SHANGHAI and NANJING, China and SAN JOSE,
Calif., March 29, 2024 /PRNewswire/ -- 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
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SOURCE IASO Bio