According to the announcement issued by Jenkem Technology (688356.SH), the results of Phase II study on the safety, tolerability, and preliminary efficacy of the injectable polyethylene glycol iloprostane (drug code: JK1201I) developed by its wholly-owned subsidiary Tianjin Jenkem Technology Co., Ltd. for the treatment of small cell lung cancer have been published in the international academic journal "Cancer Medicine" (impact factor: 4.0).

Polyethylene glycol iloprostane (JK1201I) is a small molecule long-acting anti-cancer class 1 innovative drug developed by the company. The drug is a new type of chemical drug that modifies iloprostane with polyethylene glycol. In the previous non-clinical trials, JK1201I showed better efficacy and safety than commercially available iloprostane hydrochloride. Phase I clinical trials completed in advanced solid tumor patients also showed good safety and tolerability of JK1201I, and achieved partial relief in small cell lung cancer patients. As of the date of this announcement, there are no drugs of the same type and indication on the global market.

The company obtained the clinical trial approval for the drug in January 2016 (approval number: 2016L01726), and the ethical approval from the leading unit of the clinical trial in August 2021 (approval number: 2021YW162). The main purpose of this trial is to evaluate the safety, tolerability, and preliminary efficacy of polyethylene glycol iloprostane given by single and multiple doses for the treatment of small cell lung cancer. The Phase II clinical trial of injectable polyethylene glycol iloprostane for the treatment of small cell lung cancer enrolled its first subject in November 2021 and completed the last subject in October 2022. The study population consists of subjects diagnosed with small cell lung cancer by histology and/or cytology, with recurrence or progression within 6 months of completion of first-line treatment and at least one measurable lesion according to RECIST 1.1 criteria. The study observed promising efficacy endpoints during the trial. Overall survival (OS): The definition of OS is the time from randomization to death from any cause.

This trial is a multicenter, open design study, including two stages of dose escalation and dose expansion. A total of 33 subjects were screened in this study, and 29 of them were eligible and successfully enrolled. All 29 enrolled subjects received the investigational drug treatment. The statistical analysis results of this ongoing study show that the safety of JK1201I as a second-line treatment for extensive-stage small cell lung cancer is satisfactory, and patients can tolerate it well. Among the 26 subjects included in the overall best tumor response analysis (EAS analysis) (180mg/m2 group: 24 subjects, 220mg/m2 group: 2 subjects), the median OS in the 180mg/m2 group reached 12.1 months, showing a trend of prolonging patient survival, which is expected to provide more benefit to patients from treatment.

With positive research data, more detailed information about this clinical trial has been published in the international academic journal "Cancer Medicine". In addition, Phase II clinical trial research on JK1201I combined with temozolomide for the treatment of glioblastoma is still ongoing.