Noveome Biotherapeutics, Inc. Announces New Appointments to its Board of Directors

PITTSBURGH, PA – October 22, 2020 – Noveome Biotherapeutics, Inc., a clinical stage biopharmaceutical company focused on developing next-generation biologics for the restoration of cellular integrity of damaged tissues, has appointed M. Michelle Berrey, M.D., M.P.H. and Annamaria T. Kausz, M.D., M.S. as members of the company’s Board of Directors.

 

“We are delighted to welcome Drs. Berrey and Kausz to our Board of Directors. Each brings a wealth of expertise in medical and regulatory strategy, drug development, commercialization and corporate financing,” said William Golden, Founder, Chairman and CEO of Noveome.

 

“Both Drs. Berrey and Kausz are joining Noveome at a crucial time as we continue our work to advance ST266 for the treatment of ophthalmology indications including persistent corneal epithelial defects, and  systemic inflammation including the cytokine storm often seen in COVID-19.”

 

Dr. Berrey has over 25 years of combined industry and clinical experience. She is a seasoned industry executive with a proven track record in first-in-class therapeutics targeting viral diseases. Currently, Dr. Berrey serves on the Scientific Advisory Board for ViiV/GSK, and is on the Executive Committee and Board of the NC Biotechnology Center. Dr. Berrey was most recently president and CEO at Chimerix (NASDAQ: CMRX) and previously served as Chief Medical Officer at Pharmasset (acquired by Gilead Sciences (NASDAQ : GILD) and Vice President of Clinical Development for Antivirals and Metabolic Diseases at GlaxoSmithKline (LSE/NYSE: GSK). Throughout her career she has focused on diseases threatening the most immunocompromised patient populations. Dr. Berrey holds an M.P.H. from Emory University and an M.D. from the Medical College of Georgia.

 

“It’s exciting to join the Board of a company like Noveome, rooted in novel science that is unlocking the vast potential of a multi-targeted secretome such as ST266,” said Dr. Berrey. “I look forward to working together with the Noveome management team as we aim to improve clinical outcomes in a range of complex diseases.”

 

Dr. Kausz brings 14 years of experience in drug development and regulatory strategy across several disease areas and all phases of development, including post-marketing. She led the successful filing of two new drug approvals in the U.S. and E.U for renal and metabolic indications, and supported their commercial launch in the U.S. Dr. Kausz is currently the Chief Medical Officer of Allena Pharmaceuticals (NASDAQ: ALNA), where she was instrumental in securing agreement with the FDA on an accelerated approval strategy for a novel indication using a novel endpoint, led several clinical trials, and supported financing activities. Dr. Kausz also serves on the Board of Directors for the Kidney Health Initiative (KHI). She previously held various clinical development roles at EMD-Serono, Keryx, Reata, and AMAG. Dr. Kausz has an M.D. from the University of Virginia and an M.S. in Epidemiology with a concentration in Biostatistics from the University of Washington.

 

“It is an honor to join the Noveome Board and I look forward to working with leadership on regulatory strategy, evaluation of indication expansion and business development opportunities,” said Dr. Kausz. “ST266 has exciting potential to address the challenges of severe inflammatory responses that can occur in a wide range of indications, and I am eager to help advance Noveome’s programs.”

 

About ST266

ST266 is a cell-free biologic made by culturing a novel population of human amnion-derived cells. Through a proprietary culturing method, these cells produce an array of growth factors and cytokines, known as the secretome, which promote cellular survival and reduce inflammation.

 

About Noveome Biotherapeutics, Inc.

Based in Pittsburgh, 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 has launched a program to test its novel platform biologic, ST266, as a treatment for the severe inflammatory response seen in COVID-19 infection as well as the post-COVID-19 symptoms experienced by many COVID-19 patients. Noveome has completed a Phase 2 open-label clinical trial that demonstrated the benefit ST266 had in healing persistent corneal epithelial defects (PEDs). ST266 is also being evaluated in a Phase 1 open label clinical trial to establish the safety of ST266 in intranasal transcribriform delivery from nose to brain and eye. 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. For more information, visit www.noveome.com.

