STCube, a company developing immuno-oncology drugs, announced on the 31st that it will present a poster on the detailed results of the Phase 1 clinical trial of ‘Nelmastobart’ at next month’s SITC (Society for Immunotherapy of Cancer) annual meeting.
This year’s SITC will be held from November 6 to 10 (local time) in Houston, USA. The titles of the regular abstracts were released on the 4th of this month, and the titles of the late-breaking abstracts (LBA) were additionally disclosed on the 30th.
STCube’s late-breaking abstract is titled “A Phase I study of hSTC810 (Nelmastobart), an anti-BTN1A1 antibody, in patients with advanced solid tumors.”
This is a Phase 1 clinical trial evaluating the safety and tolerability of Nelmastobart monotherapy in 47 patients with advanced solid tumors. STCube received the final clinical study report (CSR) for the Phase 1 trial of Nelmastobart last month and announced the safety results, which were the primary endpoint. At this SITC, the company plans to focus on presenting the efficacy analysis results of the Phase 1 trial of Nelmastobart.
According to the safety evaluation results of the Phase 1 trial, treatment-related adverse events (TRAE) occurred in only 25 out of 47 patients (51.1%), mostly mild reactions of grade 1 to 2 such as fatigue, headache, and drowsiness. There was one clinically significant TRAE of grade 3 or higher (2.1%). No dose-limiting toxicities (DLT) were observed in any patient.
An STCube representative stated, “We were able to confirm the excellent safety, tolerability, pharmacokinetic properties, and scientific validity of Nelmastobart in the Phase 1 trial, and based on these results, we designed Phase 1b/2 clinical trials for small cell lung cancer and investigator-initiated Phase 1b/2 trials for colorectal cancer.” He added, “At this SITC, we plan to present promising data related to the efficacy evaluation of the Phase 1 trial along with basic research results on BTN1A1.”
He continued, “The safety and efficacy of Nelmastobart observed in preclinical studies have been consistently demonstrated in the Phase 1 and Phase 1b/2 clinical trials, giving us confidence in achieving successful outcomes in future clinical studies. We will devote ourselves further to drug development and commercialization to achieve rapid results.”
Nelmastobart is an immune checkpoint inhibitor developed by STCube targeting the novel immune checkpoint BTN1A1. BTN1A1 is a protein that regulates immune responses against cancer cells by suppressing the activity of T cells, which are immune cells. It is strongly expressed in cancer cells but not in normal cells, and is expressed mutually exclusively with PD-L1. STCube is developing immuno-oncology drugs targeting BTN1A1 as a new treatment option for refractory cancers.
Currently, Phase 1b/2 clinical trials of Nelmastobart in combination with paclitaxel are underway in the US and Korea for patients with relapsed or refractory extensive-stage small cell lung cancer (ES-SCLC). Investigator-initiated Phase 1b/2 trials of Nelmastobart combined with capecitabine are also ongoing as a third-line or later treatment for metastatic colorectal cancer.
Previously disclosed STCube’s SITC regular abstract is titled “Spatial Biology Insights into Simultaneous Targeting of BTN1A1 and YAP in Cancer.” This presentation covers the mechanism of BTN1A1 related to YAP, which is known as a cause of resistance to anticancer drugs.
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