Peking Union Medical College

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

SHANGHAI and NANJING, China and SAN JOSE, Calif., Sept. 27, 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 outcomes of relapsed/refractory multiple myeloma (R/RMM) patients with renal impairment (RI) treated with the fully human anti-BCMA CAR-T cell therapy Equecabtagene Autoleucel (Eque-cel, FucasoTM), from the pivotal phase 2 FUMANBA-1 study at the 2024 International Myeloma Society (IMS) Annual Meeting. Results indicate that Eque-cel achieve equivalent efficacy and safety for R/RMM patients with renal impairment and improve the renal function as well. Continue Reading Table 1 Baseline characteristics & efficacy& & Figure1 CrCl improvement Abstract Number: P-100 Abstract Title: The Outcomes of R/R MM Patients with Renal Impairment (RI) Treated with Eque-cel in the Pivotal Phase 2 FUMANBA-1 Study Presentation Date: September 26, 2024（UTC-3) A total of 91 subjects, all without prior CAR-T treatment, were enrolled in the FUMANBA-1 study to receive Eque-cel, with a median follow-up of 18.07 months. Subjects were divided into RI group and non-RI group, based on creatinine clearance (CrCl) levels at the time of CAR-T therapy, of which 28 subjects had RI with CrCl between 40 and 70 ml/min, and 63 belonged to non-RI group, with CrCl>70 ml/min. The baseline characteristics in the RI group were comparable to those in the non-RI group. The RI group achieved a response as rapid and deep as the non-RI group. Long-term efficacy in the RI group were not inferior (as shown in Figure1) as non-PI group. In terms of safety, both group developed cytokine release syndrome (CRS) Only one case of grade 2 immune effector cell-associated neurotoxicity syndrome (ICANS) was reported in the non-RI group, while no cases of ICANS occurred in the RI group. A slightly higher prevalence of short-term severe cytopenia was noted in the RI group, but recovered by day 60. Conclusions: In the FUMANBA-1 study, R/RMM patients with RI could achieved a similarly rapid, deep, and durable response with Eque-cel treatment without compromising safety status. Additionally, renal function was improveddue to the clearance of myeloma cells by Eque-cel. 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: "In the past, we were concerned about the potential intolerance of R/R MM patients with impaired renal function to CAR-T treatment. The current study confirmed that even in patients with renal impairment, Eque-cel can induce rapid, deep, and durable remission, with efficacy comparable to that of patients without renal impairment. This data provides invaluable insights for clinical treatment with Eque-cel for camplcated case. Dr. Yongke Zhang, Chief Scientific Officer of IASO Bio, said: "We are pleased to present the retrospective study on the use of Eque-cel (FucasoTM) for treating R/RMM patients with renal impairment at the IMS Annual Meeting. Data from the FUMANBA-1 study demonstrated the promising efficacy and safety of Eque-cel in this patient population, with the added benefit of improving renal function. We believe CAR-T therapy will offer new therapeutic options for R/RMM patients with moderate to severe renal function impairment, enabling broader application in the field of myeloma treatment." 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 . 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JINAN, China, Sept. 10, 2024 /PRNewswire/ -- During the World Conference on Lung Cancer (WCLC) held from September 7-10, 2024, in San Diego, California, updated findings from the Phase II clinical trial (INTELLECT study) were presented. The study assessed the efficacy and safety of Qilu Pharmaceutical's iruplinalkib tablets (Qixinke®) in treating patients with anaplastic lymphoma kinase (ALK)-positive crizotinib-resistant non-small-cell lung cancer (NSCLC). The highlights were showcased in a poster presentation. Iruplinalkib, a next-generation ALK/ROS1 kinase inhibitor formulated by Qilu Pharmaceutical, was approved by NMPA in June 2023 for the treatment of patients with ALK-positive locally advanced or metastatic NSCLC who had disease progression after treatment with crizotinib or who were intolerable to crizotinib. In January of this year, iruplinalkib was approved for the first-line treatment of patients with ALK-positive NSCLC. The trial is led by principal investigator, Prof. Yuankai Shi from the Cancer Hospital Chinese Academy of Medical Sciences & Peking Union Medical College. The results of the study were published in BMC Medicine in 2023. Updated data with an extended two-year follow-up were presented during the WCLC. A total of 146 subjects were enrolled in this study. As of December 29, 2023, the median follow-up time was 42.41 months, revealing a median overall survival (OS) of 41.79 months. The investigator-evaluated objective response rate (ORR) was 63.7%, while the disease control rate (DCR) reached 94.5%. Additionally, the median duration of response (DoR) and median progression-free survival (PFS) were reported to be 14.06 months and 14.55 months, respectively. According to the RECIST v1.1 evaluation criteria, the ORR and DCR in the subgroup with CNS metastasis at baseline (90 patients) were 55.6% and 93.3%, respectively. Both the median DoR and median PFS were 17.25 months, while the median OS stood at 43.01 months. Based on RANO-BM criteria, intracranial complete response (CR) was achieved in 17 (18.9%) of the 90 patients with CNS metastasis at baseline. Among the 42 subjects with measurable intracranial lesions at baseline, the intracranial objective response rate (iORR) was 64.3% while the intracranial disease control rate (iDCR) reached 95.2%. The safety profile was characterized by a 93.8% (137 cases) incidence of treatment-related adverse events (TRAEs), with 30.8% (45 cases) being grade 3 or 4. The most common TRAEs included elevated aspartate aminotransferase (45.2%), hypercholesterolemia (37.7%), and increased alanine aminotransferase (37.0%). No new safety signals were identified. Long-term follow-up results from the INTELLECT study demonstrated that iruplinalkib provided an OS benefit with no new safety signal in patients with ALK-positive crizotinib-resistant advanced NSCLC. SOURCE Qilu Pharmaceutical Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED