cultivating

the ingenuity to heal

A novel biologic with unprecedented healing potential

ST266 is a first-of-its-kind, multi-targeted, non-cellular novel biologic with the potential to improve patients’ outcomes across a range of challenging diseases and conditions in ophthalmology, neurology, dermatology—and more. Many of these conditions currently have no or limited therapeutic options in part because they are often too complex to be treated with traditional “one-drug, one-target” therapies.

ST266 is produced by collecting the secretome from a novel population of cells generated by a proprietary method of culturing amnion-derived epithelial cells from donated full-term placentas, normally discarded after birth. The cells produce many of the biologic factors found in amniotic fluid that may be responsible for the remarkable healing capabilities and lack of scarring observed following in-utero fetal surgery.

Noveome owns 51 U.S. patents protecting ST266 and the cells and process for producing it, as well as methods of use and many other pending patent applications. In addition, Noveome has over 40 granted patents and several pending applications in major global markets including Europe, Japan, China and Canada.

Activating key mechanisms critical to healing

Healing relies upon a complex set of activities orchestrated by hundreds of biomolecules present in the microenvironment of the diseased or damaged tissue. A single-target drug can only address one aspect of this complex process.

ST266, however, uniquely provides the desirable, multi-dimensional effects needed to protect vital nerve cells, modulate inflammation, restore damaged cells and ultimately facilitate healing. Consequently, we believe it is equipped to potentially treat a range of challenging conditions.

Neuroprotection

ST266 restores nerve function, supports nerve cell survival and decreases the rate of demyelination.

Anti-inflammation

ST266 modulates the inflammatory response by decreasing pro-inflammatory cytokines and reducing vascular permeability, immune cell infiltration and edema.

Restoration

ST266 improves function and recovery of damaged cells, increases cell proliferation, reduces apoptosis and helps re-establish homeostasis.

Healing

ST266 promotes and supports normal healing by facilitating the deposition, alignment, and cross-linking of collagen fibers and matrix. ST266 may also help accelerate the notoriously slow healing of impaired conditions, such as those linked to aging or diabetes.

A range of delivery options for a spectrum of indications

ST266 can be administered via multiple routes—opening the door for effective treatment across a broad range of potential indications.

ST266 can be delivered via conventional routes of administration, including topical drops and intracameral delivery for the eye, intraoral topical delivery for the gums, as well as intravenous and intraperitoneal injection. Importantly, ST266 can also be delivered directly to the central nervous system and optic nerve using a targeted intranasal spray device that employs a non-invasive, nose-to-brain route of administration—successfully bypassing the blood-brain barrier in the process.

A single, scalable manufacturing process

Noveome’s GMP manufacturing process is efficient and scalable—and is used to produce ST266 for all indications. A drug master file has been submitted to the FDA supporting all ST266 investigational new drug (IND) applications.