STCube announced on the 21st that it has received approval from the Ministry of Food and Drug Safety for the investigational new drug application (IND) for the immune anticancer candidate nelmastovat for metastatic colon cancer phase 1b and 2 clinical trials.
Until now, the medical community has understood that the reason cancer cells spread in our bodies is due to proteins called PD-1 and PD-L1. Cancer cells disguise themselves as normal cells with these substances to evade the attack of immune cells (T cells). However, many patients still do not respond to treatments with PD-1 and PD-L1 immune checkpoint inhibitors.
In response, STCube has discovered a new immune checkpoint protein, BTN1A1, for the first time in the world and developed nelmastovat, an immune anticancer candidate substance targeting it. The company is developing it as a first-in-class immune checkpoint inhibitor targeting PD-L1 drugs and BTN1A1. It is expected to provide a new treatment alternative for patients who do not respond to existing therapies or have developed resistance.
The approved phase 1b and 2 clinical trials are planned to be conducted at five university hospitals in South Korea. Currently, the Clinical Ethics Review Committee (IRB) review at Korea University Anam Hospital is underway, and applications for IRB review will be promptly submitted to the other hospitals to accelerate the clinical process.
In phase 1b (minimum 6 participants), the maximum tolerated dose (MTD) for combination therapy and the recommended phase 2 dose (RP2D) will be confirmed, with a completion of dose-limiting toxicity (DLT) evaluation planned within the first half of this year. In the subsequent phase 2 (minimum 52 participants), it is planned to evaluate the progression-free survival (PFS) of patients with a BTN1A1 tumor proportion score (TPS) of 50% or more, measuring the duration of survival without progression or metastasis.
Jung Hyun-jin, CEO of STCube, said, "This clinical trial will be an important opportunity to prove the value of the new drug for BTN1A1, a new immune anticancer target, and nelmastovat. Since the pharmacological characteristics of nelmastovat have already been verified through previous studies, I expect the IRB procedures to proceed swiftly as well."