NANJING, China, SHANGHAI and SAN
JOSE, Calif., June 28,
2024 /PRNewswire/ -- IASO Biotechnology ("IASO Bio"),
a biopharmaceutical company engaged in discovering, developing,
manufacturing, and marketing innovative cell therapies and antibody
products, today announces that the investigational new drug
(IND) application for RD118, an independently developed, fully
human GPRC5D-targeting chimeric antigen receptor T-cell (CAR-T)
therapy, has been approved by the National Medical Products
Administration (NMPA) for treatment of relapsed/refractory multiple
myeloma (RRMM).
About RD118
RD118 is an autologous T-cell immunotherapy product targeting G
protein-coupled receptor class C group 5 member D (GPRC5D). It can
identify and eliminate malignant tumor cells expressing GPRC5D.
GPRC5D is highly expressed on multiple myeloma cells. However, in
normal tissues, its expression is limited to plasma cells and hair
follicle cells. Such a feature has made GPRC5D a promising safe and
effective target for the treatment of multiple myeloma.
The antigen recognition domain of RD118 is developed from IASO
Bio's proprietary fully human single-domain antibody library. It
has advantages of high affinity, high specificity, and low
immunogenicity. The intracellular domain is a fusion of 4-1BB
(CD137) and CD3ζ signaling domains. RD118 has been subjected to
extensive development and optimization in terms of antibody
screening and structure design. The candidate molecule has
demonstrated excellent in vitro cytotoxic activity and in
vivo tumor suppression ability. Additionally, it has good
expansion capability and persistence in vivo, indicating
high development potential.
An investigator-initiated clinical trial (IIT)
(ClinicalTrials.gov identifier: NCT05759793, NCT05219721) is being
conducted to preliminary investigate the safety and efficacy of
RD118 injection in patients with RRMM or plasma cell leukemia. The
principal investigators are Professor Jianqing Mi from Ruijin
Hospital, Shanghai Jiao Tong University School of Medicine and
Professor Chunrui Li from Tongji Hospital, Tongji Medical College
of Huazhong University of Science and Technology.
The trial enrolled patients with multiple myeloma or plasma cell
leukemia who have previously received at least three lines of
therapy (must include at least one proteasome inhibitor and one
immunomodulator). Patients who have previously received BCMA CAR-T
therapy can also be enrolled. The trial investigated RD118 at the
doses of 1.0–3.0 × 106 CAR-T cells/kg. As of
Nov. 20, 2023, the dose-escalation
phase has completed subject enrollment and infusion. The subjects
who received infusion have demonstrated good safety and efficacy
profiles. Patients with prior BCMA CAR-T therapy have also shown
benefits.
Professor Mi Jianqing, Ruijin
Hospital, Shanghai Jiao Tong University School of Medicine,
stated: " Studies have shown that malignant plasma cells
in almost all multiple myeloma patients express GPRC5D. The
GPRC5D-targeting therapy has been demonstrated to effectively
control disease progression and prolong overall survival of
patients with multiple myeloma, which makes GPRC5D an emerging
competitive target. Furthermore, GPRC5D has been shown to be
expressed on the surface of myeloma cells independently of BCMA,
and its expression is not affected by the loss of BCMA. Patients
who experience a relapse after anti-BCMA CAR-T cell therapy may
still respond effectively to the treatment with anti-GPRC5D CAR-T
cells, further indicating that anti-GPRC5D CAR-T is a candidate
therapy with potential."
Professor Chunrui Li, Tongji Hospital, Tongji Medical
College, Huazhong University of Science & Technology,
stated: "The development of CAR-T cell therapy has
significantly changed the treatment landscape for multiple myeloma.
The current therapies for multiple myeloma are mainly
BCMA-targeted. However, the heterogeneous expressions of BCMA on a
majority of malignant plasma cells may lead to varying degrees of
therapeutic response among different patients. The results of this
IIT study demonstrated that RD118 has shown positive therapeutic
effects and controllable safety in patients who have experienced
target escape from BCMA-targeted therapy, as well as in those with
low or unstable BCMA expression. This may provide a new therapeutic
approach for patients with RRMM, which is of substantial clinical
value. In future clinical studies, we will continue to investigate
the optimal treatment sequence and strategy for GPRC5D-targeting
therapy."
Ms. Jinhua Zhang, Founder and
Chairman of IASO Bio, stated, "GPRC5D is expressed on myeloma
cells. And just like BCMA, GPRC5D is one of the key targets for
treating multiple myeloma. Multiple myeloma is a complex disease
and requires different treatment strategies to address various
patient conditions. Developed by IASO Bio, RD118 is a
GPRC5D-targeting cell product for the treatment of multiple myeloma
and has demonstrated significant therapeutic potential in the
exploratory clinical trial, offering a new therapeutic approach for
both medical professionals and patients. We are excited about the
prospects of RD118 and will continue to conduct in-depth research
to ensure its safety and efficacy in clinical practice. At the same
time, we will continue our collaboration with global medical
experts and research institutions to jointly promote the
development of this field and bring more benefits to patients."
About IASO Bio
IASO Bio is a biopharmaceutical company engaged in the discovery
and development of novel cell therapies and biologics for oncology
and autoimmune diseases. IASO Bio possesses comprehensive
capabilities spanning the entire drug development process, from
early discovery to clinical development, regulatory approval, and
commercial production.
The pipeline in the company includes a diversified portfolio of
over 10 novel products, including Equecabtagene Autoleucel (a fully
human BCMA CAR-T injection). Equecabtagene Autoleucel received New
Drug Application (NDA) approval from China's National Medical Products
Administration (NMPA) and U.S. FDA IND approval for the treatment
of RRMM.
Leveraging its strong management team, innovative product
pipeline, GMP production, as well as integrated manufactural and
clinical capabilities, IASO aims to deliver transformative,
curable, and affordable therapies that fulfil unmet medical needs
to patients in China as well as
around the world. For more information, please visit
http://www.iasobio.com or
www.linkedin.com/company/iasobiotherapeutics.
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SOURCE IASO Bio