Methods utilize the Company’s proprietary biologic ST266 to treat increased vascular permeability caused by non-infectious diseases including SIRS, GVHD, and ARDS

PITTSBURGH—November 20, 2024—Noveome Biotherapeutics, Inc., is a clinical stage Pittsburgh-based biopharmaceutical company focused on developing next-generation biologics for the treatment of conditions involving abnormal inflammatory responses. These conditions are varied and include systemic inflammatory response syndrome (SIRS), graft-versus-host disease (GVHD), acute respiratory distress syndrome (ARDS), and rare conditions including necrotizing enterocolitis (NEC), an often-fatal condition in premature infants.

“This patent underscores our ongoing efforts to push the boundaries of innovation and highlights Noveome’s commitment to advancing its understanding of the therapeutic possibilities of ST266” stated Patrick Welch, CEO of Noveome.

We believe that this patent captures the essence of  ST266’s (formerly termed ACCS) ability to attenuate inflammation caused by numerous stimuli.” said Dr. Larry Brown, Chief Scientific Officer of Noveome.

About ST266

ST266 is a cell-free sterile biologic solution containing hundreds of proteins and other factors at physiologic levels. It is made by culturing a novel population of human amnion-derived cells. Using a proprietary culturing method, these cells produce a unique array of growth factors and cytokines, known as the secretome, which promote cellular survival and reduce inflammation. Extensive preclinical studies have shown that ST266’s multiple components result in a variety of anti-inflammatory and neuroprotective responses. A drug master file has been submitted to the FDA, supporting all ST266 investigational new drug (IND) applications.

About Increased Vascular Permeability

Vascular permeability, often in the form of capillary permeability or microvascular permeability, characterizes the capacity of a blood vessel wall to allow for the flow of small molecules, large molecules or even whole cells in and out of the blood vessel. A single layer of endothelial cells, called endothelium, line the blood vessel walls and the heart chambers. Gaps located between endothelial cells open and close depending on the type and physiological state of the tissue.

There are many triggers for increased vascular permeability. For example, an increase in vascular permeability occurs at the very beginning of the inflammatory response. The inflammatory response is initially triggered by agents which activate endothelial cell receptors promoting endothelial cell retraction and gap junction disorganization, leading to gap formation between the endothelial cells. This results in leakage of macromolecules from the blood into injured tissue causing edema formation. Multiple pathways, transcription factors and paracrine signaling are often involved in the inflammatory response including MAPK, PI3K, NF-κB, TNFα, TLR4, IL-6, and others. Inflammation results in increased vascular permeability. Rather than targeting a single pathway, Noveome’s ST266 secretome simultaneously targets each of these pathways to attenuate the inflammatory response,” said Dr. Larry Brown, Chief Scientific Officer of Noveome.

About Noveome Biotherapeutics, Inc.

Based in Pittsburgh, Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for a wide range of indications including for the treatment of rare pediatric diseases with high morbidity and mortality. Noveome has completed a Phase 2 open-label clinical trial that demonstrated the benefit ST266 had in healing persistent corneal epithelial defects (PEDs). ST266 also completed a Phase 1 open-label clinical trial establishing the safety of ST266 in intranasal transcribriform delivery from nose-to-brain and eye, and a Phase 1 clinical trial establishing the safety of intravenously administered ST266 in COVID-19 patients. Noveome recently disclosed the safe administration of ST266 to a premature infant diagnosed with necrotizing enterocolitis as part of its Phase 1/2 clinical trial. For more information, visit www.noveome.com.

 

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any offer, solicitation or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.  Noveome Biotherapeutics does not respond to investment inquiries from persons who do not have a pre-existing relationship with Noveome Biotherapeutics or its agents.

