SUZHOU, China, March 18, 2019 /PRNewswire/ -- Innovent
Biologics, Inc. (Innovent) (HKEX: 01801), a world-class
biopharmaceutical company that develops and commercializes high
quality medicines, today announced that the first patient has been
successfully dosed in a Phase I clinical trial of anti-cluster of
differentiation 47 (anti-CD47) monoclonal antibody drug candidate
(IBI188) in the United States
(U.S.).
The CIBI188A102 study (CIBI188A102) is a Phase I clinical study
conducted in the U.S. to evaluate IBI188 in patients with advanced
malignant tumors. The primary objectives are to evaluate the safety
and tolerability, and to define the Phase II clinical trial
recommended doses of IBI188 as monotherapy and as part of
combination therapy on subjects with advanced malignant tumors. The
Phase 1a study will explore initial and maintenance doses of IBI188
as monotherapy. CIBI188A102 will be launched simultaneously with
the CIBI188A101 study (CIBI188A101) conducted in China, with the aim of evaluating the
pharmacokinetic (PK) and pharmacodynamics (PD) profiles of IBI188
in both the U.S. and China.
Cluster of differentiation 47 (CD47) is one of the key targets
in the field of anti-tumor immunotherapy, an important component of
a critical inhibitory immune pathway that is different from T cell
targets such as programmed cell death protein 1 (PD-1), PD-1 ligand
1 (PD-L1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).
CD47 targets macrophages and suppresses phagocytosis by interacting
and activating the inhibitory receptor signal regulatory protein-α
(SIRPα). The CD47-SIRPα mechanism is hijacked in many malignant
tumors to escape immune mediated clearance. IBI188, an anti-CD47
antibody, blocks the CD47-SIRPα signaling pathway, restores
macrophages' ability to recognize tumor cells and its
antigen-presenting ability, and achieves anti-tumor effects through
both innate immunity and adaptive immunity.
"IBI188 is a pivotal product in our pipeline of cancer
immunotherapies. There is preliminary evidence that anti-CD47
monoclonal antibodies, as monotherapy or as part of combination
therapy, have shown positive biologic activities in solid tumors
and in refractory/relapsed non- Hodgkin Lymphoma. Multiple
different antibodies targeting the CD47-SIRPα signaling pathway are
in development worldwide, most are in either preclinical or Phase I
stage. IBI188 is the first anti-CD47
monoclonal antibody drug candidate of China approved for clinical trials in
the United States. We would like
to assess the potential clinical value of the drug candidate
through the simultaneous clinical studies in China and the United
States," said Michael Yu,
Founder, Chief Executive Officer and Chairman of
Innovent.
About IBI188
IBI188 is a fully human monoclonal antibody targeting CD47.
In vitro and in vivo experiments have shown that
IBI188 can bind to the CD47 antigen on the surface of tumor cells,
block the CD47-SIRPα signaling pathway, inhibit the "do not eat me"
signal, and promote the phagocytosis of tumor cells by macrophages,
thereby exerting an anti-tumor effect. Innovent will launch several
clinical trials to assess its safety and efficacy in multiple tumor
types, including non-Hodgkin's lymphoma and ovarian cancer.
About CIBI188A101
CIBI188A101 is a Phase I clinical study conducted in
China to evaluate IBI188 in the
treatment of patients with advanced malignancies. The primary
objectives of the study are to evaluate the safety, tolerability,
and the recommended doses for Phase II clinical trial of IBI188 as
a monotherapy and as part of a combination therapy. The Phase 1a
study explores priming and maintenance dosing of IBI188 as
monotherapy.
About CIBI188A102
CIBI188A102 is a Phase I clinical study conducted in
the United States to evaluate
IBI188 in patients with advanced malignant tumors. The primary
objectives are to evaluate the safety and tolerability, and to
define the Phase II clinical trial recommended doses of IBI188 as
monotherapy and as part of combination therapy on subjects with
advanced malignant tumors. The Phase 1a study will explore initial
and maintenance doses of IBI188 as monotherapy. CIBI188A102 will be
launched simultaneously with the CIBI188A101 conducted in
China, with the aim of evaluating
the PK and PD profiles of IBI188 in both the U.S. and China.
About Innovent
Inspired by the spirit of "Start with Integrity, Succeed through
Action," Innovent's mission is to develop and commercialize high
quality biopharmaceutical products that are affordable to ordinary
people. Established in 2011, Innovent is committed to developing,
manufacturing and commercializing high quality innovative medicines
for the treatment of oncology, autoimmunity and other major
diseases. On October 31, 2018,
Innovent was listed on the Main Board of the Stock Exchange of Hong
Kong Limited with the stock code: 01801.HK.
Since it was founded, Innovent has developed a fully-integrated
platform which includes R&D, CMC (Chemistry, Manufacturing, and
Controls), clinical development and commercialization capabilities.
Leveraging the platform, the company has built up a robust pipeline
of 20 innovative assets in the fields of oncology, ophthalmology,
autoimmunity, and cardiovascular diseases. Fourteen assets have
entered into clinical development, four have entered Phase III
clinical trials, two monoclonal antibodies have their New Drug
Application (NDA) under review, and one, Tyvyt®
(sintilimab injection), is now approved for relapsed or refractory
classical Hodgkin's lymphoma (r/r cHL).
Innovent has built an international team of advanced talents in
high-end biological drug development and commercialization,
including many overseas experts. The company has also entered into
strategic collaborations with Eli Lilly and Company, Adimab,
Incyte, Hanmi and other international pharmaceutical companies.
Innovent strives to work with all relevant parties to help advance
China's biopharmaceutical
industry, improve drug availability to ordinary people and enhance
the quality of the patients' lives. For more information, please
visit: www.innoventbio.com.
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SOURCE Innovent Biologics, Inc.