SHANGHAI and NANJING, China and PLEASANTON, Calif., Dec. 8, 2025 /PRNewswire/ -- IASO Biotechnology ("IASO Bio"), a commercial-stage biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of novel cell therapies and biologics for hematologic malignancies and autoimmune diseases, announced the oral presentation of updated clinical data for its independently developed, fully human BCMA-targeted CAR-T cell therapy product, Equecabtagene Autoleucel (Eque-cel), for the treatment of transplant-ineligible patients with high-risk newly diagnosed multiple myeloma (NDMM) at the 2025 American Society of Hematology (ASH) Annual Meeting. The data demonstrate that Eque-cel can provide deep and durable responses while maintaining a manageable safety profile for this patient population.

Abstract Number: abs25-8596
Abstract Title: Efficacy and safety of a fully human BCMA CAR T-cell therapy for high-risk newly diagnosed transplant-ineligible multiple myeloma: Updated results from an open label, single-arm phase 1 study fumanba-2

The primary endpoints were the proportion of minimal residual disease (MRD)-negative and progression-free survival (PFS). As of May 13, 2025, a total of 16 patients had received Eque-cel infusion. Cytogenetics were detected in all pts with at least one high risk cytogenetic abnormalities (HRCA). 11 patients had double-hit, and 2 patients had triple-hit cytogenetics. 2 patients had R-ISS stage III with a double-hit, and 1 patient had R-ISS stage III with a triple-hit. 4 patients had extramedullary disease.

With a median follow-up of 27.04 months, the median PFS was not reached. The PFS rates at 12, 18 and 24 months were 87.5%, 80.2% and 74.5%, respectively. All patients achieved MRD negativity within 1 month, and 80% of patients maintained sustained MRD negativity beyond 24 months. The objective response rate (ORR) was 100%, with 93.8% achieving stringent complete response (sCR).

After infusion of Eque-cel, cytokine release syndrome (CRS) occurred in 11 patients (68.8%), all of which were grade 1-2. The median time to CRS onset was 7 days, with a median duration of 3 days. No neurotoxic effects or immune effector cell-associated neurotoxicity syndrome (ICANS) were observed.

Professor Lijuan Chen from Jiangsu Province Hospital stated: "The updated data from the FUMANBA-2 study presented at the 2025 ASH Annual Meeting are encouraging. Among all enrolled high-risk patients, we observed an sCR rate of 93.8%, with 80% of patients maintaining sustained MRD negativity for over 24 months. In high-risk patient groups, including those with double-hit/triple-hit cytogenetics and R-ISS stage III with EMD, Eque-cel continued to demonstrate durable disease control, achieving a 24-month PFS rate of 74.5%. This suggests that this therapy could be a promising and effective treatment option as first line therapy following induction chemotherapy for high-risk NDMM."

Dr. Jie Chen, Chief Medical Officer and Senior Vice President of IASO Bio, commented: "We are delighted to present the promising data for Eque-cel in the treatment of high-risk NDMM at the 2025 ASH Annual Meeting. The FUMANBA-2 study data presented confirm its deep and durable responses in this patient population, with no observed ICANS and all CRS events limited to grade 1-2. We will continue to advance the long-term follow-up of this study and look forward to bringing this innovative therapy to patients in need earlier."

About Multiple Myeloma (MM)

Global annual incidence increased from 164,300 in 2019 to 197,200 in 2024, projected to reach 273,600 by 2040. In China, incidence rose from 28,100 in 2019 to 31,800 in 2024, with an estimated 30–40% progressing to third-line therapy.

About IASO Bio

Founded in 2017, IASO Bio is one of the few commercial-stage biopharmaceutical companies in the Advanced Therapy Medicinal Product (ATMP) sector bringing China's breakthrough innovations to the global market. We specialize in developing cell therapies and biologics for hematological malignancies and autoimmune diseases. Our industry-leading, fully integrated platforms leverage cutting-edge technologies that span the entire product lifecycle—from discovery and development to manufacturing and commercialization.

Source: IASO Bio