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信达生物在美国癌症研究协会(AACR)2024年会公布多项创新管线的临床前数据

Cinda Biotech will release preclinical data from multiple innovative pipelines at the American Association for Cancer Research (AACR) in 2024

PR Newswire ·  Apr 7 20:40

Rockville, USA, April 8, 2024/PRNewswire/ -- Cinda Biopharmaceuticals Group (HKSE: 01801), a biopharmaceutical company dedicated to the development, production and sale of innovative drugs in major diseases such as oncology, autoimmunity, metabolism, cardiovascular, and ophthalmology, announced today that it will announce a number of the latest preclinical data at the 2024 American Association for Cancer Research (AACR) annual meeting, including the company's series of dual-antibody and antibody-conjugated drug (ADC) tumor pipelines.

Major research ((Late-Breaking Research)

title: Performance of IBI3001, a potentially first-in-class (first-in-class) glycosylated fixed-site conjugated B7-H3/EGFR dual antibody ADC in multiple preclinical solid tumor models
Abstract number: LB055
Display format: poster
When: Sunday, April 7, 2024, 1:30 PM — 5:00 PM (local time)
Location: Poster Section 53
Speaker: Dr. Ho Kai Kit
IBI3001 is a potential world first bispecific ADC for B7-H3 and EGFR, using clinically proven SynteCaneFixed-point coupling platform.
IBI3001 has multiple anti-tumor mechanisms: (1) enhanced EGFR signal blocking; (2) EGFR and B7-H3-mediated drug endocytosis and cell killing; and (3) potent ADC bystander effects. The optimized B7-H3 arm not only enhances the effect of blocking EGFR signals, but also reduces the toxicity of EGFR targets.
IBI3001 has shown strong tumor killing effects in vivo and in vitro models of solid tumors, and is highly tolerable, with a treatment window of up to 40 times.

title: IBI334, an innovative ADCC-enhanced B7-H3/EGFR bispecific antibody, has shown strong anti-tumor efficacy in preclinical solid tumor models
Abstract number: LB056
Display format: poster
When: Sunday, April 7, 2024, 1:30 PM — 5:00 PM (local time)
Location: Poster Section 53
Speaker: Dr. Ho Kai Kit
IBI334 is an unfucose-modified bispecific antibody for B7-H3 and EGFR developed on the Innobody platform based on the proprietary intellectual property rights of Cinda Biotech.
With the help of B7-H3, iBi334 showed stronger tumor inhibitory effects in vivo and in vitro compared to EGFR monoclonal antibody and c-Met/EGFR dual antibody.
IBI334 has good safety characteristics. The maximum non-serious toxic dose (HNSTD) for crab-eating monkeys is as high as 120 mg/kg, and the treatment window is 200 times larger.
IBI334 is a bispecific antibody that has the potential to treat various solid tumors and is currently undergoing clinical verification.

title: IBI343, a glycosylated fixed-point conjugated antibody Claudin18.2 ADC for the treatment of solid tumors, preclinical findings and characteristics
Abstract number: LB057
Display format: poster
When: Sunday, April 7, 2024, 1:30 PM — 5:00 PM (local time)
Location: Poster Section 53
Speaker: Dr. Ho Kai Kit
IBI343 is a potentially world-first ADC molecule targeting ClauDin 18.2, based on Synaffix's GlycoConnectGlycos-based fixed-site coupling to the cytotoxin Exatecan was achieved.
IBI343 showed good in vitro killer activity specific to Claudin 18.2 in a variety of tumor cell lines, and showed good tumor inhibitory activity in various human tumor xenograft mouse models. Glycos-based fixed-point coupling technology significantly enhances the stability of the entire ADC. IBI343 has shown good safety in GLP toxicology tests on rhesus monkeys and is well tolerated at doses up to 30 mg/kg.
A phase III clinical trial of IBI343 for Claudin-18.2-positive HER2-negative gastric cancer is being prepared.

Dr. He Kaijie, Vice President of Cinda Biopharmaceutical GroupHe said, “We are delighted that our early clinical findings on anti-tumor drugs were first unveiled at the 2024 AACR Annual Meeting and selected as Late-Breaking Research (Late-Breaking Research). This is the result of National Qingyuan scientists working together to develop more effective and safe drugs. After careful design and optimization, these innovative drugs can reach a treatment window of 40 times or even 200 times higher. We look forward to the clinical performance of these molecules and hope that the fruits of these innovations will eventually help cancer patients.”

Poster display

Meeting Type: Immunology - monoclonal and dual antibodies
title:Novel TROP2 Targeting Immunostimulatory Antibody Conjugates (ISACs) with Highly Effective Antitumor Activity and Acceptable Safety
Abstract number:2718
Display format:poster
time:Monday, April 8, 2024 1:30 PM - 5:00 PM (local time)
LOCATION:Poster section 6
Speaker:Dr. Xiong Huizhong

Immunostimulatory antibody conjugates (ISACs) are a unique class of ADCs in which antibodies that recognize tumor antigens are conjugated to immune agonists. ISAC targets tumor tissue and specifically activates natural immune cells within tumors to activate downstream immune responses. As with other immune agonists, the balance between efficacy and safety remains a challenge for ISAC.

