Sunday, April 14, 2024

FDA Grants Investigational New Drug Clearance for Oricell’s Application

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Oricell Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for OriCAR-017, a novel CAR-T cell therapy designed to target GPRC5D in patients with relapsed/refractory multiple myeloma (R/R MM). This clearance marks a significant milestone for Oricell as it allows the company to initiate clinical development of OriCAR-017 in the United States immediately.

OriCAR-017 is developed using Oricell’s proprietary platforms, which include OriAb antibodies, OriCAR constructs, and their unique CMC (Chemistry, Manufacturing, and Controls) expertise. The therapy is meticulously designed to optimize binding, persistence, and anti-tumor efficacy by rejuvenating CAR-T cells.

The FDA’s approval of the Investigational New Drug application comes on the heels of the therapy receiving Investigational New Drug approval from the National Medical Products Administration (NMPA) in 2023, highlighting its potential as an innovative treatment for R/R MM.

Investigational New Drug Application for Novel CAR-T Therapy Optimized for Enhanced Binding and Efficacy

The POLARIS study, which evaluated the efficacy and safety of OriCAR-017, yielded promising results. Among the ten patients with R/R MM who participated in the study, all of them responded positively to OriCAR-017 therapy based on the International Myeloma Working Group (IMWG) criteria. This translated to an impressive overall response rate (ORR) of 100%, with 80% of patients achieving a stringent complete response.

Moreover, the study reported a 100% minimal residual disease (MRD) negative rate at day 28, which was further confirmed at month three. This indicates that OriCAR-017 was highly effective at eliminating residual disease.

One of the notable aspects of OriCAR-017 therapy was its excellent tolerability profile. No cases of Immune effector cell-associated neurotoxicity syndrome (ICANS), cerebellar disorder, or delayed infections were reported. The therapy only induced Grade 1 or Grade 2 cytokine release syndrome (CRS), which resolved rapidly.

Investigational New Drug

Efficacy Across Diverse Patients, Including High-Risk Cases and Prior BCMA CAR-T Recipients

It’s worth noting that among the ten patients treated with OriCAR-017, 40% had extramedullary disease (EMD), 50% had previously received BCMA CAR-T treatments, 70% exhibited high-risk cytogenetics, and 70% had an ECOG performance status of two, with 80% at ISS stage II & III. These results underscore the therapy’s potential to benefit a diverse range of R/R MM patients, including those with challenging clinical characteristics.

Overall, the FDA’s clearance of Oricell’s Investigational New Drug application for OriCAR-017 represents a significant step forward in the development of this innovative CAR-T cell therapy for R/R MM. The positive results from the POLARIS study provide strong evidence of its efficacy and safety, making it a promising candidate for further clinical development and potential approval as a new treatment option for patients with this challenging condition.

Resource: Pharmaceutical Business Review, January 30, 2024

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