PITTSBURGH—November 14, 2024—Noveome Biotherapeutics, Inc., a clinical stage Pittsburgh-based biopharmaceutical company focused on developing next-generation biologics for the treatment of rare pediatric diseases with high morbidity and mortality, today announced that it has completed treatment of the first baby in its Phase 1-2 clinical trial evaluating the safety and efficacy of its novel biologic ST266 in Necrotizing Enterocolitis (NEC).

The NEC Bell Stage 2a-diagnosed baby completed 10 days of treatment, as well as the required 2-week and 1-month post-treatment follow-up visits. The ST266 infusion was well tolerated, with no vital sign irregularities during or after treatment, no infusion site reactions, no systemic adverse reactions and no adverse effects related to the treatment. Following a 1-month post treatment follow-up visit, the Data Safety Monitoring Board (DSMB), composed of three board-certified neonatologists and one biostatistician independent of the study, reviewed all the data. The DSMB reported that the study may continue without modification.

 

Provided no safety issues arise after each of the first three babies are dosed and following a one month waiting period, all six sites in the study will be able to simultaneously enroll to accelerate the speed of recruitment. The clinical trial is expected to enroll approximately 36 babies diagnosed with NEC. 24 babies will be randomized to receive ST266 in addition to standard of care and 12 will be randomized to receive standard of care only. NEC-diagnosed babies in the treatment group will be treated with intravenously administered ST266 once daily for 10 days. Key endpoints are intended to demonstrate safety and tolerability as well as to assess preliminary efficacy by evaluating clinical outcomes such as time to resolution of pneumatosis, time to return to full feeding, reduction of surgical intervention, and effect on long term neurodevelopment outcomes.

 

“NEC is an often-fatal inflammatory gastrointestinal disease that can develop in premature infants,” said Dr. Karin Potoka, Chief Medical Officer of Noveome. “There are currently no pharmacological therapies approved specifically for the treatment of NEC, making it a major unmet need globally.”

“We are excited with our very preliminary NEC safety results and look forward to enrolling more babies at all of the study sites. We are also pleased with other important progress made across numerous business functions in support of future Noveome commercialization goals.” said Pat Welch, Noveome CEO.

About ST266

ST266 is a cell-free sterile biologic solution containing hundreds of proteins and other factors at physiologic levels. It is made by culturing a novel population of human amnion-derived cells. Using a proprietary culturing method, these cells produce a unique array of growth factors and cytokines, known as the secretome, which promote cellular survival and reduce inflammation. Extensive preclinical studies have shown that ST266’s multiple components result in a variety of anti-inflammatory and neuroprotective responses. A drug master file has been submitted to the FDA, supporting all ST266 investigational new drug (IND) applications.

About Necrotizing Enterocolitis

Necrotizing Enterocolitis (NEC) is a devastating disease caused by infection and inflammation of the intestines observed primarily in premature and very low birth weight babies (VLBWB). The localized inflammation can result in loss of bowel wall integrity and overwhelming sepsis which quickly becomes a medical emergency and often requires surgery as a life-saving measure. Necrotizing enterocolitis affects 2% to 10% of all premature infants worldwide. Currently, one baby in the US dies every day from NEC. Treating and managing premature infants with NEC is responsible for over $5 billion annually in Neonatal Intensive Care Unit (NICU) expenditures in the United States.  Babies that do survive can be left with life-long intestinal complications and a significant proportion of babies have neurodevelopmental delays including cognitive, visual, and motor impairments.

About Noveome Biotherapeutics, Inc.

Based in Pittsburgh, Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for a wide range of indications including for the treatment of rare pediatric diseases with high morbidity and mortality. Noveome has completed a Phase 2 open-label clinical trial that demonstrated the benefit ST266 had in healing persistent corneal epithelial defects (PEDs). ST266 also completed a Phase 1 open-label clinical trial establishing the safety of ST266 in intranasal transcribriform delivery from nose-to-brain and eye, and a Phase 1 clinical trial establishing the safety of intravenously administered ST266 in COVID-19 patients. The FDA has previously granted both Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) to ST266 for the treatment of NEC. For more information, visit www.noveome.com.

