Clinical-stage oncology company SciTech Development Inc announced on Tuesday that it has received its second Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for ST-001, a fenretinide phospholipid suspension for intravenous infusion.

This new authorisation enables the company to begin a Phase 1a/b trial targeting relapsed or refractory small cell lung cancer (SCLC).

SciTech previously secured IND approval for ST-001 in the treatment of T-cell non-Hodgkin lymphoma. The upcoming SCLC trial will evaluate safety, pharmacology and the maximum tolerated dose of ST-001, with patient recruitment scheduled to begin in the second or third quarter of 2025.

ST-001 utilises a patented nanoparticle drug delivery platform designed to enhance fenretinide bioavailability and reduce toxicity. The company aims to address the lack of effective therapies for aggressive cancers like SCLC.

The FDA's decision followed a completed safety review of the IND submission. SciTech said that this milestone affirms its strategy to expand the clinical reach of ST-001 across multiple cancer indications.