SUZHOU, China, Sept. 20, 2018 /PRNewswire/ -- Innovent Biologics, Inc.
(Innovent), a world-class China-based biopharmaceutical company that
develops and commercializes high quality drugs, today presented
clinical trial data from a phase Ib clinical trial (NCT02937116)
that treated patients with neuroendocrine tumors (NET) who have
failed of standard therapy with single agent sintilimab, a fully
human anti-programmed cell death 1 (PD-1) monoclonal antibody
(mAb), at the 2018 Annual Meeting of Chinese Society of Clinical
Oncology (CSCO).
To our best knowledge, this is one of the largest clinical
studies of anti-PD-1 antibody for the treatment of NET. Based on
data from 22 patients with at least one radiological assessment,
the objective response rate (ORR) is 22.7%. Furthermore, in 19
patients with poorly differentiated neuroendocrine carcinoma, the
ORR was 26.3%. As of the data analysis cutoff on June 28, 2018, median duration of response (DOR)
is 5.8 months and progression free survival (PFS) is 2.2 months,
median overall survival has not been reached. The safety profile of
sintilimab in this trial is consistent with safety profile in
trials with other tumors.
"The efficacy of current treatments available for poorly
differentiated NET is very limited. We are excited to see the solid
evidence of significant clinical activity with sintilimab in the
patients with difficult-to-treat cancers. We are delighted to see
that sintilimab may give such patients a new option as an effective
therapy," said Professor Jianming
Xu, from the 307 Hospital of PLA, and study data
presenter.
"At present, the overall prognosis of neuroendocrine tumor is
still unfavorable, with limited therapeutic approaches," said
Michael Yu, Founder, Chief Executive
Officer and Chairman of Innovent, "We are encouraged by the initial
study results and we anticipate a new therapy will be developed for
this patient population. Hopefully, it can help to extend the
overall survival and quality of life for NET patients."
About Neuroendocrine Tumor (NET)
Arising from neuroendocrine cells, neuroendocrine tumor is one
kind of neoplasm which can develop in any part of the body, but
most commonly occur in the digestive system such as stomach,
intestine and pancreas. Medical treatment aims at controlling tumor
growth and relieving symptoms caused by functioning NET. Biotherapy
and target therapy are considered for well differentiated NET.
Cytotoxic medication remains the first-line treatment for poorly
differentiated NET, the overall survival of which is approximately
10 months.
About Sintilimab
Sintilimab is a fully human anti-PD-1 antibody. It binds to the
PD-1 receptor on T cells, blocking the PD-L1 ligand from
interacting with PD-1 to help restore T-cell response and immune
response, thus destroying the tumor cells. Sintilimab is an
anti-PD-1 monoclonal antibody jointly developed by Innovent and Eli
Lilly and Company in China.
National Medical Products Administration (NMPA, formerly known as
CFDA) accepted the New Drug Application (NDA) submitted by Innovent
for sintilimab on April 16, 2018, and
granted it priority review status on April
23, 2018. The indication for the first new drug application
is relapsed/refractory classical Hodgkin's Lymphoma.
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. Since its establishment from 2011, Innovent has developed a
fully-integrated platform which includes R&D, CMC (Chemistry,
Manufacturing, and Controls), clinical development and
commercialization capabilities, and a pipeline of innovative and
commercially promising monoclonal antibodies and other biologics in
the fields of oncology, ophthalmology, autoimmune and metabolic
diseases. Innovent has built up a pipeline of 17 antibody drug
candidates, with four core products in late-stage clinical
development in China and one that
has a New Drug Application (NDA) accepted by the NMPA with priority
review status.
Innovent has a highly talented international team, including
many expert returnees with experience in innovative
biopharmaceutical drug discovery, development, production and
commercialization. The company has also entered into various key
strategic alliances with Eli Lilly and Company, Adimab, and other
biopharmaceutical companies. Innovent has raised 580 million USD in private financing from
numerous world-renowned VC or PE firms, including Eight Roads and
F-Prime Capital (which form part of the proprietary investment
business of Fidelity), Lilly Asia Ventures, Capital Group, Legend
Capital, Temasek, Rock Springs Capital, Cormorant Private
Healthcare, Hillhouse Capital, China Life, Ally Bridge, Taikang Insurance Group, and State
Development & Investment Corporation.
About the partnership between Innovent Biologics and Eli
Lilly and Company
Eli Lilly and Company (Lilly) and Innovent Biologics (Innovent)
in March 2015 announced one of the
largest biotech drug development collaborations in China to date between a multi-national and
domestic company. Under the terms of the agreement, Lilly and
Innovent shall collaborate to provide support to the development
and potential commercialization of at least three cancer treatments
over the next decade. In October
2015, they announced an expansion of their drug development
collaboration. These collaborations represent that Innovent has
struck one of the most comprehensive strategic partnerships of any
Chinese company with a multinational partner in terms of the scope
and breadth ranging from discovery to commercialization and
involving up to six therapeutic antibodies for cancers.
For inquiries, please contact:
Email: ir@innoventbio.com
Tel: 86 512 6956 6088
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SOURCE Innovent Biologics, Inc.