Innovative Anti-BCMA CAR-T Therapy Co-Developed by IASO Bio and Innovent Biologics Designated as Breakthrough Therapy in China for Relapsed/Refractory Multiple Myeloma

Original Title: CAR-T Therapy Co-developed by IASO Bio and Innovent Bio Proposed for Inclusion in Breakthrough Therapy Designation Source: Medical Observer

▎WuXi AppTecContent Team Report

On February 9, the website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration disclosed that IASO Bio’s applicationFully Human BCMA Chimeric Antigen Receptor Autologous T Cell InjectionGranted Breakthrough Therapy Designation, intended for the treatment of relapsed/refractory multiple myeloma. Public information shows that,This investigational CAR-T therapy is jointly developed by IASO Bio and Innovent BioHair, it is designated as CT103A in IASO Bio’s development program and as IBI326 in Innovent Bio’s development program.

IASO Bio, founded in 2017, is dedicated to the research, development, and industrialization of tumor cell immunotherapy drugs. The company’s founder and chairwoman is Ms. Zhang Jinhua, and its Chief Scientific Officer (CSO) is Dr. Zheng Biao. With the development of hematologic malignancy cell-based therapies and antibody drugs as the cornerstone of its innovation, IASO Bio is expanding into the fields of solid tumors and autoimmune diseases, currently boasting more than ten products in its pipeline.

According to the official website of IASO Bio, high-dose BCMA-targeted CAR-T cell therapy may achieve better remission in patients with relapsed/refractory multiple myeloma (RRMM), but is associated with more severe adverse events. Furthermore, re-infusion of CAR-T cells is ineffective once the disease progresses again.The development of CT103A aims to address this challenge.。CT103A utilizes a lentiviral vector to transduce autologous T cells. The CAR comprises a fully human scFv, CD8α hinge and transmembrane domains, 4-1BB co-stimulatory domain, and CD3ζ activation domain., this product demonstrates potent and rapid efficacy, with outstanding durability.

In September 2019, the investigational new drug (IND) application for the Phase 1b/2 chimeric protocol of CT103A in relapsed/refractory multiple myeloma received implicit approval for clinical trials. At the 61st American Society of Hematology (ASH) Annual Meeting held in 2019, researchers presented clinical study data on CT103A for the treatment of relapsed/refractory multiple myeloma.

Research indicates thatCT103A demonstrated favorable safety, efficacy, and durability of response:

Of the 18 patients enrolled in the completed classic Phase I dose-escalation trial, 17 were evaluable.Objective Response Rate (ORR) reached 100%;

Furthermore,70.6% of patients achieved complete response (sCR/CR), and 88.2% of patients attained very good partial response (VGPR) or better.。Even in the lowest dose group (1 × 10⁶ cells/kg),CT103A Maintains a 100% ORR，Among them, 78% of patients achieved a very good partial response or better efficacy.。

Cytokine Release Syndrome (CRS) occurred in 17/18 patients, but was generally manageable and without neurotoxicity.

The study also included four patients who had relapsed after prior treatment with murine anti-BCMA CAR-T cells, and their overall performance indicatedCT103A can also provide an effective treatment option for patients who relapse after murine-derived CAR-T therapy.。

Multiple myeloma is one of the most common hematologic malignancies. For newly diagnosed multiple myeloma patients, first-line therapies commonly include proteasome inhibitors, immunomodulatory drugs, and alkylating agents. In most patients, these standard first-line treatments can stabilize the disease for 3 to 5 years; however, a small subset exhibits primary resistance at initial treatment, resulting in inadequate disease control. Furthermore, among the majority of newly diagnosed patients who initially respond to therapy, relapse and refractoriness inevitably occur after the period of disease stability. Consequently, there remains an unmet medical need for patients with relapsed/refractory multiple myeloma.

We look forward to the smooth progress of subsequent clinical studies on this fully human BCMA chimeric antigen receptor (CAR) autologous T-cell therapy, bringing new treatment options to patients at an early date.