Hanmi Pharmaceutical announces Clinical Trial Collaboration
with MSD to evaluate 'BH3120' in combination with KEYTRUDA in phase
1 clinical trial in patients with progressive or metastatic solid
tumors
SEOUL,
South Korea, April 23,
2024 /PRNewswire/ -- Hanmi Pharmaceutical (KOSPI:
128940, CEO: Jae-Hyun Park), a
leading biopharma company in Korea that focuses on research areas
such as oncology, obesity/metabolism, and rare diseases, announced
it has entered into a Clinical Trial Collaboration and Supply
Agreement (CTCSA) with MSD (a tradename of Merck & Co., Inc.,
Rahway, NJ, USA).
Upon the execution of the agreement, Hanmi Pharmaceutical will
conduct a phase 1 clinical trial to evaluate the safety and
efficacy of its immuno-oncology drug, 'BH3120', in combination with
MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in
patients with progressive or metastatic solid tumors. Hanmi
Pharmaceutical will sponsor the clinical trial, and MSD will supply
KEYTRUDA.
'BH3120' is a next-generation immunotherapy drug that applies
'Pentambody', a bispecific antibody platform technology, currently
under joint development by Hanmi Pharmaceutical and its Chinese
subsidiary, BJHM (Beijing Hanmi Pharmaceutical).
Pentambody is a technology that combines one antibody to two
different targets simultaneously, facilitating both immuno-oncology
therapy and targeted therapy.
More specifically, BH3120 is an lgG-like bivalent bispecific
antibody targeting PD-L1 and 4-1BB with biased binding affinities
towards PD-L1.
This design aims to induce strong anti-tumor activities, particularly in
PD-L1 overexpressed tumor tissues within the tumor microenvironment
(TME), while minimizing undue immune activation in normal
tissues.
Most of the existing antibody candidates targeting 4-1BB have
limitations in terms of safety. However, BH3120 has been shown
through various non-clinical studies to exhibit a clear decoupling
of immune activity between TME and normal tissue, confirming its
potential as an effective and safe anticancer agent.
Dr. Kim Dong-wan, the director of
the Seoul National University Hospital
Clinical Trials Center (Hemato-Oncology Department), is the
Principal Investigator of the phase 1 clinical trial of BH3120 in
Korea and the US. He said, "Through
the collaboration with MSD, we expect BH3120 in combination
with KEYTRUDA could improve outcomes for patients with relapsed or
refractory disease."
A Hanmi representative stated, "BH3120 is our first global
clinical research project using the next-generation bispecific
antibody platform technology 'Pentambody' in the field of
immuno-oncology therapy, potentially changing the paradigm of
anticancer treatment," and added, "We are dedicated to surpassing
the constraints of current therapies and innovatively boosting
therapeutic efficacy through our next-generation immune-oncology
therapy."
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
Introducing Hanmi Pharmaceutical
Established in 1973, Hanmi Pharmaceutical is an R&D-centric
pharmaceutical company that strives to create global first-in-class drugs through
industry-leading R&D investments. Hanmi Pharmaceutical has
strategically established more than 30 pipelines covering metabolic
diseases(diabetes, obesity), inflammation-fibrosis(MASH) treatment,
anticancer drugs, and rare disease
treatments, among which 'Rolontis', a neutropenia treatment, has
received marketing authorization from the FDA in 2022. The company
retains solid partnerships with leading global pharmaceutical
companies based on proprietary technologies such as 'LAPSCOVERY', a
platform technology that prolongs the duration of action of
biologics, and 'PENTAMBODY', a bispecific antibody platform
technology. Hanmi Pharmaceutical is enhancing the synergy of
various R&D activities, such as AI new drug development and
immuno-anticancer drug development, through the 'Open Innovation'
strategy that opens the door to excellent external R&D
capabilities. For more information, please refer to our website
https://www.hanmipharm.com
About BH3120
BH3120 is a heterodimeric bispecific antibody (PENTAMBODY)
designed to target 4-1BB and PD-L1 simultaneously to stimulate
anti-tumor immune response either by inhibition of an immune
checkpoint mechanism and by activation of a co-stimulatory signal
in tumor microenvironment (TME) focused manner. Non-clinical
observations with BH3120, either as a monotherapy or in combination
settings, consistently explain strong anti-tumor T cell activities
in a tumor tissue-specific manner
with clear dose dependency, while systemic immune response is
minimally modulated. These properties support further evaluation of
the immune-modulating bispecific antibody, and BH3120 will be
studied as a therapeutic candidate with multiple types of solid
tumors.
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SOURCE Hanmi Pharmaceutical