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As the world's first universal "modular" CAR-T cell product, IBI345 has potential advantages over traditional CAR-T cells: 1) By using the "targeting" effect of antibodies, it can amplify the antigen target signal and guide the CAR -T cells enter the tumor and initiate recognition and killing effects
At present, there are limited clinical treatments for advanced gastric cancer and pancreatic cancer, and everyone is looking forward to how to improve the treatment status of these patients.
Xu Wei, Vice President and Head of Cell Therapy R&D of Innovent Biopharmaceutical Group, said: "IBI345 is a highly differentiated CAR-T cell product with a new mechanism of action developed by Innovent Biopharmaceuticals.
2 ( Claudin18.
On the one hand, tight junctions can act as a "barrier" to select the size and charge of substances, thereby regulating the transport of substances in the paracellular pathway
Studies have found that Claudin18.
The latest global cancer statistics show that in 2020, there are about 1.
Contains two components: anti-Claudin18.
2 antibody and "modular" CAR-T cells; different from traditional CAR-T cells that directly recognize and kill tumor cells, IBI345 recognizes tumor cell antigen targets through antibodies, thereby "calibrating and amplifying" "Tumor antigen signal, and guide "modular" CAR-T cells to enter the tumor, start the CAR-T cell killing effect, and play an anti-tumor effect
.
Compared with traditional CAR-T cells, IBI345 has a variety of potential advantages, including dual effects of antibodies and cells to increase anti-tumor efficacy, and control of side effects by regulating cell activity through antibodies; in addition, "modular" CAR-T cells have a universal type It can be used in combination with different antibodies without changing CAR-T cells, by sequentially or simultaneously administering more than one antibody targeting different antigen targets, to treat tumors with highly heterogeneous antigen expression or tumors caused by antigen deletion Relapse, which is expected to reduce the cost of CAR-T cell therapy and improve the accessibility of CAR-T cell therapy for patients
.
The study (NCT05199519) is an investigator-initiated (IIT) clinical trial with the primary objective of evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of IBI345 in subjects with Claudin18.
2-positive solid tumors
.
CAR-T cells, as a new type of highly efficient and precisely targeted tumor cell immunotherapy drug modified by genetic engineering, have shown great therapeutic potential in the treatment of hematological tumors.
A breakthrough is needed
.
As the world's first universal "modular" CAR-T cell product, IBI345 has potential advantages over traditional CAR-T cells: 1) By using the "targeting" effect of antibodies, it can amplify the antigen target signal and guide the CAR -T cells enter the tumor and initiate recognition and killing effects
The principal investigator of the study, Secretary of the Party Committee of the First Affiliated Hospital of Soochow University, Chief Physician of the Department of Gastroenterology, and Professor Chen Weichang pointed out: "Solid tumors such as gastric cancer and pancreatic cancer are malignant tumors with high incidence in the world, and Claudin18.
2 in the patient population.
The positive rate exceeds 50%
.
At present, there are limited clinical treatments for advanced gastric cancer and pancreatic cancer, and everyone is looking forward to how to improve the treatment status of these patients.
Dr.
Xu Wei, Vice President and Head of Cell Therapy R&D of Innovent Biopharmaceutical Group, said: "IBI345 is a highly differentiated CAR-T cell product with a new mechanism of action developed by Innovent Biopharmaceuticals.
About Claudin 18.
2 ( Claudin18.
Claudin protein is a key component of tight junction complex molecules, and tight junctions play an important role in the life activities of the human body
.
On the one hand, tight junctions can act as a "barrier" to select the size and charge of substances, thereby regulating the transport of substances in the paracellular pathway
Claudin18.
2 is a member of the Claudin protein family, which is a highly tissue-specific protein expressed only in differentiated epithelial cells on the gastric mucosa under normal physiological conditions
.
Studies have found that Claudin18.
Globally, there is currently no therapy targeting Claudin18.
2 approved for marketing, but there are many candidate therapies in clinical development.
These drug development types include monoclonal antibodies, bispecific antibodies, antibody-conjugated drugs and CARs -T cell products
.
About Stomach and Pancreatic Cancer
Gastric cancer and pancreatic cancer are both malignant tumors of the digestive system that seriously endanger human life and health
.
The latest global cancer statistics show that in 2020, there are about 1.
About IBI345
IBI345 is the first universal "modular" CAR-T cell product developed by Innovent based on Roche's patented technology.
It is an internationally pioneered highly differentiated CAR-T cell product with a new mechanism of action
.
