SAN JOSE, CALIF., NANJING, CHINA and SHANGHAI, Nov 10, 2021 – IASO Biotherapeutics (“IASO Bio”), a clinical-stage biopharmaceutical company focused on discovering, developing, and manufacturing innovative medicines, today announced that the updated data from Phase1/2 study of CT103A, a fully human B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy co-developed with Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801) for the treatment of patients with relapsed/refractory multiple myeloma (RRMM), was accepted for an oral presentation at the 63rd American Society of Hematology (ASH) Annual Meeting, December 11-14, 2021 (Abstract # 547).
Highlights of the presentation include the latest data from 13 clinical sites involved in the Phase 1/2 clinical study of CT103A (ChiCTR1800018137) in the treatment of patients with RRMM, showing safety and efficacy results from more subjects with longer follow-up, as well as CT103A’s pharmacokinetic data.
• Abstract Title: “A Phase 1/2 Study of a Novel Fully Human B-Cell Maturation Antigen-Specific CAR T Cells (CT103A) in Patients with Relapsed and/or Refractory Multiple Myeloma”
• Presentation type: Oral Presentation Abstract #547
• Session Title: 704. Cellular Immunotherapies: Cellular Therapies for Myeloma
• Session Time: Sunday, December 12, 2021 at 4:30 PM - 6:00 PM EST Time
• Speaker: Chunrui Li, MD, PhD, from Department of Hematology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
The investigator-initiated trials (IIT) study on CT103A (a single-center, open-label, Phase I clinical study evaluating the safety and efficacy of CT103A in the treatment of relapsed/refractory plasma cell tumors) has completed 23 cases of reinfusion to date, with at least 2 years of follow-up. The Phase Ib/II registrational clinical study (ChiCTR1800018137) of CT103A for the treatment of patients with RRMM is now underway. In addition to multiple myeloma, CT103A is being investigated for potentials in patients with autoimmune diseases. An IIT study of CT103A on Neuromyelitis Optica Spectrum Disorders (NMOSD) has achieved positive results and has completed the pre-Investigational New Drug (pre-IND) study, with the IND expected to be filed early 2022.
About Multiple Myeloma (MM)
Multiple Myeloma is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems, and bone fractures. For multiple myeloma patients, common first-line drug treatments include proteasome inhibitors, immunomodulatory drugs, and alkylating agents. While treatment may result in remission, most patients will inevitably enter the relapsed or refractory stage as there’s currently no cure. As a result, there is a significant unmet need for patients with relapsed/refractory multiple myeloma. In the United States, MM accounts for nearly 2% of all cancer cases, and more than 2% of cancer-related deaths. According to Frost & Sullivan:
The number of new MM cases in the United States rose from 30,300 in 2016 to 32,300 in 2020 and is expected to increase to 37,800 by 2025. The total number of patients diagnosed with MM in the United States increased from 132,200 in 2016 to 144,900 in 2020 and is expected to rise to 162,300 by 2025.
The number of new MM cases in China rose from 18,900 in 2016 to 21,100 in 2020 and is expected to increase to 24,500 by 2025. The total number of patients diagnosed with MM in China increased from 69,800 in 2016 to 113,800 in 2020 and is expected to rise to 182,200 by 2025.
About CT103A (BCMA CAR-T)
CT103A is an innovative therapy co-developed by IASO Bio and Innovent Biologics. Previous studies indicate subjects with relapsed/refractory multiple myeloma (RRMM) who received high-dose BCMA-targeting CAR-T cells may achieve better remission but have worse adverse events. Moreover, once the disease progresses again, the re-infusion of CAR-T cells will not be effective. To solve this dilemma, CT103A has been developed, a lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3ζ activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform and integrated in house manufacture process improvement, the construct of the BCMA CAR-T is potent and CT103A shows prolonged persistency in patients. In February 2021, CT103A was granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA) for the treatment of RRMM. In addition to multiple myeloma, IASO Bio is investigating CT103A in patients with autoimmune diseases.
About IASO Bio
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 10 novel pipeline products, including IASO’s leading asset, CT103A, an innovative anti-BCMA CAR-T cell therapy under pivotal study for relapsed/refractory multiple myeloma (RRMM). CT103A received Breakthrough Therapeutic Designation by China’s National Medical Products Administration (NMPA) in February 2021. In addition, the company’s in-house developed fully human CD19/CD22 dual-targeted chimeric antigen receptor (CAR)-T cell therapy has entered phase I/II registrational clinical trial for the treatment of CD19/CD22-positive relapsed/refractory B-cell non-Hodgkin's lymphoma (r/r B-NHL). It has also received IND clearance from NMPA for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). For more information on IASO Bio, please visit www.iasobio.com and or LinkedIn.