바이오스펙테이터

바이오스펙테이터 Euna Lee 기자

‘BEY1107’, a CDK1 inhibitor from BeyondBio, is now having clinical trials in patients with pancreatic cancer. On February 19th, BeyondBio announced their FDA approval of phase 1, 2 clinical trial projects on ‘BEY1107’, a candidate for pancreatic cancer treatment.

Clinical trials will be performed on patients with locally advanced or metastatic pancreatic cancer with either BEY1107 alone or combination with Gemcitabine in a single institute at Yonsei University College of Medicine Severance Hospital, South Korea. Maximum tolerated dose, safety, and efficacy will be evaluated in these phase 1,2 clinical trials.

BEY1107 inhibits CDK1 (Cyclin-Dependent Kinase 1), a cell cycle control proteins involved in cell division process, blocks G2/M phase in cell division, and eliminates cancer stem cells. Cancer stem cells have a tolerance on anti-cancer drugs targeting tumor cells, which can induce cancer recurrence; pancreatic cancer has positive CD44 cancer stem cells and is notorious for bad prognosis.

Min Chang-Hee, CEO of BeyondBio, mentioned, “BEY1107 not only controls the cell division of cancer cells but also may overcome the tolerance on anti-cancer drugs with targeting mechanism by eliminating cancer stem cells. And we may expect it to be used in a combination therapy with many other anti-cancer treatments.”

According to the results from non-clinical testing completed in last year, mono-therapy of BEY1107 inhibits CDK1, inhibits self-replication of cancer stem cells, and induces cell destruction. Also, the combination therapy with Gemcitabine, a first line therapy for pancreatic cancer, showed synergistic effects of inhibiting metastasis of cancer cell. The company is expecting a maximized treatment effect of combo therapy of BEY1107 and Gemcitabine by resolving the metastasis, recurrence, and medication tolerance in pancreatic cancer.

Meanwhile, BeyondBio had filed an application for patent of substance use regarding BEY1107 in 12 foreign countries including EU 38 countries.