NMPA’s Clearance of CT120 Marks Major Milestone in Treatment for B-Cell Malignancies
PLEASANTON, Calif. & NANJING, China & SHANGHAI, August 02, 2021--(BUSINESS WIRE)--IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company advancing the development of novel cell therapies for cancer, today announced the clearance from China’s National Medical Products Administration (NMPA) of two Initial New Drug (IND) applications for CT120, the company’s in-house developed fully human CD19/CD22 dual-targeted chimeric antigen receptor (CAR)-T cell therapy for the treatment of CD19/CD22-positive relapsed/refractory B-cell non-Hodgkin's lymphoma (r/r B-NHL) and relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).
With these clearances (acceptance numbers: CXSL2101070, CXSL2101088, CXSL2101089), CT120 becomes the world's first fully human CD19/CD22 dual-targeted CAR-T cell therapy to enter clinical development, marking a significant milestone in IASO Bio’s effort to address unmet clinical needs in the treatment of B-cell malignancies.
CT120’s dual-target design enables it to effectively address the tumor escape caused by the target antigen loss commonly associated with existing CAR-T therapies, conceivably reducing the risk of relapse and improving patient survival. Moreover, CT120 uses fully human antibody sequences, which can reduce the anti-drug antibody (ADA) effect and improve the in vivo persistence of CAR-T cells.
In investigator-initiated clinical studies (IIT), CT120 demonstrated a favorable safety efficacy profile. Clinical trials indicated that CT120 not only benefits patients with CAR-T-naïve relapsed/refractory B-NHL and B-ALL but patients who had progressed on prior treatment with the murine antigen targeting CAR-T therapies, showing enormous potential in both clinical utility and addressable patient population.
The CD19 antibody sequence of CT120 is developed on IASO Bio’s fully human antibody platform IMARS and high throughput CAR-T drug selection platform. IMARS, one of the industry’s top antibody discovery platforms in terms of database capacity, has over 240 billion candidate antibodies and can provide 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 efficiently and cost-effectively.
"CT120 is the first fully human dual-targeted CAR-T candidate in the world, and we’re poised to accelerate these clinical programs and further develop innovative cell therapies that address patient needs," said Dr. Wen Wang, CEO and CMO at IASO Biotherapeutics. "These IND clearances for CT120 is the first of many milestones that will be followed by a series of INDs for multiple high-potential assets and marks the beginning of the full adoption our platform IMARS in discovery and development."
CT120 is an autologous dual-target CAR-T therapy. Its extracellular domain contains two fully human single-chain fragment variable (scFv) sequences that can specifically bind to CD19 and CD22, identifying tumor cells with CD19 and CD22 expressions, thereby reducing the tumor escape caused by the loss of target antigen. Adopting a fully human design, CT120 has low immunogenicity, reduces the ADA effect, and improves CAR-T cells’ viability.
Compared to the intracellular costimulatory signal CD28, CT120’s intracellular costimulatory signal 4-1BB and CD3ζ have lower neurotoxicity and improved viability of CAR-T cells, thus more durable efficacy. Upon binding with CD19/CD22 antigens on the tumor cells, CT120 eliminates targeted tumor cells through the release of granzyme and perforin while simultaneously releases cytokine to promote the proliferation of CAR-T cells, thus achieves its durable antitumor activity.
About Non-Hodgkin Lymphoma (NHL)
Lymphoma arises from immune cells. It may cause various organ damage and is commonly associated with a complicated pathological process. Lymphoma has two subtypes: Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). NHL accounts for around 90% of all lymphoma cases, and 85% of NHL cases are B-NHL, which has numerous subtypes, including diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and small lymphocytic lymphoma (CLL). According to a Frost & Sullivan report, there were approximately 92,800 new incidences of NHL in China in 2020 with a total patient population of 514,200 and is expected to reach 632,300 in 2025. NHL has a high mortality rate, with a five-year survival rate of just 37% in China. According to National Cancer Institute, the rate of new cases of non-Hodgkin lymphoma was 19.6 per 100,000 men and women per year. The death rate was 5.4 per 100,000 men and women per year. Non-Hodgkin lymphoma represents 4.3% of all new cancer cases in the U.S.
About Acute B-Lymphoblastic Leukemia (B-ALL)
Acute B-Lymphoblastic Leukemia (B-ALL), a subtype of leukemia, is a rapidly progressing hematologic malignancy and myelogenous tumor that occur in both adults and children. The five-year survival rate of leukemia patients in China is only 25.4%, significantly lower than that in the United States. B-cell acute lymphocytic leukemia (B-ALL) is the most common subtype of ALL, accounting for 75% of all adult patients with ALL. According to a Frost & Sullivan report, there were 12,800 new cases of ALL in China in 2020, with a total patient population of 143,900 that is expected to reach 150,300 in 2025. 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 the ages of two and five and adults over the age of 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 more than 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 (R/R) multiple myeloma (RRMM), which 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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