Keji Pharmaceutical's CT041 CAR-T treatment of digestive system tumors and advanced gastric cancer efficacy data is eye-catching

Shanghai September 20, 2021/PRNewswire/ - On September 19, 2021, Keji Pharmaceutical (stock code: 2171.

The CT041 independently developed by Keji is the only CAR-T cell targeting CLDN18.

Solid tumor CAR-T debuts with ESMO clinical treatment data for advanced gastric cancer

The study presented in the 2021 ESMO oral report is a clinical trial initiated by a multi-center, open-label Phase I investigator in China.

As of April 8, 2021, 37 patients with advanced digestive system tumors with positive CLDN18.

From the specific clinical data, CT041 is generally well tolerated, and there is no treatment-related death or immune cell therapy-related neurotoxic syndrome (ICANS)

In terms of efficacy, among 36 patients with tumor target lesions, 31 patients observed varying degrees of target lesion reduction, with an overall objective response rate (ORR) of 48.

Among the 18 patients with gastric cancer/gastroesophageal junction cancer who had failed at least 2 lines of therapy and received the recommended dose of phase II (RP2D) 2.

In 28 patients with gastric cancer/gastroesophageal junction cancer, a subgroup analysis showed that ORR can be maintained at 50% or under different baseline characteristics such as CLDN18.

Historical data shows that for patients with gastric cancer who have failed at least 2 lines of treatment, the effective rate of chemotherapy drugs is about 4% to 8%, and the effective rate of anti-PD-1 monoclonal antibody is about 11%

More data from this clinical trial will be disclosed in academic journals or academic conferences in the future

Crowds compete for CAR-T therapy for solid tumors, Keji Pharmaceuticals leads global R&D

Up to now, the indications of CAR-T products approved for marketing worldwide are all hematological tumors, and the treatment effect is very significant

Comparison of the number of cell therapy trials for solid tumors and hematological tumors, source: Nature Reviews Drug Discovery, Changjiang Securities Research Institute

According to an article published by Nature Reviews Drug Discovery, about 90% of cancer cases worldwide are solid tumors, and the unmet clinical needs are still huge

The reason is mainly because the development of CAR-T cell therapy for solid tumors is facing many challenges, such as the malignant tumor microenvironment of solid tumors, the heterogeneity of tumor antigens and the escape mechanism still need to be resolved

Keji Pharmaceutical is the first company in the world to successfully identify, verify and report that CLDN18.

Among them, the expression of CLDN18.

Source: Huachuang Securities Research Report

China is a country with a high incidence of gastric cancer.

Keji Pharmaceuticals has submitted an application to initiate a key phase II clinical trial of CT041 to the National Food and Drug Administration of China, and it is expected that the company will initiate a key phase II clinical trial in the United States in 2022
.

At present, Keji Pharmaceutical has 11 candidate products, all of which are independently developed and have global rights and interests, covering conventional, new-generation CAR-T technology and allogeneic therapies.
The layout is comprehensive and forward-looking
.
Keji Pharmaceutical has obtained IND approvals for 7 CAR-T therapies in China, the United States and Canada, ranking first among all CAR-T companies in China
.

Source: Keji Pharmaceutical 2021 Interim Results Report

According to the Nature Biotechnology article data, as of the end of 2019, according to the total number of CAR-T patent statistics, Keji Pharmaceutical is the only Asian company on the list among the top 20 institutions and companies in the world
.
According to the 2021 interim performance report of Keji Pharmaceuticals, as of August 15, 2021, Keji Pharmaceuticals has 52 authorized patents and 231 patents in more than 19 countries or regions (including China, the United States, Europe and Japan) Apply
.

Source: Nature Biotechnology

On the basis of the existing product pipeline, Keji will continue to develop innovative proprietary technologies (CycloCAR, THANK-uCAR, etc.
) around the four R&D strategic directions of "solid tumor efficacy, safety, patient accessibility, and target availability" , In order to solve the main challenges in the field of CAR-T therapy
.
In the future, these technology platforms will continue to provide more independent research and development candidate products for the clinical stage
.

Professor Lin Shen, deputy dean of Peking University Cancer Hospital, director of the Department of Digestive Oncology, director of the Phase I clinical ward, and deputy director of the Beijing Institute of Cancer Prevention and Treatment, said: Gastric cancer is a tumor with a high incidence worldwide, especially in Asia and China.
Patients account for about 50% of the global number of gastric cancer patients.
Compared with other solid tumors, the overall drug research and treatment methods for gastric cancer are relatively lagging.
How to change the current dilemma of gastric cancer treatment has always been highly anticipated
.

The results of the study reported in ESMO this time show that CT041 has significant efficacy and good safety in the treatment of advanced gastric cancer.
We expect it to benefit more cancer patients
.

Dr.
Li Zonghai, the founder, chairman of the board, CEO, and CSO of Keji Pharmaceuticals expressed his gratitude to Dr.
Changsong Qi from Peking University Cancer Hospital for sharing the clinical research data of CT041 with the industry at the ESMO conference on behalf of the researcher team.
Thanks to all researchers for their dedication to this project.
Efforts
.
Such groundbreaking work would not have achieved such results without the dedicated efforts of researchers
.
Of course, it is the wish of all of us to provide better treatments for gastric cancer and other tumor patients worldwide, and it is also worth fighting for
.

About CT041

CT041 is a potential first-in-class autologous CAR-T candidate product that targets CLDN18.
2 and is independently developed by Keji Pharmaceuticals.
It is used to treat CLDN18.
2-positive solid tumors such as gastric cancer/gastroesophageal junction cancer and pancreatic cancer
.
Keji Pharmaceuticals is the first in the world to successfully identify, verify and report that CLDN 18.
2 can be used as a reasonable therapeutic target for CAR-T for solid tumors
.
In addition to the trials initiated by researchers in China, Keji Pharmaceuticals has also initiated phase Ib/II clinical trials for advanced (unresectable or metastatic) gastric cancer/gastric junction cancer and pancreatic cancer in China, and launched in the United States A phase Ib clinical trial for advanced (unresectable or metastatic) gastric cancer or pancreatic cancer was launched
.

About Keji Pharmaceutical

Keji Pharmaceutical (stock code: 2171.
HK) is a biopharmaceutical company with operations in China and the United States, focusing on innovative CAR-T cell therapies for the treatment of hematological malignancies and solid tumors
.
We have established a comprehensive cell therapy platform whose internal capabilities cover everything from target discovery, antibody development, clinical trials to commercial-scale production
.
We use independent research and development of new technologies and product pipelines with global rights to solve the major challenges of CAR-T cell therapy, such as improving safety, improving the efficacy of treating solid tumors and reducing treatment costs
.
Our mission is to be a global biopharmaceutical leader that can bring innovative and differentiated cell therapies to cancer patients around the world and make cancer curable
.

Source: Keji Biomedical (Shanghai) Co.
, Ltd.