Fucaso (equecabtagene autoleucel) / Innovent Biologics, IASO BIO - LARVOL DELTA

Key predictors of long-term outcomes in BCMA-targeted CAR-T therapy for relapsed/refractory multiple myeloma. (PubMed, J Transl Med) - P=N/A, P1/2 | "BCMA CAR-T therapy provides durable responses in a subset of patients with r/r MM. Early intervention may improve patient prognosis by promoting sustained MRD negativity, thus improving overall treatment outcomes."

Journal • Observational data • Retrospective data • Hematological Malignancies • Multiple Myeloma • Oncology

Key predictors of long-term outcomes in BCMA-targeted CAR-T therapy for relapsed/refractory multiple myeloma. (J Transl Med) - "At a median follow-up of 39.6 months, the overall response rate (ORR) was 96.4%. Among the patients, 96.4% (54 of 56) achieved minimal residual disease (MRD) negativity, whereas 80.4% (45 of 56) achieved complete response (CR) or stringent complete response (sCR). Poorer outcomes were observed in patients with triple exposure, high cytogenetic risk, or failure to achieve CR. Better outcomes were associated with a CAR-T cell persistence of at least six months and sustained MRD negativity. Prolonged MRD negativity was strongly correlated with longer progression-free survival (PFS), with median PFS durations of 58 months, 64 months, and not reached (NR) for patients who maintained MRD negativity for 12, 24, and 36 months, respectively."

Retrospective data • Multiple Myeloma

IASO Bio Receives Orphan Drug Designation from the Saudi Food and Drug Authority for Equecabtagene Autoleucel (PRNewswire) - "ASO Biotherapeutics...today announced that its self-developed BCMA-targeted CAR-T cell therapy product, Equecabtagene Autoleucel (FUCASO), has been granted Orphan Drug Designation (ODD) by the Saudi Food and Drug Authority (SFDA) for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent....With the ODD approval, Equecabtagene Autoleucel can now directly submit a New Drug Application (NDA) in Saudi Arabia, which is expected to shorten the approval process and enable earlier access for patients in the Middle East region."

Orphan drug • Multiple Myeloma

First-line anti-BCMA CAR-T cell therapy in a fragile patient with biclonal gammopathy and giant plasma cell tumor multiple myeloma with multiple comorbidities: a case report. (PubMed, Front Immunol) - "After one cycle of bortezomib, cyclophosphamide, and dexamethasone (VCD) regimen), she reached very good partial response (VGPR)...After lymphodepletion was performed using fludarabine and cyclophosphamide (FC) chemotherapy, her equecabtagene autoleucel was transfused...Hitherto, her deep remission persisted for 12 months without any maintenance therapy. First-line anti-BCMA CAR-T cell therapy is effective and safe for high-risk MM patients, even in fragile patients with multiple comorbidities."

Journal • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Epilepsy • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology • Orthopedics • Pain • Plasmacytoma • Pneumonia • Respiratory Diseases • Thrombosis

Equecabtagene Autoleucel Injection (Eque-cel) for Relapsed/Refractory Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P=N/A | N=6 | Recruiting | Sponsor: Tongji Hospital

New trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

IASO Bio Announces Approval of New Drug Application for Equecabtagene Autoleucel by the Macau Pharmaceutical Administration Bureau (PRNewswire) - "IASO Biotherapeutics...today announced that the Pharmaceutical Administration Bureau of the Macao Special Administrative Region (ISAF) has approved the New Drug Application (NDA) for Equecabtagene Autoleucel. This treatment is indicated for adult patients with relapsed or refractory multiple myeloma (R/RMM) who have received three or more lines of prior therapies....The Macau NDA approval is based on data from the pivotal FUMANBA-1 trial (CTR20192510, NCT05066646)..."

China approval • Multiple Myeloma

IASO Bio Announces Acceptance of New Drug Application for Equecabtagene Autoleucel (FUCASO) by the Hong Kong Department of Health (PRNewswire) - "IASO Biotherapeutics...today announced that the Hong Kong Department of Health (DOH) has officially accepted the New Drug Application (NDA) for Equecabtagene Autoleucel. This treatment is indicated for patients with relapsed and/or refractory multiple myeloma (R/R MM) who have received three or more prior lines of therapies."

Filing • Multiple Myeloma

IASO Bio Announces Acceptance of New Drug Application for Equecabtagene Autoleucel (FUCASO) by the Singapore Health Sciences Authority (HSA) (PRNewswire) - "IASO Biotherapeutics...today announced that the Singapore Health Sciences Authority (HSA) has officially accepted the New Drug Application (NDA) for Equecabtagene Autoleucel. This treatment is indicated for patients with relapsed and/or refractory multiple myeloma (R/R MM) who have received three or more prior lines of therapies....The official acceptance of the NDA for Equecabtagene Autoleucel by the HSA marks a significant milestone in our journey to 'go global.' Equecabtagene Autoleucel has demonstrated outstanding efficacy and safety in both clinical trials and real-world settings....Upon NDA approval, we plan to implement an innovative model of 'Manufactured in China, supplied overseas', enabling the export of domestically produced autologous CAR-T therapies to other countries."

Commercial • Filing • Multiple Myeloma

Impact of CAR T-Cell Persistence on Clinical Outcomes in Relapsed/Refractory Multiple Myeloma: Insights from the Phase 2 Fumanba-1 Study (ASH 2024) - "This ratio may serve as a biomarker for future treatment planning, highlighting the need for extended CAR T-cell persistence to achieve optimal disease control. While baseline characteristics like previous ASCT influence persistence, baseline sBCMA levels do not adversely affect the treatment efficacy of Eque-cel."

CAR T-Cell Therapy • Clinical • Clinical data • IO biomarker • P2 data • Acute Lymphocytic Leukemia • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

IASO Bio Presented Study Findings on the Impact of CAR T-Cell Persistence on Clinical Outcomes in Relapsed/Refractory Multiple Myeloma with Equecabtagene Autoleucel (FUCASO) Myeloma at 2024 ASH (PRNewswire) - P1/2 | N=132 | FUMANBA-1 (NCT05066646) | Sponsor: Nanjing IASO Biotechnology Co., Ltd. | "This post-hoc analysis of the Phase 2 study of FUMANBA-1 primarily investigated the relationship between CAR T-cell persistence and progression-free survival (PFS) as well as time to progression (TTP)....At the data cutoff, the ongoing remission group showed a longer median VCN duration than those with progression or relapse (12.52m vs 9.03m)....The median efficacy-to- target ratio for the 107 subjects was 1.05 (days*mL/ng)....Those with a lower ratio had a significantly higher risk of disease progression, with a hazard ratio (HR) for TTP of 3.07 (95% CI: 1.51–6.24, p=0.0011) and for PFS of 2.3 (95% CI: 1.27–4.14, p=0.0045), both indicating a strong correlation between the efficacy-to-target ratio and the risk of disease progression."

P2 data • Multiple Myeloma

Elucidating Structural Epitope Mapping and Soluble BCMA in the Microenvironment: Impact on Anti-BCMA CAR-T Cell Functionality (ASH 2024) - "Furthermore, the methodologies employed here could serve as a template for investigating other CAR-T cell products and target antigens, potentially accelerating progress in the field of cellular immunotherapy.In conclusion, this refined and comprehensive study not only advances our understanding of CT103A but also contributes significantly to the broader field of CAR-T cell therapy. By elucidating the intricate relationships between CAR structure, antigen binding, and microenvironmental factors, this research paves the way for more effective, personalized, and rationally designed cellular immunotherapies, holding promise for improved outcomes in patients with hematological malignancies and potentially other cancer types."

CAR T-Cell Therapy • IO biomarker • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology

Promising Safety and Efficacy of Eque-Cel Followed ASCT in Ultra High-Risk Multiple Myeloma (UHR-MM) Patients: Primary Real World Data from a Single Center (ASH 2024) - "5 patients received melphalan and 1 received bendamustine combining melphalan conditioning...All patients had received daratumumab based triplet or quadruplettherapy...CRS events are slight, hematopoietic reconstruction rate was 100%. We are looking forward to more patients gaining long-term benefit from this new treatment."

Clinical • Real-world • Real-world evidence • Hematological Disorders • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • TP53

JAMA Oncology Publishes Phase 1b/2 Study Data on IASO Bio's Equecabtagene Autoleucel (Fucaso) in the Treatment of Relapsed/Refractory Multiple Myeloma (JAMA Oncol) - P1b/2 | N=132 | FUMANBA-1 (NCT05066646) | Sponsor: Nanjing IASO Biotechnology Co., Ltd. | "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)."

P1/2 data • Multiple Myeloma

IASO Bio Presented Comparative Clinical Outcomes on the Optimal Lymphodepletion Prior to Infution of Equecabtagene Autoleucel (Fucaso) in Patients with Relapsed Refractory Multiple Myeloma at 2024 IMS Annual Meeting (PRNewswire) - P1/2 | N=132 | FUMANBA-1 (NCT05066646) | Sponsor: Nanjing IASO Biotechnology Co., Ltd. | "IASO Biotherapeutics...announced a poster presentation of the comparative clinical outcomes of patients from FUMANBA-1...under different lymphodepletion regimens at the 2024 International Myeloma Society (IMS) Annual Meeting....Of the 91 subjects, 33 underwent a lymphodepletion dose adjustment, while the remaining 58 received the standard lymphodepletion dose....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."

P1/2 data • Multiple Myeloma

IASO Bio Presented the Outcomes of Relapsed/Refractory Multiple Myeloma (R/RMM) Patients with Renal Impairment Treated with Equecabtagene Autoleucel (Fucaso) at 2024 IMS Annual Meeting (PRNewswire) - P1/2 | N=132 | FUMANBA-1 (NCT05066646) | Sponsor: Nanjing IASO Biotechnology Co., Ltd. | "IASO Biotherapeutics...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, Fucaso)...Results indicate that Eque-cel achieve equivalent efficacy and safety for R/RMM patients with renal impairment and improve the renal function as well....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."

P1/2 data • Multiple Myeloma

The Optimal Lymphodepletion Prior to Eque-cel in Patients with Refractory Relapsed Multiple Myeloma in FUMANBA-1 Study (IMW 2024) - "LD conditioning prior to CAR-T cell therapy is necessary for optimal CAR-T efficacy. Our study further confirms that the current adequate LD regimen and dosages are optimal for Eque-cel with improved disease remission and clinical outcomes. Administering full LD doses when possible can lead to greater benefits without increasing toxicity.Thanks to professor Chunrui Li, the corresponding author of this paper."

Clinical • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia

Outcomes of R/R MM Patients with Renal Function Impairment Treated with Eque-cel in the Pivotal Phase 2 FUMANBA-1 Study (IMW 2024) - P1/2 | "In the FUMANBA-1 study,RRMM patients with RI could also achieve similarly rapid, deep, and durable response with eque-cel treatment without compromising safety status. Renal function could also be improved due to the clearance of myeloma cells by eque-cel. Thanks to professor Lugui Qiu,the corresponding author of this paper."

Clinical • P2 data • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Renal Disease

Association Between Risk Factors and Outcomes Following Fully Human Anti-BCMA CAR-T Progression in Patients with Relapsed/Refractory Multiple Myeloma (IMW 2024) - " A retrospective, single-institution study on a cohort from China, comprising a total 54 patients with RRMM who received the same fully human anti-BCMA CAR-T therapy (CT103A)... We identified specific factors (a history of previous SCT, triple exposure, high marrow burden, or a best response ≥ CR) as independent predictors of progression. An increase in the number of risk factors correlates with a progression in patient. In addition, in the post-anti BCMA CAR-T progression setting, BCMA– progression is distinctly associated with decreased survival outcomes."

Clinical • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology

Anti-BCMA CAR T-Cell Therapy in a Patient with Refractory Anti-SRP Necrotizing Myopathy (ANA 2024) - "Eque-cel is a fully human B-cell maturation antigen (BCMA) targeted chimeric antigen receptor (CAR) T-cell therapy...The patient received multiple immunomodulatory therapies including pulsed oral steroids, tacrolimus, methotrexate, rituximab, tocilizumab, mycophenolate mofetil, cyclosporin A, cyclophosphamide, plasma exchange, regular intravenous immune globulin, and mesenchymal stem cell infusion, but still suffered from persistent impairments with recurrent attacks... Our case showed that anti-BCMA CAR T-cell therapy was well-tolerated and ought sustained clinical remission, offering a novel option for these refractory patients."

