Equecabtagene Autoleucel

—— 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 or . SOURCE IASO Bio WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SHANGHAI and NANJING, China and SAN JOSE, Calif, Sept. 29, 2024 /PRNewswire/ -- IASO Biotherapeutics ("IASO Bio"), a biopharmaceutical company dedicated to discovering, developing, manufacturing and commercializing innovative cell therapy and antibody products, today announced a poster presentation of the comparative clinical outcomes of patients from FUMANBA-1 study with relapsed/refractory multiple myeloma (R/R MM) who received the fully human anti-BCMA CAR-T cell therapy Equecabtagene Autoleucel (Eque-cel, Fucaso™) under different lymphodepletion regimensat the 2024 International Myeloma Society (IMS) Annual Meeting. Results indicate that a full lymphodepletion dose can significantly improve the depth and duration of remission, prolong progression-free survival, without more treatment-related toxicity in patients. Abstract Number：P-094 Abstract Title: The Optimal Lymphodepletion Prior to Eque-cel in Patients with Refractory Relapsed Multiple Myeloma in FUMANBA-1 Study Presentation Date：September 28, 2024（UTC-3) The poster presents a post-hoc analysis of the FUMANBA-1 study which enrolled 91 subjects without prior CAR-T treatment to receive Eque-cel. The median follow-up period was 18.07 months. Of the 91 subjects, 33 underwent a lymphodepletion dose adjustment, while the remaining 58 received the standard lymphodepletion dose. Both groups had similar baseline characteristics, including age range, physical fitness scores, tumor staging, high-risk cytogenetic abnormalities, and previous lines of treatment. The results indicate that, in terms of efficacy, the overall response rate (ORR) and stringent complete remission rate (sCR) for the standard-dose group were 100% and 82.8%, respectively, while the dose-adjusted group had rates of 97% and 78.8% .The standard-dose group also exhibited greater remission depth and better long-term prognosis, with 92.2% of patients maintaining a duration of response (DOR) exceeding one year, compared to 70.6% in the dose-adjusted group. Additionally, the median time to achieve minimal residual disease (MRD) negativity was longer in the dose-adjusted group at 22 days, compared to 15 days in the standard-dose group. The 12-month MRD negativity rate was 90.4% in the standard-dose group, significantly higher than the 63.7% observed in the dose-adjusted group (HR=3.33, P=0.0166). Regarding the 12-month progression-free survival (PFS) rate, the standard-dose group achieved 92.2% with a median PFS not yet reached, while the dose-adjusted group had a 12-month PFS of 73.5% and a median PFS of 30.28 months (HR=3.64, P=0.0032). A similar trend was noted in PFS among patients receiving a 90% dose adjustment. In terms of safety, no significant differences in the severity and incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) between the two groups. CRS (grades 1-2) occurred in 94.8% of the standard dose group and 93.9% of the dose-adjusted group, with no severe CRS (≥grade 3) in either group. Apart from one grade 2 ICANS case in the adjusted group, no ICANS (≥grade 3) occurred in either group . Conclusions：lymphodepletion prior to CAR-T cell therapy is essential for achieving optimal CAR-T efficacy. The study further confirms that appropriate lymphodepletion regimen is crucial for effectiveness of eue-cel treatment, significantly improving treatment outcomes and prognosis. When patients can tolerate it, administering the full lymphodepletion doses, when possible, can lead to greater benefits without increasing toxicity. The principal investigator of this study, Professor Lugui Qiu, from the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, and Professor Chunrui Li, from Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, stated: "The lymphodepletion regimen is crucial for CAR-T cell therapy. Data from this study indicate that standardized and sufficient lymphodepletion can lead to a higher quality of remission and more ideal clearance of minimal residual disease without increasing the potential of adverse reactions. These findings provide a scientific basis to ensure the efficacy and safety of CAR-T cell therapy through optimizing regimens of lymphodepletion, which will ultimately lead to longer survival and improved quality of life for patients with R/R MM." Dr. Yongke Zhang, Chief Scientific Officer of IASO Bio, said: "We are delighted to present new finding from our FUMANBA-1 study. This study demonstrated the critical role of standard lymphodepletion in enhancing treatment outcomes and prognosis for patients.. these findings will contribute significantly to the establishment and optimization of lymphodepletion preconditioning standards in the field of CAR-T cell therapy, Our goal is to drive the standardization of industry practices, ensuring that every patient receiving CAR-T therapy benefits from a more scientific and efficient treatment plan." About FUMANBA-1 Study The FUMANBA-1 Study is a Phase Ib/II, single-arm, multicenter study to assess the efficacy and safety of the investigational drug Equecabtagene Autoleucel, a fully human BCMA CAR-T cell therapy, in patients with R/R MM who have received 3 or more lines of treatment. 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 2023 and 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 or . SOURCE IASO Bio WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED