Agreement furthers study of intranasal delivery of ST266 for ophthalmology and brain-related conditions

PITTSBURGH – June 1, 2021, Noveome Biotherapeutics, Inc., Pittsburgh, PA and SipNose, Ltd., Yokneam, Israel, announced today that they have entered into a Commercial License Agreement (“Agreement”) for Noveome’s use of SipNose’s proprietary intranasal Cribriform Targeted Device (CT6) to deliver Noveome’s first-of-its-kind biologic, ST266 to the central nervous system (CNS). The two companies have been collaborating since 2015. This Agreement represents an important and significant step forward for both companies as they work together to develop promising therapies for patients in need.

The field of use includes intranasal delivery of ST266 in ophthalmological conditions and brain-related conditions. In addition to the license terms, the companies have agreed to terms for a supply agreement which is expected to be finalized before Phase 3 trials are initiated.

“Noveome and SipNose have established a great working relationship which has enabled a successful collaboration” said William J. Golden, Founder and Chairman of the Board at Noveome. “Noveome recently closed enrollment and completed the treatment phase of its Phase 1 safety study using the SipNose device to administer ST266 to Glaucoma Suspect patients. Safety analyses are underway and are expected to be announced soon. Once we have established the safety of ST266 by this novel route of administration, we plan to execute on the vast potential of our cell-free platform biologic in a variety of neurological and ophthalmological indications.”

“This Agreement represents a breakthrough in the area of non-invasive direct nose to brain delivery resulting from our intensive collaboration over the past 5 years” said Dr. Iris Shichor, Co-Founder and CEO at SipNose. “We are proud to collaborate with Noveome and to promote the use of their biologic ST266 with our proprietary delivery technology for the benefit of patients suffering from ophthalmological and neurological conditions.”

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About ST266
ST266 is a cell-free biologic containing hundreds of proteins and other factors involved in cellular healing, neuroprotection, and modulation of inflammation. ST266 is produced by collecting proteins and other factors secreted by a novel population of cells generated by a proprietary method of culturing amnion-derived epithelial cells collected from full term placentas which are normally discarded after birth. This secretome contains physiologic levels of multiple growth factors and cytokines and stimulates a variety of anti-inflammatory and neuroprotective responses in preclinical studies. In addition to ophthalmologic conditions, ST266 is being evaluated in CNS conditions, gastrointestinal conditions, and cytokine storm associated with COVID-19 infection. The ST266 platform biologic enables the use of a scalable manufacturing process to produce quantities for all indications, a drug master file has been submitted with the FDA, supporting all ST266 investigational new drug (IND) applications.

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 completed a Phase 2 open-label clinical trial that demonstrated the benefit ST266 had in healing persistent corneal epithelial defects (PEDs). In addition to the Phase 1 study mentioned above, the company has initiated a Phase 1 study evaluating the safety of intravenously administered ST266 in COVID-19 patients and is currently planning a follow-up clinical study to further characterize the efficacy and safety of ST266 for the treatment of PEDs. For more information, visit www.noveome.com.

About SipNose Cribriform Targeted Device
SipNose’s innovative Cribriform Targeted Device (CT6) represents a new generation of nasal delivery devices that utilize a unique combination of parameters to allow aerosolize drugs to be delivered to the cribriform area in the upper area of the nasal cavity. The outcome is highly reproducible dosing, high absorption of drug, the potential for higher efficacy, and an improved user experience.

About SipNose Ltd.
Based in Israel, SipNose is a clinical stage nasal delivery company that has developed an innovative Cribriform Targeted Device for non-invasive delivery of pharmaceuticals. SipNose is a leader in the challenging area of direct nose to brain administration. This technology bypasses the Blood-Brain Barrier that typically blocks delivery of about 98% of existing drugs and potentially all biologic drugs. The device platform allows for the delivery of a wide range of liquid formulations (ranging from low to high viscosity), as well as powders. For more information, visit www.sipnose.com.

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Media Contact:
Erik Clausen
CG Life for Noveome Biotherapeutics, Inc.
781-608-7091
noveome@cglife.com

• Appointment is Effective May 24, 2021
• Mr. Velis will continue his role on Noveome’s Board of Directors
• William J. Golden steps down as CEO, remains as Founder and Chairman of the Board of Directors

PITTSBURGH, PA – May 24, 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 announced that Christopher J. P. Velis has joined the Company as Chief Executive Officer. Mr. Velis was appointed to the Company’s Board of Directors in March 2021.
“We are thrilled to have Chris take on this additional role as our new CEO. His vast experience in innovative medical technologies will help guide Noveome as it continues to develop and commercialize its novel platform biologic, ST266,” said William Golden, Founder, Chairman and prior CEO of Noveome.

Mr. Velis added, “I’m proud to join Noveome as CEO. It’s a very innovative company with next generation therapeutic applications such as traumatic brain injury and COVID-19. I intend to apply my leadership experience to guide the Company, advance commercialization, and get therapies to patients in need as quickly and safely as possible.”