CAR T-Cell Therapy • Clinical • Late-breaking abstract • CNS Disorders • CD8 • MB

Anti-BCMA CAR T-Cell Therapy in Patients with Refractory Myasthenia Gravis (ANA 2024) - "Eque-cel is a fully human B-cell maturation antigen (BCMA) targeted chimeric antigen receptor (CAR) T-cell therapy...Clinical remission was not achieved under regular administration of acetylcholinesterase inhibitor, prednisolone, tacrolimus and rituximab... CAR-BCMA T cells are well tolerated and highly effective in treating refractory MG, demonstrated by the improvement in physical function and serologic remission."

CAR T-Cell Therapy • Clinical • Late-breaking abstract • CNS Disorders • Myasthenia Gravis • TTN

IASO Bio Receives U.S. FDA Approval of Investigational New Drug Application for Equecabtagene Autoleucel for Two New Autoimmune Disease Indications (PRNewswire) - "IASO Biotherapeutics...today announced that the investigational new drug (IND) application for its fully human anti-BCMA chimeric antigen receptor autologous T cell injection (Equecabtagene Autoleucel，Eque-cel) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of Non-renal Systemic Lupus Erythematosus (SLE) and Lupus Nephritis(LN). This is the fifth IND approval obtained for Eque-cel for autoimmune diseases in China and the United States."

IND • New trial • Immunology • Lupus • Lupus Nephritis • Systemic Lupus Erythematosus

IASO Bio Receives U.S. FDA Approval of Investigational New Drug Application for Equecabtagene Autoleucel for Multiple Sclerosis (PRNewswire) - "IASO Biotechnology...announced that the investigational new drug (IND) application for the independently developed fully human anti-BCMA chimeric antigen receptor autologous T cell injection (Equecabtagene Autoleucel, Eque-cel) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of multiple sclerosis (MS)."

IND • Multiple Sclerosis

IASO Bio Presented Clinical Data and Single-cell Analysis of Equecabtagene Autoleucel for the Treatment of Central Nervous System Autoimmunity in Oral Presentation at EAN Congress 2024 (PRNewswire) - P0 | N=18 | CARTinNS (NCT04561557) | "IASO biotechnology...presented the clinical data and single-cell analysis of the fully human anti-BCMA CAR T cell therapy (Equecabtagene Autoleucel, Eque-cel) for the treatment of central nervous system autoimmunity in an oral presentation at the 2024 European Academy of Neurology (EAN) Annual Meeting....This report is based on an investigator-initiated study to evaluate the safety and efficacy of Eque-cel for the treatment of relapsed/refractory antibody-mediated idiopathic inflammatory disorders of the nervous system (NCT04561557)....The study results preliminarily demonstrated the good tolerability and safety, durable pathogenic antibody clearance, and potential clinical efficacy of Eque-cel in NMOSD. And CAR-T cells with chemotactic properties can cross the blood-brain barrier and enter the central nervous system to directly kill abnormal plasma cells in the central nervous system."

Clinical data • Immunology • Neuromyelitis Optica Spectrum Disorder

Innovent and IASO Bio Enhance Strategic Collaboration in Cell Therapy (PRNewswire) - "Innovent Biologics...and IASO Biotechnology...jointly announced the agreement on a series of cooperation, including IASO Bio's purchase from Innovent regarding its relevant right of FUCASO (Equecabtagene Autoleucel) and obtaining license from Innovent regarding the intellectual property related to FUCASO, as well as Innovent's equity investment in IASO Bio. According to the agreement, IASO Bio will purchase Innovent's relevant rights of FUCASO under the original 'BCMA CAR-T Cell Therapy Cooperation Agreement' at the agreed price and Innovent will use the proceeds to acquire an 18% stake in IASO Bio. Under the new strategic cooperation framework, the parties will achieve high-level integration in the field of cellular immunotherapy. IASO Bio obtains global commercial rights and the intellectual property license for FUCASO and will be fully responsible for development, manufacturing and commercialization of the product..."

Licensing / partnership • Hematological Malignancies • Oncology

A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03) (clinicaltrials.gov) - P3 | N=240 | Recruiting | Sponsor: Nanjing IASO Biotechnology Co., Ltd.

New P3 trial • Hematological Malignancies • Multiple Myeloma • Oncology