SHANGHAI, NANJING,
China and SAN JOSE, Calif., Aug. 12,
2024 /PRNewswire/ -- IASO Biotherapeutics ("IASO
Bio"), a biopharmaceutical company dedicated to discovering,
developing, manufacturing and commercializing innovative cell
therapy and antibody products, 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.
"We are delighted that the IND for the two new indications—SLE
and LN—has been approved by the U.S. FDA, further highlighting
Eque-cel's potential as a product for autoimmune diseases," said
Yongke Zhang, M.D., Chief Scientific
Officer of IASO Bio. "Clinical trial data from China have demonstrated Eque-cel's significant
efficacy and safety in treating relapsed/refractory
autoantibody-mediated neurological diseases. We believe it holds
similar promise for other autoimmune diseases, such as SLE and LN,
where autoantibodies play key pathogenic roles. We are eager to
accelerate this innovative therapy to benefit more patients with
autoimmune diseases in China and
globally."
To date, Eque-cel has received three IND approvals from the
U.S. FDA for autoimmune indications, including the treatment of
Myasthenia Gravis (MG), Multiple Sclerosis (MS), and SLE/LN. In
China, the product has also
received two IND approvals from the National Medical Products
Administration (NMPA) for autoimmune indications Neuromyelitis
Optica Spectrum Disorder (NMOSD) and MG. Additionally, Eque-cel
(FUCASO®) received marketing approval by the NMPA in
June 2023 for the treatment of
patients with relapsed and/or refractory Multiple Myeloma (R/RMM)
who received ≥3 lines of prior therapies containing at least one
proteasome inhibitor and an immunomodulatory agent.
About Systemic Lupus Erythematosus (SLE)
SLE is a systemic autoimmune disease and is one of the earliest
discovered human autoimmune diseases related to the abnormalities
of the B lymphocyte subpopulation. The main symptoms of patients
are characterized by involvement of multiple systems and organs
throughout the body, with a large amount of autoantibodies present
in the body, and the natural course of the disease is mostly an
alternation of exacerbation and remission. If not treated in time,
it can cause irreversible damage to the affected organs, ultimately
leading to the death of the patient. According to Frost &
Sullivan, there were about 8.049 million SLE patients worldwide in
2023, including 289,000 in the United
States.
About Lupus Nephritis (LN)
Lupus nephritis (LN) is the most common severe complication of
SLE, and studies have shown that 60% of SLE patients will develop
LN during the course of their disease[1], making it a
major cause of high mortality in SLE patients. Current
standard-of-care treatments for SLE have limited efficacy, with
14%–33% of LN patients showing no response to
treatment[2,3]。
About Equecabtagene Autoleucel
Equecabtagene Autoleucel is an individually tailored,
BCMA-targeted genetically modified autologous T cell immunotherapy
product that identifies and eliminates BCMA-expressing cells. Based
on the understanding of the pathological mechanisms of SLE,
particularly the pivotal role played by B cells and pathogenic
antibodies in the disease, Equecabtagene Autoleucel employs
second-generation CAR technology to precisely identify and
eliminate cells expressing BCMA. By clearing the activated B cells
and plasma cells from the body of the SLE patients, it reduces the
pathogenic cells and autoantibodies, thereby suppressing
autoimmune inflammation and alleviate the disease.
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 2023and 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
http://www.iasobio.com or www.linkedin.com/company/iasobiotherapeutics.
REFERENCE
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1. Saxena R, Mahajan T,
Mohan C.Lupus nephritis: current update.Arthritis Res
Ther.2011;13(5):240.
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2. Anders HJ,
Hiepe F.Treatment options for refractory lupus nephritis.Clin J Am
Soc Nephrol.2019;14:653–655. [PubMed: 30979714]
|
3. Moroni G, Ponticelli
C.The multifaceted aspects of refractory lupus nephritis.Expert Rev
Clin Immunol.2015;11:281–8. [PubMed: 25487410]
|
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SOURCE IASO Bio