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IASO Bio’s Equecabtagene Autoleucel Injection Wins “China First-in-Class” Award, Showcasing China’s Biopharmaceutical Innovation
**IASO Bio’s Equecabtagene Autoleucel Injection Wins “China First-in-Class” Award, Showcasing China’s Biopharmaceutical Innovation**
Multiple myeloma
On June 28, 2024, at the “2024 First CBA-China Annual Conference” hosted by the Chinese Biopharmaceutical Association, USA, at the Suzhou International Expo Centre, IASO Bio’s Equecabtagene Autoleucel Injection was honored with the “China First-in-Class Targeted Drug” award. This award recognizes the drug’s outstanding innovation and therapeutic efficacy, making it the only brand in the cell therapy category to receive this prestigious honor. This accolade not only highlights IASO Bio’s innovative capabilities and research strength in the biopharmaceutical field but also represents the rise of China’s biopharmaceutical industry on a global scale.
In recent years, China’s innovation capabilities in the biopharmaceutical field have significantly improved. From 2015 to 2021, most “first-in-class” drugs on the market were dominated by foreign companies. However, from 2021 to 2023, data on approved new drugs in China showed that among 35 “first-in-class” products, nearly half were from domestic companies, with four being independently developed. This not only marks the rise of China’s innovative drugs but also demonstrates China’s increasing competitiveness in the global biopharmaceutical industry.
The success of IASO Bio’s Equecabtagene Autoleucel Injection is the best embodiment of the innovative power of China’s biopharmaceutical industry. In the future, IASO Bio aims to leverage more international platforms to advance biopharmaceutical technology in China and worldwide, contributing significantly to human health.
**About IASO Bio**
IASO Bio is a biopharmaceutical company focused on the research, development, production, and sale of innovative cell therapies. The company bases its innovation on the development of cell therapies for hematologic malignancies and antibody drugs, expanding into autoimmune diseases. IASO Bio possesses full capabilities from early discovery, clinical development, and regulatory submission to commercial production.
The company has more than ten innovative drug candidates in various stages of development, among which Equecabtagene Autoleucel Injection (a fully human BCMA CAR-T product) has been approved for marketing by the National Medical Products Administration (NMPA) and has received FDA approval for clinical trials in the United States for the treatment of relapsed/refractory multiple myeloma.
With a strong management team, an innovative product pipeline, in-house GMP production facilities, and outstanding clinical development capabilities, IASO Bio is dedicated to providing transformative, curative innovative therapies, bringing hope for a cure to patients in China and worldwide.
To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China for preliminary evaluation!
WhatsApp: +8613717959070
Email: doctor.huang@globecancer.com
#IASOBio #InnovationInMedicine #ChinaFirstInClass #EquecabtageneAutoleucel #GlobalHealth #multiplemyeloma #RRMM
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Interpretation of Hot Topics Conerning Relapsed/Refractory Mutiple Myeloma Patients
Interpretation of Hot Topics Conerning Relapsed/Refractory Mutiple Myeloma Patients:
What other treatment options are available for patients with relapsed Multiple Myeloma?
How effective is the new drug treatment for the first relapse of Multiple Myeloma?
What treatment options are available for initial relapse of multiple myeloma?
What are the treatment goals for Relapsed/Refractory Multiple Myeloma (RRMM)?
What treatment strategy should be adopted for RRMM in order to achieve maximum relief?
For Relapsed/Refractory Multiple Myeloma, what are the Grades of Response?
Expert Introduction
👩🔬Zhuang Junling
Associate Chief Physician Department of Hematology
Peking Union Medical College Hospital
Published over 50 papers in journals such as Blood, Leukemia Research, and others.
🎉🎉To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China for preliminary evaluation!
WhatsApp: +8613717959070
Email: doctor.huang@globecancer.com
#CART #Mutiplemyeloma #CARTtherapy #myeloma #leukemia #drug #RRMM #cancer #cancersurvivor #cancerpatient #bloodcancer #tumor #cartcell #cartcelltherapy #cancertreatment #advancedmedicineinchina #hematology
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#EBMT Conference Reveals the Best CAR-T Therapy for Multiple Myeloma – Equecabtagene Autoleucel
#EBMT Conference Reveals the Best CAR-T Therapy for Multiple Myeloma – Equecabtagene Autoleucel
Multiple myeloma
Introduction:
In recent years, there has been a breakthrough in the research of #CART therapy for relapsed and refractory #multiplemyeloma (RRMM). This treatment method holds promise to address the challenges of inadequate response depth and short duration of response in #RRMM patients, offering hope for achieving minimal residual disease (#MRD) negativity and functional cure in this population.
