STCube Submits IND for Nelmastovat Phase 1b/2 Clinical Trial to US FDA

STCube, a bio company developing immuno-oncology drugs, announced on the 25th that it has submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for approval of clinical Phase 1b/2 trials of its first-in-class innovative drug, Nelmastobat (hSTC810).

The Phase 1b/2 clinical trial will be conducted in combination with the taxane-class drug paclitaxel, targeting patients with relapsed or refractory extensive-stage small cell lung cancer (R/R ES-SCLC). The company plans to conduct clinical trials simultaneously with the Ministry of Food and Drug Safety (MFDS) in Korea and the FDA in the U.S. The U.S. trials will be carried out at MD Anderson Cancer Center (MDACC), Yale Cancer Center, and Northwestern University Hospital.

Small cell lung cancer is a rare and difficult-to-treat disease characterized by very rapid progression and a survival rate below 5%. There are currently few new drugs under development, resulting in a significant unmet medical need.

An STCube representative stated, "Generally, small cell lung cancer (SCLC) has a low PD-L1 expression rate, but Phase 1 clinical trial results confirmed a high expression rate of BTN1A1. Taxane-class anticancer drugs have immunomodulatory effects, which are known to improve the efficacy of immuno-oncology drugs by reducing the recruitment of Treg cells into the tumor microenvironment, thereby controlling tumor growth."

For patients with extensive disease (ED) where cancer has metastasized to the opposite lung or other organs, overall survival (OS) is less than one year, and progression-free survival (PFS) is approximately three months. Among the Phase 1 trial participants of STCube, two patients with advanced small cell lung cancer maintained a PFS of about 8 to 9 months. One small cell lung cancer patient has maintained a stable disease (SD) state with tumor size reduction and no adverse reactions to date. Two additional enrolled patients are currently under continuous observation.

A company representative added, "Nelmastobat is a first-in-class innovative drug that could provide a progressive treatment option for small cell lung cancer patients. If the expected efficacy is verified in the Phase 1b/2 trials, we anticipate it will become a backbone treatment drug desired for combination therapy by pharmaceutical and bio companies worldwide."

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