 

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Investor Contact:

Julie Seidel

Stern Investor Relations, Inc.

212-362-1200

julie.seidel@sternir.com

 

Media Contact:

Erik Clausen

CG Life

781-608-7091

noveome@cglife.com

Noveome Biotherapeutics, Inc. Announces Publication of Preclinical Results Demonstrating the Neuroprotective Properties of Amnion-derived Multipotent Progenitor Cells in Spinal Cord and Retinal Ganglion Cells

PITTSBURGH, PA October 21, 2020 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 for Amnion-derived Multipotent Progenitor Cells (AMP cells) in the journal Neurotherapeutics. These new, peer-reviewed results demonstrate, for the first time, the neuroprotective properties of systemically delivered AMP cells in mice with experimental autoimmune encephalomyelitis (EAE)-induced experimental optic neuritis (ON) and myelitis. The studies were conducted in the laboratory of Kenneth S. Shindler, MD, PhD, an associate professor of Ophthalmology and Neurology at the University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA.

 

The publication, entitled “Amnion-derived Multipotent Progenitor Cells Suppress Experimental Optic Neuritis and Myelitis,” details the neuroprotective effects of intravenous (IV) or intraperitoneal (IP) injected AMP cells, a novel population of cells produced by the proprietary culturing of cells selected from the amnion of a placenta, using different treatment regimens in the ON and myelitis mouse model. In these studies, AMP cell dosing was either a 1X dose of 2 x 106 cells/200µl vehicle on day 9 post-immunization or a 3X dose 1 x 106 cells/200µl vehicle on days 9, 12 and 15 post-immunization. Controls received 200µL vehicle on the same dosing schedule. All mice were sacrificed on day 42 post-immunization, and optic nerves and spinal cords were collected for analyses.

 

“Noveome’s previous studies have shown that a single daily dose of ST266, the secretome which is produced by the AMP cell during culturing, administered through the nose, attenuated visual dysfunction, prevented retinal ganglion cell loss, and reduced both inflammation and demyelination 6 weeks after induction of EAE,” said Larry Brown, Sc.D., Noveome’s Chief Scientific Officer. “In this study, we wanted to see if systemically administered AMP cells could have a similar effect. The hypothesis was that the cells would continue to secrete the secretome in vivo, thus acting like a delivery system.”

 

IV and IP administration of AMP cells significantly reduced ascending paralysis and attenuated visual dysfunction in EAE mice. Histological analysis revealed a statistically significant decrease in spinal cord demyelination and a trend towards decreased inflammation scores. In the optic nerves, all AMP cell treatments demonstrated a statistically significant decrease in inflammation and reduced demyelination. Both the IV and IP 3X dose significantly attenuated visual dysfunction. The 1X IP dose showed a trend in attenuating visual dysfunction, but it was not statistically significant. Protective effects of systemically administered AMP cells suggest they may serve as a potential novel treatment for multiple sclerosis.

 

“We are pleased to see these preclinical results for the treatment of damaged optic nerves and spinal cord myelitis using systemically administered AMP cells. These results further demonstrate the potential of our novel cell-free platform biologic ST266, the AMP cell secretome containing multiple growth factors and anti-inflammatory cytokines, to achieve neuroprotective benefits in systemically delivered treatment regimens,” said William J. Golden, Founder, Chairman and Chief Executive Officer of Noveome.

 

Disclosure: Dr. Shindler serves as a consultant for Noveome and as such has received consulting fees and honoraria payments.

 

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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Investor Contact:

Julie Seidel

Stern Investor Relations, Inc.

212-362-1200

julie.seidel@sternir.com

 

Media Contact:

Erik Clausen

CG Life

781-608-7091

noveome@cglife.com