PharmAbcine Unveils Olinvacimab’s
Positive Results from Phase Ib Combination Studies at KSMO 2020
DAEJEON, South Korea, September 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
The interim results from the two Phase 1b 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
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
"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."
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.
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.
For additional information
about PharmAbcine, visit http://www.pharmabcine.com