Received IRB Approval to enter the clinic at Rush University Medical Center (RUMC)
Oncology Therapeutic With Biomimetic Drug Delivery
SciTech is a clinical stage, specialty pharmaceutical company that has developed a patented, nanoparticle delivery platform (SciTech Drug Delivery Platform, SDP) to maximize the bioavailability of water-insoluble therapeutics, while maintaining or improving safety profiles.
SciTech’s lead drug candidate ST-001 nanoFenretinide is a nano-particle formulation that enables the safe, rapid, intravenous (IV) delivery of high-dose fenretinide. In thousands of patients and multiple clinical trials, fenretinide has been shown to be a safe and effective anticancer therapeutic, with evidence of multiple Mechanisms of Action (MOA) providing a broader therapeutic reach with greater clinical outcomes.
The National Cancer Institute (NCI) saw the vast potential of fenretinide and funded SciTech’s ST-001 nanoFenretinide development. Existing studies and data support a rapid time-to-market of the ST-001 therapeutic opportunity (2-3 years).
PROBLEM: LOW DRUG BIOAVAILABILITY SEVERELY LIMITS CLINICAL USE
Many anti-cancer drug substances have low bioavailability resulting in challenges with achieving full clinical potential. Sub-therapeutic dose levels lead to insufficient delivery to the cancer cell, and unacceptable toxicity to patients. This is true of fenretinide, where low bioavailability for cancer indications has previously remained unsolved - until now.
SOLUTION: AN EFFECTIVE DELIVERY PLATFORM FOR ST-001 NANOFENRETINIDE
• ST-001, a nanoparticle combination of fenretinide and biocompatible phospholipids will allow for the rapid infusion of high-dose fenretinide to 1) solve bioavailability challenges, 2) avoid triglyceride toxicity, and 3) optimize therapeutic efficacy with simple infusion (IV).
• ST-001 should safely produce benefits for fenretinide bioavailability previously unattainable.
• Costs to commercialize and manufacture are believed to be reasonable.
SciTech’s Drug Delivery Platform (SDP), the biomimetic phospholipid matrix which has enabled fenretinide, is capable of delivering other drugs with similar properties, including non-cancer drugs. SDP is capable of delivering drugs alone or as a combination therapy with other drugs or treatment regimens (radiation, surgery). ST-001 fills a large underserved market in the oncology space.
SciTech is seeking funding and strategic partnerships to conduct clinical trials to reconfirm the safety and efficacy of fenretinide in its new nano-formulation.
SciTech Pitch Deck
(Click to scroll through slides)
SCITECH at a glance
ST-001 nanoFenretinide (Proprietary Formulation)
= Fenretinide + SDP
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
$20MM 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)