Key Findings at EBMT:
The upcoming 50th European Society for Blood and Marrow Transplantation (EBMT) congress is set to unveil abstracts shedding light on the efficacy of targeted #BCMA CAR-T therapies. A recent abstract titled “Indirect Comparison of the Effectiveness of Targeted BCMA CAR-T Products in RRMM (#MAIC)” for the first time reveals efficacy comparisons among four BCMA CAR-T products. The study demonstrates that Equecabtagene Autoleucel outperforms other BCMA CAR-T therapies in terms of overall response rate (#ORR) and complete response (#CR) rate, offering significant hope for RRMM patients.
#Equecabtagene Autoleucel: Pioneering Fully-human BCMA #CARTTherapy:
#EquecabtageneAutoleucel, the world’s first approved Fully-human BCMA CAR-T therapy, received priority review and approval in China on June 30, 2023. The MAIC analysis underscores its favorable efficacy. This article provides a systematic analysis of the efficacy data of Equecabtagene Autoleucel in the Chinese population over the past two years, as revealed in the dynamic disclosures at various international academic conferences post-approval.
Efficacy Data Highlights:
– In the #FUMANBA-1 Ib/II clinical study conducted in China, the sCR/CR rate reached an impressive 82.4% among RRMM patients.
– The latest data presented at the 2023 International Myeloma Society (#IMS) conference demonstrated a MRD negativity rate of 97.8% among the enrolled patients, indicating substantial tumor burden reduction.
– With a median follow-up of 18.07 months, long-term efficacy data showcased remarkable outcomes, including a median PFS not yet reached, 12-month continuous MRD negativity rate of 81.7%, and 12-month PFS rate of 85.5%.
Differentiating Factors:
– Equecabtagene Autoleucel exhibited shorter median time to response (#TTR) compared to other CAR-T therapies, indicating faster onset of action.
– The dissociation kinetics of Equecabtagene Autoleucel closely resemble those of natural T cells, facilitating efficient activation, killing, and proliferation within the body.
– Its rapid dissociation pattern minimizes CAR-T cell exhaustion, ensuring sustained efficacy and long-term surveillance against tumor recurrence.
Conclusion:
The emergence of Equecabtagene Autoleucel heralds a new era in CAR-T therapy for RRMM, offering superior efficacy and durable responses. With its unique structural advantages and promising clinical data, Equecabtagene Autoleucel stands as a beacon of hope for RRMM patients worldwide, bringing them closer to achieving disease control and improved quality of life.
To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China for preliminary evaluation!
Email: doctor.huang@globecancer.com
WhatsApp: +8613717959070
The latest research findings of BCMA CAR-T therapy for multiple myeloma in 2023 | Equecabtagene Autoleucel (FUCASO)
The latest research findings of BCMA CAR-T therapy for multiple myeloma in 2023 | Equecabtagene Autoleucel (FUCASO®)
IASO Bio and Innovent presented their latest research findings on the Equecabtagene Autoleucel injection (brand name: FUCASO®) for multiple myeloma at the 2023 American Society of Hematology (ASH) Annual Meeting. This study was primarily based on a post-hoc analysis of the FUMANBA-1 study, an Ib/II phase research assessing the efficacy and safety of this therapy in treating patients with relapsed and refractory multiple myeloma (RRMM).
As of December 31, 2022, with a median follow-up of 18.07 months, deep and sustained responses were observed in 103 evaluable patients. Among these patients, the overall response rate (ORR) was 96.1%, and the stringent complete response/complete response (sCR/CR) rate was 77.7%. Among subjects without prior CAR-T therapy, the ORR reached 98.9%, the sCR/CR rate reached 82.4%, and the 12-month progression-free survival (PFS) rate was 85.5%.
Minimal residual disease (MRD) negativity rate is 94.2% in the total evaluable patients, and all patients who achieved CR or above were MRD negative. The median time to achieve MRD negativity was 15 days, with 80.8% of patients remaining MRD negative at 12 months post infusion.
In addition, Equecabtagene Autoleucel could persist in the body for an extended period of time the median duration was 307.5 days. 12 months after infusion, 50% of patients had a vector copy number (VCN) above the lower limit of detection; and 24 months after infusion, VCN could still be detected in 40% of the patients.