The molecule reported this time consists of TLR7/8 agonists, ligands, and antibodies that have been optimally designed and screened, and is a TROP2 ISAC with first-in-class potential. Among them, TROP2 antibodies can cause macrophages to have a strong cytophagy effect (ADCP) on TROP2-positive tumor cells. In vitro, TROP2 ISAC is only slightly active, while in vivo, it shows strong anti-tumor activity and can act as a synergetic killer with cytotoxic ADCs. As far as safety is concerned, the molecule is well tolerated in mice and, more importantly, in monkeys.

Research data prove that a novel ISAC that combines efficacy and controllable safety is possible, and may provide new single or combination options for TROP2+ cancer patients.

Meeting Type:Immunology - Immunomodulation (immunostimulatory agonists or costimulatory pathways)
title:Tumor-Targeting CD28 Bispecific Antibody: Appropriate Potency, Effective Antitumor Activity, and Strict CD3 Dependence
Abstract number:5295
Display format:poster
time:Tuesday, April 9, 2024 1:30 PM - 5:00 PM (local time)
LOCATION:Poster section 3
Speaker:Dr. Xiong Huizhong

We report a finely designed and rigorously screened CD28 agonist antibody and its bispecific form psmaxCD28 (IAR038).

IAR038 showed the same excellent tumor killing effect as the Regeneron benchmark antibody currently under clinical development in preclinical animal experiments. At the same time, IAR038 has significantly improved CD3 dependency, stronger target dependency, and better pharmacokinetics. This dual antibody may provide a wider treatment window and safer drug options for patients with advanced prostate cancer.

Dr. Xiong Huizhong, Senior Director of Immunology, Cinda Biopharmaceutical Group“As always, the R&D team at Cinda Biotech remains curious and eager to explore science, and continues to promote a deeper understanding and more rational design of immune agonists and immune co-stimulators,” he said. “Our work on tumor-targeted TLR7/8 agonists and tumor-targeted CD28 antibodies has proven our ability to develop biologically driven drugs to achieve a better balance between efficacy and safety through advanced technology platforms.”

About Cinda Biotech

The mission and goal of Cinda Biotech is to develop high-quality biopharmaceuticals that ordinary people can afford to use. Founded in 2011, Cinda Biotech is committed to developing, producing and selling innovative drugs for major diseases such as oncology, autoimmunity, metabolism, and ophthalmology, so that our work can benefit more lives. The company has been approved for listing 10 products. They are cindilizumab injections (dabershu), bevacizumab injection (dayoutong)), adalimumab injection (sulisin), rituximab injection (dabervac), pemitinib tablets (dabartan), orebatinib tablets (Nelik), remoxieumab injection (xiranze)), ceptinib capsules (Ruitul), igiorencet injection (Focusol) and tolecizumab injections (Cimpiroc). Currently, there are also 3 varieties in the NMPA review. 5 new drug molecules have entered phase III or key clinical research, and 18 new drug types have entered clinical research.

The company has reached more than 30 strategic partnerships with international partners such as Eli Lilly, Roche, Sanofi, Adimab, Incyte, and MD Anderson Cancer Center. While continuously developing innovative drugs and seeking its own development, Cinda Biotech adheres to the people-centered development philosophy of economic construction. Over the years, we have always been scientific and kind, adhering to the “patient-centered” approach, caring for patients and their families, and actively fulfilling social responsibilities. The company has successively initiated and participated in a number of drug charity aid projects, so that more and more patients can benefit from advances in life science and can buy and use high-quality biopharmaceuticals. By the end of 2023, the Cinda Biotech Patient Assistance Program had benefited more than 170,000 ordinary patients, with a total drug donation value of RMB 3.4 billion. Cinda Biotech hopes to work with everyone to raise the level of development of China's biopharmaceutical industry to meet people's accessibility to medicine and people's pursuit of a better life and health.

For more information, please visit the company website:.

Disclaimer: Cinda Biotech does not recommend unapproved drugs/Indications for use.

Forward-looking statements

The information published in this press release may include certain forward-looking statements. These statements are inherently risky and uncertain. When using “anticipate”, “believe”, “anticipate”, “expect”, “intention” and other similar terms, the purpose of any statement relating to the Company is to indicate that it is a forward-looking statement. The Company is under no obligation to update these predictive statements on an ongoing basis.

These forward-looking statements are based on the Company's management's existing views, assumptions, expectations, estimates, predictions and understandings of future affairs at the time the statements are made. These statements are not a guarantee of future development and are affected by risks, uncertainties and other factors. Some are beyond the Company's control and are difficult to predict. As a result, actual results may differ significantly from the information contained in forward-looking statements due to future changes and developments in our business, competitive environment, and political, economic, legal and social conditions.

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