Noveome Biotherapeutics
Navigating the Drug Development Pipeline

Treating necrotizing enterocolitis (NEC), a life-threatening gastrointestinal disease that affects premature infants, is a significant challenge due lack of efficacious medical advances. However, current research offers a promising, for treating this debilitating condition, could result in new hope for effectively treating NEC. Published studies in premature piglets with NEC showed the ST266 biologic product co’uld reduce mortality, thereby reducing the need for surgical intervention and the number of days of hospitalization. This novel therapeutic could mitigate common NEC complications including, developmental delays, failure to thrive, and gastrointestinal problems, short bowel syndrome, strictures and adhesions. Consequently, ST266 could conceivably provide a significantly better quality of life for the survivors of the disease..

Noveome Biotherapeutics, a clinical-stage biopharmaceutical company, is making a substantial impact in this field by developing next-generation biologics that promote and restore cellular integrity in inflamed or damaged tissues. The firm has worked closely with Dr. David Hackam, MD, PhD, a distinguished pediatric surgeon and researcher at the Johns Hopkins University School of Medicine, whose laboratory is acknowledged as one of the leading NEC research labs in the world. His laboratory identified a key treatment pathway implicated in the etiology of NEC using animal models that closely mimic NEC in human neonates.

Noveome has developed and produces a novel secretome currently termed ST266 (formerly known as amnion-derived cellular cytokine solution) under good manufacturing practice (GMP) conditions. ST266 has undergone evaluation in numerous preclinical models. Noveome is advancing its ST266 biologic, a first-of-its-kind, multi-targeted secretome that contains hundreds of biologically active proteins and other factors crucial to neuroprotection, modulation of inflammation, cell recovery, and healing.

Testing ST266 in Premature Piglets

NEC is a challenging issue that is the most common cause of death in two to eight week old low birth weight preterm infants. . Their prematurity deprives them of swallowing adequate volumes of amniotic fluid had they been full term infant. Amniotic fluid contains many key biological molecules necessary for normal GI tract development.

NEC suspect premature babies are classified as high-risk babies in the neonatal intensive care units (NICU’s) when they are very low birth weight, and are formula-fed and have low birth weight. Definitive diagnosis is based upon observations such as lethargy, abdominal distention, low platelet counts, bloody diarrhea, etc. At this point, babies are taken off oral feeding and are intravenously administered total parenteral nutrition (TPN) and antibiotics.

This harmful gastrointestinal ailment affects approximately 11 percent of very low birth weight neonates.

Unfortunately, its mortality rate is about 30 percent of these infants. The disease can quickly become fatal as it progresses, causing the gastrointestinal tract to rupture, and result in systemic infection. That said, the mouse and piglet models are used to identify novel compounds that can prevent or treat NEC and are validated in human NEC tissue ex vivo, suggesting the validity of these models in establishing the potential benefit of ST266.

Dr. Hackam’s latest research proposes a unique approach to treating NEC. He uses bacterial mixtures obtained from the gastrointestinal tracts of NEC affected infants and introduces it to formula-fed piglets, as that mimics the etiology NEC development in babies. The piglet’s intestine shares various anatomical and functional similarities with premature infants, making them perfect candidates for these experiments. In addition, premature delivery of piglets from pregnant sows results in the birth of animals that are of similar weight to premature NEC babies.

Dr. Hackam’s laboratory has administered ST266 to these piglets, and the results were astounding. The treatment improved the GI tract’s maturation and restored its metabolism and intestinal immunity. The study suggests it may be able to prevent or treat clinical NEC. Noveome intends to support this treatment with antibacterial therapy using ST266.

The mechanisms of action include a potent anti-inflammatory effect, as well as pleiotropic effects establishing gut integrity, metabolism, and immunity. Given the lack of alternative, specific, and effective anti-NEC medications, these findings raise the possibility that ST266 can be useful in the prevention or treatment of clinical NEC.

“ST266 has significantly reduced the severity score of the disease and inflammatory cytokines, improved gastrointestinal membrane integrity, and upregulated GI tract maturation,” says Patrick Welch, CEO of Noveome Biotherapeutics.

Dr. Hackam’s research, published in the Journal of American Physiology in 2022, concluded that these findings raise the possibility that ST266 could be useful in the prevention or treatment of clinical NEC.”

Exploring the Potential Applications of ST266

In the 1970s, a fascinating phenomenon was observed during a surgery performed on fetuses to treat conditions like spina bifida or heart diseases. Despite undergoing surgery, these babies were born without any scars, which have been attributed to growth factors and cytokines secreted by placenta amnion epithelial cells into amniotic fluid.

Noveome, recognizing the potential of this observation, collects and cultures placenta-derived amnion cells to produce ST266.

The firm’s ST266 is a next-generation anti-inflammatory, cell survival and neuroprotective platform biologic—has been studied in many challenging diseases and conditions spanning ophthalmology, neurology, and dermatology. Noveome conducted an extensive study on ST266, a non-cellular novel biologic, in its NEC model. ST266’s multi-dimensional effects protect nerve cells, reduce inflammation, repair damaged cells, and promote recovery.

“Our primary focus is ST266. Through our extensive involvement in 12 clinical trials, we have garnered significant evidence attesting to its safety and potential efficacy,” says Larry Brown, ScD, Executive Vice President and Chief Scientific Officer, Noveome Biotherapeutics.

In addition, Noveome conducted a published clinical case report that involved targeting ST266 delivery to the olfactory nerves of the nose in glaucoma suspect patients. Intranasal ST266 reversed complete anosmia and dysgeusia in one test subject who experienced COVID-19 one year before vaccines became available. This result suggests the far-reaching potential of ST266 to treat a variety of important inflammatory and neurological diseases. .

Noveome has also conducted 12 clinical trials to confirm the safety of ST266 in humans, by the intravenous, oral, dermal, ocular and intranasal nose to brain routes of administration. The firm aims to advance in the regenerative medicine sector to help millions of patients suffering from complex diseases and conditions.

ST266 has Significantly Reduced the Severity Score of the Disease and Inflammatory Cytokines, Improved Gastrointestinal Membrane Integrity, And Up-regulated GI Tract Maturation

From Startup to Success: The Journey of a Thriving Business

Noveome’s regulatory department oversees the pre-IND and IND approval processes. It is currently gearing up for ST266’s NEC clinical human trial. By influencing multiple pathways essential to healing, ST266 can potentially improve patient outcomes in a wide range of clinical indications.

Welch plays a crucial role in devising plans for these critical stages as the firm moves toward commercialization, FDA market approval, product launch, and market readiness. Noveome has completed a pre IND meeting with the FDA discussing its clinical trial plans and present a comprehensive protocol synopsis that outlines the measurements it intends to undertake during the trial. Notably, Noveome has garnered the Orphan Disease and Rare Pediatric Disease Designation, showcasing its commitment to solving unmet medical needs in these critical areas.