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Gracell Biotechnologies Inc. (GRCL) is a global clinical-stage biopharmaceutical company dedicated to the discovery and development of breakthrough cell therapies. The company leverages its pioneering FasTCAR and TruUCAR technology platforms to create a robust clinical-stage pipeline of autologous and allogeneic product candidates. These innovations aim to address significant challenges in conventional CAR-T therapies such as lengthy manufacturing times, suboptimal production quality, high costs, and the lack of effective CAR-T therapies for solid tumors.
One of Gracell's leading developments is GC012F, an autologous CAR-T candidate that dual-targets B cell maturation antigen (BCMA) and CD19. Utilizing the proprietary FasTCAR next-day manufacturing platform, GC012F has shown promise in treating multiple myeloma and other hematological cancers. The candidate is currently undergoing various clinical trials, including a Phase 1b/2 U.S. IND study for relapsed/refractory multiple myeloma and a Phase 1/2 trial for refractory systemic lupus erythematosus set to initiate in 2024.
Gracell’s FasTCAR platform, introduced in 2017, has revolutionized CAR-T cell manufacturing by drastically shortening cell production times from weeks to overnight, reducing patient wait times and the likelihood of disease progression. FasTCAR T-cells appear younger and more proliferative, enhancing their effectiveness in killing cancer cells. The platform has garnered multiple accolades, including the Biotech Innovation category award at the 2022 Fierce Life Sciences Innovation Awards and the Overall Immunology Solution of 2023 by BioTech Breakthrough Awards.
As part of its ongoing efforts, Gracell is also expanding the clinical development of GC012F in early-line multiple myeloma therapies and other indications. The company's recent milestone achievements include receiving its third U.S. IND clearance for GC012F, marking its entry into early-line multiple myeloma treatment. This strategic move aims to address unmet needs and drive improved patient outcomes through GC012F's unique dual-targeting approach and FasTCAR manufacturing capabilities.
Moreover, Gracell recently announced a merger agreement approved by its shareholders, making significant strides in its corporate development. The company intends to delist from the Nasdaq Global Select Market and suspend its SEC reporting obligations, following the merger's effective date on February 22, 2024. For more information, visit www.gracellbio.com or follow @GracellBio on LinkedIn.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced it will present updated clinical data on its dual-targeting CAR-T cell therapy, GC012F, at the 2023 ASCO Annual Meeting from June 2-6, 2023. This therapy targets B-cell maturation antigen (BCMA) and CD19 and aims to treat relapsed-refractory multiple myeloma (RRMM) and B-cell non-Hodgkin's lymphoma (B-NHL). Gracell is set to present new long-term follow-up data for GC012F in RRMM during an oral session and additional results from an ongoing trial for B-NHL in a separate poster presentation. With investigational new drug applications approved in both the U.S. and China, Gracell is poised to initiate clinical trials in 2023, emphasizing the potential of their FasTCAR next-day manufacturing technology in improving treatment outcomes.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced on April 25, 2023, that it has filed its annual report on Form 20-F with the SEC for the fiscal year ending December 31, 2022. This filing provides comprehensive financial details, including results of operations, financial condition, and management's discussion and analysis pertaining to the company’s cell therapy developments. Gracell focuses on innovative therapies, utilizing FasTCAR, TruUCAR, and SMART CAR™ technologies to improve the efficacy and affordability of cancer treatments. Shareholders can request hard copies of the report, which is accessible via Gracell's investor relations website and the SEC’s website.
Gracell Biotechnologies Inc. (NASDAQ: GRCL), a clinical-stage biopharmaceutical firm focusing on innovative cell therapies for cancer, will engage in two key investor conferences. The first is Cantor’s the Future of Oncology Virtual Symposium on April 3, 2023, featuring a panel discussion at 12:00 pm ET and one-on-one meetings on April 4. The second is the 22nd Annual Needham Virtual Healthcare Conference on April 19, 2023, with a presentation at 9:30 am ET and additional one-on-one meetings on the same day. Webcasts for these events will be available on the Company’s website, with replays accessible for 90 days.
Gracell Biotechnologies (NASDAQ: GRCL) announced it will initiate a Phase 1b/2 clinical trial of its FasTCAR-T candidate GC012F in the US for relapsed/refractory multiple myeloma (RRMM) after receiving FDA clearance for its IND application in January 2023. A parallel trial in China is expected to commence in Q3 2023 following NMPA approval. The company reported a cash balance of RMB1,458.2 million (US$211.4 million) as of Dec 31, 2022, and net losses of RMB130.7 million (US$18.9 million) for Q4 2022. R&D expenses increased due to heightened clinical trial activities, with total losses of RMB607.5 million (US$88.1 million) for the full year 2022.
Roots Analysis released a report on the Cell Therapy Manufacturing Market indicating a projected growth at an annualized rate of over 12% from 2022 to 2035. The report highlights that the demand for cell therapies is expected to grow at a CAGR of 16%. Currently, there are 340+ production facilities globally, with North America leading at 46% of facilities. The report also notes that 240 organizations engage in contract manufacturing of cell therapies. Partnerships and expansions in the field increased significantly, and over 1,038 clinical trials have been registered since 2019, with a CAGR of 73%. These insights underscore the growing significance of cell therapies in the biopharmaceutical industry.
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