InnoCare Announces First Pediatric Patient Dosed in Clinical Trial of pan-TRK Inhibitor Zurletrectinib in China

Jan. 24, 2024 - InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the first pediatric patient has been dosed in clinical trial with its second generation pan-TRK inhibitor zurletrectinib at Sun Yat-sen University Cancer Center. This is the first time that zurletrectinib will be evaluated in a clinical study of pediatric (2 to 12 years old) patients, after demonstrating good safety and efficacy in adult and adolescent patients (12 to 18 years old).

Zurletrectinib, developed by InnoCare, is a pan-TRK inhibitor which markedly inhibits the activity of the wild type TRKA, TRKB and TRKC, as well as mutant TRKA with resistant mutations G595R or G667C. Zurletrectinib could overcome acquired resistance to the first-generation TRK inhibitors.

InnoCare has been advancing the registrational trial of zurletrectinib in China and is expecting to submit the new drug application in the second half of 2024. An overall response rate (ORR) of 80-90%, indicating favorable efficacy, was observed in adult patients with various cancers carrying NTRK gene fusion who received dosages of 8 mg or more. 

Dr. Jasmine, the Co-founder, Chairwoman, and CEO of InnoCare, said, "NTRK gene fusion is a driving factor for various adult and pediatric cancers. It is inspiring that we continue to make positive progress in our clinical research of zurletrectinib for patients of different ages with NTRK gene fusion. We expect to see our innovative assets benefit solid tumor patients in the near future."

In some rare tumor types, such as congenital infantile fibrosarcoma, the incidence of NTRK gene fusion is as high as 90%. NTRK gene fusion is associated with at least 19 tumor types in adults and children, including lung cancer, colorectal cancer, breast cancer, pancreatic cancer and melanoma.