STCube, an immuno-oncology drug development company, is embarking on the development of a treatment for small cell lung cancer (SCLC), a disease with a very high unmet medical need. The company has designed Phase 1b/2 clinical trials to enable potential orphan drug designation and aims for rapid product approval.
On the 4th, STCube announced that it submitted an Investigational New Drug (IND) application for the Phase 1b/2 clinical trial to the Ministry of Food and Drug Safety (MFDS) to validate the efficacy of Nelmastovat (hSTC810).
The Phase 1b/2 trial targets patients with relapsed or refractory extensive-stage small cell lung cancer (R/R ES-SCLC). STCube plans to conduct clinical trials simultaneously with the MFDS and the U.S. Food and Drug Administration (FDA). Domestic trials will be 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.
An STCube representative stated, “Principal investigators (PIs) from major multinational hospitals have evaluated the Phase 1 results of Nelmastovat very positively and are actively participating in the clinical trials. We expect the number of hospital sites to increase during the trial period, which will accelerate the clinical progress significantly.”
Furthermore, investigator-initiated trials are expected to be actively conducted. Many clinicians wish to expand indications to colorectal cancer, bladder cancer, and non-small cell lung cancer through separate investigator-initiated studies. In particular, investigator-initiated trials considering Nelmastovat as a first-line treatment for small cell lung cancer are currently under discussion.
Small cell lung cancer, a rare and intractable disease, progresses rapidly and has a high recurrence rate. For patients with extensive disease (ED) where cancer has metastasized to the opposite lung or other organs, overall survival (OS) is known to be less than one year, and progression-free survival (PFS) is approximately three months.
BTN1A1, the immune checkpoint protein targeted by Nelmastovat, shows a high expression rate in small cell lung cancer, which is known to have low PD-L1 expression and generally does not respond to most immune checkpoint inhibitors. When combined with standard chemotherapy, it is expected to demonstrate innovative efficacy.
A company representative said, “If orphan drug designation is granted and efficacy results superior to existing treatments are achieved, accelerated approval applications will be possible, enabling rapid product approval. Additionally, investigator-initiated trials for various indications will serve as important opportunities to prove therapeutic effects and achieve commercialization, which we believe will rapidly increase the value of Nelmastovat.”
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