Cullinan Oncology, Inc. (CGEM) stock prices were up by 18.63% shortly after market trading commenced on June 4th, 2021, bringing the price per share up to USD$35.30 early on in the trading day.
CLN-081 Trial Update
The oncology company announced supplementary information about Cullinan Pearl’s ongoing Phase 1/2a trial of CLN-081 on June 4th, 2021. The trial targets patients with Non-Small Cell Lung Cancer (NSCLC) whose tumor harbor epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The treatment is available orally and is an irreversible EGFR inhibitor which utilizes an innovative pyrrolopydrimidine scaffold. This scaffold is designed to selectively target cells expressing mutant EGFR variants, including exon 20 while circumventing doing damage to cells expressing wild type (WT) EGFR.
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Details of Trial
The existing analysis of the current trial saw the evaluation of a total of 45 NSCLC patients with EGFR exon 20 insertion mutations, with each patient having been administered at least one dose of CLN-081 as of April 1st of 2021 and had been deemed evaluable for safety. The treatment was dosed orally at dosage levels that included 30, 45 65, 100, and 150 mg twice daily. As of April 1st, 2021, 42 out of the total 45 patients were response evaluable across all of the cohorts that had been tested.
Rashes were limited to Grade 1 and 2 events, with 76% of all patients have experienced an event across the range of doses administered, as of April 1st, 2021. Incidents were manageable with conventional supportive care, with no patients reporting having experienced Grade 3 or higher treatment-related rashes as an adverse event.
Similarly, diarrhea was by and large limited to Grade 1 and 2 events, with incident reports of 22% across the range of doses administered as of April 1st, 2021. A single Grade 3 or higher TRAE was reported, with the patient having been administered the highest dose tested to date, 150 mg BID. The incident was resolved with supportive care, with no need for a prophylactic regimen to ameliorate the situation or severity of diarrhea.
Future Outlook for CGEM
With the recent disclosure of the additional information regarding the efficacy and safety of the CLN-081 trial, CGEM is poised to continue pushing for the speedy commercialization of their treatment. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.