Contains two components: anti-Claudin18.
2 antibody and "modular" CAR-T cells; different from traditional CAR-T cells that directly recognize and kill tumor cells, IBI345 recognizes tumor cell antigen targets through antibodies, thereby "calibrating and amplifying" "Tumor antigen signal, and guide "modular" CAR-T cells to enter the tumor, start the CAR-T cell killing effect, and play an anti-tumor effect
.
Compared with traditional CAR-T cells, IBI345 has a variety of potential advantages, including dual effects of antibodies and cells to increase anti-tumor efficacy, and control of side effects by regulating cell activity through antibodies; in addition, "modular" CAR-T cells have a universal type It can be used in combination with different antibodies without changing CAR-T cells, by sequentially or simultaneously administering more than one antibody targeting different antigen targets, to treat tumors with highly heterogeneous antigen expression or tumors caused by antigen deletion Relapse, which is expected to reduce the cost of CAR-T cell therapy and improve the accessibility of CAR-T cell therapy for patients
.
The investigator-initiated clinical trial (NCT05199519) of IBI345 in the treatment of advanced Claudin18.
2-positive solid tumors announced in February 2022 that the first subject has been dosed, and enrollment is currently ongoing
.
The safety, tolerability, pharmacokinetics and preliminary efficacy of IBI345 will be explored, and the clinical dosage and regimen will be explored to provide clinical data support for the subsequent formal IND application
.
About Innovent
"Begins with faith, achieves in action", and developing high-quality biological drugs affordable to the common people is the ideal and goal of Innovent
.
Founded in 2011, Innovent Bio is committed to the development, production and sales of innovative drugs for the treatment of major diseases such as tumors, metabolic diseases, and autoimmunity
.
On October 31, 2018, Innovent Biopharma was listed on the main board of The Stock Exchange of Hong Kong Limited, stock code: 01801
.
Since its establishment, the company has stood out among many biopharmaceutical companies with its innovative achievements and international operating model
.
A product chain including 29 new drug varieties has been established, covering tumor, metabolic diseases, autoimmunity and other disease fields, of which 7 varieties have been selected for the national "Major New Drug Creation" project
.
The company has 6 products (Sintilimab injection, trade name: Daboshu® , English trademark: TYVYT ® ; Bevacizumab biosimilar, trade name: Dayutong® , English trademark: BYVASDA ® ; Adalimumab biosimilars, trade name: Sulixin® , English trademark: SULINNO® ; Rituximab biosimilars, trade name: Dabohua® , English trademark: HALPRYZA® ; pemigatinib oral inhibitor , trade name: Darbotan® , English trademark: PEMAZYRE® ; Orebatinib, trade name: Nerlik® ) was approved for marketing, 5 varieties entered phase III or pivotal clinical studies, and 18 more The product has entered clinical research .
Innovent Bio has established a high-end biopharmaceutical development and industrialization talent team with international advanced level, including many returnee experts, and has cooperated with international partners such as Eli Lilly, Adimab, Incyte, MD Anderson Cancer Center and Hanmi in South Korea.
reach a strategic cooperation
.
Innovent hopes to work together with everyone to improve the development level of China's biopharmaceutical industry to meet the availability of medicines and the pursuit of people's good wishes for life and health
.
For details, please visit the company's website: or the company's LinkedIn account: Innovent Biologics
.
statement:
1.
The indication is the use of the drug under investigation and has not been approved in China;
2.
Innovent does not recommend the use of any unapproved drugs/indications;
3.
For communication use by healthcare professionals only
.
Forward-Looking Statements
Information published in this press release may contain certain forward-looking statements
.
These statements are inherently subject to considerable risk and uncertainty
.
The use of words such as "anticipates," "believes," "forecasts," "expects," "intends," and other similar words in relation to the Company is intended to identify forward-looking statements
.
The Company undertakes no obligation to continually update these forward-looking statements
.
These forward-looking statements are based on the Company's management's current beliefs, assumptions, expectations, estimates, projections and understanding of future events at the time the statements are made
.
These statements are not guarantees for future development and are subject to risks, uncertainties and other factors, some of which are beyond the control of the company and are difficult to predict
.
Accordingly, actual results may differ materially from those contained in forward-looking statements as a result of future changes and developments in our business, competitive environment, political, economic, legal and social conditions
.
The Company, its directors and employee agents disclaim (a) any obligation to correct or update the forward-looking statements contained in this website; and (b) if any forward-looking statement does not materialize or becomes incorrect responsibility
.