Mr. Velis, who has pioneered some of the most innovative medical technologies brought to market, brings extensive entrepreneurial and venture capital experience to Noveome. He is the Founder and Executive Chairman of Miraki Innovation, where he forecasts global health and medical challenges, uncovers innovative technologies and assembles teams of industry experts to build companies that solve these global problems. He brings a differentiated approach to venture investing through entrepreneurial science. Auris Health is one of several ventures founded, grown or brought to exit by Mr. Velis’ leadership. Chris has set the gold standard for motion preservation, regeneration of cartilage and soft tissue through the use of novel peptides, tissue regeneration using DNA pairs, and stem cell and PRP technologies for use in regenerative medicine. Throughout his 27-year career, Mr. Velis has also represented more than 150 medical device companies in a variety of business transactions. He is now focused on revolutionizing the way we battle infectious disease, greater advancements in surgical robotics, and bringing technologies that optimize human performance to the world.

Mr. Velis graduated from the University of Massachusetts Amherst with a Bachelor of Arts in Economics and earned a Master of Business from the Questrom School of Business at Boston University. He has given talks at the Hamlyn Symposium on Medical Robotics, China’s Global Innovation and Entrepreneurship Fair, the U.A.E.’s Innovation Week, Massachusetts General Hospital’s Biotech Funding Panel, LSI’s Emerging MedTech Summit, and Harvard University’s Medical and Kennedy Schools. He has been featured on NBC10, the Wall Street Journal, Boston Business Journal and PE Hub. Companies he has founded have won numerous awards including MedTech Insight Award for Best Technological Innovation, CNBC Disrupter 50, Acquisition International Finance Award for Best Medical Technology VC Firm and Corporate LiveWire M&A Award for Health & Medical Technology Consultancy of the Year.

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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 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. The
company is actively planning a follow-up clinical study to further characterize the efficacy and safety of ST266 for the treatment of PEDs and has initiated 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 for Noveome Biotherapeutics, Inc.
781-608-7091
noveome@cglife.com

PITTSBURGH, PA – March 8, 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 Christopher J. P. Velis to the company’s Board of Directors.

Mr. Velis is an entrepreneur and venture capitalist who has pioneered some of the most innovative medical technologies brought to market in the last decades. As Founder and Executive Chairman of Miraki Innovation, he forecasts imminent global health and medical challenges, uncovers technologies at leading research institutions and assembles teams of industry experts to solve these global problems. Mr. Velis not only offers investment guidance and critical research and industry connections, but also helps guide each portfolio company along the fund’s proven, repeatable process that reduces new venture risk and enhances returns.

Auris Health, recognized by CNBC as one of the 50 most disruptive companies in the world, is one of a number of ventures founded, grown or brought to exit by Mr. Velis. Companies Mr. Velis has worked on have set the industry gold standard for motion preservation, regeneration of cartilage and soft tissue through the use of novel peptides, tissue regeneration using DNA pairs, and stem cell and PRP technologies for use in regenerative medicine. Throughout his 27-year career, Mr. Velis has also represented more than 150 medical device companies in a variety of business transactions including licensing agreements, joint ventures and M&A.

Mr. Velis has spoken at the Hamlyn Symposium on Medical Robotics, China’s Global Innovation and Entrepreneurship Fair, the U.A.E.’s Innovation Week, Massachusetts General Hospital’s Biotech Funding Panel and Harvard University’s Medical and Kennedy Schools. In 2016, Mr. Velis was honored by the U.A.E.’s Ministry of Health for his commitment to bringing medtech innovation to Middle East and North Africa. He graduated from the University of Massachusetts Amherst with a Bachelor of Arts in Economics and earned a Master of Business from the Questrom School of Business at Boston University.

“We are delighted to welcome Chris to our Board of Directors. His vast entrepreneurial and venture capitalist experience in innovative medical technologies will provide significant value to Noveome,” said William Golden, Founder, Chairman and CEO of Noveome.

Mr. Velis added, “I’m excited to join the Noveome board and look forward to helping the company move toward commercialization of its novel biologic ST266.”

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 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. The company is currently planning a follow-up clinical study to further characterize the efficacy and safety of ST266 for the treatment of PEDs and is about to begin 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 for Noveome Biotherapeutics, Inc.
781-608-7091
noveome@cglife.com

 

PITTSBURGH, PA – February 22, 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 that Larry Brown, Sc.D., Executive Vice President and Chief Scientific Officer at Noveome, will host a live presentation during the 9^th Annual Virtual Neurodegenerative Drug Development Summit, entitled, “Exploring Cellular Approaches to Neurodegenerative Drug Discovery. ” The live presentation will take place Wednesday, February 24, 2021 at 5:00PM EDT.

Dr. Brown will present the evolution of Noveome’s neuroprotection research and development program from “cell therapy to secretome”. His presentation will include neuro-repair data in acute CNS injury and chronic nerve inflammation. The studies examined various routes of administration ranging from direct intracranial, intravenous and intraperitoneal delivery of AMP cells to non-invasive targeted intranasal delivery of Noveome’s proprietary ST266 secretome. The path for translation into the clinical will also be discussed.

 

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 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. In addition to the Phase 2 trial described above, 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 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. For more information, visit www.noveome.com.

 

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Media Contact:

Erik Clausen

CG Life for Noveome Biotherapoeutics, Inc.

781-608-7091

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.

 

 

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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.

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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.

 

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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, 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