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IASO Announced Acceptance of  IND Application by NMPA for CT120, a Fully Human CD19/CD22 Dual-Targeting CAR-T Therapy

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  • Time of issue:2021-05-23 20:55
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IASO Announced Acceptance of  IND Application by NMPA for CT120, a Fully Human CD19/CD22 Dual-Targeting CAR-T Therapy

  • Categories:Press Release
  • Author:
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  • Time of issue:2021-05-23 20:55
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PLEASANTON, CALIF., NANJING, CHINA, May 19, 2021 - IASO Biotherapeutics (IASO Bio) today announced that the Center for Drug Evaluation of the China National Medical Products Administration (NMPA) has accepted (acceptance number CXSL2101070) the investigational new drug (IND) application for CT120, an investigational fully human CD19/CD22 dual-targeting chimeric antigen receptor (CAR)-T cell therapy independently developed by IASO Bio for treatment of relapsed/refractory B-acute lymphoblastic leukemia (B-ALL). CT120 is the second clinical stage CAR-T therapies developed by IASO Bio, which signifies the company’s solid step in the development of next-generation CAR-T therapies.

 

Acute lymphoblastic leukemia (ALL) is a common type of leukemia among which B-ALL is the most common. The emergence of CAR-T therapy and its application in ALL diseases recent years have brought revolutionary changes to the treatment of B-ALL, while the risk for poor prognosis and loss of lives remains high with significant number of relapsed/refractory patients. Tumor recurrence and drug resistance are often attributed to the loss of target antigen expression. Therefore, next-generation CAR-T therapy such as dual targeting with multiple antigens is important to overcome relapse challenge.

 

About CT120:
CT120 is an autologous dual-antigen specific CAR-T therapy. Its extra cellular domain contains two fully-human scFv sequences that can specifically recognize CD19 and CD22. Dual-antigen specific CAR-T cells have the potential to persistent in vivo longer than mono-specific CAR-T cells, also enhances therapeutic effects by reducing relapse resulted from antigen escape. 

CT120 proves to be significantly effective in an ongoing investigator-initiated trial (IIT) in China. The results show that CT120 not only has a durable response on CAR-T treatment-naive relapsed/refractory B-ALL patients, but also has a curative effect on relapsed patients who have previously received mono-specific CAR-T treatment. CT120 can reduce the risk of antigen escape and tumor relapse as a result of lower/loss of CD19 or CD22 expression following mono-specific CAR-T treatment, which will bring better therapeutic outcome and longer survival benefit for patients.

 

About B-ALL:
Acute lymphoblastic leukemia (ALL) is a rapidly progressing cancer of the blood and bone marrow that occurs in both adults and children. Acute B-Lymphoblastic Leukemia (B-ALL) is one of the most common forms of ALL. About 75% of cases in adult patients occur in B cell lineage. Statistical information in the United States showed that the rate of new cases of acute lymphocytic leukemia was 1.8 per 100,000 men and women per year. The death rate was 0.4 per 100,000 men and women per year. In 2016 alone there were 6,590 new ALL cases, with 1,400 deaths. Globally, ALL affected around 837,000 people and resulted in 110,000 deaths in 2015. It is also the most common cause of cancer and death from cancer among children. The relapse rate for children afflicted by ALL is nearly 10% and that for adults is as high as 50%. B-ALL, a major form of acute lymphoblastic leukemia (ALL), is one of the most common forms of cancer in children between the ages of two and five and adults over the age of 50. 

 

About IASO Biotherapeutics:
IASO Bio is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and autoimmune diseases. Leveraging its proprietary fully human antibody discovery platform (IMARS), high-throughput CAR-T drug priority platform, and proprietary manufacturing processes, IASO Bio is developing a rich clinical-stage pipeline of multiple autologous and allogeneic CAR-T and biologics product candidates. Currently, the company is developing a diversified portfolio of over 10 novel pipeline products, IASO’s leading asset, CT103A, an innovative anti-BCMA CAR-T cell therapy under pivotal study for relapsed/refractory (R/R) multiple myeloma (RRMM),  was granted Breakthrough Therapeutic Designation by China’s National Medical Products Administration (NMPA) in February 2021. For more information on IASO, please visit www.iasobio.com.

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