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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 advancements in its TruUCAR platform, which aims to develop affordable allogeneic CAR-T cell therapies. The company will present early results from its GC502 study, a CD19/CD7 dual-directed CAR-T therapy for B-ALL, at the AACR Annual Meeting 2022. GC502 is in a Phase 1 trial in China, targeting B-cell malignancies. Additionally, GC027, another product candidate targeting T-ALL, is also being investigated. These developments highlight Gracell's commitment to addressing challenges in CAR-T therapies, focusing on convenience and cost-effectiveness.
Gracell Biotechnologies (GRCL) has initiated dosing of patients in a Phase 1 investigator-initiated trial in China for GC012F, its autologous CAR-T therapy targeting both B cell maturation antigen (BCMA) and CD19 in relapsed/refractory B-cell non-Hodgkin's lymphoma (B-NHL). This marks the first human study of a dual-targeting CAR-T for this indication. The FasTCAR platform enables next-day manufacturing, potentially improving treatment efficacy and accessibility. GC012F also holds Orphan Drug Designation from the FDA.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) will participate in the Citi 2022 Immuno-Oncology Summit on February 16, 2022. Dr. William Cao, the company's Founder and CEO, will engage in a fireside chat from 3:30 PM to 4:30 PM ET. A webcast of the discussion will be accessible on Gracell's Investors webpage, with a replay available for 180 days post-event. Gracell focuses on developing advanced cell therapies for cancer treatment, utilizing its unique technology platforms to improve therapy quality, reduce costs, and enhance effectiveness against solid tumors.
Gracell Biotechnologies (NASDAQ: GRCL), a clinical-stage biopharmaceutical company, announced its participation in the B Riley Securities 2022 Virtual Oncology Conference, scheduled for January 27-28, 2022. The management team will present on January 27 from 2:30 PM to 3:30 PM Eastern Time, and will host virtual investor meetings on both event days. A webcast of the presentation will be accessible on the company's website, with a replay available for 90 days afterward. Gracell specializes in developing innovative cell therapies to effectively treat cancer.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced the opening of its Innovation Center in San Diego, California, scheduled for the first quarter of 2022. This facility aims to enhance Gracell's R&D capabilities and diversify its drug discovery process, supporting its proprietary FasTCAR and TruUCAR technology platforms. The company plans to recruit top biotech talent to boost its research efforts. This development is part of Gracell's strategy to solidify its presence in the U.S. market and further its mission in advancing cell therapies for cancer treatment.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) has been selected for inclusion in the NASDAQ Biotechnology Index, effective December 20, 2021. This index tracks biotechnology and pharmaceutical companies meeting specific trading and market capitalization criteria. Gracell is known for its innovative cell therapy platforms, which aim to address key challenges in CAR-T therapies, including production time and cost. This addition is likely to enhance the visibility of Gracell within the biotechnology sector.
Gracell Biotechnologies (NASDAQ: GRCL) announced that its senior management, including CEO Dr. William Cao, CFO Dr. Yili Kevin Xie, and CMO Dr. Martina A. Sersch, plan to purchase up to $2 million of the company's American depositary shares (ADSs) over the next three months. This move indicates confidence in the company's future, as the management team opts to invest their personal funds in the company's stock. Gracell is focused on developing affordable cell therapies for cancer treatment, leveraging innovative technology platforms.
Gracell Biotechnologies (NASDAQ: GRCL) announced FDA Orphan Drug Designation for its GC012F, a dual-targeting CAR-T cell therapy for multiple myeloma. This designation is pivotal, offering development incentives and market exclusivity post-approval. GC012F shows promising results in ongoing studies in China, demonstrating quick and enduring responses in hard-to-treat patients. The therapy aims to enhance patient outcomes and is supported by Gracell's innovative FasTCAR manufacturing technology, which boosts efficiency and accessibility. A U.S. IND filing is planned for mid-2022.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced its participation in the Piper Sandler 33rd Annual Virtual Healthcare Conference from November 29th to December 2nd, 2021. The management team will hold a fireside chat starting November 22nd, available on demand, and will conduct virtual investor meetings on December 1st and 2nd. A webcast of the chat will be accessible for 90 days on the Company's website. Gracell is focused on developing affordable cell therapies for cancer, utilizing its FasTCAR and TruUCAR technology platforms.
Gracell Biotechnologies (NASDAQ: GRCL) reported its Q3 2021 financial results, highlighting ongoing advancements in its cell therapy pipeline. Notable developments include progress with the FasTCAR candidate GC012F for multiple myeloma and the TruUCAR candidate GC502 for B-cell malignancies. R&D expenses surged to RMB88.6 million ($13.7 million), reflecting increased activity, while net loss rose to RMB129.3 million ($20.1 million). Cash reserves stood at RMB1,957.5 million ($303.8 million) as of September 30, 2021, bolstered by an IPO that raised approximately $220 million.
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