SHANGHAI and NANJING, China and SAN JOSE, CA, USA I March 29, 2024 I IASO Bio, a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, today announced that China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for Equecabtagene Autoleucel (IASO Bio R&D code: CT103A), a self-developed fully-human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) autologous T-cell injection, for an expanded indication in treating relapsed and/or refractory multiple myeloma (R/RMM) patients who have undergone 1-2 lines of prior therapies and are refractory to lenalidomide.
The New Drug Application (NDA) for FUCASO ® (Equecabtagene Autoleucel) was approved by NMPA for the treatment of relapsed and/or refractory multiple myeloma (R/R MM) who received ≥3 lines of prior therapies containing at least one proteasome inhibitor and an immunomodulatory agent on June 30, 2023. The NDA approval was based on the data from the pivotal FUMANBA-1 study (CTR20192510, NCT05066646) conducted at multiple sites in China. According to the updated long-term follow-up data of the study published at the 2023 International Myeloma Society (IMS) Annual Meeting, as of December 31, 2022, among the 103 efficacy-evaluable patients, the overall response rate (ORR) was 96.1%, and the stringent complete response/complete response (sCR/CR) rate was 77.7%; in 91 participants without prior CAR-T therapy, ORR was 98.9%, 82.4% of patients reaching sCR/CR, and the 12-month progression-free survival (PFS) rate was 85.5%; 94.2% (97/103) of patients achieved minimal residual disease (MRD) negativity, and all sCR/CR patients achieved MRD negativity. Among the 105 participants, only one experienced ≥ Grade 3 cytokine release syndrome (CRS), with no ≥ Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS). Pharmacokinetics indicated that Equecabtagene Autoleucel persisted in vivo, with gene copy numbers detectable in 40% of participants at 24 months after infusion.
About Multiple Myeloma (MM)
Multiple myeloma (MM), a prevalent hematological malignancy, is marked by abnormal proliferation of clonal plasma cells. For treatment-naïve MM patients, common first-line treatments include multiple-drug induction therapy, consolidation therapy, and maintenance therapy, as well as autologous stem cell transplantation (ASCT). Despite initial remission, most patients will inevitably enter the relapsed or refractory stage, with no known cure to date.
According to the relevant study results published in the New England Journal of Medicine, CAR-T therapy significantly prolonged PFS and improved clinical response as compared with standard regimens in patients with relapsed/refractory multiple myeloma who had received 2-4 regimens previously[1]. In patients with lenalidomide-refractory, relapsed and refractory multiple myeloma who had received 1-3 previous therapies, the risk of disease progression or death was lower in those treated with CAR-T therapy than in those with standard care[2].
Data from Globocan indicates a rise in new MM cases in China from 20,066 in 2018 to 30,300 in 2022, and is projected to further rise to an anticipated 37,082 by 2030. Similarly, new MM cases in the United States increased from 25,962 in 2018 to 32,258 in 2022, and is projected to reach 38,000 by 2030. Worldwide, new MM cases increased from 159,985 in 2018 to 187,952 in 2022, and is projected to increase to 231,284 by 2030.
Ms. Jinhua Zhang, Founder, Chairman, and Chief Executive Officer of IASO Bio, stated, “The NMPA’s IND approval for Equecabtagene Autoleucel in second- and third-line R/RMM treatment marks a pivotal advancement in its clinical journey. Evidence suggests that earlier CAR-T therapy in R/RMM patients leads to improved survival outcome. Given the compelling efficacy and safety profile demonstrated in previous clinical studies, Equecabtagene Autoleucel is poised to address significant unmet needs in early-stage MM treatment. We are eager to commence clinical enrollment, aiming to extend the benefits of this innovative therapy to more patients experiencing early relapse.”
About IASO Bio
IASO Bio is a biopharmaceutical company engaged in 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 commercial production.
The pipeline in the company includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received New Drug Application (NDA) approval from China’s National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of R/RMM.
Leveraging its strong management team, innovative product pipeline, GMP production, as well as integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China as well as around the world. For more information, please visit http://www.iasobio.com or www.linkedin.com/company/iasobiotherapeutics.
