PITTSBURGH – February 1, 2021 – Noveome Biotherapeutics, Inc., a clinical stage biopharmaceutical company focused on developing next-generation biologics for the restoration of cellular integrity of damaged tissues, has finalized a new Cooperative Research and Development Agreement (CRADA) with Walter Reed Army Institute of Research (WRAIR). The research will test Noveome’s lead product candidate, ST266, in animal models of closed traumatic brain injury (TBI).

 

The TBI models will utilize targeted intranasal nose-to-brain administration of ST266. The ultimate goals are to advance ST266 into human clinical trials of targeted intranasal administration for TBI. The preclinical research will be conducted in the laboratory of Deborah Shear, Ph.D., Branch Chief at WRAIR and is expected to continue for several years leading up to human clinical trials.

 

“We are excited to work with WRAIR on this project, which will build on our previous research using ST266 in a penetrating ballistic brain injury model,” said William Golden, Founder, Chairman and CEO of Noveome.

 

Noveome board member Ronald Poropatich, M.D., M.S. added, “Noveome and WRAIR are committed to developing immediate-use therapies for warfighters who suffer these types of traumatic injuries and this collaboration is vital to achieving that goal.”

 

About WRAIR

Around the world, WRAIR works alongside civilian researchers, medical professionals, and military personnel to develop and test products that will ultimately reduce the impact of some of the most dangerous and debilitating diseases. WRAIR provides unique research capabilities and innovative medical solutions to a range of Force Health Protection and Readiness challenges currently facing U.S. Service Members, along with threats anticipated during future operations.

 

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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Media Contact:

Erik Clausen

CG Life

781-608-7091

noveome@cglife.com

PITTSBURGH, PA – January 27, 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 that Larry Brown, Sc.D., Chief Scientific Officer, and David Steed, M.D., Chief Medical Officer, will present an update on its retinal and optic nerve disease clinical program at the Glaucoma Research Foundation’s 10^th Annual Glaucoma 360 Virtual Meeting. The pre-recorded presentation will take place on Saturday, January 30, 2021 during the New Horizon’s Forum and is scheduled for 9:27 AM – 10:07 AM P.T. (12:27 PM – 1:07 PM E.T.) with a live question and answer session. Advance registration is required. In addition, the pre-recorded video presentation is currently available on demand by visiting https://www.glaucoma360-2021.org/page/1704365/video-on-demand.

 

About the Retinal and Optic Nerve Disease Clinical Programs
Noveome’s multi-target platform biologic and lead product, ST266, is the first potential therapeutic focused on treating the underlying nerve degeneration that occurs in glaucoma through an innovative, non-invasive, targeted intranasal device to deliver ST266 directly to the retina and optic nerve by-passing the blood-brain barrier. Noveome is currently conducting a Phase 1 open-label clinical trial to establish the safety of ST266 by intranasal delivery. Thus far, no drug-related serious adverse events and no pattern of safety concerns have been observed. The trial is expected to be completed in Q1 2021.

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. In addition to the Phase 1 open label clinical trial to establish the safety of intranasal ST266 described above, Noveome has launched a program to test 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 in healing persistent corneal epithelial defects (PEDs) and is currently planning follow-up clinical studies to further characterize the efficacy and safety of ST266 for the treatment of PEDs. For more information, visit www.noveome.com.

 

 

###

 

Media Contact:

Erik Clausen

CG Life

781-608-7091

PITTSBURGH, PA – January 25, 2021 – 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 Ronald K. Poropatich, M.D., M.S., to the company’s Board of Directors.

 

Dr. Poropatich is an experienced Pulmonary/Critical Care Medicine physician-scientist who serves as the Director of the Center for Military Medicine Research (CMMR), Health Sciences and Professor of Medicine in the Division of Pulmonary, Allergy, and Critical Care Medicine at the University of Pittsburgh. The University of Pittsburgh CMMR has been instrumental in building collaborative multi-disciplinary and multi-organizational research teams to improve the health and well-being of service members, veterans and their families that has led to significant DoD medical research collaboration with the University of Pittsburgh . Dr. Poropatich has also been on the faculty at the Uniformed Services University of the Health Science (USUHS) since 1985 and currently serves as an Adjunct Professor of Medicine. Dr. Poropatich served 30 years on active duty in the U.S. Army retiring in 2012 at the rank of Colonel with extended assignments at the Walter Reed National Military Medical Center (1985 to 2012) and the US Army Medical Research and Development Command (2006-2012).

