The phase 1 clinical trial of 21 patients with solid cancer was conducted to assess the efficacy and safety of the monotherapy of SNB-101. The purpose of the trial was to establish the recommended dose for the phase 2 trial, and it was conducted under the supervision of Professor Joo-Hang Kim at CHA Bundang Medical Center, Professor Myung A Lee at Catholic University of Korea Seoul ST. Mary’s Hospital, and Professor Sun Young Rha at Severance Hospital of the Yonsei University.
Solid cancer patients with various solid tumors, such as small cell lung cancer, non-small cell lung cancer, stomach cancer, esophageal cancer, cervical cancer, and colorectal cancer, participated in the phase 1 clinical trial and failed to have the expected results from the standard therapeutic approach. And those subjects had experience of 1 ~ 9 cycles of treatment.
The result of the phase 1 clinical trial showed excellent safety in the scope of the delivery dose of 5~50mg/m2 of SN-38. Notably, even when the highest delivery dose of 50mg/m2 was administered, the drug didn’t reach the Maximum Tolerable Dose.
One of the common side effects is hematological ones, such as neutropenia, and it was properly managed. Specifically, the frequent grade 3 event or higher diarrhea, a major side effect reaction observed with similar drugs like irinotecan, was not observed, indicating superior safety and tolerability compared to competing drugs.
Regarding efficacy evaluation, among the total of 21 patients, partial response (PR) was observed in 14.3% (3 patients with small cell lung cancer, non-small cell lung cancer, and colorectal cancer), stable disease (SD) in 28.6% (6 patients with small cell lung cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and stomach cancer), and progressive disease (PD) in 57.1% (12 patients), resulting in an overall disease control rate (DCR) of 42.9%, reflecting the characteristics of conventional cytotoxic anticancer agents. Particularly, the disease control rate (DCR) in the high-dose group (40-50mg/m2) was 83.3%, demonstrating a dose-response relationship.
SNB-101 is a polymer nanoparticle with an average particle size of about 100 ㎚, and preclinical studies have shown that it has significantly higher lung distribution compared to conventional aqueous anticancer agents, indicating its effectiveness in lung-related tumors such as small cell lung cancer and non-small cell lung cancer in preclinical and phase 1 studies. Based on these preclinical and phase 1 results, SN BioScience plans to conduct a phase 2 clinical trial targeting small-cell lung cancer in multiple countries, including the United States, in 2024.
Small cell lung cancer, which is one of the areas with high unmet medical needs, is currently treated with a combination therapy of cisplatin and etoposide as first-line treatment. Second-line therapies include recently approved orphan drugs like Lurbinectedin (marketed as ZEPZELCA), as well as traditional chemotherapeutic agents such as topotecan and paclitaxel.
According to the National Comprehensive Cancer Network (NCCN) guidelines, clinical trials are included as second-line treatment options, reflecting the extremely limited options for treatment. However, SNB-101 demonstrated superior efficacy as a second-line therapy for small-cell lung cancer based on preclinical trials and superior efficacy compared to first-line therapies. In the phase 2 clinical trial, SN BioScience aims to secure superior clinical data compared to competing drugs through monotherapy or combination with immune checkpoint inhibitors and aims for rapid approval based on the results for global market entry.
SN BioScience, established in May 2017, is a biotech venture specializing in nanomedicines in the second Pangyo Techno Valley in Seongnam, Gyeonggi Province.
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