 

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any offer, solicitation or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.  Noveome Biotherapeutics does not respond to investment inquiries from persons who do not have a pre-existing relationship with Noveome Biotherapeutics or its agents.

In connection with the FDA notification, Noveome anticipates a closing on at least an additional $13.5 million of Series E convertible preferred stock financing

 

PITTSBURGH, PA, UNITED STATES, December 11, 2023 /EINPresswire.com/ — Noveome Biotherapeutics, Inc. Receives FDA Notification to Proceed with its Phase 1-2 Clinical Trial Evaluating ST266 in the Treatment of Necrotizing Enterocolitis in Premature Infants

Pre-clinical results suggest that ST266 may be effective in both preventing and treating Necrotizing Enterocolitis; first potential breakthrough therapy in over 30 years.

Noveome Biotherapeutics, Inc., a clinical stage Pittsburgh-based biopharmaceutical company focused on developing next-generation biologics for the treatment of rare pediatric diseases with high morbidity and mortality, today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that it may proceed with its Phase 1-2 clinical trial evaluating the safety and efficacy of its novel biologic ST266 in Necrotizing Enterocolitis (NEC). In connection with the FDA notification, the Company anticipates a closing on at least an additional $13.5 million of Series E convertible preferred stock financing from MAK Capital and other existing investors to supplement the $22.1 million raised to date in the Series E financing announced in August of this year. The additional funding is expected to be completed by December 20, 2023. Proceeds from the financing will be primarily used to support the conduct of the NEC clinical trial.

The planned Phase 1-2 clinical trial is expected to enroll approximately 36 patients with NEC of which 24 patients will receive ST266 in addition to standard of care and 12 will receive standard of care only. Patients will be enrolled upon diagnosis of NEC and, if randomized to the treatment group, will be treated with intravenously administered ST266 once-daily for 10 days. Key endpoints are intended to demonstrate safety and tolerability as well as to assess preliminary efficacy by evaluating clinical outcomes such as time to resolution of pneumatosis, time to return to full feeding, reduction of surgical intervention, and effect on long term neurodevelopment outcomes. First patients are expected to be enrolled in early Q1 2024. The FDA has previously granted both Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) to ST266 for the treatment of NEC.

“The FDA’s clearance of our Investigational New Drug application for Phase 1-2 testing in premature infants with NEC is an important milestone for Noveome and represents a new paradigm in the treatment of NEC patients,” stated Patrick Welch, CEO of Noveome. “The additional funding will enable the company to continue our clinical progress to address this critical medical need in the most vulnerable patient population.”

“NEC is an often fatal inflammatory gastrointestinal disease that can develop in premature infants,” said Dr. Karin Potoka, Chief Medical Officer of Noveome. “There are currently no pharmacological therapies approved specifically for the treatment of NEC, making it a major unmet need globally, and we are excited about the potential for ST266 to revolutionize both the prevention and the treatment of this devastating disease.”

About ST266

ST266 is a cell-free sterile biologic solution containing hundreds of proteins and other factors at physiologic levels. It is made by culturing a novel population of human amnion-derived cells. Using a proprietary culturing method, these cells produce a unique array of growth factors and cytokines, known as the secretome, which promote cellular survival and reduce inflammation. Extensive preclinical studies have shown that ST266’s multiple components result in a variety of anti-inflammatory and neuroprotective responses. A drug master file has been submitted to the FDA, supporting all ST266 investigational new drug (IND) applications.

About Necrotizing Enterocolitis

Necrotizing Enterocolitis (NEC) is a devastating disease caused by inflammation of the intestines observed primarily in premature and very low birth weight babies (VLBWB). The inflammation can result in an overwhelming infection which quickly becomes a medical emergency and often requires surgery as a life-saving measure. Necrotizing enterocolitis affects 2% to 10% of all premature infants worldwide. Overall, the mortality from NEC ranges from 10% to 50%. Treating and managing premature infants with NEC is responsible for over $5 billion annually in Neonatal Intensive Care Unit (NICU) expenditures in the United States. Babies that do survive can be left with life-long intestinal complications and are also at increased risk for neurodevelopmental delays with cognitive, visual, and motor impairments.

