Innovent Biologics and IASO Biotech Announce Positive Clinical Data of Fully Human Anti-BCMA CAR-T (CT103A) Presented at ASCO and EHA

Suzhou, June 18, 2019 /PRNewswire/ -- Innovent Biologics (HKEX stock code: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs for the treatment of major diseases such as cancer and autoimmune disorders, announced today that clinical trial data from an investigator-initiated study conducted at Tongji Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology on the fully human BCMA CAR-T cell therapy (development code: CT103A), jointly developed by Innovent Biologics and Nanjing IASO Biotherapeutics Co., Ltd., were presented at the recently concluded 24th Annual Congress of the European Hematology Association (EHA) and the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO). The data were disclosed via a poster presentation (Poster Abstract #8013; June 4, Central Time) and an oral presentation (Oral Presentation Abstract #S827; June 15, Saturday, 12:35 PM – 12:45 PM Central European Summer Time), respectively.

CT103A is an anti-BCMA CAR-T cell injection co-developed by Innovent Bio and IASO Bio, intended for the treatment of relapsed or refractory multiple myeloma. At the ASCO and EHA annual meetings, CT103A demonstrated positive data: an objective response rate (ORR) of 100%, with robust persistence and expansion capability of the CAR-T cells in vivo. It is expected to provide a novel therapeutic option for patients with relapsed/refractory multiple myeloma (RRMM), particularly showing favorable efficacy in patients who have relapsed after prior treatment with murine single-chain antibody-based CAR-T therapy.

Multiple Myeloma (MM) is a malignant hematologic tumor characterized by the clonal abnormal proliferation of plasma cells, and it remains incurable in medical practice to date. In many countries, multiple myeloma is the second most common hematologic malignancy. According to estimates by the American Cancer Society, there will be 32,110 new diagnosed cases in the United States in 2019.2018In Europe, over 48,200 patients are diagnosed with multiple myeloma annually, 40% of whom have intermediate- to high-risk disease and a median survival time of no more than 5 years.

As of May 22, 2019, among the 11 evaluable subjects treated with CT103A, the objective response rate (ORR) was 100% (7 complete responses [CR] and 4 very good partial responses [VGPR]), with a maximum follow-up duration of 8 months. The CAR-T cells demonstrated robust expansion capacity and persistence in patients. All patients underwent assessment for cytokine release syndrome (CRS). CRS occurred within 2–5 days (median: 2.6 days) and resolved within 14 days. Most cases of CRS in the low- and medium-dose cohorts were Grade 1–2, while higher-grade CRS was observed in the high-dose cohort. CRS was routinely managed with tocilizumab and corticosteroids. Notably, the 11 evaluable patients included 4 who had relapsed after prior treatment with murine anti-BCMA CAR-T therapy; among these, 3 achieved complete response (CR) and 1 achieved very good partial response (VGPR).

“Relapsed/refractory multiple myeloma (RRMM) is associated with a poor prognosis,” stated Dr. Li Chunrui, Director at Tongji Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology. “Many patients who received murine single-chain variable fragment (scFv) CAR-T therapy have experienced relapse and cannot be retreated due to immunogenicity. CT103A features a fully human BCMA scFv, which not only demonstrates outstanding efficacy in first-line treatment but also provides an effective solution for these relapsed patients. These data suggest that such patients should not be excluded from future clinical trials.”