Press Releases

SAN DIEGO, Calif., and SUZHOU and SHANGHAI, China, Sept. 6, 2023 /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing  innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today announced that it will present updated, longer-term results from the ongoing investigator-initiated Phase 1 trial in China evaluating FasTCAR-enabled GC012F in transplant-eligible, high-risk patients with newly diagnosed multiple myeloma (NDMM). The findings will be presented in a poster presentation at the 20th International Myeloma Society (IMS) Annual Meeting, taking place September 27-30, 2023, in Athens, Greece and virtually.

"We look forward to presenting the latest findings from our clinical study evaluating GC012F for patients with newly diagnosed multiple myeloma at this year"s IMS Annual Meeting," said Dr. Wendy Li, Gracell"s Chief Medical Officer. "There remain significant opportunities to improve outcome for front-line high-risk multiple myeloma patients. With a demonstrably impressive safety profile, differentiated BCMA/CD19 dual-targeting design and FasTCAR next-day manufacturing, we believe GC012F is a compelling, innovative candidate to address the unmet needs for this patient population."

Poster presentation details are as follows:

• Abstract title: Phase I open-label single-arm study of dual targeting BCMA and CD19 FasTCAR-T cells (GC012F) as first-line therapy for transplant-eligible newly diagnosed high-risk multiple myeloma 
• Abstract number: P-136
• Abstract category: Treatment of Newly Diagnosed Myeloma – Transplant Eligible 
• Presentation time: 1:30-2:30PM EEST, Wednesday, September 27, 2023

Additional information about the poster and the IMS Annual Meeting is available on the IMS website. 

About GC012F

GC012F is Gracell"s FasTCAR-enabled BCMA/CD19 dual-targeting autologous CAR-T cell therapy, which aims to transform cancer and autoimmune disease treatment by driving fast, deep and durable responses with improved safety profile. GC012F is currently being evaluated in clinical studies in multiple hematological cancers as well as autoimmune diseases, and has demonstrated a consistently strong efficacy and safety profile. Gracell has initiated a Phase 1b/2 trial evaluating GC012F for the treatment of relapsed/refractory multiple myeloma in the United States and a Phase 1/2 clinical trial in China is to be commenced imminently. Gracell has also launched an investigator-initiated trial (IIT) evaluating GC012F for the treatment of refractory systemic lupus erythematosus (rSLE). 

About Gracell 

Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies for the treatment of cancers and autoimmune diseases. Leveraging its innovative FasTCAR and TruUCAR technology platforms and SMART CAR™ technology module, 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 and autoimmune diseases. The lead candidate BCMA/CD19 dual-targeting FasTCAR-T GC012F is currently being evaluated in clinical studies for the treatment of multiple myeloma, B-NHL and systemic lupus erythematosus (SLE). 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. The words "anticipate," "look forward to," "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 U.S. Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof. Gracell specifically disclaims any obligation to update any forward-looking statement, whether due to 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 

Jessica Laub
jessica.laub@westwicke.com  

Investor contacts

Gracie Tong
gracie.tong@gracellbio.com 

Stephanie Carrington
stephanie.carrington@westwicke.com

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SOURCE Gracell Biotechnologies Inc.