About Noveome Biotherapeutics, Inc.

Based in Pittsburgh, Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for a wide range of indications including for the treatment of rare pediatric diseases with high morbidity and mortality. Noveome has completed a Phase 2 open-label clinical trial that demonstrated the benefit ST266 had in healing persistent corneal epithelial defects (PEDs). ST266 also completed a Phase 1 open-label clinical trial establishing the safety of ST266 in intranasal transcribriform delivery from nose-to-brain and eye, and a Phase 1 clinical trial establishing the safety of intravenously administered ST266 in COVID-19 patients. For more information, visit www.noveome.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any offer, solicitation or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. Noveome Biotherapeutics does not respond to investment inquiries from persons who do not have a pre-existing relationship with Noveome Biotherapeutics or its agents.

 

 

 

 

The financing will be primarily used to support the advancement of the Company’s clinical stage program, for the treatment of Necrotizing Enterocolitis

 

We are encouraged by the support from both MAK and existing investors in this Series E financing, providing Noveome with the necessary funding to progress our clinical stage NEC program”— Patrick WelchPITTSBURGH, PA, UNITED STATES, August 17, 2023/EINPresswire.com/ — Noveome1 Biotherapeutics, Inc. Completes First Close of $40 Million Series E Financing to Advance Growing Pipeline of Next-Generation Biologics and Support Clinical Trials Evaluating ST266 in Necrotizing Enterocolitis

 

Pre-clinical results suggest that ST266 may be effective in both preventing and treating Necrotizing Enterocolitis; first potential breakthrough therapy in over 30 years

 

Noveome Biotherapeutics, Inc., a Pittsburgh-based biopharmaceutical company in clinical-stages focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, today announced a $20.7 million first tranche closing of a total $40.2 million Series E financing. The financing was led by MAK Capital, along with additional investment from existing investors. Prior to this Series E financing, Noveome has raised a total of $170 million from both private investors and non-dilutive financing from the U.S. Department of Defense and the Commonwealth of Pennsylvania and Allegheny County. The Company expects to complete the Series E financing by December 31, 2023.

 

Proceeds from the financing will be primarily used to support the advancement of the Company’s clinical stage program investigating its proprietary, cell-free platform biologic, ST266, for the treatment of Necrotizing Enterocolitis (NEC), a rare pediatric disease. ST266 is made by culturing a novel population of human amnion-derived cells. Using a proprietary culturing method, these cells produce a unique array of growth factors and cytokines, known as the secretome, which promote cellular survival and reduce inflammation. NEC is an often-fatal inflammatory gastrointestinal disease that can develop in premature infants. The U.S. Food and Drug Administration (FDA) has previously granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) to the Company’s lead product ST266 for the treatment of NEC.

 

“NEC is a devastating disease that affects the most vulnerable among us,” said Patrick Welch, Chief Executive Officer of Noveome. “We are encouraged by the support from both MAK and existing investors in this Series E financing, providing Noveome with the necessary funding to progress our clinical stage NEC program.”

 

“We are excited to join Noveome and support the broad therapeutic potential of ST266 to deliver novel treatments to patients suffering from a wide variety of complex diseases,” added Michael Kaufman, CEO of MAK Capital. “We are motivated by the prospect of providing the first major improvement in lifesaving therapy for infants affected by NEC in over 30 years.”

