Noveome Biotherapeutics
Combating Complex Disorders with Cell-Less Amnion-Derived Drug Product

Necrotizing enterocolitis (NEC) is a devastating gastrointestinal disease that affects approximately 11 percent of all in very low birth weight, premature neonates. NEC is predominant in babies generally born before 28 weeks of gestation who are often deprived of oral amniotic fluid that contains biological molecules critical to proper gastrointestinal tract development. Today, NEC accounts for an estimated annual expenditure of six billion dollars in the US for neonatal intensive care. Yet there has been no change in 40 years for NEC treatment.

Noveome Biotherapeutics, a dynamic biopharmaceutical company, is shifting this paradigm with ST266, a first-of-its-kind, multi-targeted, and non-cellular novel biologic with the potential to improve patient outcomes across a wide range of challenging diseases, including NEC and other conditions in ophthalmology, neurology, dermatology, and more. Many of these conditions currently have no or limited therapeutic options because they are often too complex to be treated with traditional “one-drug, one-target” therapies.

According to Dr. Larry R. Brown, Chief Scientific Officer at Noveome Biotherapeutics, NEC is the most common cause of death of 2 to 8 week old extremely preterm infants. The current treatment requires an average hospitalization of 49 to 60 days, depending on surgery. Even after surgical intervention, 89 percent of NEC survivors experience long-term complications like neurodevelopmental delay, failure to thrive, cholestasis, short bowel syndrome, and GI tract problems like stricture and adhesions.

ST266 addresses these issues with its complex mixture of biomolecules that can simultaneously address the multi-faceted issues associated with NEC and various other diseases conditions and injuries. ST266 is essentially cell therapy without the cell, taking advantage of an observation made in the 1970s called fetal non-scarring.

When surgery is conducted on a fetus in the womb for diseases such as spina bifida, the growth factors and cytokines in the amniotic fluid heal these surgical wounds without leaving any scars.

“The Noveome secretome ST266 product contains numerous disease fighting growth factors and cytokines. This allows ST266 to deliver an unprecedented treatment outcome for NEC and other complex diseases,” says Patrick T. Welch, CEO of Noveome Biotherapeutics.

Noveome Biotherapeutics manufactures ST266 by collecting full-term C-section placentas, removing the amnion cell layer, and culturing a subset of proprietary cells called amnion-derived multipotent progenitor cells (AMP cells). These cells are cultured in a single use bioreactor and produce a cell secretome containing hundreds of anti-inflmmatory growth factors and cytokines. Finally, the secretome product is filtered and collected to yield the ST266 product. Importantly, these growth factors and cytokines are present in ST266 in tiny picogram per ml concentrations or lower, resulting in a lack of drug-related adverse events through 12 clinical trials.

The Noveome secretome ST266 product contains numerous disease fighting growth factors and cytokines. This allows ST266 to deliver an unprecedented treatment outcome for NEC and other complex diseases

A study using 1 kg sized piglets conducted in collaboration with Dr. David Hacken from Johns Hopkins University showcased ST266’s effectiveness. In this test, piglets suffering from NEC were administered one ml per kilogram of ST266, which significantly decreased NEC mortality and prevented the disease’s adverse effects. ST266 reduced the disease’s inflammatory cytokines and severity score while up-regulating the gastrointestinal tract maturation.

Driven by its ability to culture AMP cells, produce the ST266 secretome containing critical anti-inflammatory and regenerative growth factors and cytokines, Noveome envisions ST266 as an off-the-shelf product that NICU caregivers can administer to effectively prevent full-blown NEC and other complicated disorders.