On March 8, 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 the details of its poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, being held from April 8-13 in New Orleans, Louisiana (Press release, Gracell Biotechnologies, MAR 8, 2022, View Source [SID1234609730]).

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Gracell will present early clinical results of a first-in-human investigator-initiated trial (IIT) on GC502, an allogeneic CD19/CD7 dual-directed CAR-T cell therapy currently under development for multiple B-cell malignancy indications including B-cell acute lymphoblastic leukemia (B-ALL). GC502 is currently being studied in an open-label single-arm Phase 1 IIT in China for patients with B-ALL. This product candidate leverages the novel dual-directed CAR design of Gracell’s proprietary TruUCAR platform, which allows the CD19 CAR to target malignant cells, while the CD7 CAR is designed to suppress host-versus-graft rejection response.

Details of the presentation are as follows:

Presentation Title: Early results of a safety and efficacy study of allogeneic TruUCAR GC502 in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)
Session Title: Phase I Clinical Trials 2
Session Date and Time: Tuesday, April 12, from 9:00AM – 12:30PM CT
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 33
Poster Board Number: 21
Permanent Abstract Number: CT196
The full text of the abstract will be published to the AACR (Free AACR Whitepaper) Online Itinerary Planner at 1:00PM ET on Friday, April 8. The e-poster will be viewable to registered attendees on the AACR (Free AACR Whitepaper)’s e-poster website from Friday, April 8, through Wednesday, July 13. Additional meeting information is available on the AACR (Free AACR Whitepaper) website.

About GC502

GC502 is a TruUCAR-enabled CD19/CD7 dual-directed, off-the-shelf allogeneic CAR-T product candidate that is being studied for the treatment of B-cell malignancies. GC502 is manufactured using T cells from non-human leukocyte antigen (HLA) matched healthy donors. An enhancer molecule is embedded in the basic construct of TruUCAR to enhance proliferation of TruUCAR T cells. Optimized for CD19/CD7 dual-CAR functionality and in vivo durability, GC502 has demonstrated robust anti-tumor efficacy with promising potential to suppress host versus graft (HvG) rejection in preclinical models.

About B-ALL

Acute lymphoblastic leukemia (ALL) is a type of blood cancer characterized by proliferation of immature lymphocytes in the bone marrow, which can involve either T lymphocytes (T-ALL), or B lymphocytes (B-ALL). Globally, approximately 64,000 patients are diagnosed with ALL every year with approximately 6,000 diagnosed in the United States, and approximately 7,400 diagnosed in China in 2020[1]. B-ALL accounts for 85%-88% of ALL diagnosed.

About TruUCAR

TruUCAR is Gracell’s proprietary technology platform and is designed to generate high-quality allogeneic CAR-T cell therapies that can be administered "off-the-shelf" at lower cost and with greater convenience. With differentiated design enabled by gene editing, TruUCAR is designed to control host versus graft rejection (HvG) as well as graft versus host disease (GvHD) without the need for being co-administered with immunosuppressive drugs. The novel dual-directed CAR design allows tumor antigen-CAR moiety to target malignant cells, while the CD7 CAR moiety is designed to suppress HvG response.