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