|Title||PharmAbcine Announces Last Patient Last Visit in its Phase Ib mTNBC Combination Trial|
PharmAbcine Announces Last Patient Last Visit in its Phase Ib mTNBC Combination Trial
DAEJEON, South Korea, February 25, 2022 /PRNewswire/ -- PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next-generation antibody therapeutics, announced today the completion of last patient last visit in its Phase Ib combination trial for mTNBC (metastatic Triple-Negative Breast Cancer) patients in Australia.
The clinical study, which had the first patient dosed in December 2018, evaluated the safety and clinical efficacy of olinvacimab, the Company’s anti-VEGFR2 (Vascular Endothelial Growth Factor Receptors) antibody candidate, in combination with MSD’s (Merck & Co., Inc., Kenilworth, NJ., USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). A total of 11 patients were recruited and divided into two cohorts. The low-dose cohort (five patients) received a 12mg/kg weekly dose of olinvacimab, and the high-dose cohort (six patients) received a 16mg/kg weekly dose of olinvacimab. All patients equally received a 200mg flat dose of pembrolizumab every three weeks.
In December 2020, PharmAbcine presented the highly encouraging interim data of the study at SABCS (San Antonio Breast Cancer Symposium). In the high-dose olinvacimab cohort, an ORR (Overall Response Rate) of 50% was reported in three of six patients, and a DCR (Disease Control Rate) of 67% was reported in four out of six patients. Notably, one patient in the high-dose cohort showed CR (Complete Response) in the target lesion but was labeled as PR (Partial Response) due to a tumor remaining in a non-target lesion.
The last patient, who just completed 35 cycles of olinvacimab and pembrolizumab combo treatment, will receive olinvacimab in monotherapy as compassionate use starting from early March 2022. In addition, another patient, who showed CR in the target lesion, has already been receiving olinvacimab as compassionate use since August 2021 and is in stable condition.
The encouraging data from this study provided strong scientific rationale for PharmAbcine to proceed to a Phase IIa study. In September 2021, PharmAbcine received Australian HREC (Human Research Ethics Committee) clearance to commence the subsequent Phase IIa combo trial designed to evaluate the clinical efficacy of 16mg/kg weekly dose of olinvacimab in combination with 200mg of pembrolizumab in a larger population setting. The study had the first patient dosing in December 2021, and is actively recruiting patients.
“The patients, who continued to receive the treatment since the interim data presentation in 2020, showed no serious adverse events,” said Dr. Jin-San Yoo, CEO of PharmAbcine. “We are pleased to report this critical milestone and looking forward to getting the final report made available in the future,”
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
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 10-20% 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.
Olinvacimab is the Company's leading pipeline that neutralizes the VEGF/VEGFR2 pathway, suppresses tumor angiogenesis, and results in tumor growth inhibition. It is undergoing multiple global clinical trials. Other than the ongoing Phase II olinvacimab and pembrolizumab combo trial in mTNBC, which had the first patient dosed in December 2021, a Phase II olinvacimab mono study for bevacizumab-nonresponding rGBM (recurrent glioblastoma multiforme) patients is ongoing at multiple sites in both US and Australia. The olinvacimab and pembrolizumab combo treatments in two Phase Ib studies for both mTNBC and rGBM are finished. Two patients in the mTNBC study and one patient in the rGBM study are receiving olinvacimab monotherapy as compassionate use.
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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