components and pathogenic antibodies are present on the ocular surface in chronic dry eye disease; therefore several different mechanisms of inflammation are simultaneously active and contribute to symptoms and signs of dry eye disease. Immunoglobulins have beneficial actions on each of these mechanisms; thus providing broad-spectrum anti-inflammatory actions and potentially providing mechanistic superiority over currently approved therapies for chronic dry eye disease. The anti-inflammatory actions of eye drops that are currently approved for treating chronic dry eye disease are narrow-spectrum and limited primarily to targeting T-cell inflammatory mechanisms.
"This collaboration builds upon complementary expertise of the two companies to provide a clear pathway to completing development and regulatory activities and executing a successful commercial launch of immunoglobulin eye drops for chronic dry eye disease indication," said Sandeep Jain, MD, founder and president of Selagine and B.A. Field professor of ophthalmology at University of Illinois College of Medicine. "With its strategic commitment to ophthalmics and its global leadership in immunoglobulins, we believe Grifols provides an ideal partner for realizing Selagine's goal of developing the full potential of plasma protein-based eye drops across all ophthalmic indications." Dr. Jain was assisted in the startup and development of Selagine by Michael Flavin, PhD, a research professor in the Colleges of Medicine and Pharmacy at UIC and a staff member at the university's Discovery Partners Institute. "Dr. Jain is the perfect example of a physician scientist entrepreneur who is successfully commercializing his technology," said Dr. Flavin. "The UIC College of Medicine and the Discovery Partners Institute are supporting stellar faculty members in advancing their exciting, cutting-edge discoveries toward the marketplace."
"The ability for research discoveries at universities to become therapies for patients relies upon collaboration with biopharmaceutical companies," said Mark Rosenblatt MD, PhD, MBA, MHA, executive dean of the University of Illinois College of Medicine. "We are so delighted that this novel application of immunoglobulin eye drops to treat dry eye disease has resulted from Dr. Sandeep Jain's world-class and innovative research work. This new sublicense agreement between Selagine and Grifols will facilitate the continued development of this therapeutic to potentially help the millions of patients around the world suffering from dry eye disease."
Under the agreement, Selagine will receive an upfront payment and annual collaboration fee. In addition, Grifols has committed to fund the development of immunoglobulin eye drops through FDA approval, which will be managed collaboratively by Grifols and Selagine, including the clinical, manufacturing and regulatory activities required for FDA approval for dry eye disease indication. Upon commercialization, Selagine will receive tiered royalties on net sales and milestone payments upon achievement of certain annual sales thresholds. Selagine will share a part of the royalties with UIC. "Grifols is extremely pleased to drive ophthalmological innovation to help patients, combining our industry-leading knowledge of immunoglobulins with Selagine's life-changing research and therapeutics to treat eye diseases," said Víctor Grifols Deu, co-CEO of Grifols. "We look forward to a close working relationship that will deliver important breakthroughs."