“We are delighted to welcome Dr. Poropatich to our Board of Directors. He brings a wealth of medical experience from both his long career in the U.S. Army as well as his post-military achievements at the University of Pittsburgh,” said William Golden, Founder, Chairman and CEO of Noveome.

 

Dr. Poropatich received his medical degree from Drexel University in 1985. He completed his internship and residency in Internal Medicine at Walter Reed in 1988 and his fellowships in Pulmonary and Critical Care Medicine at the Walter Reed in 1992. His career includes a strong clinical foundation coupled with managing large medical research programs and expansion of telemedicine across 22 time zones to meet the global Army medical need for peacetime and wartime settings.

 

“I’m excited to join the Noveome board, especially at this pivotal time in the company’s history. The vast potential of its multi-targeted secretome, ST266, in systemic inflammation is very compelling for a variety of clinical applications,” said Dr. Poropatich. “I look forward to working with the Noveome team to improve clinical outcomes in a range of complex diseases.”

 

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.

###

 

Media Contact:

Erik Clausen

CG Life

781-608-7091

noveome@cglife.com

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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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

PITTSBURGH – November 3, 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, announced that Larry Brown, Sc.D., the company’s Executive Vice President and Chief Scientific Officer, will present a talk entitled, “Neuroprotection by Intranasal ST266, an Amnion Multipotent Progenitor Cell-Derived Secretome” at the virtual 10^th Annual Traumatic Brain Injury Conference at 1:35 pm EST on November 03, 2020.

 

Dr. Brown will discuss the development of Noveome’s neuroprotective program which is evaluating intranasal “nose-to-brain” delivery of its novel platform biologic, ST266, to treat traumatic brain injury and optic nerve/retinal diseases and injuries. ST266 is a cGMP-produced secretome, secreted by proprietary Amnion-derived Multipotent Progenitor (AMP) cells. AMP cells are produced by culturing a select population of amnion-derived epithelial cells under proprietary conditions. This cell secretome is anti-inflammatory, neuroprotective, and anti-apoptotic. Noveome has demonstrated successful intranasal delivery of this secretome to the brain via the olfactory nerves. With evidence of neuroprotection in animal models, the program has now advanced into Phase 1 human trials using a targeted intranasal device to deliver ST266 directly to the brain and eye. This trial is being conducted at The University of Pennsylvania.

 

About ST266

ST266 is a cell-free platform biologic containing hundreds of proteins and other factors in physiologic levels that are involved in cellular healing, protection of the brain and nerves, and modulation of inflammation.  ST266 is the first potential therapeutic focused on treating the underlying nerve degeneration that occurs in glaucoma, optic nerve and retinal diseases and injuries using an innovative, non-invasive, targeted intranasal device to deliver ST266 directly to the optic nerve and eye, by-passing the blood-brain barrier. Noveome has multiple successful preclinical studies available for reference. Topline data from Noveome’s Phase 1 open-label clinical trial in Glaucoma Suspect patients are expected in the fourth quarter of 2020.

 

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. In addition to the Phase 1 trial described above, the company recently announced the results of a Phase 2 open-label clinical trial evaluating ST266 as a treatment for Persistent Corneal Epithelial Defects (PEDs). ST266 was found to be both safe and beneficial in treating PEDs. Additional clinical trials are being planned, including a Phase 2b PED trial and a Phase 2 wet Age-related Macular Degeneration trial. Noveome recently initiated a clinical program to evaluate the ability of ST266 to treat the severe inflammatory response called “cytokine storm” that occurs in some COVID-19 patients. This Phase 1 intravenous trial on COVID-19 patients is expected to begin in the first quarter of 2021. To date, Noveome has received over $160 million in research and infrastructure funding. Noveome is based in Pittsburgh, PA. For more information, please visit, www.noveome.com.

 

###

 

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

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.

 

###

 

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

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.

 

###

 

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

PITTSBURGH – August 31, 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, announced that Larry Brown, Sc.D., the company’s Executive Vice President and Chief Scientific Officer, will co-lead a workshop entitled, “Bypassing the BBB for More Effective Delivery to the Brain” at the digital Blood-Brain Barrier Summit on Monday August 31, 2020 at 1:00 PM – 3:00 PM EDT.

 

The workshop will provide an evaluation of intranasal and intrathecal delivery routes of drug administration for brain targeting. Dr. Brown will discuss Noveome’s targeted intranasal program, including preclinical research and how those data support clinical indications using this novel drug delivery approach. Noveome is currently conducting a Phase 1 trial using a targeted intranasal device to deliver its lead product candidate, ST266, directly to the brain and eye. This trial is being conducted at The University of Pennsylvania.

 

About ST266

ST266 is a cell-free platform biologic containing hundreds of proteins and other factors in physiologic levels that are involved in cellular healing, protection of the brain and nerves, and modulation of inflammation.  ST266 is the first potential therapeutic focused on treating the underlying nerve degeneration that occurs in glaucoma, optic nerve and retinal diseases and injuries using an innovative, non-invasive, targeted intranasal device to deliver ST266 directly to the optic nerve and eye, by-passing the blood-brain barrier. Noveome has multiple successful preclinical studies available for reference. Topline data from Noveome’s Phase 1 open-label clinical trial in Glaucoma Suspect patients are expected in the fourth quarter of 2020.

 

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. In addition to the Phase 1 trial described above, the company recently announced the results of a Phase 2 open-label clinical trial evaluating ST266 as a treatment for persistent Corneal Epithelial Defects (PEDs). ST266 was found to be both safe and beneficial in treating PEDs. Additional clinical trials for ophthalmological indications are being planned, including a Phase 2b PED trial and a Phase 2 wet Age-related Macular Degeneration trial. Noveome recently initiated a clinical program to evaluate the ability of ST266 to treat the severe inflammatory response called “cytokine storm” that occurs in some COVID-19 patients. This Phase 1 intravenous trial on COVID-19 patients is expected to begin in the first quarter of 2021. To date, Noveome has received over $160 million in research and infrastructure funding. Noveome is based in Pittsburgh, PA. For more information, please visit, www.noveome.com.

 

###

 

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 to conduct Phase 2b trial of ST266 in Persistent Corneal Epithelial Defects

 

PITTSBURGH—June 12, 2020—Noveome Biotherapeutics, Inc., a clinical stage biopharmaceutical company developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, today announced positive data from its Phase 2, multi-center, open-label clinical trial of ST266 in patients with persistent corneal epithelial defects (PEDs). These data were published today as an online presentation for the Association for Research in Vision and Ophthalmology (ARVO) 2020 Online Presentations and its associated platform, ARVOLearn.

 

“There remains a clear unmet need for patients suffering from PEDs as there is no gold standard for treating this condition. These non-healing wounds can lead to serious consequences such as infections and blindness, which makes identifying an effective treatment all the more critical,” said Lead Investigator Bennie H. Jeng, M.D., Chair of the Department of Ophthalmology and Visual Sciences at the University of Maryland School of Medicine. “While additional research is necessary to ensure the efficacy and safety of ST266 in treating PEDs, it is encouraging to see initial data that validate the potential for ST266 in this challenging condition.”

 

Corneal defects are classified as persistent when the defect has not healed within 14 days. There are many different causes of PEDs, and treatment varies depending on the etiology. As commonly used treatments such as autologous serum and amnionic membranes are not always successful, patients are at risk for permanent vision loss. Noveome’s Phase 2 multi-center, open-label clinical trial was designed to evaluate the safety and efficacy of topical delivery of ST266 in patients with PEDs. Each study eye received a total of four drops per day of ST266 over the course of 28 days.

 

At data cutoff for this analysis, 11 patients had been enrolled in the study. Of the 11 enrolled patients, 10 completed treatment. All 10 eyes demonstrated response to treatment by day 28 with significantly decreased size (p=0.001). Three eyes had complete healing during the 28-day treatment window. One of the three eyes with complete healing on day 21 had a re-opening on day 28; however, the PED was almost completely healed by day 35 of the study. The remaining 7 eyes all had smaller areas of defect compared with baseline. No drug-related serious adverse events (SAEs) were reported. One patient withdrew for reasons deemed unrelated to the trial or study drug.

