STCube receives US FDA IND approval for Phase 1b and 2 clinical trials... "Full-scale development of small cell lung cancer treatment"

STCube is accelerating the development of Nelmastobat (hSTC810), an immuno-oncology drug for small cell lung cancer.

On the 25th, STCube announced that it received IND (Investigational New Drug) approval from the U.S. Food and Drug Administration (FDA) for the Phase 1b/2 clinical trials of Nelmastobat. Nelmastobat also received Phase 1b/2 clinical trial approval from the Ministry of Food and Drug Safety (MFDS) on the 21st.

An STCube representative stated, “Through organoid experiments, we confirmed the potential of Nelmastobat as an innovative drug for combination therapy that can enhance treatment efficacy for small cell lung cancer,” and added, “We will strive for rapid commercialization as an innovative drug for small cell lung cancer, which is characterized by rapid metastasis and high recurrence rates.”

They continued, “All research results so far have come out as expected,” and added, “Based on reliable data on the safety and efficacy of Nelmastobat, we are confidently advancing the Phase 1b/2 clinical trials.”

Currently, STCube is conducting multinational clinical trials targeting small cell lung cancer with a combination therapy of the chemotherapy drug paclitaxel. The Phase 1b/2 trials have officially commenced, with plans to start dosing the first patient within this year.

Domestic clinical trials are being conducted at Samsung Seoul Hospital, Seoul National University Hospital, Seoul National University Bundang Hospital, Asan Medical Center, Korea University Anam Hospital, and The Catholic University of Korea St. Vincent’s Hospital. U.S. clinical trials are being conducted at MD Anderson Cancer Center (MDACC), Yale Cancer Center, and Northwestern University Hospital.

In Phase 1b, the safety of the combination of Nelmastobat and paclitaxel will be evaluated. In both Phase 1b and 2, the objective response rate at 3 months (12 weeks) and progression-free survival at 6 months (24 weeks) will be assessed. Phase 1b will involve up to 12 patients, and Phase 2 will involve up to 118 patients.