On May 26, 2022 Gracell Biotechnologies Inc. ("Gracell" or the "Company",NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that it will present updated clinical data from a multicenter investigator-initiated trial (IIT) evaluating GC012F, the company’s B-cell maturation antigen (BCMA) and CD19 dual-targeting CAR-T candidate, for the treatment of relapsed/refractory multiple myeloma (RRMM) in an oral abstract presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO 2022) Annual Meeting (Press release, Gracell Biotechnologies, MAY 26, 2022, View Source [SID1234615143]).

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GC012F is an autologous CAR-T therapeutic candidate dual-targeting BCMA and CD19, developed using Gracell’s proprietary FasTCAR platform, which enables next-day manufacturing of CAR-T therapies. In November 2021, GC012F was granted Orphan Drug Designation for the treatment of multiple myeloma (MM) by the U.S. Food and Drug Administration. GC012F is currently being evaluated in IITs in China including in MM and B-NHL.

"We are thrilled to present updated data from our ongoing study of GC012F for the treatment of patients with RRMM at the oral abstract session at ASCO (Free ASCO Whitepaper)," said Dr. Martina A. Sersch, Chief Medical Officer of Gracell. "GC012F is the first dual-targeting CAR-T with clinical data in RRMM, which is designed to improve depth of response as well as tackling some of the major challenges of CAR-T therapy, including the need for faster delivery to the patients in need . We have followed patients for over two and a half years and also enrolled new patients into the study. RRMM still remains an area of unmet medical need, including the need of deepening responses for eligible patients."

From October 2019 to November 2021, 28 heavily pretreated RRMM patients were enrolled and treated in this single-arm, open label, multicenter IIT with a single infusion of GC012F at three dose levels: 1×105 cells/kg (DL1), 2×105 cells/kg (DL2), and 3×105 cells/kg (DL3). An additional 9 patients were treated in three different dose levels since the last update reported at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) in 2021. 89.3% (25/28) patients were high risk based on mSMART 3.0 criteria and patients had received a median of five prior lines of therapy.

At the data cutoff of January 26, 2022, the 28 patients had been evaluated for response with a median follow-up time of 6.3 months, ranging from 1.8 to 29.9 months. Patients are continued to be followed for deepening responses. The response rate at different dose levels was 100% (2/2) in DL1, 80% (8/10) in DL2, and 93.8% (15/16) in DL3. All (27/27, 100%) MRD-assessable patients achieved minimal residual disease (MRD) negativity. 75% (21/28) of all patients treated achieved MRD- sCR.

The safety profile of GC012F was consistent with previous findings with mostly low grade of cytokine release syndrome (CRS) (Grade 0-2 (93%)). No Grade 4 or 5 CRS, or any Grade immune effector cell-associated neurotoxicity syndrome (ICANS) were observed. Patients continue to be monitored for safety and efficacy including best overall response and duration of response.

Gracell will also present as an oral abstract presentation the updated results from this IIT evaluating GC012F for the treatment of RRMM patients at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress. For more information on the study, please visit ClinicalTrials.gov using the identifier: NCT04236011.

Details of the ASCO (Free ASCO Whitepaper) presentation follow below:

2022 ASCO (Free ASCO Whitepaper) Annual Meeting

Abstract title: Updated results of a multicenter first-in-human study of BCMA/CD19 dual-targeting FasTCAR-T GC012F for patients with relapsed/refractory multiple myeloma (RRMM)
Abstract number: 8005
Session title: Hematologic Malignancies – Plasma Cell Dyscrasia
Presentation time: Sunday, June 5 at 9:36 AM CT
Presentation location: S406
About GC012F

GC012F is a FasTCAR-enabled dual-targeting CAR-T product candidate that is currently being evaluated in IIT studies in China for the treatment of multiple myeloma and B-cell non-Hodgkin’s lymphoma. GC012F simultaneously targets CD19 and BCMA to drive fast, deep and durable responses, which can potentially improve efficacy and reduce relapse in multiple myeloma and B-NHL patients.

About FasTCAR

CAR-T cells manufactured on Gracell’s proprietary FasTCAR platform appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next-day manufacturing, FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, and, together with fast turnaround time, enables enhanced accessibility of cell therapies for cancer patients.