Express delivery enhances the durability of therapy, and differentiated CAR-T therapy is recognized by the FDA as an advanced therapy for regenerative medicine

▎WuXi AppTec Content Team Editor A few days ago, Autolus Therapeutics (hereinafter referred to as Autolus) announced that its investigational therapy obecabatagene autoleucel (obe-cel) has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the US FDA
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Obe-cel, a CD19-targeting CAR-T therapy, is in a Phase 2 clinical trial called FELIX for the treatment of relapsed/refractory adult B-cell acute lymphoblastic leukemia (B-ALL)
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Adult B-ALL is an aggressive leukemia characterized by the presence of excess B lymphocytes in the bone marrow and peripheral blood
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Without treatment, ALL in adults usually progresses very rapidly
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Combination chemotherapy can achieve complete remission in 90% of adult patients, but only 30-40% of these patients achieve long-term remission
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The median overall survival in relapsed/refractory adult ALL is less than 1 year
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Obe-cel is a CD19-targeting CAR-T cell therapy designed to overcome the limitations of current CAR-T cell therapy in terms of clinical activity and safety
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The chimeric antigen receptor designed by Obe-cel has a faster dissociation speed after binding to the CD19 target, which can minimize the over-activation of T cells, reduce the toxicity and side effects, and is less prone to T cell depletion, so as to enhance the CAR -The persistence of T therapy, improving its ability to continuously kill target cancer cells
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Last year, obe-cel achieved a 100% complete response rate in a cohort of patients with indolent B-cell non-Hodgkin lymphoma (iNHL), while no high-grade cytokine release syndrome and immune effects were found in patients Cell-Associated Neurotoxicity Syndrome (ICANS)
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Autolus received an investment of up to $250 million from Blackstone Life Sciences in November last year to advance the clinical development and commercialization of obe-cel
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Dr.
Christian Itin, CEO of Autolus, said: "Receiving RMAT designation is an important regulatory milestone for obe-cel and highlights its potential to address the unmet medical need of adult patients with relapsed and refractory B-ALL
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FDA's RMAT designation , EMA’s PRIME designation and the UK Medicines and Healthcare Products Regulatory Agency’s (MHRA) Innovative Licensing and Access Pathway (ILAP) designation facilitates engagement with regulators and supports us in accelerating the delivery of this innovative therapy to patients
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” References : 1.
FDA Grants Regenerative Medicine Advanced Therapy (RMAT) designation to Autolus' CAR T cell therapy, obe-cel, for the treatment of adult B-ALL.
Retrieved April 26, 2022, from https://autolus.
gcs-web .
com/news-releases/news-release-details/fda-grants-regenerative-medicine-advanced-therapy-rmat2.
Autolus Therapeutics website, Retrieved April 26, 2022, from https:// obe-cel/Disclaimer: The WuXi AppTec content team focuses on introducing global biomedical health research progress
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This article is also not a treatment plan recommendation
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For guidance on treatment options, please visit a regular hospital
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