 

These early results suggest that ST266 may be effective in healing PEDs that have been refractory to standard therapies. They are consistent with pre-clinical studies, in which ST266 treatment was associated with reduced inflammation, decreased neutrophil infiltration, and increased re-epithelization in a rabbit model for corneal incision and abrasion.

 

“Treating PEDs is just one of the many exciting uses we have identified for ST266, and it is promising to see this positive result. We will continue to advance this program alongside our diverse pipeline aimed at providing patients across multiple disease areas with safe and effective therapies,” said William Golden, Founder, Chairman and CEO of Noveome. “We look forward to further exploring ST266 for this indication in a Phase 2b masked, placebo-controlled trial in PEDs we are currently planning.”

 

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, PA, 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. In addition to the Phase 2 open-label clinical trial evaluating the efficacy of ST266 in healing persistent corneal epithelial defects (PEDs) reported here, 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 also currently planning follow-up clinical studies to characterize the efficacy and safety of ST266 further for the treatment of PEDs. 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

Singota Solutions, a pharmaceutical contract development and manufacturing organization, will manufacture Noveome’s lead candidate for Phase I / II clinical trials

 

Bloomington, IN (May 12, 2020)- Singota Solutions has been selected to collaborate with Noveome Biotherapeutics, Inc. to manufacture the ST266 investigational drug product, a biologic being evaluated in clinical studies for its potential treatment of the severe inflammatory reaction known as Cytokine Release Syndrome (CRS), also known as the Cytokine Storm, observed in COVID-19 patients.

 

Singota specializes in small batch aseptic filling of high-value injectable products into vial, syringe, and cartridge formats using the robotic Vanrx SA25 Aseptic Filling Workcell. Singota will manufacture Noveome’s ST266 to be used for IV infusion in Phase I and II clinical trials. In preclinical and clinical studies, ST266 has demonstrated significant anti-inflammatory activity, which could potentially be lifesaving for patients experiencing the often-fatal CRS, a severe and systemic complication of COVID-19 that causes multi-organ damage, especially to the lungs.

 

“We commit to working quickly, yet carefully to get our clients’ products out to patients,” said Laura Englander, Sr. Business Development and Marketing Manager. “Noveome has been a great partner for Singota. They have moved swiftly on the front-end, entrusting us to excel at our promise of adhering to their tight timeline to get this critical product ready for their patients.”

 

Singota will manufacture 30 mL vial fills of ST266 in June. This timeline helps Noveome in its accelerated efforts to treat patients in the clinic, which they are prepared to initiate immediately should the FDA approve its requested authorization to proceed with dosing.

 

In response to the collaboration, Alisa Kilgas, CEO at Singota stated, “We’re all in this together. Singota is proud to work with Noveome in the fight against the Coronavirus, especially to help the patients around the world, but also those close to home.”

 

“Noveome is aggressively pursuing our investigational drug ST266 as an important therapeutic in the treatment of patients experiencing one of the most serious and life-threatening conditions brought about by COVID19 infection. Singota’s application of isolators paired with single-use technologies uniquely positions them to establish GMP manufacturing in weeks as opposed to what would typically take several months. In addition to this enabling technology, the response and flexibility of the team at Singota has been exceptional in the rapid establishment of this collaboration,” said Kevin McCracken, Chief Operating Officer, Noveome Biotherapeutics, Inc.

 

For more information about our services, please contact: Laura Englander, Sr. Business Development and Marketing Manager – laura.englander@singota.com or 812.961.1752.

About Singota Solutions

Singota Solutions is a contract development and manufacturing organization focused on moving products through the development pipeline faster—with agility, accountability, and transparency. Founded in 2006, the company is a woman-owned business operating in Bloomington, Indiana. Singota’s gloveless, robotic aseptic filling service is ideally suited for the production of clinical and niche commercial injectable products in vial, syringe, and cartridges formats. Singota also provides customized solutions for formulation development, supply chain & materials management, analytical testing, and labeling & kitting services. For more information, please visit www.singota.com.

About Noveome® Biotherapeutics

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.  ST266 is currently being evaluated in multiple indications including a Phase 1 open label clinical trial to establish the safety of ST266 in intranasal transcribriform delivery from nose to brain and eye and a Phase 2 open-label clinical trial evaluating the efficacy of ST266 in healing persistent corneal epithelial defects (PEDs). For more information, visit www.noveome.com.