Gracell to present longer-term follow-up clinical data evaluating GC012F, an autologous CAR-T therapeutic candidate dual-targeting BCMA and CD19, for the treatment of relapsed/refractory multiple myeloma

SAN DIEGO, Calif. and SUZHOU, China, April 28, 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 oral abstract presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held from June 3-7 in Chicago, Illinois.

Longer-term follow-up clinical data from a multicenter investigator-initiated trial (IIT) evaluating GC012F for the treatment of relapsed/refractory multiple myeloma (RRMM) will be presented at an oral abstract session. GC012F is an autologous CAR-T therapeutic candidate dual-targeting B cell maturation antigen (BCMA) and CD19. It is developed using Gracell’s proprietary FasTCAR platform, which enables next-day manufacturing. In November 2021, GC012F was granted Orphan Drug Designation for the treatment of multiple myeloma by the U.S. Food and Drug Administration.

Details of the presentation are as follows:

  • Abstract title: Updated results of a multicenter first-in-human study of BCMA/CD19 dual-targeting fast CAR-T GC012F for patients with relapsed/refractory multiple myeloma (RRMM)
  • Abstract number: 8005
  • Session title: Hematologic Malignancies – Plasma Cell Dyscrasia
  • Session type: Oral Abstract Session
  • Presentation time: Sunday, June 5 at 9:36 AM CT
  • Presentation location: S406

Full abstract will be released on May 26, 2022 at 5:00 PM (EDT). Additional information about the presentation and the ASCO Annual Meeting is available on the ASCO website.

About GC012F

GC012F is a FasTCAR-enabled dual-targeting CAR-T product candidate that is currently being evaluated in IIT studies in China for the treatment of multiple myeloma (MM) and B-cell non-Hodgkin’s lymphoma (B-NHL). GC012F simultaneously targets CD19 and BCMA to drive fast, deep and durable responses, which can improve efficacy and may reduce relapse in MM and B-NHL patients. The U.S. Food and Drug Administration granted Orphan Drug Designation to GC012F for the treatment of RRMM.

About FasTCAR

CAR-T cells manufactured on Gracell’s proprietary FasTCAR platform appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next-day manufacturing, FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, increasing the accessibility of cell therapies for cancer patients.

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 and TruUCAR technology platforms and SMART CARTM 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. For more information on Gracell, please visit Follow @GracellBio on LinkedIn.

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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.

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