The research findings indicate a strong correlation between sustained MRD negativity and patient progression-free survival (PFS), along with the continuous presence of Equecabtagene Autoleucel in the body, which correlates positively with sustained MRD negativity.
The Equecabtagene Autoleucel injection may improve the long-term survival prospects of RRMM patients, offering enduring deep remission and holding significant importance for the sustained maintenance of MRD negativity in patients.
About Multiple Myeloma (MM)
Multiple Myeloma is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems, and bone fractures. For multiple myeloma patients, common first-line drug treatments include proteasome inhibitors, immunomodulatory drugs, and alkylating agents. While treatment may result in remission, most patients will inevitably enter the relapsed or refractory stage as there’s currently no cure. As a result, there is a significant unmet need for patients with relapsed/refractory multiple myeloma. In the United States, MM accounts for nearly 2% of all cancer cases, and more than 2% of cancer-related deaths.
According to Frost & Sullivan, the number of new MM cases in the United States rose from 30,300 in 2016 to 32,300 in 2020 and is expected to increase to 37,800 by 2025. Additionally, the total number of patients diagnosed with MM increased from 132,200 in 2016 to 144,900 in 2020 and is expected to rise to 162,300 by 2025. In China, the number of new MM cases rose from 18,900 in 2016 to 21,100 in 2020 and is expected to increase to 24,500 by 2025. The total number of patients diagnosed with MM in China increased from 69,800 in 2016 to 113,800 in 2020 and is expected to rise to 182,200 by 2025.
About Equecabtagene Autoleucel
Equecabtagene Autoleucel is an innovative fully-human anti-BCMA CAR-T cell therapy that uses lentivirus as a gene vector to transfect autologous T cells. The CAR comprises a fully-human scFv, CD8a hinge and transmembrane, as well as 4-1BB-mediated co-stimulation and CD3ζ activation domains. Through rigorous screening and comprehensive in vivo and in vitro evaluation, Equecabtagene Autoleucel has been proven to possess potent and rapid anti-myeloma activity, along with outstanding safety, efficacy, and persistence results.
Equecabtagene Autoleucel has received acceptance for New Drug Application (NDA) from China’s National Medical Products Administration (NMPA) for the treatment of RRMM and has obtained IND approval from the U.S. FDA. Additionally, the company was granted Breakthrough Therapy Designation (BTD) by the NMPA in February 2021, Orphan Drug Designation (ODD) in February 2022, and Regenerative Medicine Advanced Therapy (RMAT) and Fast Track (FT) Designations from the FDA in February 2023. Besides multiple myeloma, NMPA has accepted its IND application for the new extended indication of Neuromyelitis Optica Spectrum Disorder (NMOSD). Innovent and IASO Bio are collaboratively developing Equecabtagene Autoleucel for the treatment of RRMM in mainland China.
About IASO Biotechnology
IASO Bio is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and autoimmune diseases. Leveraging its proprietary fully human antibody discovery platform (IMARS), high-throughput chimeric antigen receptor T-cell (CAR-T) drug screening platform, and proprietary manufacturing processes, IASO Bio is developing a robust clinical-stage pipeline of multiple autologous and allogeneic CAR-T and biologics product candidates. This pipeline comprises a diversified portfolio of over 10 novel products, including IASO’s flagship asset, Equecabtagene Autoleucel (CT103A), a fully human BCMA CAR-T injection.
In addition to Equecabtagene Autoleucel, the company’s pipeline includes the fully developed in-house human CD19/CD22 dual-targeted CAR-T cell therapy, which has received two IND clearances for treating relapsed/refractory B-cell non-Hodgkin’s lymphoma (r/r B-NHL) and relapsed/refractory acute B-lymphoblastic leukemia (r/r B-ALL). CD19/CD22 is currently in Phase I clinical trials for r/r B-NHL. It was also granted ODD by the FDA in October 2021. In the approximately 20 patients dosed to date in the investigator-initiated trial, there were no immune effector cell-associated neurotoxicity syndrome (ICANS) observed in any patient, and the rate of grade 3 cytokine release syndrome (CRS) was less than 5%, with the remainder of patients experiencing no CRS or less than grade 3.
Leveraging its strong management team, innovative product pipeline, integrated manufacturing, and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfill unmet medical needs to patients in China and around the world.