 

“The previously published preclinical studies (Am J Physiol Gastrointest Liver Physiol. 2022 Sep 1;323(3):G265-G282. (https://pubmed.ncbi.nlm.nih.gov/35819175/) suggest that ST266 could be useful in the prevention or treatment of clinical NEC, and support initiating a Phase 1-2 clinical trial to further assess ST266’s safety, tolerability and preliminary efficacy in this indication,” said Larry Brown, Sc.D., Executive Vice President and CSO of Noveome. Dr. Brown continued, “No approved therapeutic agent has been developed for NEC in over 30 years and we are excited about the potential for ST266 to revolutionize both prevention and treatment of this devastating disease.”

 

About ST266

 

ST266 is a cell-free sterile biologic solution containing hundreds of proteins and other factors at physiologic levels. Extensive preclinical studies have shown that ST266’s multiple components result in a variety of anti-inflammatory and neuroprotective responses. A drug master file has been submitted to the FDA, supporting all ST266 investigational new drug (IND) applications.

 

About Necrotizing Enterocolitis

 

Necrotizing Enterocolitis (NEC) is a devastating disease caused by inflammation of the intestines observed primarily in premature and very low birth weight babies (VLBWB). The inflammation can result in an overwhelming infection which quickly becomes a medical emergency and often requires surgery as a life-saving measure. NEC affects between 4,000 – 6,000 VLBWB each year in the United States and carries a 30% mortality rate. Babies that do survive are often left with life-long intestinal complications and are also at increased risk for neurodevelopmental delay with cognitive, visual, and motor impairment. Treating and managing NEC costs over $5 billion annually in Neonatal Intensive Care Unit (NICU) expenditures.

 

There is currently no FDA-approved treatment for NEC.

 

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 also completed a Phase 1 open-label clinical trial establishing the safety of ST266 in intranasal transcribriform delivery from nose-to-brain and eye, and a Phase 1 clinical trial establishing the safety of intravenously administered ST266 in COVID-19 patients. For more information, visit www.noveome.com.

 

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any offer, solicitation or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. Noveome Biotherapeutics, Inc. does not respond to investment inquiries from persons who do not have a pre-existing relationship with Noveome Biotherapeutics, Inc. or its agents.

 

PITTSBURGH–(BUSINESS WIRE)–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 Eric Keller, J.D. and Houman D. Hemmati, M.D., Ph.D. to the company’s Board of Directors.

Eric Keller is a proven business and legal executive with nearly 30 years of experience in life sciences-based companies. He is Founder and CEO of Redux Therapeutics, LLC, a clinical-stage small molecule drug development company; Co-Founder and Head of Strategy at C₂Sense, an MIT-based medical diagnostic company; Executive Vice President of SGH2 Energy Global, a developer and operator of waste to green hydrogen projects; and Strategic Advisor and Chief Business Officer of SipNose, Ltd., a pioneering Israeli company delivering drugs direct nose-to-brain to treat a variety of CNS and other brain-related disorders.

Houman Hemmati is a board-certified ophthalmologist and leader in translational and late-stage drug development. He is presently Chief Medical Officer of Vyluma, Inc., which is developing a pharmacologic treatment for nearsightedness (myopia). He is also Co-Founder and Chief Scientific Officer of aesthetic medicine company Levation Pharma and retina therapeutics company Optigo Biotherapeutics, which is developing long-acting intravitreal drugs for wet macular degeneration and diabetic eye disease. Additionally, he is on the Board of Directors of Trailhead Biosystems (stem cells) and MediPrint Ophthalmics (contact lens drug delivery) and advises a handful of companies in ophthalmology drug development. He previously served as Director, Clinical Development at Allergan, as Clinical Scientist in the Ophthalmology Therapeutic Area on several Phase 1, 2, and 3 studies, including the Phase 2 study for the program that led to the approval of Vuity to treat presbyopia.

“We are delighted to welcome Eric and Houman to our Board of Directors. Their vast experience in the scientific, legal and business aspects of late state drug development will provide significant value to Noveome as we focus our efforts on our most promising therapeutic targets,” said Patrick Welch, Acting CEO and current Board member of Noveome.

