Advancing Cancer Treatment Through Safer Drug Delivery
SciTech is a clinical stage, specialty pharmaceutical company that has developed a proprietary nanoparticle delivery platform (SciTech Drug Delivery Platform, SDP) to maximize the bioavailability of water-insoluble therapeutics, while maintaining or improving safety profiles.
SciTech's first engineered therapeutic using the delivery platform is our patented lead drug candidate ST-001 nanoFenretinide, a combination of SDP with the promising cancer drug fenretinide. ST-001 nanoFenretinide is a nano-particle formulation that should enable the safe, rapid, intravenous (IV) delivery of high-dose fenretinide. In thousands of patients and multiple clinical trials [2] fenretinide has been shown to be a relatively safe and effective anticancer therapeutic, with evidence of multiple Mechanisms of Action (MOA) potentially providing a broader therapeutic reach with greater clinical outcomes. [3, 4]
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). [5]
PROBLEM: LOW DRUG BIOAVAILABILITY SEVERELY LIMITS CLINICAL USE [6]
SOLUTION: AN EFFECTIVE DELIVERY PLATFORM FOR ST-001 NANOFENRETINIDE
• ST-001, a nanoparticle combination of fenretinide and biocompatible phospholipids [7] should 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). [8]
• 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, should be capable of delivering other drugs with similar properties, including non-cancer drugs. SDP should be capable of delivering drugs alone or as a combination therapy with other drugs or treatment regimens (radiation, surgery). ST-001 could fill a large underserved market in the oncology space.
SciTech is seeking funding and strategic partnerships to conduct clinical trials to assess the safety and efficacy of fenretinide in its new nano-formulation.
REFERENCES
1. ClinicalTrials.gov Identifier: NCT04234048.
2. Cazzaniga, M., Varricchio, C., Montefrancesco, C., Feroce, I., & Guerrieri-Gonzaga, A. (2012). "Fenretinide (4-HPR): a preventive chance for women at genetic and familial risk?". Journal of biomedicine & biotechnology, 2012, 172897. https://doi.org/10.1155/2012/172897.
3. Mody N, Mcilroy GD. "The mechanisms of Fenretinide-mediated anti-cancer activity and prevention of obesity and type-2 diabetes". Biochem Pharmacol. 2014 Oct 1;91(3):277-86. doi: https://doi.org/10.1016/j.bcp.2014.07.012. Epub 2014 Jul 25. PMID: 25069047.
4. Cooper, J. P., Reynolds, C. P., Cho, H., & Kang, M. H. (2017). "Clinical development of fenretinide as an antineoplastic drug": Pharmacology 3. perspectives. Experimental Biology and Medicine, 242(11), 1178–1184. https://doi.org/10.1177/1535370217706952.
5. United States Food and Drug Administration (2018). Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry. Accessed at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm616325.pdf
6. Orienti, I., Francescangeli, F., De Angelis, M.L. et al. "A new bioavailable fenretinide formulation with antiproliferative, antimetabolic, and cytotoxic effects on solid tumors". Cell Death Dis 10, 529 (2019). https://doi.org/10.1038/s41419-019-1775-y.
7. FDA Substance Registration System, Unique Ingredient Identifier (UNII) for phospholipids DPPC (319X2NFW0A), DOPC (H026DM5V6U), DMPC (52QK2NZ2T0) and DMPG (L34S99KZCX).
8. Mohrbacher AM, Yang AS, Groshen S, Kummar S, Gutierrez ME, Kang MH, Tsao-Wei D, Reynolds CP, Newman EM, Maurer BJ. "Phase I Study of Fenretinide Delivered Intravenously in Patients with Relapsed or Refractory Hematologic Malignancies: A California Cancer Consortium Trial". Clin Cancer Res. 2017 Aug 15;23(16):4550-4555. doi: https://doi.org/10.1158/1078-0432.CCR-17-0234. Epub 2017 Apr 18. PMID: 28420721; PMCID: PMC5559312.
9. Koinis, F., Kotsakis, A., & Georgoulias, V. (2016). "Small cell lung cancer (SCLC): no treatment advances in recent years". Translational lung cancer research, 5(1), 39–50. https://doi.org/10.3978/j.issn.2218-6751.2016.01.03
10. Zhang, Y., Xu, W., Liu, H. et al. "Therapeutic options in peripheral T cell lymphoma". J Hematol Oncol 9, 37 (2016). https://doi.org/10.1186/s13045-016-0267-0
11. Umberto Veronesi, Giuseppe De Palo, Ettore Marubini, Alberto Costa, Franca Formelli, Luigi Mariani, Andrea Decensi, Tiziana Camerini, Marco Rosselli Del Turco, Maria Gaetana Di Mauro, Maria Grazia Muraca, Marcella Del Vecchio, Carmine Pinto, Giuseppe D'Aiuto, Corrado Boni, Tiziana Campa, Andrea Magni, Rosalba Miceli, Marjorie Perloff, Winfred F. Malone, Michael B. Sporn, For the Fenretinide Trial Investigators, "Randomized Trial of Fenretinide to Prevent Second Breast Malignancy in Women With Early Breast Cancer", JNCI: Journal of the National Cancer Institute, Volume 91, Issue 21, 3 November 1999, Pages 1847–1856, https://doi.org/10.1093/jnci/91.21.1847
12. Companioni Osmel, Mir Cristina, Garcia-Mayea Yoelsis, LLeonart Matilde E., "Targeting Sphingolipids for Cancer Therapy",
Front. Oncol., Volume 11, 19 October 2021, https://doi.org/10.3389/fonc.2021.745092
SCITECH at a glance
Drug Candidate
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. [9, 10]
Fenretinide: A Proven Anti-Cancer Agent
Fenretinide has established efficacy in humans;
shown to be safe in 1,000’s of patients. [11]
Unique ST-001 nanoFenretinide Formulation
Expected drug delivery of therapeutic doses - with anticipated safety & effectiveness;
Patented.
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.
Exit Strategy
Potential targeted acquisition.
Time to Market
2-3 years (unusually short).
Drug Mechanism of Action (MOA) [3, 12]
ST-001 NanoFenretinde Drug MOA (YouTube video)
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