|Title||PharmAbcine Receives HREC Clearance for Phase II Trial of Olinvacimab and Pembrolizumab in mTNBC|
DAEJEON, South Korea, September 3, 2021 /PRNewswire/ -- PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of antibody therapeutics, announced today that the company has received Human Research Ethics Committee (HREC) clearance to commence the Phase II combination trial of olinvacimab, PharmAbcine’s anti-VEGFR2 antibody, and KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 molecule, for the treatment of metastatic Triple-Negative Breast Cancer (mTNBC) in Australia.
The Phase II clinical trial is an open-label and multicenter trial that will enroll 36 immuno-oncology drug naïve mTNBC patients regardless of their PD-L1 expression level. The study will evaluate the clinical efficacy, safety, pharmacodynamics, and the expression level of VEGFR-2 and PD-L1 after the administration of 16mg/kg of olinvacimab, and 200mg of pembrolizumab. PharmAbcine will sponsor the clinical trial that will take place in Australia, and MSD will supply pembrolizumab.
PharmAbcine and MSD decided to enter this collaboration based on the promising clinical data obtained from the Phase Ib olinvacimab and pembrolizumab study in mTNBC which is still ongoing in Australia. According to the interim result presented at San Antonio Breast Cancer Symposium (SABCS) 2020, olinvacimab in combination with pembrolizumab showed a clear safety profile and certain encouraging efficacy data, including 50% Overall Response Rate (ORR) and 67% Disease Control Rate (DCR) in the high-dose olinvacimab (16mg/kg) cohort (n=6pts). In addition, one patient in Partial Response (PR) showed Complete Response (CR) in the target lesion and another PR patient showed CR in a non-target lesion.
mTNBC is a highly malignant type of cancer that shows a high recurrence rate within the first five years after the diagnosis. mTNBC accounts for 15-20% of all breast cancers and shows a 5-year survival rate of approximately 11%. Unlike some other breast cancers, mTNBC does not express estrogen or progesterone receptors or human epidermal growth factor receptor 2 (HER2), and it does not respond to existing cancer drugs designed to target these markers. mTNBC is very difficult to treat, and there are very few FDA approved treatment options for these patients.
"This is a significant milestone for the company, as we strongly believe that olinvacimab could be a new therapeutic option for mTNBC patients," said Dr. Jin-San Yoo, CEO of PharmAbcine. "We are excited to initiate this study and expect the first patient enrollment to take place in October 2021.
PharmAbcine's leading pipeline, olinvacimab is an anti-VEGFR2 neutralizing fully human IgG. It is currently in a Phase II study for bevacizumab-nonresponding rGBM (recurrent glioblastoma multiforme) patients in both US and Australia. In addition to the ongoing Phase Ib olinvacimab and pembrolizumab combo trial in mTNBC, another olinvacimab plus pembrolizumab Phase Ib trial for rGBM is ongoing in Australia.
About PharmAbcine Inc.
PharmAbcine is a clinical-stage biotech company focusing on the development of fully human antibody therapeutics to treat neovascular disorders, tumors, and other medically unmet diseases. It provides therapeutic antibodies for a wide spectrum of indications from oncology, immuno-oncology, ophthalmology, pulmonology, to renal pathology.
PharmAbcine has its own HuPhage library and innovative selection system. PharmAbcine's advanced 3G expression system accommodates high levels of antibody production and steady reproducibility. With these cutting-edge technology platforms, it provides state-of-the art antibody generation services.
PharmAbcine also has unique knowhow in the area of the antibody production, early drug development, and clinical development.
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