PITTSBURGH – August 31, 2020 – Noveome Biotherapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, announced that Larry Brown, Sc.D., the company’s Executive Vice President and Chief Scientific Officer, will co-lead a workshop entitled, “Bypassing the BBB for More Effective Delivery to the Brain” at the digital Blood-Brain Barrier Summit on Monday August 31, 2020 at 1:00 PM – 3:00 PM EDT.

 

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

 

About ST266

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

 

About Noveome Biotherapeutics, Inc.

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

 

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Investor Contact:

Julie Seidel

Stern Investor Relations, Inc.

212-362-1200

julie.seidel@sternir.com

 

Media Contact:

Erik Clausen

CG Life

781-608-7091

noveome@cglife.com

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

About ST266

ST266 is a cell-free biologic made by culturing a novel population of human amnion-derived cells. Through a proprietary culturing method, these cells produce an array of growth factors and cytokines, known as the secretome, which promote cellular survival and reduce inflammation.

 

About Noveome Biotherapeutics, Inc.

Based in Pittsburgh, PA, Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome has launched a program to test its novel platform biologic, ST266, as a treatment for the severe inflammatory response seen in COVID-19 infection. In addition to the Phase 2 open-label clinical trial evaluating the efficacy of ST266 in healing persistent corneal epithelial defects (PEDs) reported here, ST266 is also being evaluated in a Phase 1 open label clinical trial to establish the safety of ST266 in intranasal transcribriform delivery from nose to brain and eye. Noveome is also currently planning follow-up clinical studies to characterize the efficacy and safety of ST266 further for the treatment of PEDs. For more information, visit www.noveome.com.

 

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Investor Contact:

Julie Seidel

Stern Investor Relations, Inc.

212-362-1200

julie.seidel@sternir.com

 

Media Contact:

Erik Clausen

CG Life

781-608-7091

noveome@cglife.com

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

About Singota Solutions

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

About Noveome® Biotherapeutics

Based in Pittsburgh, Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome has launched a program to test its novel platform biologic, ST266, as a treatment for the severe inflammatory response seen in COVID-19 infection.  ST266 is currently being evaluated in multiple indications including a Phase 1 open label clinical trial to establish the safety of ST266 in intranasal transcribriform delivery from nose to brain and eye and a Phase 2 open-label clinical trial evaluating the efficacy of ST266 in healing persistent corneal epithelial defects (PEDs). For more information, visit www.noveome.com.

Funding Enables Existing Clinical Trials to Proceed as Company Joins Global Response with COVID-19 Program

 

PITTSBURGH – May 7, 2020 – Noveome Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, has received a $4 Million grant from the Commonwealth of Pennsylvania to continue clinical trials of its lead product candidate, ST266, in a wide range of diseases, including multiple ophthalmic indications. The funding will enable Noveome to shift its existing resources to support the company’s recently launched COVID-19 program evaluating ST266 as a treatment for the “cytokine storm”—the severe inflammatory response often observed in COVID-19 infections.

 

“While researchers around the world race to deliver a vaccine that will address this COVID-19 pandemic head on, we need a range of new therapeutics and diagnostics to stem the tide. This very timely funding will enable us to advance our ongoing programs while concurrently accelerating our evaluation of ST266 against COVID-19 in clinical trials,” said William Golden, Founder, Chairman and CEO of Noveome. “We’re incredibly grateful to the leaders and people of Pennsylvania who have provided tremendous support throughout our company’s journey—particularly Representative Frank Dermody and Senator Jay Costa, who both helped us to secure this timely grant.”

 

“It remains our top priority to do everything that we can to protect the public health of Pennsylvanians,” said Senator Costa. “Part of our strategy is to support innovative companies in the Commonwealth like Noveome that are working to find solutions in this unprecedented health crisis.”

 

“We are proud to support Pittsburgh-based Noveome as they pursue new potential treatments for a range of challenging conditions, including COVID-19,” added Representative Dermody.  “Now, more than ever, all of us in state government must do our part to enable science to bring new treatments into the fight against this virus.”

 

ST266 is a cell-free biologic made by culturing a novel population of cells derived from full term placentas donated after a birth. When cultured in a bioreactor, these cells produce an array of bioactive molecules, known as a secretome, which promote cellular survival and resuscitate damaged cells. The ST266 secretome contains a vast array of active biomolecules in very minute and safe physiologic concentrations that are anti-inflammatory, preserve cellular survival and resuscitate damaged cells. Given these observed characteristics, ST266 has the ability to potentially prevent the cytokine storm associated with COVID-19 as well as promote lung healing and prevent multiple organ injuries.

 

“Recent internal models in an acute systemic inflammation model demonstrated that ST266 was able to significantly reduce multiple inflammatory cytokines,” said Noveome Chief Science Officer Larry Brown, Sc.D. “ST266 has also been shown to have significant anti-inflammatory activity in both preclinical and clinical studies in other indications. Relevant preclinical studies showed that systemic administration of ST266 protected lung against elastase-induced lung injury, ischemia-induced lung injury and cytokine-related pulmonary inflammation. Based on these data, we believe ST266 has the capacity to potentially address multiple treatment requirements of COVID-19 infection.”

 

About Noveome Biotherapeutics, Inc.

Based in Pittsburgh, Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome has launched a program to test its novel platform biologic, ST266, as a treatment for the severe inflammatory response seen in COVID-19 infection.  ST266 is currently being evaluated in multiple indications including a Phase 1 open label clinical trial to establish the safety of ST266 in intranasal transcribriform delivery from nose to brain and eye and a Phase 2 open-label clinical trial evaluating the efficacy of ST266 in healing persistent corneal epithelial defects (PEDs). For more information, visit www.noveome.com.

 

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Investor Contact:

Julie Seidel

Stern Investor Relations, Inc.

212-362-1200

julie.seidel@sternir.com

 

Media Contact:

Erik Clausen

CG Life

781-608-7091

noveome@cglife.com