Hanmi unveils tiral in progress poster on BH3120 at the
Society for Immunotherapy of Cancer (SITC) in the U.S.
Phase 1 trial is progressing smoothly, with no dose-limiting
toxicity observed
Phase 1 trial evaluating the combination of BH3120 and MSD's
anti-PD-1 therapy, KEYTRUDA® (pembrolizumab)
underway
SEOUL,
South Korea, Nov. 24,
2024 /PRNewswire/ -- The latest progress in the
clinical trial of BH3120, an innovative immunotherapy jointly
developed by Hanmi Pharmaceutical and Beijing Hanmi Pharmaceutical,
was recently presented at a major global academic conference,
drawing significant attention in the field of immunotherapy.
On November
25, Hanmi announced that it presented the research
and clinical progress of BH3120 in a poster session at the Society
for Immunotherapy of Cancer (SITC) conference, held in Houston, USA,
from November 6 to 10.
BH3120 is a novel anticancer drug based on Hanmi's proprietary
dual antibody platform, "Pentambody." This technology enables a
single antibody to simultaneously bind to two distinct targets,
allowing for a targeted anticancer action by specifically attacking
cancer cells while activating immune cells to enhance immunotherapy
effects.
BH3120 is designed to target PD-L1 on cancer cells and 4-1BB on
immune cells, thereby acting as a "bridge" that facilitates immune
cells' recognition and killing of tumor cells.
While other 4-1BB-targeting antibody candidates have faced
anticancer efficacy or safety challenges, BH3120's preclinical
studies reveal robust anticancer efficacy alongside a unique
decoupling of immune activity between the tumor microenvironment
(TME) and normal tissues. This distinct mechanism highlights
BH3120's potential as a breakthrough in developing an effective and
safer anticancer therapy.
During the SITC presentation, Hanmi outlined the background,
design, and clinical progress of BH3120. Currently, a global Phase
1 clinical trial is underway in South
Korea and the United
States, assessing the safety and tolerability of BH3120 as a
monotherapy in patients with advanced or metastatic solid
tumors.
The Phase 1 clinical trial has progressed smoothly through
cohort 3 (1 mg/kg) of the dose escalation phase, with no
dose-limiting toxicities (DLT) or grade 3 or higher adverse drug
reactions observed to date.
Dr. Dong-wan Kim, director of the Seoul National University Hospital Clinical Trials Center
(Hemato-Oncology Department) and lead investigator for the phase 1
clinical trial of BH3120 remarked, "The phase 1 clinical trial of
BH3120 is a critical step in verifying the potential of this
next-generation immunotherapy. We are optimistic about achieving
positive outcomes." He added, "We hope further research will
establish BH3120 as an effective and safe treatment option for
various cancer types, reducing the side effects often associated
with current immunotherapies."
In parallel, Hanmi is also conducting a Phase 1 trial to assess
the safety and efficacy of BH3120 in combination with MSD's (Merck
& Co., Inc., Rahway, NJ, USA)
anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients
with advanced or metastatic solid tumors.
In September, Hanmi obtained approval from both the Korean
Ministry of Food and Drug Safety and the U.S. Food and Drug
Administration (FDA) to modify the Phase 1 trial plan to evaluate
BH3120 in combination with KEYTRUDA. Full-scale clinical
development is expected to commence early next year. Hanmi will
serve as the lead sponsor and conduct the clinical trial, while MSD
will supply KEYTRUDA for the trial.
Young Su Noh, Director of Hanmi's
ONCO Clinical Team, emphasized, "The BH3120 trial represents a
milestone as Hanmi's first global clinical research project
utilizing our proprietary Pentambody dual antibody platform in
immuno-oncology, a field at the forefront of cancer treatment
innovation." He continued, "We are committed to advancing a
next-generation immunotherapy that overcomes the limitations of
existing treatments and enhances therapeutic efficacy."
KEYTRUDA® is a registered trademark of Merck Sharp
& Dohme LLC, a subsidiary of Merck & Co., Inc.,
Rahway, NJ, USA.
- Contact info:
Official Websites: www.hanmipharm.com
innovation@hanmi.co.kr, +08-2-410-0467
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SOURCE Hanmi Pharmaceutical
