Yokneam, Israel–based SipNose develops its intranasal Cribriform Targeted Device (CT6), which, under the agreement, was licensed to Noveome to deliver the Pittsburgh-based company’s ST266 biologic to the central nervous systems, according to a news release.
CT6 allows aerosolized drug delivery to the cribriform area in the upper area of the nasal cavity, SipNose said, offering highly reproducible dosing, high absorption of the drug and the potential for higher efficacy combined with an improved user experience.
Noveome produces ST266 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 that are normally discarded following birth.
The secretome holds physiologic levels of multiple growth factors and cytokines while demonstrating the stimulation of anti-inflammatory and neuroprotective responses in preclinical studies. Noveome said it continues to evaluate ST266 in central nervous system conditions, gastrointestinal conditions and cytokine storm associated with COVID-19 infection.
Noveome has submitted a drug master file with the FDA to support all ST266 investigational new drug applications, while the company says the ST266 platform biologic enables a scalable manufacturing process for all of those indications.
SipNose and Noveome have collaborated since 2015, with the licensing agreement covering the intranasal delivery of ST266 for treating ophthalmological conditions and brain-related conditions. Along with the license terms, Noveome and SipNose agreed to terms for a supply agreement set to be finalized before initiating Phase 3 trials.
Noveome founder & chairman William J. Golden said in the release that the companies have a great working relationship, while Noveome recently closed enrollment for and completed the treatment phase of its Phase 1 study using the SipNose device in glaucoma-suspect patients.
“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,” SipNose co-founder & CEO Dr. Iris Shichor said in the release. “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.”