Noveome Biotherapeutics Announces Positive Data Safety Monitoring Board Recommendation in ongoing NEC Clinical Trial

PITTSBURGH, PA, UNITED STATES, March 26, 2026Noveome Biotherapeutics, Inc, a clinical-stage biotechnology company focused on developing innovative therapies for rare and life-threatening conditions, today announced that the independent Data Safety Monitoring Board (DSMB) has completed its review of safety data from Cohort 1 of the ongoing clinical trial evaluating ST266 for the treatment of necrotizing enterocolitis (NEC) in neonates.

Following its review, the DSMB recommended that the study continue without modifications, noting no safety concerns in any of the infants treated with ST266 in the first Cohort of this groundbreaking trial.

“The DSMB’s unanimous recommendation to proceed without changes, along with the absence of any safety concerns, represents an important milestone for this program,” said Patrick Welch, CEO of Noveome Biotherapeutics. “These findings support continued advancement of ST266 into the next cohorts of this study, including both dose escalation and expansion into additional patient populations.”

Based on this positive recommendation, the Company plans to proceed with:
• Cohort 2, which will evaluate an increased dose of ST266 (1 mL/kg body weight) in infants weighing greater than 1000 to 3000 grams; and
• Cohort 3, which will evaluate the 0.5mL/kg body weight dose of ST266 in smaller infants weighing 500 to 999 grams, a particularly vulnerable population affected by NEC.

As previously agreed with by the U.S. Food and Drug Administration (FDA), Cohorts 2 and 3 will be conducted simultaneously.

The DSMB is composed of independent neonatologists and physicians with extensive experience in the treatment of NEC. The board is responsible for ongoing safety oversight throughout the trial.

The Company has received the DSMB’s formal written recommendation and has promptly notified clinical trial sites to initiate enrollment in Cohorts 2 and 3, as patients present and meet the eligibility criteria.

About Necrotizing Enterocolitis (NEC)
Necrotizing enterocolitis is a devastating gastrointestinal disease that primarily affects premature infants weighing less than 1500 grams and is associated with significant morbidity and mortality. “There remains a critical unmet need for safe and effective therapies for NEC, as we haven’t seen a significant therapy developed for this terrible disease in over 40 years,” according to Dr. Potoka, a practicing Neonatologist and CMO of Noveome Biotherapeutics.

About ST266
ST266, a novel multi-component biologic secretome derived from human amnion epithelial cells, has demonstrated protective anti-inflammatory, anti-apoptotic in experimental mouse and piglet NEC models through reduction of TLR4 activity. Strikingly, ST266 upregulated critical genes associated with gut remodeling, intestinal immunity, gut differentiation and energy metabolism. ST266 is currently being evaluated in an ongoing clinical trial (NCT06315738) assessing safety and preliminary efficacy in Bell Stage 2A–3A neonatal NEC patients.

About Noveome Biotherapeutics
Noveome Biotherapeutics, Inc. is a clinical stage, Pittsburgh-based biotechnology company advancing the development of ST266, a proprietary, amnion cell-derived secretome platform. ST266 is designed to utilize physiologic paracrine signaling to promote cellular survival and tissue repair through complementary anti-inflammatory, anti-apoptotic, neuroprotective, maturational and regenerative mechanisms.

Noveome’s therapeutic focus includes rare pediatric diseases like NEC, ophthalmology, neurology and other CNS disorders, inflammatory conditions, and tissue injury and repair, with potential expansion into additional indications where a multi-target, biologic approach may offer a meaningful clinical benefit.

Forward-Looking Statements This press release contains forward-looking statements within the meaning of applicable securities laws, including, without limitation, statements regarding the continued development of ST266, the initiation, enrollment, and anticipated timing of Cohorts 2 and 3 of the Company’s clinical trial evaluating ST266 for the treatment of NEC, the potential safety and therapeutic benefit of ST266, expectations regarding regulatory interactions with the FDA, and the Company’s plans and strategies for its clinical programs. Words such as “expects,” “anticipates,” “plans,” “believes,” “potential,” “will,” and similar expressions are intended to identify forward-looking statements. These statements are based on management’s current expectations, assumptions and beliefs and involve known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to differ materially from those expressed or implied by such statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release.

