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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 (NASDAQ: GRCL), a clinical-stage biopharmaceutical company, announced its participation in key virtual conferences for June 2021. The company will hold one-on-one and small group meetings during the Jefferies Virtual Healthcare Conference from June 1-4, including a fireside chat on June 4 at 8:00 AM ET. Additionally, Gracell will participate in the Citi Pan-Asia Regional Investor Conference from June 2-4. These events aim to enhance communication with investors and showcase Gracell's innovative cell therapy technologies.
Gracell Biotechnologies (NASDAQ: GRCL) announced a conference call on June 4, 2021, at 11:00 am ET to discuss results from a Phase 1 study of its FasTCAR-enabled CAR-T cell therapy, GC012F, targeting relapsed/refractory multiple myeloma. The study's data will be presented at the 2021 American Society of Clinical Oncology Annual Meeting. Investors can join via domestic dial-in at 877-407-0784 or international dial-in at +1 201-689-8560. A live webcast will also be available, with a replay accessible for 90 days post-event.
Gracell Biotechnologies (NASDAQ: GRCL) announced updates on its GC012F CAR-T cell therapy for relapsed/refractory multiple myeloma at the ASCO 2021 and EHA2021 congresses. As of January 12, 2021, 19 patients were enrolled, achieving a remarkable 94.7% overall response rate (ORR). Notably, all patients treated with the highest dose level demonstrated minimal residual disease (MRD) negativity. The safety profile of GC012F remains consistent with earlier studies, with low instances of cytokine release syndrome. Gracell aims to expand its global program to include earlier treatment lines.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) reported its first quarter 2021 results, highlighting significant advancements in CAR-T cell therapies. The company completed an initial public offering (IPO), raising approximately US$220 million, and reported cash and equivalents of US$331.1 million as of March 31, 2021. Notable achievements include the presentation of follow-up data for GC027 at the AACR 2021 Annual Meeting and the dosing of the first patient in a pivotal study for GC007g. The leadership team expanded with Dr. Jenny Ni appointed as Chief Technology Officer.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced the appointment of Dr. Jenny (Yajin) Ni as its new Chief Technology Officer on May 10, 2021. With over 25 years of experience in gene and cell therapies, Dr. Ni will oversee CAR-T product development and ensure a smooth technology transfer to strategic collaborator Lonza for manufacturing. The company is confident that her leadership will enhance its manufacturing capabilities and accelerate the development of its FasTCAR product candidates, aimed at addressing major challenges in conventional CAR-T therapies.
Gracell Biotechnologies (NASDAQ: GRCL) announced participation in several virtual conferences, aimed at enhancing its profile in the biopharmaceutical sector. Key events include the Morgan Stanley Virtual Asia Healthcare Conference on May 13-14, 2021, the ICA China Healthcare Corporate Day on May 18, 2021, and the Sachs Associates 7th Annual Immuno-Oncology Innovation Forum on May 20, 2021. Gracell focuses on developing affordable cell therapies using its FasTCAR and TruUCAR technologies, addressing challenges in CAR-T therapies.
Gracell Biotechnologies (NASDAQ: GRCL) has filed its annual report on Form 20-F for the fiscal year ending December 31, 2020, with the SEC on April 23, 2021. This document is available on Gracell's investor relations website and the SEC's site. The company focuses on developing innovative cell therapies to address challenges in CAR-T treatments. Gracell aims to provide significant advancements in the field by overcoming issues such as long manufacturing times and high costs. Shareholders can request a hard copy of the report free of charge.
Gracell Biotechnologies (NASDAQ: GRCL) presented updated long-term follow-up data for its allogeneic CAR-T therapy candidate, GC027, at the 2021 AACR Annual Meeting. GC027 targets CD7 and aims to treat relapsed/refractory T-cell acute lymphoblastic leukemia (r/r T-ALL). In a Phase 1 trial, all six treated patients achieved complete remission, with 60% maintaining minimum residual disease-negative status at 6 months. The therapy demonstrated a favorable safety profile, with no severe neurotoxicity or graft-versus-host disease reported. Gracell plans to expedite global clinical development of GC027.
Gracell Biotechnologies (NASDAQ: GRCL), a clinical-stage biopharmaceutical firm, will present at the 20th Annual Needham Virtual Healthcare Conference on April 12, 2021, from 8:45 to 9:25 am ET. Founder and CEO Dr. William (Wei) Cao will lead the presentation. The webcast will be available via the company's investor website. Additionally, one-on-one meetings will occur from April 12-15, featuring Dr. Cao and CFO Dr. Kevin Xie. Gracell is focused on developing innovative cell therapies with its FasTCAR and TruUCAR technology platforms, addressing challenges in CAR-T therapies.
Gracell Biotechnologies Inc. (NASDAQ:GRCL) has entered a Manufacturing Service Agreement with Lonza for the clinical manufacturing of its FasTCAR-enabled CAR-T cell products in the U.S. This collaboration aims to enhance the efficiency of its CAR-T therapies, particularly the GC012F for multiple myeloma, reducing manufacturing time from weeks to just one day. Gracell's innovative FasTCAR platform has shown promise in improving cell production efficiency and accessibility for cancer patients, with plans for expanded global operations and IND-enabling clinical development.
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