PITTSBURGH – JANUARY 6, 2021 – Noveome Biotherapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, today announced the publication of preclinical results evaluating the neuroprotective properties of fractionated and unfractionated ST266 in the journal PLOS ONE.
The studies demonstrated that the complete ST266 secretome is required to obtain the full neuroprotective and myelin-protective effects in the experimental autoimmune encephalomyelitis (EAE) mouse model of optic neuritis. The research was conducted in the laboratory of Kenneth S. Shindler, MD, PhD, an associate professor of Ophthalmology and Neurology in the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.
“Noveome has shown that when ST266 is administered using the intranasal nose to brain route, it can attenuate visual dysfunction, prevent retinal ganglion cell loss, and reduce both inflammation and demyelination of optic nerves six weeks after induction of EAE in mice,” said Larry Brown, Sc.D., Noveome’s Chief Scientific Officer. “In this study, we wanted to determine how specific molecular weight protein ranges impact neuroprotective activity.”
The publication, entitled “Mechanism of Neuroprotection Mediated by ST266 Requires full Complement of Proteins Secreted by Amnion-derived Multipotent Progenitor Cells,” highlights the comparison of the neuroprotective and myelin-protective effects of two molecular weight ST266 fractions, a <30kDa fraction and a <50kDa fraction, and the full complement ST266 in the EAE model. The experiments evaluated retinal ganglion cell (RGC) survival in isolated retinas and assessed optic nerves for inflammation and demyelination. In addition, Schwann cell proliferation was evaluated in vitro.
The results demonstrated that the full complement of the ST266 secretome significantly improved RGC survival and reduced optic nerve demyelination in EAE mice. In contrast, the <50kDa molecular weight ST266 fraction significantly improved optic nerve demyelination, but only showed a trend towards improved RGC survival. Both the <30kDa and the <50kDa fractions increased Schwann cell proliferation in vitro but were less effective than full complement ST266. Demyelination attenuation was partially associated with the <50kDa fraction, but removal of higher molecular weight biomolecules from ST266 diminished its neuroprotective effects, suggesting at least some high molecular weight proteins play a role in ST266-mediated neuroprotection.
In all, the results support intranasal nose to brain and eye delivery of ST266 as a candidate neuroprotective therapy for optic neuritis. For more information about Noveome’s interest in optic neuritis and the other ophthalmological applications in its pipeline, visit www.noveome.com/pipeline.
About Noveome Biotherapeutics, Inc.
Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome’s multi-target platform biologic and lead product, ST266, is a complex, non-cellular product containing hundreds of biologically active proteins and other biologic factors. ST266 is currently being evaluated in multiple indications across ophthalmic, CNS and systemic inflammatory conditions. Topline data from an ongoing Phase 1 trial using a novel intranasal delivery method to deliver ST266 to the optic nerve and brain are expected later in 2020. A Phase 2 trial in persistent corneal epithelial defects (PEDs) is completed and results demonstrate ST266’s benefit in healing PEDs. Noveome is currently planning follow-up clinical studies to characterize the efficacy and safety of ST266 further for the treatment of PEDs and a Phase 1 study evaluating the safety of intravenously administered ST266 in COVID-19 patients. The Company received seed funding from Lancet Capital, a venture capital consortium of leading Pittsburgh healthcare institutions including UPMC Enterprises, Highmark Blue Cross/Blue Shield, University of Pittsburgh and Carnegie Mellon University. To date, Noveome has received over $120 million in research and infrastructure funding from the U.S. Department of Defense, the Commonwealth of Pennsylvania and Allegheny County. Noveome is based in Pittsburgh, PA. For more information, please visit Noveome.com.
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