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Technology | Fenretinide | nanoFenretinide | SciTech Development
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SCITECH ST-001

Clinical Trials

SciTech’s gateway clinical trial is underway, targeting T-cell non-Hodgkin lymphoma (T-cell NHL) indications including all sub-types of Cutaneous T-cell lymphoma (CTCL), Mycosis Fungoides (MF), Sézary Syndrome (SS), Angioimmunoblastic T-cell lymphoma (AITL), and other types of systemic T-cell lymphomas. The trial is activated and enrolling at 9 prestigious cancer institutions across the U.S., supported by world-renowned scientific advisors and principal investigators specializing in T-cell NHL.

 

SciTech’s Innovative Clinical Trial Design and Approach

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Unlike traditional Phase 1 trials that are focused primarily on safety, the FDA approved the Phase 1a accelerated dose-escalation design based on extensive research and prior clinical testing of fenretinide in over 3,000 patients. In addition, ST-001 was predicted to have a favorable safety profile, supporting the FDA’s decision to proceed.

 

  • The accelerated Phase 1a stage of the trial is designed to achieve multiple objectives early in clinical development. These include confirming safety, assessing pharmacokinetics, and pharmacodynamics. The accelerated stage of the trial has completed enrollment with final data expected in late Q1, 2025.

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  • Phase 1a standard is the next stage of the trial and was started in January 2025.  This trial is a dose-escalation 3+3 design with ~15 patients, to determine the optimal therapeutic dosing in patients with T-cell NHL. This clinical trial approach could likely reduce the time needed to meet key endpoints, allowing for a faster transition to Phase1b.

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  • The Phase 1b expanded stage of the trial will include ~20 patients at the maximum tolerated dose (MTD) and is expected to begin in Q4 2025.​

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* Ann M. Mohrbacher, Allen S. Yang, Susan Groshen, Shivaani Kummar, Martin E. Gutierrez, Min H. Kang, Denice Tsao-Wei, C. Patrick Reynolds, Edward M. Newman and Barry J. Maurer; Phase I Study of Fenretinide Delivered Intravenously in Patients with Relapsed or Refractory Hematologic Malignancies: A California Cancer Consortium Trial; Clin Cancer Res August 15 2017 (23) (16) 4550-4555; doi: https://doi.org/10.1158/1078-0432.CCR-17-0234​

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ST-001 nanoFenretinide is an IND approved, orphan designated, small-molecule immune oncology (IO) nano size fenretinide drug candidate with FDA designed accelerated path to NDA at Phase 1b completion. The API is safe & efficacious in 5 cancers. 

 

 

 

SciTech’s lead drug candidate, ST-001 nanoFenretinide, is a small-molecule immune oncology nano fenretinide cancer drug candidate 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 drug delivery platform also offers the potential of being used to deliver other APIs.

nanoFenretinide brand logo

Manufacturing

ST-001 nanoFenretinide Manufacturing Status: 

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  • 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​

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