Yooyoung Pharmaceutical will present the results of its phase 1 clinical trial for YYB101, an anti-hepatocyte growth factor (HGF) antibody in refractory solid tumor patients, at ASCO 2019.
The study, conducted on 39 patients with refractory solid tumors, is on the integrative pathologic-genomic analysis and the final results of the drug in the company’s phase 1 clinical trial.
The company intravenously administered YYB101 at once every two weeks doses of 0.3, 1, 3, 5, 10, 20, 30 mg/kg, according to a 3+3 dose escalation design. The enrolled patients received YYB101 until disease progression or intolerable toxicity.
The company completed the escalation and expansion cohorts (20mg/kg) while performing a pre-planned biomarker analysis in parallel to the study.
As a result, none of the patients discontinued treatment due to side effects, and data on efficacy were encouraging. YooYoung Pharma plans to conduct a phase 2 clinical trial to evaluate YYB101 combination therapy in patients with metastatic colorectal cancer (CRC).
“YYB101 has a favorable safety profile in patients with refractory solid tumors and dose-proportional pharmacokinetics,” the company concluded. “Efficacy data are encouraging, and the company plans to conduct a phase 2 clinical trial on combination therapy with YYB101 in metastatic CRC patients as salvage treatment.”
The predictive power of mesenchymal signature in YYB responders will be defined prospectively, it added.
Yooyoung started developing the drug in partnership with the National OncoVenture, which is under the Ministry of Health and Welfare, from 2009.
Unlike competitor drugs, the drug has differentiated functions as Yooyoung designed the drug with a new method. According to the company, the treatment showed cancer cell death and metastasis inhibition in nonclinical studies on glioblastoma, sarcoma, and ovarian cancer.
The company plans to present its poster session on June 1, at Hall A of the McCormick Place in Chicago, Ill.
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