ST-001 nanoFenretinide is an IND approved, orphan designated, small-molecule immune oncology (IO) nano size fenretinide drug with FDA designed accelerated path to NDA at Phase 1b completion. The API is safe & efficacious in 5 cancers.
SciTech’s lead compound, ST-001 nanoFenretinide, is a small-molecule immune oncology nano Fenretinide cancer drug employing a nanoparticle suspension for IV administration comprised of fenretinide in a patented combination with carefully selected phospholipids (inactive ingredients). The phospholipids, comprising ST-001 nanoFenretinide, were chosen because their extensive in humans and are recognized as safe for IV use by the FDA. Moreover, they were chosen because of their unique chemical and physical properties, that when combined with those of fenretinide, yielded an integrated, robust structure that contained much higher concentrations of fenretinide. The nature and relative proportions of all the ingredients (composition of matter covered in our patents), that are assembled and manufactured in a very specific manner and defines the unique attributes of ST-001 nanoFenretinide.
ST-001 nanoFenretinide is designed to deliver a 15-fold higher drug to lipid ratio and a >6x concentration of the API than conventional IV formulations achieving therapeutically effective doses without the toxic side effects observed with other delivery systems – a benefit previously unattainable. Recent discovery of the API’s immunotherapeutic effect, in which a reactivated natural immune response compliments the previously understood safe, direct, chemotherapeutic effect (functioning as dual mechanisms of action), resulting in cancer cell destruction (apoptosis).
This technology has been uniquely validated by the availability of Phase I clinical trial data that employed a slightly different IV delivery system that showed efficacy, even though the therapeutic outcome was partially diminished by dose limiting toxicities associated with the delivery system itself.
Previously, SciTech's pharmacokinetic animal (rat) studies demonstrated that blood levels of fenretinide necessary for cytotoxicity were achieved and maintained for relatively long periods of time (at least 12 hours after single dose); and, SciTech's in vitro studies successfully demonstrated cytotoxicity in human pancreatic cancer cells as well as in a non-Hodgkin’s Lymphoma model (DLCL2). SciTech’s liposomal drug delivery system also offers the potential of being used to deliver other APIs.
Drug Manufacturing Status:
Completed manufacturing validation of ST-001 nanoFenretinide
Confirmed that the product met all agreed to quality standards
Reconfirmed that all standard operating procedures yield the anticipated results
Completed a third party regulatory affairs audit of the manufacturing site
Validated the site’s ability to meet cGMP manufacturing standards
The FDA Regulatory Strategy: Past fenritinide drug studies conducted by McNeil Laboratories, Johnson & Johnson, National Cancer Institute (NCI) and others have generated a large database of public information that allows SciTech to optimize its clinical program (accelerated dose titration designs for oncology clinical trials).
FDA Fast Track designation and/or other FDA expedited designations will lead to early drug product launch and added IP protection. SciTech expects to prove the clinical efficacy of its ST-001 nanoFenretinide drug formulation in <2 years and commence marketing in the unusually rapid time frame of 2-3 years.
IND Application & Clinical Trial Studies
An Investigative New Drug Application (IND) for the treatment of T-cell non-Hodgkin lymphoma has been approved by the FDA (IND 135475). The FDA approved IND provides clearance for ST-001 nanoFenretinide to enter the clinic. SciTech's Phase I clinical trial will be conducted at the Rush University Medical Center (Chicago, IL) under the guidance and direction of Timothy M. Kuzel, MD, FACP, Samuel G Taylor III MD Professor of Oncology, Chief, Division of Hematology/Oncology/Cell Therapy; Deputy Director, Clinical Affairs, Rush University Cancer Center (Principal Investigator, PI). The study is planned to enroll patients with relapsed/refractory (R/R) T-Cell NHL and is scheduled to begin in mid-2020 with the potential to advance to a registration trial in late 2021.