BARDA COVID-19 ST-001 application filed
Pre-IND for COVID-19 submitted to FDA
U.S. Army (USAMRDC) COVID-19 application filed
Received IRB Approval to enter the clinic at Rush University Medical Center (RUMC)
SciTech Advances ST-001 nanoFenretinide to Clinical Trials for SARS-CoV-2
Enabling Proven Cancer Drugs
SciTech Development, LLC is a Michigan based oncology drug development company currently bringing to market proven cancer drugs for diseases with limited therapeutic options.
Originally associated with the Karmanos Cancer Institute (KCI) and Wayne State University (WSU), SciTech was tasked with addressing the therapeutic performance limitations of fenretinide; namely, its inherently poor solubility, the associated poor bioavailability and the consequent inability to deliver safe and effective doses.
By creating the first ever triglyceride-free (oil free) intravenous vehicle, the company has successfully completed the task of finally delivering on the promise of fenretinide as an anticancer agent.
SciTech Development has developed unique, patented nano delivery systems
(SciTech Drug Delivery Vehicle - SDV) to enable intravenous (IV) delivery of water insoluble (hydrophobic) drugs. One such challenged drug is fenretinide which has been shown in extensive clinical trials to be a safe and effective anticancer therapy with targeted cancer destroying activity. The combination of the new SDV and fenretinide has led to SCI’s first proprietary drug product, ST-001 nanoFenretinide.
SciTech is seeking funding and strategic partnerships to conduct Phase 1A & 1B clinical trials to reconfirm the safety and efficacy of the active pharmaceutical (API), fenretinide, in its new nano-formulation while confirming the newly identified immune mechanism of action (MOA) as a further goal of the protocol. The API has been proven to be safe in prior clinical trials involving >3k patients while showing partial efficacy in the treatment of 5 cancer indications and potential in the treatment of ~ 10 other cancer indications.
SciTech’s lead compound, ST-001 nanoFenretinide, is a small molecule immune oncology nanoFenretinide 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 of their extensive use 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 multiple mechanisms of action), resulting in cancer cell destruction (apoptosis).
SCITECH at a glance
ST-001 nanoFenretinide (Proprietary Formulation)
= Fenretinide + SDV.
2 cancer indications: t-cell lymphoma; and,
small cell lung cancer (SCLC);
All diseases with limited therapeutic options.
Unique ST-001 nanoFenretinide Formulation
Drug delivery of therapeutic doses - safely & effectively.
Strategic & Rapid Drug Development
Existing human efficacy data;
Access to NCI data;
Streamlined clinical trials design;
Fenretinide provided free by NCI.
FDA expedited programs anticipated:
(1) Fast Track designation
(2) FDA Orphan Drug designation - Granted Dec. 2017
(3) Accelerated Approval pathway
(4) Priority Review designation.
Amount of Financing Sought
$15MM Series A for completion of clinical trials required for NDA filing.
Use of Funds
cGMP drug manufacture (ST-001) Clinical Trials (Phase I);
FDA compassionate use approval & NDA filings.
Time to Market
2-3 years (unusually short).
Drug Mechanism of Action (MOA)