References
1. N Engl J Med.2023 Mar 16;388(11):1002-1014
2. N Engl J Med.2023 Jul 27;389(4):335-347
SOURCE: IASO Bio
Post Views: 443
SHANGHAI and NANJING, China and SAN JOSE, CA, USA I March 29, 2024 I IASO Bio, a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, today announced that China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for Equecabtagene Autoleucel (IASO Bio R&D code: CT103A), a self-developed fully-human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) autologous T-cell injection, for an expanded indication in treating relapsed and/or refractory multiple myeloma (R/RMM) patients who have undergone 1-2 lines of prior therapies and are refractory to lenalidomide.
The New Drug Application (NDA) for FUCASO ® (Equecabtagene Autoleucel) was approved by NMPA for the treatment of relapsed and/or refractory multiple myeloma (R/R MM) who received ≥3 lines of prior therapies containing at least one proteasome inhibitor and an immunomodulatory agent on June 30, 2023. The NDA approval was based on the data from the pivotal FUMANBA-1 study (CTR20192510, NCT05066646) conducted at multiple sites in China. According to the updated long-term follow-up data of the study published at the 2023 International Myeloma Society (IMS) Annual Meeting, as of December 31, 2022, among the 103 efficacy-evaluable patients, the overall response rate (ORR) was 96.1%, and the stringent complete response/complete response (sCR/CR) rate was 77.7%; in 91 participants without prior CAR-T therapy, ORR was 98.9%, 82.4% of patients reaching sCR/CR, and the 12-month progression-free survival (PFS) rate was 85.5%; 94.2% (97/103) of patients achieved minimal residual disease (MRD) negativity, and all sCR/CR patients achieved MRD negativity. Among the 105 participants, only one experienced ≥ Grade 3 cytokine release syndrome (CRS), with no ≥ Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS). Pharmacokinetics indicated that Equecabtagene Autoleucel persisted in vivo, with gene copy numbers detectable in 40% of participants at 24 months after infusion.
About Multiple Myeloma (MM)
Multiple myeloma (MM), a prevalent hematological malignancy, is marked by abnormal proliferation of clonal plasma cells. For treatment-naïve MM patients, common first-line treatments include multiple-drug induction therapy, consolidation therapy, and maintenance therapy, as well as autologous stem cell transplantation (ASCT). Despite initial remission, most patients will inevitably enter the relapsed or refractory stage, with no known cure to date.
According to the relevant study results published in the New England Journal of Medicine, CAR-T therapy significantly prolonged PFS and improved clinical response as compared with standard regimens in patients with relapsed/refractory multiple myeloma who had received 2-4 regimens previously[1]. In patients with lenalidomide-refractory, relapsed and refractory multiple myeloma who had received 1-3 previous therapies, the risk of disease progression or death was lower in those treated with CAR-T therapy than in those with standard care[2].
Data from Globocan indicates a rise in new MM cases in China from 20,066 in 2018 to 30,300 in 2022, and is projected to further rise to an anticipated 37,082 by 2030. Similarly, new MM cases in the United States increased from 25,962 in 2018 to 32,258 in 2022, and is projected to reach 38,000 by 2030. Worldwide, new MM cases increased from 159,985 in 2018 to 187,952 in 2022, and is projected to increase to 231,284 by 2030.
Ms. Jinhua Zhang, Founder, Chairman, and Chief Executive Officer of IASO Bio, stated, “The NMPA’s IND approval for Equecabtagene Autoleucel in second- and third-line R/RMM treatment marks a pivotal advancement in its clinical journey. Evidence suggests that earlier CAR-T therapy in R/RMM patients leads to improved survival outcome. Given the compelling efficacy and safety profile demonstrated in previous clinical studies, Equecabtagene Autoleucel is poised to address significant unmet needs in early-stage MM treatment. We are eager to commence clinical enrollment, aiming to extend the benefits of this innovative therapy to more patients experiencing early relapse.”
About IASO Bio
IASO Bio is a biopharmaceutical company engaged in 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 commercial production.
The pipeline in the company includes a diversified portfolio of over 10 novel products, including Equecabtagene Autoleucel (a fully human BCMA CAR-T injection). Equecabtagene Autoleucel received New Drug Application (NDA) approval from China’s National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of R/RMM.
Leveraging its strong management team, innovative product pipeline, GMP production, as well as integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China as well as around the world. For more information, please visit http://www.iasobio.com or www.linkedin.com/company/iasobiotherapeutics.
References
1. N Engl J Med.2023 Mar 16;388(11):1002-1014
2. N Engl J Med.2023 Jul 27;389(4):335-347
SOURCE: IASO Bio
Post Views: 443
