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Application for clinical trial of the 2nd indication of IASO Biotherapeutics’ fully human CD19/CD22 dual-targeted CAR-T drug accepted by NMPA

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  • Time of issue:2021-06-01 13:05
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Application for clinical trial of the 2nd indication of IASO Biotherapeutics’ fully human CD19/CD22 dual-targeted CAR-T drug accepted by NMPA

  • Categories:NEWS
  • Author:
  • Origin:
  • Time of issue:2021-06-01 13:05
  • Views:0
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PLEASANTON, CALIF., NANJING, CHINA, May 21, 2021 - IASO Biotherapeutics announces today that its clinical trial application for the in-house developed CD19-CD22 fully human dual-targeted CAR T-cell therapy (CT120) for the treatment of its second indication, relapsed/refractory B-cell non-Hodgkin's lymphoma (B-NHL), has been accepted by National Medical Products Administration  (NMPA) (Acceptance No.: CXSL2101088, CXSL2101089). This acceptance comes only one day after the acceptance of the drug’s first indication for the treatment of CD19/CD22 positive relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). This success in clinical trial application further highlights the company’s speed of and strength in the development of innovative novel CAR-T therapies.

 

CT120 is developed on the company’s fully human antibody platform IMARS and high throughput CAR-T drug selection platform. IMARS antibody discovery platform is among the top ones in the industry in terms of database capacity - over 240 billion candidate antibodies render the platform powerful capacity and fast speed of antibody screening., The company’s high through-put CAR-T drug selection platform that makes use of cutting edge single-cell analysis and next-generation sequencing (NGS) technology is capable of implementing cost effective, high efficiency functional CAR-T candidate screening. CT120 is prepared at company’s integrated in-house good manufacturing practice (GMP) compliant manufacturing facility in Nanjing, which is fully equipped to produce high quality plasmids, viral vectors and gene edited cellular products in a cost-efficient manner.  

 

B-cell non-Hodgkin's lymphoma (B-NHL) is a group of hematologic malignancies of B-lymphocytes origin. Current standard of care (SOC)include chemotherapy, radiotherapy, hematopoietic stem cell transplant, molecular targeted drug, etc.Most patients can achieve short-term remission after the administration of standard of care, however,  relapsed or refractory disease are frequent in some patients. For such patients, conventional therapies are limited and CAR-T therapy is considered to be one of the most promising ones. CD19-targeted single-targeted CAR-T therapy has shown good efficacy in clinical studies, but some patients would still experience progression or recurrence with a short time after CD19 CAR-T therapy (ref). CD19 antigen escape on the surface of tumor cells is thought to be one of the possible mechanisms.

 

It has been shown in studies that both CD22 and CD19 are generally expressed on the surface of multiple B-cell tumors, including B-NHL. Similar to CD19, CD22 is also expressed ontumor with certain specificity, which makes it another ideal therapeutic target. In light of this, CD19 and CD22 dual-targeted CAR-T therapy theoretically can reduce the risk of treatment evasion as a result of the missing of a single target and show the prospect for further reducing disease recurrence, yielding long-term survival benefit for patients.


“The Investigator initiated trials (IITs) underway in Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology and the First Affiliated Hospital, College of Medicine, Zhejiang University showed the fully human dual-targeted CT120 not only benefits CAR-T naïve relapsed/refractory B-ALL patients but also benefits patients whose disease progressed during or after murine single-targeted CD19 CAR-T. Therefore, the therapy is of promising prospect in terms of both market landscape and patient benefits. More importantly, the submission of IND for this product marks the maturation of the company’s phage antibody library-based antibody discovery platform. It is expected that fully human antibody products based on this antibody library will continuously contribute to the company’s cell therapy and antibody therapy pipelines. In IASO Biotherapeutics, we will continue to expand and exploit new product pipelines to benefit more patients in the future.” Dr. Wang Wen, CEO, IASO Biotherapeutics.

 

About CT120:
CT120 is an autologous dual-target 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 IIT trial 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 NHL:
Lymphomas of immune system cells origin may cause damage to any organ in the body and give rise to a variety of accompanying complicated pathologic processes. Lymphomas are divided into two categories: Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). Approximately 85% of non-Hodgkin’s lymphomas are of B-cell origin. Diffuse large B-cell lymphoma (DLBCL) is the most common type of NHL. DLBCL accounts for 31% of NHLs in European and American countries and more than 40% of NHLs in Asian countries. The incidence of the disease increases with age. According to statistics from 2006 to 2016, the standardized morbidity and mortality rates of NHLs in China were 4.29/100,000 and 2.45/100,000, respectively.

 

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 (BTD) by China’s National Medical Products Administration (NMPA) in February 2021. For more information on IASO, please visit www.iasobio.com.


 

驯鹿医疗