JAMA Oncology Publishes Phase 1b/2 Study Data on IASO Bio's Equecabtagene Autoleucel (Fucaso™) in the Treatment of Relapsed/Refractory Multiple Myeloma

—— The Phase 1b/2 study FUMANBA-1 demonstrates Equecabtagene Autoleucel led to deep and durable responses in patients with R/RMM

—— The data shows the overall response rate（ORR）was 96.1%，the ORR reached 98.9% among the patients without prior CAR-T therapy

——Among the 103 patients, only one experienced ≥ Grade 3 cytokine release syndrome (CRS), with no ≥ Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS)

SHANGHAI and NANJING, China and SAN JOSE, Calif., Nov. 7, 2024 /PRNewswire/ -- IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing innovative cell therapy and antibody products, today announced that the results of the phase 1b/2 clinical study FUMANBA-1 of its fully human anti-BCMA CAR-T therapy, Equecabtagene Autoleucel (trade name: Fucaso™), for the treatment of relapsed/refractory multiple myeloma (R/RMM), have been published in the leading medical journal JAMA Oncology. The study evaluated the efficacy and safety of Equecabtagene Autoleucel in patients with R/RMM who had previously received ≥3 lines of prior therapies. The results demonstrated that Equecabtagene Autoleucel achieved a high overall response rate and durable remission in patients, with a favorable safety profile.

JAMA Oncology published clinical data on 103 patients who received infusion of Equecabtagene Autoleucel (Fucaso^™) as of September 9, 2022, with a median follow-up of 13.8 months (range: 0.4-27.2 months). In terms of efficacy, among the 101 evaluable patients, the overall response rate (ORR) was 96.0% (97/101), and the stringent complete response/complete response rate (sCR/CR) was 74.3% (75/101). Among the 89 patients without prior CAR-T therapy, the ORR was 98.9% (88/89), and the sCR/CR rate was 78.7% (70/89). In these 101 patients, the median time to response was 16 days (range: 11-179), while the median duration of response (DOR) and median progression-free survival (PFS) had not been reached yet. The 12-month PFS rate was 78.8% (95% CI: 68.6-86.0). Additionally, 95% (96/101) of the patients achieved minimal residual disease (MRD) negativity, with a median time to MRD negativity of 15 days (range: 14-186). All patients with sCR/CR achieved MRD negativity, and the median duration of MRD negativity had not been reached.

In terms of safety, 93.2% (96/103) of the patients experienced cytokine release syndrome (CRS), most of which were grade 1 or 2, with only one patient experiencing grade 3 or higher CRS. Only 1.9% (2/103) of the patients developed immune effector cell-associated neurotoxicity syndrome (ICANS), with one case each of grade 1 and grade 2.

Notably, updated data from this study, as of December 31, 2022, was presented during the 2023 American Society of Hematology (ASH) Annual Meeting. The median follow-up had increased to 18.07 months, with an ORR of 96.1% among the 103 evaluable patients. The sCR/CR rate was 77.7%, and all patients who achieved CR or better exhibited 100% MRD negativity. Among the 91 patients without prior CAR-T therapy, the ORR reached 98.9%, with an sCR/CR rate of 82.4% and an MRD negativity rate of 97.8%. Notably, 81.7% of these patients remained MRD-negative at 12 months post-infusion, with a 12-month PFS rate was 85.5%. In addition, Equecabtagene Autoleucel could showed prolonged persistence in the body, at 12 months post-infusion, 50% of patients had a vector copy number (VCN) above the limit of detection, and 40% still had detectable VCN persistence at 24 months.

Professor Lu-gui Qiu, from the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, stated: "The results of the FUMANBA-1 study demonstrate the encouraging efficacy and safety of Equecabtagene Autoleucel in treating patients with relapsed/refractory multiple myeloma. Its groundbreaking fully human scFv design overcomes the high immunogenicity issues commonly associated with animal-derived CAR-T cells while maintaining optimal affinity for BCMA-expressing tumor cells. Its excellent dissociation kinetics facilitates rapid expansion and long-term persistence of Equecabtagene Autoleucel in vivo."

Professor Huang He, from The First Affiliated Hospital, Zhejiang University School of Medicine, stated, "Equecabtagene Autoleucel (Fucaso^™) was approved in China in June 2023. Over the past year since its launch, it has brought significant survival benefits to patients with relapsed/refractory multiple myeloma in China and from overseas. Meanwhile, we have accumulated valuable real-world experience, and we expect this innovative therapy to benefit more patients."

Professor Chunrui Li, from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, stated: "Equecabtagene Autoleucel is the world's first fully human CAR-T therapy to be approved. It's binding to BCMA, utilizing both heavy and light chains with optimal affinity, facilitates dissociation from BCMA antigen after tumor cell killing, thereby reducing CAR-T cell self-exhaustion. Along with lower immunogenicity, this leads to rapid, deep, and sustained remission in patients with multiple myeloma."

Dr. Jie Chen, Chief Medical Officer of IASO Bio, stated: "We are delighted that the phase 1b/2 clinical study data of Equecabtagene Autoleucel for the treatment of R/RMM has been published in JAMA Oncology. The results of this study, which targeted patients with R/RMM who had previously received ≥3 lines of prior therapies are very inspiring. We thank the FUMANBA-1 research team for their rigorous scientific approach and high-standard execution. Currently, IASO Bio is actively conducting and advancing the phase III clinical study (FUMANBA-3) of Equecabtagene Autoleucel for the treatment of multiple myeloma patients who have received 1-2 lines of prior therapies. We anticipate this clinical study, based on clinical data from Chinese patients, will yield positive results soon, bringing new treatment option for more patients."

About FUMANBA-1 study

FUMANBA-1 is a single-arm, open-label phase 1b/2 registrational clinical study conducted in 14 Chinese centers to assess the efficacy and safety of the Equecabtagene Autoleucel in patients with R/RMM who have received ≥3 lines of prior therapies. The trial enrolled patients with RRMM who had previously received at least three lines of therapy, including proteasome inhibitors and immunomodulatory agents-based chemotherapy regimens, and had disease progression on their last line of therapy. Patients who had previously received BCMA CAR-T therapy were also eligible for enrollment.

About Equecabtagene Autoleucel (Fucaso^™)

Equecabtagene Autoleucel (Fucaso^™) is an innovative fully-human anti- BCMA CAR-T cell therapy which uses lentivirus as a gene vector to transfect autologous T cells. The CAR contains a fully-human scFv, CD8a hinge and transmembrane, and 4-1BB-mediated co-stimulation and CD3ζ activation domains. Based on rigorous molecular structure screening and comprehensive in vitro and in vivo functional evaluations, Fucaso^™ demonstrates rapid and potent efficacy, accompanied by exceptional long-term persistence in vivo, enabling patients to achieve higher and deeper remissions, providing continuous protection and care for those suffering from multiple myeloma.

About IASO Bio

IASO Bio is a biopharmaceutical company focused on the discovery and development of novel cell therapies and biologics for oncology and autoimmune diseases. IASO Bio possesses comprehensive capabilities spanning the entire drug development process, from early discovery to clinical development, regulatory approval, and commercialization.

Its pipeline includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received Biologics License Application (BLA) approval from China's National Medical Products Administration (NMPA) in June 2023and U.S. FDA IND approval for the treatment of R/RMM in December 2022.

Leveraging its strong management team, innovative product pipeline, as well as integrated and high quality manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China and around the world. For more information, please visit http://www.iasobio.com or www.linkedin.com/company/iasobiotherapeutics.

SOURCE IASO Bio