Oricell Therapeutics Announces Long-Term Follow-Up Data from Phase 1 Trial of OriCAR-017, a GPRC5D-Targeted CAR-T Therapy, in Relapsed/Refractory Multiple Myeloma

May 25, 2024 21:46 CST Updated 21:46

Oricell Therapeutics

Developer of Tumor Immunocyte Products

Recently, Qrigincell Therapeutics announced that the abstract of the 2-year long-term follow-up results of its GPRC5D-targeted CAR-T drug (OriCAR-017) in the Phase I clinical trial for the treatment of relapsed/refractory multiple myeloma (RRMM) has been officially published on the website of the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract ID: 7511).

Latest data shows that OriCAR-017 has demonstrated deep and durable efficacy responses in RRMM patients, including those refractory to anti-CD38, PIs, IMiDs, as well as those who failed BCMA CAR-T therapy, with a favorable safety profile. Long-term follow-up results on its efficacy and safety indicate that OriCAR-017 holds promise as an effective treatment option for RRMM patients. Currently, the registrational clinical trials of OriCAR-017 are ongoing in both China and the United States (China NCT05016778; USA NCT06271252).

OriCAR-017 Demonstrates Deep and Durable Efficacy

As of January 16, 2024, all (10) patients responded well to OriCAR-017 treatment, and the last patient has completed 24 months of follow-up.The overall response rate (ORR) was 100.0%, the stringent complete response rate (sCR) was 80.0%, and the very good partial response rate (VGPR) was 20.0%.All patients achieved a 100% minimal residual disease-negative rate (MRD) on Day 28, which was further confirmed to be 100% negative at the 3-month mark.The median duration of response (mDoR) was 10.43 months (95% CI, 5.00-17.00); the median progression-free survival (mPFS) was 11.37 months (95% CI, 5.93-18.00); the median overall survival (mOS) has not yet been reached (7 patients are still in survival follow-up, 1 patient died of disease progression, and 2 patients died of COVID-19 infection).In the high-dose group (67% were patients previously treated with BCMA CAR-T), the mDoR was 17.23 months (95% CI, 7.33-NR), and the mPFS was 19.10 months (95% CI, 8.30-NR).

OriCAR-017 Shows Good Safety and Tolerability

Nine patients (90%) experienced Grade 1 cytokine release syndrome (CRS), with only one patient (10%) developing Grade 2 CRS, and no cases of Grade ≥3 CRS were observed.The median time of CRS onset was 2 days (range 1–9 days), with a median duration of 6 days (range 3–9 days).No immune effector cell-associated neurotoxicity syndrome (ICANS) or dose-limiting toxicities (DLTs) were observed.No serious adverse events (SAEs) or treatment-related deaths occurred, no cerebellar disorders were observed, and no delayed infections were reported.No pharmacokinetic differences were observed between dose levels, with Cmax at 7354.7 copies/μL and AUC0-28 days at 68587 copies•day/μg.At high doses, CAR-T cells were still detectable at 9 months; after 21 months of follow-up, the expansion of CAR-T cells in one patient remained above the lower limit of quantification (LLOQ).Compared with T_last<9-month-old patients, T_lastPatients with ≥9 months have a longer progression-free survival period.No correlation was observed between antigen expression and efficacy.Baseline data of all patients showed their bone marrow CD138⁺GPRC5D was positively expressed in plasma cells (MMPC), and 50% of relapsed patients showed downregulated expression as detected by flow cytometry.

OriCAR-017 Patients' Baseline Conditions Are More Challenging

40% of patients had extramedullary disease (EMD), 50% received one or more CAR-T treatments targeting BCMA, 70% of patients had high-risk cytogenetic abnormalities, 70% of patients had an ECOG score of 2, and 80% of patients were ISS stage II or III. These data further demonstrate the application potential of OriCAR-017 in very advanced patients.

Updated data will be presented orally at the ASCO Annual Meeting:

Abstract ID #7511

Title: OriCAR-017, a novel GPRC5D-targeting CAR-T, in patients with relapsed/refractory multiple myeloma: Long term follow-up results of phase 1 study (POLARIS).

Session Type: Rapid Oral Abstract Session

Session Title: Hematologic Malignancies—Plasma Cell Dyscrasia

Date/Time: June 4, 2024 at 9:57 AM Central Time

Location: S102

Link:https://meetings.asco.org/abstracts-presentations/239043

About OriCAR-017

OriCAR-017, a chimeric antigen receptor (CAR) T-cell therapy targeting GPRC5D, offers new hope for patients with relapsed/refractory multiple myeloma.This therapy, based on Qrigincell Therapeutics' self-developed technology platform, demonstrates excellence in cell affinity, antigen binding activity and persistence, anti-tumor efficacy, and safety.Following the IND approval by China's National Medical Products Administration (NMPA), OriCAR-017 received further IND approval from the U.S. FDA in January 2024.

Currently, Qrigincell Therapeutics has established operational teams in both China and the United States, and is fully committed to advancing the global clinical development of its product pipeline.

About Oricell Therapeutics

Qrigincell Therapeutics is a clinical-stage biotechnology company dedicated to becoming an innovation-driven global leader in the field of tumor immunotherapy. The company is currently focused on developing innovative cell therapies to address unmet medical needs in the global fields of oncology and immunology. Leveraging its proprietary Ori®Ab antibody screening and engineering platform, Ori®CAR structural platform, and expertise accumulated in the CMC domain, Qrigincell Therapeutics has developed multiple product pipelines for the treatment of hematological malignancies and solid tumors. These have demonstrated favorable safety and efficacy in exploratory clinical studies, with related clinical research data published at conferences such as the 2021 ASCO, 2022 ASCO, 2022 EHA, 2023 *The Lancet Haematology*, and 2024 ASCO, as well as in international academic journals.

Forward-Looking Statements

This press release contains "forward-looking statements" that are not historical facts but constitute predictions about future events based on the beliefs, assumptions, and current knowledge of the management of Oricell Therapeutics Holdings Limited ("the Company"). Terms such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements involve known and unknown risks, uncertainties, and other important factors that could cause the actual results, performance, or achievements of the Company or industry outcomes to differ materially from any future results, performance, or achievements expressed or implied by such forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date of this press release. The Company expressly disclaims any obligation to update any forward-looking statement due to new information, future events, or otherwise.

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