 

 

Noveome Biotherapeutics, Inc. Completes $51 million Series E Financing to Support Clinical Trials in NEC

PITTSBURGH, PA, UNITED STATES – April 23, 2025Noveome 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 the successful completion of its upsized $51 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, the Commonwealth of Pennsylvania, and Allegheny County.

Proceeds from the financing will primarily be 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. 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.

“We are grateful for the continued support of MAK Capital and the strong ongoing commitment of our existing investors who are deeply committed to the success of Noveome as a leading biotechnology company in Pittsburgh,” said Patrick Welch, Chief Executive Officer of Noveome. “This funding will allow us to continue the promising early results seen in our NEC study, as well as to support the ongoing operational and manufacturing activities needed to support our efforts to obtain the first Biological License Application (BLA) for ST266.”

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 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 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 and administration of ST266 to a premature infant diagnosed with necrotizing enterocolitis as part of 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.

 

 

Noveome Biotherapeutics, Inc. Announces Issuance of U.S. Patent No. 12,121,546 Entitled, “Treatment of Systemic Inflammatory Responses”

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, 2024Noveome 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.

Noveome Biotherapeutics, Inc. Announces Completion of Treatment of the First Baby in its Phase 1-2 Clinical Trial Evaluating ST266 in the Treatment of Necrotizing Enterocolitis in Premature Infants

PITTSBURGH—November 14, 2024Noveome 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.

The novel secretome ST266 activates Akt and protects against oxidative stress-mediated injury in human RPE and Müller cells

Alan C. Tang, Nicholas A. Besley, Rose Trimpey-Warfhatig, Ping Yang, Howard Wessel, Larry Brown, Ziv Kirshner, Glenn J. Jaffe, The novel secretome ST266 activates Akt and protects against oxidative stress-mediated injury in human RPE and Müller cells, Experimental Eye Research, 2024, 110060, ISSN 0014-4835

Full Publications here.

Noveome Biotherapeutics, Inc. Receives FDA Notification to Proceed with its Phase 1-2 Clinical Trial in Treatment of NEC

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.

 

 

 

 

Noveome Biotherapeutics, Inc. Completes First Close of $40 Million Series E Financing to Support Clinical Trials in NEC

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.

 

Human amnionic progenitor cell secretome mitigates the consequence of traumatic optic neuropathy in a mouse model

Robyn McCartan, Arissa Gratkowski, Mackenzie Browning, Coral Hahn-Townsend, Scott Ferguson, Alexander Morin, Corbin Bachmeier, Andrew Pearson, Larry Brown, Michael Mullan, Fiona Crawford, Radouil Tzekov, Benoit Mouzon, Human amnionic progenitor cell secretome mitigates the consequence of traumatic optic neuropathy in a mouse model, Molecular Therapy – Methods & Clinical Development, 2023, 29: 303-318, ISSN 2329-0501

 

Full Publications here.

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

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

 

The administration of amnion-derived multipotent cell secretome ST266 protects against necrotizing enterocolitis in mice and piglets

Chhinder P. Sodhi, Raheel Ahmad, Hongpeng Jia, William B. Fulton, Carla Lopez, Andres J. Gonzalez Salazar, Asuka Ishiyama, Maame Sampah, Steven Steinway, Sanxia Wang, Thomas Prindle Jr., Menghan Wang, David L. Steed, Howard Wessel, Ziv Z. Kirshner, Larry R. Brown, Peng Lu, and David J. Hackam, The administration of amnion-derived multipotent cell secretome ST266 protects against necrotizing enterocolitis in mice and piglets, American Journal of Physiology-Gastrointestinal and Liver Physiology, 323: G265–G282, 2022, doi:10.1152/ajpgi.00364.2021

 

Full Publications here.