|Title||PharmAbcine announces Clinical Trial Collaboration with MSD for the Phase II study in mTNBC|
PharmAbcine announces Clinical Trial Collaboration with MSD for the Phase II study in mTNBC
DAEJEON, South Korea, April 19, 2021 /PRNewswire/ -- PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of antibody therapeutics, announced today that the company has entered into an agreement with MSD to initiate a Phase II combination trial of olinvacimab, an anti-VEGFR2 antibody, and KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy, in metastatic Triple-Negative Breast Cancer(mTNBC).
The phase II clinical trial, an open-label, multicenter trial, will enroll immuno-oncology drug naïve mTNBC patients regardless of their PD-L1 expression level to evaluate the clinical efficacy, safety, pharmacodynamics, and the expression level of VEGFR-2 and PD-L1 after administering 16mg/kg of olinvacimab and 200mg of pembrolizumab.
The companies have entered this collaboration based on the promising clinical data obtained from the phase Ib olinvacimab and pembrolizumab study in mTNBC which is currently ongoing in Australia. According to the interim result as of September 2020, the combo therapy showed a manageable safety profile with 50% ORR (Overall Response Rate) and 67% DCR (Disease Control Rate) in patients who received olinvacimab plus pembrolizumab at the recommended phase 2 dose (RP2D) (N=6pts). In addition, 1 patient in PR (Partial Response) showed CR (Complete Response) in the target lesion and another PR patient showed CR in a non-target lesion.
Under the terms of the agreement, PharmAbcine will sponsor a phase II clinical trial that will take place in both Australia and South Korea, and MSD will supply KEYTRUDA.
“Helping cancer patients is core to our mission. Based on the safety profile and early clinical efficacy observed in the phase Ib trial, we feel we have a responsibility to explore olinvacimab in combination with pembrolizumab in mTNBC patients further in phase II,” said Dr. Jin-San Yoo, CEO of PharmAbcine. "We will try our best so the multinational clinical study can begin in the first half of 2021."
About Metastatic Triple Negative Breast Cancer (TNBC)
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 receptor, progesterone receptors and human epidermal growth factor receptor 2 (HER2), and it does not respond to existing cancer drugs designed to target these markers. mTNBC is still very difficult to treat, and there are very few FDA approved treatment options for these patients.
PharmAbcine's leading pipeline, olinvacimab, an anti-VEGFR2 neutralizing fully human IgG, is currently in a phase II study for bevacizumab-nonresponding rGBM (recurrent glioblastoma multiforme) patients in both US and Australia. In addition to the combination of olinvacimab and pembrolizumab 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.