Innovent announced the preliminary results of the Phase Ia dose escalation study of IBI315 (anti-Her2/PD-1 bispecific antibody) in patients with advanced solid tumors at the CSCO annual meeting in 2021

San Francisco, USA and Suzhou, China September 29, 2021/PRNewswire/ - Cinda Biopharmaceutical Group (Hong Kong Stock Exchange stock code: 01801), a company dedicated to R&D, production and sales for the treatment of tumors, metabolic diseases, A biopharmaceutical company that is an innovative drug for major diseases such as autoimmunity will report the preliminary results of a phase Ia clinical study of IBI315 (the world's first anti-Her2/PD-1 bispecific antibody) at the 2021 China Clinical Oncology Conference (CSCO)
.

As of May 25, 2021, a total of 27 patients with advanced solid tumors expressing Her2 who failed the standard treatment were enrolled in this study.
They received 7 study preset dose levels from 0.
03 mg/kg QW to 15 mg/kg Q3W, respectively.
No dose-limiting toxicity (DLT) occurred, and the maximum tolerated dose (MTD) was not reached
.

Among all subjects who received the expected effective dose (≥ 1 mg/kg), a total of 15 patients completed at least one tumor assessment, and the objective response rate (ORR) was 20%

Professor Xichun Hu from the Cancer Hospital of Fudan University said: "IBI315 has shown good safety and preliminary effectiveness in the phase Ia study, and preliminary verification of the bispecific antibody design combining targeted therapy and immunotherapy
.

In the phase Ia study The data that has been obtained greatly increases our confidence in the follow-up study of IBI315, and supports the further exploration of the therapeutic effect of this molecule in more Her2-expressing tumor types

Dr.
Zhou Hui, senior vice president of Cinda Biotech, said: “IBI315 is the world’s first anti-Her2/PD-1 bispecific antibody
.

We are very pleased to observe the good safety, tolerability and preliminary results of IBI315 in this study.

About the CIBI315A101 study

CIBI315A101 is a phase I clinical study that evaluates the safety, tolerability and effectiveness of IBI315 monotherapy and combined chemotherapy in the treatment of patients with advanced solid malignancies expressing Her2
.

This study is the first-in-human study of IBI315

About IBI315

IBI315 is jointly developed by Cinda Biopharmaceuticals and Hanmi Pharmaceuticals, and Cinda Biopharmaceuticals is responsible for clinical development in China
.

IBI315 is the world's first (first-in-class) recombinant fully human anti-programmed death receptor 1 (PD-1) and humanized anti-human epidermal growth factor receptor 2 (HER2) IgG1 bispecific antibody

About Cinda Bio

"Starting from the letter, reaching the line", to develop high-quality biological drugs that the common people can afford is the ideal and goal of Cinda Bio
.

Founded in 2011, Cinda Bio is committed to the development, production and sales of innovative drugs for the treatment of tumors, autoimmune, metabolic diseases and other major diseases

Since its establishment, the company has stood out among many biopharmaceutical companies with its innovative achievements and international operating model
.

A product chain including 26 new drug varieties has been established, covering multiple disease fields such as tumors, metabolic diseases, and autoimmunity.

Cinda Bio has established an internationally advanced high-end biopharmaceutical development and industrialization talent team, including many returned experts, and has cooperated with international partners such as Eli Lilly, Adimab, Incyte, MD Anderson Cancer Center and Hanmi of South Korea.
Reach strategic cooperation
.

Cinda Bio hopes to work with everyone to improve the development level of China's biopharmaceutical industry to meet the people's access to medicines and the people's pursuit of life and health

About Hanmi Pharmaceutical

Hanmi Pharmaceutical is an international pharmaceutical company headquartered in Seoul, South Korea
.
Hanmi Pharmaceutical is committed to the research and development of innovative drugs, and has established a complete drug R&D and production platform, as well as market and sales channels in China and South Korea
.
The company’s annual R&D investment in new drugs exceeds 20% of its sales profit, and currently has more than 30 product pipelines covering 3 main R&D directions: 1) New long-acting biological agents developed based on the company’s LAPSCOVERY platform, mainly used in diabetes and obesity And rare diseases; 2) new targeted preparations, mainly used in tumors and autoimmune diseases; 3) fixed-dose combination drug project
.
Hanmi Pharmaceutical has reached joint development and strategic cooperation with multiple global partners
.
For details, please visit the company's website:
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About the strategic cooperation between Cinda and Hanmei

On March 30, 2017, Cinda Biopharmaceuticals and Hanmi Pharmaceuticals announced the joint development and commercialization of new tumor immune antibodies on a global scale
.
IBI315 is a bispecific antibody developed using the PENTAMBODYTM technology platform
.
PENTAMBODYTM is a next-generation bispecific antibody platform technology developed by Beijing Hanmei, which can simultaneously target immunotherapy and multiple targets in targeted therapy to form a bispecific target pair
.
This technology platform has an antibody structure similar to autologous IgG, and has good stability and other important biophysical properties
.
Several bispecific antibodies developed using the PENTAMBODYTM technology platform are under development
.

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.
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.
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.
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.

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.
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Some of them are beyond the control of the company and are difficult to predict
.
Therefore, due to future changes and developments in our business, competitive environment, political, economic, legal and social conditions, actual results may differ significantly from the information contained in the forward-looking statements
.

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Responsibility
.

Source: Cinda Bio