SynCore Biotechnology Co., Ltd. (SynCore) is selected to present the Phase I study of SB01 at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting.
Dr. Muh-Hwan Su, General Manager, SynCore Biotechnology Co., Ltd, indicated that this Phase I data demonstrated the safety and efficacy profiles of SB01.
SB01 is a novel anti-microtubular agent with vascular disrupting activity. Phase I was conducted on 33 patients with solid tumor. Partial response (PR) was observed in one subject with right buccal squamous cell carcinoma and a total of 57.6% (19/33) subjects had stable disease for at least 2 cycles (6 weeks). Besides, the longest stable disease had reached 24 treatment cycles (72 weeks). The Maximum tolerance Dose (MTD) of SB01was established at 24 mg/m2, and cardiovascular and neurological side effects are identified.
The Phase I study showed that SB01 is safe and tolerable. Clinical disease response was observed in patient with head and neck cancer. Besides, it also demonstrated outstanding disease controls in cholangiocarcinoma, thyroid cancer, and laryngeal cancer. Phase II clinical trial is currently conducted on patients with squamous cell carcinoma of head and neck, under the investigational new drug (IND) approved by both USFDA and TFDA.