FDA Clears IND Application for ST-001 in SCLC

US FDA

• The FDA has approved an investigational new drug (IND) application, allowing for a phase 1a/b trial of ST-001 in relapsed/refractory small cell lung cancer (SCLC).
• The trial will evaluate ST-001’s pharmacology with the goal of determining the agent’s maximum tolerated dose and safety profile.
• With this IND clearance, the trial can begin recruiting patients.

The FDA has cleared the IND application for ST-001 in relapsed/refractory SCLC, allowing for the start of a phase 1a/b trial to determine the agent’s pharmacology, maximum tolerated dose, and safety profile.¹

The FDA’s approval comes after a comprehensive safety evaluation, granting clearance for the clinical investigation of ST-001 in SCLC.

The study now can begin recruiting patients and is expected to begin in the second or third quarter of 2025.

"Small cell lung cancer remains a formidable challenge with few effective therapies for patients who relapse or don't respond to initial treatment," said Greg Kalemkerian, MD, thoracic oncologist at the University of Michigan and principal investigator on the trial, in the press release. "ST-001 represents a promising approach, and I'm excited to oversee this trial to evaluate its safety and potential for SCLC patients who desperately need new options."

Small cell lung cancer : © Ekaterina- stock.adobe.com

ST-001 nanoFenretinide uses a proprietary drug delivery platform from SciTech Development to address the longstanding issue of fenretinide’s limited bioavailability. The agent combines fenretinide with biocompatible phospholipids to target hard-to-treat cancers. By enabling high-dose intravenous administration, ST-001 achieves improved systemic exposure, enhanced antitumor activity, and a favorable toxicity profile.¹

Fenretinide itself has undergone extensive clinical evaluation, with several studies showing both its tolerability and therapeutic potential.² First, a large-scale breast cancer chemoprevention trial of approximately 3000 patients demonstrated consistent safety and tolerability in a broad patient population for a 5-year duration. A National Cancer Institute case report also documented a clinical response in a patient with advanced cutaneous T-cell lymphoma (CTCL), offering an early signal of efficacy.

Subsequent findings presented at the American Society of Clinical Oncology Annual Meeting confirmed responses in both CTCL and angioimmunoblastic T-cell lymphoma, while also differentiating fenretinide favorably from comparator agents. Further, in a phase 2 study involving patients with SCLC, fenretinide was well tolerated, with disease stabilization observed in 30% of patients.

"We are thrilled about the FDA's approval of our IND for ST-001 in SCLC," said Earle T. Holsapple, chief executive officer of SciTech Development, in the press release.¹ "This is a pivotal moment that brings us closer to offering a transformative treatment option for patients facing this devastating disease. Our team's dedication to advancing ST-001's potential through innovative nanotechnology is showing promising results, and we're eager to see its impact in the clinic."

References:

1. SciTech Development announces 2nd FDA approval of a phase 1 a/b IND for ST-001. New IND targets the treatment of relapsed/refractory small cell lung cancer following its previous approval in the treatment of T-cell NHL. News release. SciTech Development, Inc. April 8, 2025. Accessed April 8, 2025. https://tinyurl.com/2xfu4zjs

2. SciTech Development. Products. Accessed April 8, 2025. https://www.scitechdevelopment.com/the-product