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IASO Biotherapeutics Application for Clinical Trials of the Second Indication of its Fully Human CD19/CD22 Dual-targeted CAR-T Drug Accepted by NMPA

2021年06月07日 PM09:00
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PLEASANTON, Calif. & NANJING, China

IASO Biotherapeutics, a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and autoimmune diseases, announced today that its clinical trial application for the in-house developed CD19xCD22 fully human dual-targeted CAR T-cell therapy (CT120) for treatment of its second indication for relapsed/refractory B-cell non-Hodgkin’s lymphoma (B-NHL), has been accepted by the National Medical Products Administration (NMPA) (Acceptance No.: CXSL2101088, CXSL2101089). This acceptance came just one day after the acceptance of the drug’s first indication for treatment of CD19xCD22 positive relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). These successful clinical trial applications highlight the company’s speed and strength in developing innovative novel CAR-T therapies.

CT120 is developed on IASO Bio’s fully human antibody platform IMARS and high throughput CAR-T drug selection platform. IMARS is one of the industry’s top antibody discovery platforms in terms of database capacity. With over 240 billion candidate antibodies, the platform has powerful capacity and provides speedy antibody screening. The company’s high-throughput CAR-T drug selection platform, which uses cutting-edge single-cell analysis and next-generation sequencing (NGS) technology, can implement cost effective, high efficiency functional CAR-T candidate screening. CT120 is prepared at IASO Bio’s integrated 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 cost-efficiently.

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, and more. While most patients can achieve short-term remission following standard care, relapsed or refractory disease is common. For such patients, conventional therapies are limited, and CAR-T therapy is considered to be a promising alternative. And while CD19-targeted single-targeted CAR-T therapy has shown good efficacy in clinical studies, some patients still experience progression or recurrence a short time after such therapy (Nature). It is thought that CD19 antigen escape on the surface of tumor cells is one of the possible reasons.

Studies have shown 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 on tumors with certain specificity, which makes it another ideal therapeutic target. In light of this, CD19xCD22 dual-targeted CAR-T therapy theoretically can reduce the risk of treatment evasion due to missing a single target. As a result, it shows good potential for further reducing disease recurrence and thus, yielding long-term survival benefits for patients.

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

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, which have the potential to persistent in vivo longer than mono-specific CAR-T cells, enhance therapeutic effects by reducing relapse resulting from antigen escape.

CT120 proves to be significantly effective in an ongoing IIT trial in China. 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, resulting in better therapeutic outcomes and longer survival benefits for patients.

About Non-Hodgkin Lymphoma (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 (Biomed Central).

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. This includes a diversified portfolio of over 10 novel pipeline products, as well as IASO’s leading asset, CT103A, an innovative anti-BCMA CAR-T cell therapy under pivotal study for relapsed/refractory multiple myeloma (RRMM), which was granted Breakthrough Therapeutic Designation by China’s National Medical Products Administration (NMPA) in February 2021. For more information, please visit www.iasobio.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210607005275/en/

CONTACT

Mary Placido

SKC, Inc.

mary@skc-pr.com

(415) 218-3627

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