PLEASANTON, Calif. & NANJING, China
First sentence of release should read: “…has been accepted by the China National Medical Products Administration (NMPA)…” (instead of “…has been approved by the China National Medical Products Administration (NMPA)…”).
The updated release reads:
IASO RECEIVES NMPA ACCEPTANCE OF ITS FIRST INDICATION IND APPLICATION FOR CT120, A FULLY HUMAN CD19/CD22 DUAL-TARGETING CAR-T THERAPY
IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and autoimmune diseases, announced that its investigational new drug (IND) application for CT120, a fully human CD19/CD22 dual-targeting chimeric antigen receptor (CAR)-T cell therapy, has been accepted by the China National Medical Products Administration (NMPA) (acceptance number CXSL2101070) 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.
B-ALL is the most common of all Acute lymphoblastic leukemia (ALL). The emergence of CAR-T therapy and its application in ALL diseases in recent years have brought revolutionary changes to B-ALL treatment. However, the risk for poor prognosis and loss of lives remains high with a 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 the relapse challenge.
CT120 is an autologous dual-antigen specific CAR-T therapy. Its extracellular 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, and also enhance 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.
Acute B-Lymphoblastic Leukemia (B-ALL) is a rapidly progressing cancer of the blood and bone marrow that occurs in both adults and children. About 75% of cases in adult patients occur in B cell lineage. Based on 2014-2018 cases and deaths, new cases of ALL were 1.8 per 100,000 men and women per year with the death rate at 0.4 per 100,000 men and women per year in the United States. In 2016 alone, there were 6,590 new ALL cases, and 1,400 deaths. Globally, ALL affected around 837,000 people and resulted in 110,000 deaths in 2015. The relapse rate for children afflicted by ALL is nearly 10% and for adults is as high as 50%. B-ALL is one of the most common forms of cancer in children between ages two and five and adults over age 50. (National Cancer Institute)
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.
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