Press Releases

Gracell to present first-in-human data on GC502, an allogeneic CD19/CD7 dual-directed chimeric antigen receptor (CAR) T cell therapy

 

PALO ALTO, Calif. and SUZHOU, China, March 8, 2022 /PRNewswire/ -- 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, today announced the details of its poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2022, being held from April 8-13 in New Orleans, Louisiana.

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 Online Itinerary Planner at 1:00PM ET on Friday, April 8. The e-poster will be viewable to registered attendees on the AACR"s e-poster website from Friday, April 8, through Wednesday, July 13. Additional meeting information is available on the AACR 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.

 

About Gracell

Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR, TruUCAR and SMART CART^TM technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal cell quality, high therapy cost, and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit www.gracellbio.com. Follow @GracellBio on LinkedIn.

 

Cautionary Noted Regarding Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words "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. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the section entitled "Risk Factors" in Gracell"s most recent annual report on Form 20-F as well as discussions of potential risks, uncertainties, and other important factors in Gracell"s subsequent filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

 

Media contacts
Marvin Tang
marvin.tang@gracellbio.com
Kyle Evans
kyle.evans@westwicke.com

 

Investor contacts
Gracie Tong
gracie.tong@gracellbio.com
Stephanie Carrington
stephanie.carrington@westwicke.com

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SOURCE Gracell Biotechnologies Inc.