 

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 also completed a Phase 1 open-label clinical trial establishing the safety of ST266 in intranasal transcribriform delivery from nose-to-brain and eye, and a Phase 1 clinical trial establishing the safety of intravenously administered ST266 in COVID-19 patients. For more information, visit www.noveome.com.

Contacts

412-402-9914
General Inquires: info@noveome.com

 

PITTSBURGH, PA – May 24, 2022 – Noveome Biotherapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) to the company’s lead product ST266 for the treatment of Necrotizing Enterocolitis (NEC).

“NEC is a devastating disease that affects the most vulnerable among us,” said Christopher Velis, Chief Executive Officer of Noveome. “We remain motivated by the prospect of providing the first major improvement in lifesaving therapy for infants affected by NEC in over 40 years. These babies, their families, and the doctors and nurses who have devoted their own lives to fighting this disease deserve our collective best efforts to advance our therapy into clinical practice.”

The FDA grants RPDD for serious and life-threatening diseases affecting children aged 18 years or younger and ODD for rare diseases that impact fewer than 200,000 people in the United States. ST266 is being evaluated in multiple preclinical animal models and the company is in the planning stages for clinical trials to investigate treatment with ST266 for NEC.

About Necrotizing Enterocolitis (NEC)
Necrotizing Enterocolitis (NEC) is a devastating disease caused by inflammation of the intestines observed primarily in premature and very low birth weight babies (VLBWB). The inflammation can result in an overwhelming infection which quickly becomes a medical emergency and often requires surgery as a life-saving measure. NEC affects between 4,000 – 6,000 VLBWB each year in the United States and carries a 30% mortality rate. Babies that do survive are often left with life-long intestinal complications and are also at increased risk for neurodevelopmental delay with cognitive, visual, and motor impairment. Treating and managing NEC costs over $5 billion annually in Neonatal Intensive Care Unit (NICU) expenditures.

There is currently no FDA-approved treatment for NEC.

About ST266
ST266 is a cell-free sterile biologic solution containing hundreds of proteins and other factors at physiologic levels. Extensive preclinical studies have shown that ST266’s multiple components result in a variety of anti-inflammatory and neuroprotective responses. A drug master file has been submitted to the FDA, supporting all ST266 investigational new drug (IND) applications.

About Noveome Biotherapeutics, Inc.
Based in Pittsburgh, PA, Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologic therapeutics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome has a robust pipeline developing novel treatments for various systemic and ophthalmic indications and has recently completed a Phase 1 study evaluating the safety of intravenously administered ST266 in the treatment of systemic inflammation associated with COVID-19. For more information, visit www.noveome.com.

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Media Contact: press@noveome.com

PITTSBURGH, PA – June 23, 2021 – Noveome Biotherapeutics, Inc. (Noveome) announced that it has commenced its Phase 1 clinical trial by dosing its first patient. This Phase 1 trial is evaluating the safety and tolerability of intravenous (IV) administration of their ST266 product to treat deadly inflammatory responses in COVID-19 patients. ST266, a novel platform biologic that possesses anti-inflammatory and neuroprotective properties, already has Phase 1 and Phase 2 clinical study data through other forms of administration.

ST266 is an investigational treatment for severe systemic inflammation, known as a cytokine storm, and ultimately sepsis, which is frequently associated with infectious diseases such as COVID-19. Sepsis accounts for nearly $24 billion in annual costs in the U.S. alone, making it the most costly condition for the healthcare system to treat. Previous preclinical and clinical studies have demonstrated that ST266 has the potential to significantly reduce this inflammatory response.

“When successful, this study will advance tools to treat one of the world’s most prevalent and deadly conditions, sepsis. The impact of ST266 on the inflammatory response in COVID-19 patients will give us an understanding of the drug’s ability to treat this response across a wide variety of bacterial, fungal and viral infections,” said Christopher Velis, CEO of Noveome.

