Suzhou-based biotech company Gracell Biotechnologies Inc., (NASDAQ: GRCL) has reported its financial results for the second quarter of 2023. The report highlights the company’s core product, GC012F, which has shown excellent data in multiple melanoma (MM) studies, as a key focus of their strategy moving forward.
Clinical Trials and Development Progress for GC012F
Gracell has initiated a Phase Ib/II clinical trial in the US to evaluate FasTCAR-T GC012F for the treatment of relapsed/refractory multiple myeloma (r/r MM), with patient screening underway for the Phase Ib portion. Additionally, a Phase I/II clinical trial in China for the same indication is set to commence in Q3 2023. The company plans a US IND filing for a Phase I trial of GC012F in refractory systemic lupus erythematosus (rSLE) in 2023, following an investigator-initiated trial (IIT) already underway in China evaluating GC012F in rSLE with multiple patients dosed.
GC012F: A Dual-Targeting Autologous CAR-T Cell Therapy
GC012F is Gracell’s FasTCAR-enabled BCMA/CD19 dual-targeting autologous CAR-T cell therapy designed to transform the treatment of cancer and autoimmune diseases by driving fast, deep, and durable responses with an improved safety profile. Long-term follow-up data from a multicenter IIT presented at ASCO 2023 Annual Meeting and EHA2023 Congress demonstrated deep and durable responses related to the drug in MM.
GC007g: An Allogeneic CD19-Targeted CAR-T Cell Therapy
GC007g, an allogeneic CD19-targeted CAR-T cell therapy derived from human leukocyte antigen (HLA) matched donors, is being developed for the treatment of relapsed/refractory b-cell acute lymphoblastic leukemia (r/r B-ALL) patients who have failed transplant and may not be eligible for autologous CAR-T therapy. Phase 1 data presented at EHA2023 Congress showed a 100% MRD- complete response or complete response with/without complete hematologic recovery (CR/CRi). A registrational Phase II trial for the drug is ongoing in China.
SMART CART Technology and GC506 Development
SMART CART is designed to enhance CAR-T cell proliferation and duration of killing, resist exhaustion, and improve the persistence of CAR-T cells, taking advantage of the suppressive tumor microenvironment (TME) to combat solid tumors effectively. GC506, based on this technology, has initiated an IIT in China for Claudin18.2 positive solid tumors.
Financial Position and R&D Expenses
As of June 30, 2023, Gracell Biotechnologies had RMB 1,188.0 million (USD 163.8 million) in cash and cash equivalents and short-term investments. Research and development expenses for the three months ended June 30, 2023, were RMB 103.8 million (USD 14.3 million), compared to RMB 117.1 million in the corresponding prior year period.-Fineline Info & Tech
