DAEJEON, South Korea, Sept. 14, 2020 /PRNewswire/ -- PharmAbcine Inc. (KOSDAQ: 208340ks) today announced positive data from its two combination trials of olinvacimab, its leading clinical candidate in oncology, with MSD's pembrolizumab at the 13th Annual Meeting of the Korean Society of Medical Oncology (KSMO 2020).
The interim results from the two Phase Ib studies showed that olinvacimab & pembrolizumab, combo has an excellent safety profile in both recurrent glioblastoma multiforme (rGMB) and metastatic Triple-Negative Breast Cancer (mTNBC) patients. The results from the mTNBC study, in particular, demonstrated meaningful efficacy.
Both rGBM and mTNBC trials assessed dose-limiting toxicity (DLT) and safety, as the primary endpoint to establish a preliminary RP2D (Recommended Phase II Dose). The studies also measured ORR, DCR, PFS, and OS for efficacy as the secondary endpoint.
The data indicates that both combination therapies have an excellent safety profile. DLT, the most crucial factor that determines the safety and dosage, was not observed. In both trials, many patients showed manageable symptoms of fatigue, rash, or hemangioma in grade 1 or 2.
In terms of efficacy, the data from the mTNBC trial was more pronounced. Among 11 patients, 4 patients (36%) had PR (Partial Response) and 1 patient had CR (Complete Response), and the total of 5 patients had clinical benefits (PR+SD≥24weeks) from the combination therapy.
The rGBM trial showed that 4 patients (44%) had SD (Stable Disease), including 1 patient staying on SD over 12 cycles. The median OS (Overall Survival) was 7.2 months vs 4 months, the average life span of rGBM patients.
"The interim results provide a strong rationale to proceed the mTNBC combination trial to Phase II," said Dr. Jin-San Yoo, CEO of PharmAbcine. "Despite the encouraging data from the rGBM study, we plan to pursue Phase II with mTNBC only for more efficient use of our resources. We just added three molecules with first-in-class potential in our pipeline and we need to be more careful with our resource utilization."
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, respiratory, to renal pathology.
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 collaboration with MSD, olinvacimab plus pembrolizumab Phase Ib trials for mTNBC and rGBM are on-going.
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.