To date, Noveome has received approximately $115 million in grant funding from the U.S. Department of Defense and approximately $10 million from other public and private sources to support their studies. This study brings them one step closer to translating ST266 out of the lab and to patients in need.

The clinical outcome status of ST266-treated patients and the potential effects on clinical laboratory parameters and inflammatory markers will be monitored from baseline through the post-treatment follow-up period. These effects with be observed through clinical and serologic assessments that are measured for the duration of the trial.

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About Noveome
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, the Phase 1 trial described above, the company recently announced the results from their Phase 2 open-level 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. A Phase 2b PED trial is scheduled to begin in the third quarter of 2021. The company also recently announced positive preliminary safety results for its Phase 1 transcribriform delivery of intranasal ST266 for traumatic brain injury and diseases of the retina and optic nerve. For more information, please visit www.noveome.com.

Media Contact: press@noveome.com

Preliminary results show intranasally delivered ST266 is safe

PITTSBURGH, PA – June 7, 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 preliminary results of a Phase 1 open label clinical trial to establish the safety of ST266 when delivered intranasally in Glaucoma Suspect patients. The trial was conducted at the University of Pennsylvania by Ahmara Ross, M.D., Ph.D. and Kenneth Shindler, M.D., Ph.D. of the University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA.

ST266 is a novel “secretome”, a cell-free platform biologic containing hundreds of proteins and other growth factors involved in cellular healing and was administered as a targeted nasal spray using the SipNose, Ltd. Cribriform Targeted Device, for which Noveome recently announced a commercial license agreement (http://ow.ly/TqOj50EZYyy.) The device is able to deliver ST266 to the cribriform plate at the back of the upper nasal cavity where is able to reach the optic nerve, eye and brain, bypassing the blood-brain barrier. Previously published preclinical efficacy and distribution studies laid the groundwork for the Phase 1 clinical trial reported here.

The Phase 1 open label clinical trial was designed to assess the safety of intranasally delivered ST266 in Glaucoma Suspect patients diagnosed as having pre-glaucoma conditions that have not yet caused damage to the optic nerve. Dosing occurred in three cohorts. In the first cohort, subjects were intranasally administered ST266 at a dose of two hundred microliters (200 µL) daily for 14 days, in alternating single nostrils. In the second cohort, subjects were intranasally administered 200 µL to each nostril daily (400 µL total per day) for 14 days. In the third cohort, subjects were intranasally administered 200 µL to each nostril daily (400 µL total per day) for 28 days. No drug-related serious adverse events were reported. Preliminary safety assessments, reported here, were performed at baseline and at the end of drug treatment and included visual acuity, slit lamp exam, tonometry, retina exam and ERG, OCT for optic nerve fiber thickness layer, corneal pachymetry, gonioscopy, neuro-cognitive exam, MRI, lumbar puncture, chemistry panel, hematology, and nasopharyngeal exam. All results were normal. Three-, six- and twelve-month safety follow-up visits are planned for all subjects. More information about the study is available at www.clinicaltrials.gov under the identifier NCT03901781.

“The preliminary safety results of this Phase 1 clinical trial of intranasally delivered ST266 is an important milestone for Noveome. Now that we have established safety of ST266 by this route of administration, we are actively planning efficacy trials in a variety of neurological and ophthalmological indications” said Christopher Velis, CEO of Noveome. “We intend to pursue intranasal ST266 in our broad pipeline of indications such as concussion, glaucoma, optic neuritis, and retinal diseases.”

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. 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. In addition to the Phase 1 trial reported above, Noveome has completed a Phase 2 open-label clinical trial that demonstrated the benefit ST266 had in healing persistent corneal epithelial defects (PEDs). The company has initiated a Phase 1 study evaluating the safety of intravenously administered ST266 in COVID-19 patients and is currently planning a Phase 2 clinical study 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 for Noveome Biotherapeutics, Inc.
781-608-7091
noveome@cglife.com

 

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