GC019F / AstraZeneca - LARVOL DELTA

Gracell drops 3 CAR-T programs in hopes of speeding more advanced assets to the finish line (Fierce Pharma) - "Gracell Biotechnologies is shaving down its CAR-T pipeline, throwing several programs out the window in an effort to speed its most advanced programs to the finish line...GC019F, a CD19 program targeting advanced B-cell acute lymphoblastic leukemia, has been cut. The CAR-T was being assessed in a phase 1 clinical trial. The second program left behind is GC027, an allogenic CAR-T designed to treat relapsed or refractory T-cell acute lymphoblastic leukemia. Lastly, Gracell dropped GC503, a mesothelin program designed to treat solid tumors...The company hopes to instead focus on the dual-targeting therapy GC012F derived from the company’s FasTCAR-T autologous platform made for next-day manufacturing....After completing a $150 million private placement financing earlier this month, Gracell anticipates its current cash will stretch into the second half of 2026, Chief Financial Officer Kevin Xie, Ph.D., said on the earnings call."

Commercial • Discontinued • Pipeline update • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Gynecologic Cancers • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Solid Tumor • T Acute Lymphoblastic Leukemia

Gracell Biotechnologies Receives IND Approval from China NMPA for GC019F, a FasTCAR-Enabled CAR-T Therapy for the Treatment of Relapsed or Refractory Adult B-ALL (PRNewswire) - “Gracell Biotechnologies Inc…announced that the National Medical Products Administration (NMPA) in China has approved an investigational new drug (IND) application to study GC019F, a FasTCAR-enabled chimeric antigen receptor (CAR)-T therapy in patients with relapsed or refractory adult B-cell acute lymphoblastic leukemia (B-ALL).”

Non-US regulatory • B Acute Lymphoblastic Leukaemia • Hematological Malignancies • Oncology

Gracell Bio’s second CAR-T therapy nodded for clinics in China (GBI Health) - "China's Center for Drug Evaluation (CDE) website indicates that Gracell Biotechnologies (Nasdaq.GRCL) has been approved to put a chimeric antigen receptor (CAR)-T cell therapy, GC019F, into clinical studies in patients between the ages of 8 and 70 with relapsed or refractory CD19+ acute B lymphocytic leukemia. This follows the cell therapy specialist’s GC007g, a donor-derived CAR-T cell therapy that was approved for clinics in April 2020, the first domestic allogeneic CAR-T therapy to be approved for study."

Non-US regulatory • B Acute Lymphoblastic Leukaemia • Hematological Malignancies • Oncology

A Study of GC019F CAR-T Cell Immunotherapy for Relapsed or Refractory B- ALL (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: Peking University Third Hospital

New P1 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukaemia • Hematological Malignancies • Leukemia • Oncology