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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 its participation in the Oppenheimer 33rd Annual Healthcare Conference from March 13 to 15, 2023. The management team will present on March 14 at 1:20 PM ET and will host investor meetings that day. A live webcast of the presentation will be available on the Company's website, along with a replay for 90 days post-event. Gracell focuses on developing innovative and cost-effective cell therapies for cancer using its proprietary FasTCAR and TruUCAR platforms.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced its plan to release unaudited financial results for the fourth quarter ended December 31, 2022, on Monday, March 13, 2023, before U.S. markets open. The company, focused on developing affordable cell therapies for cancer treatment, will provide updates on its recent developments during a live audio webcast and conference call at 8:00 a.m. ET. Investors can join the call via domestic dial-in at (800) 715-9871 or international dial-in at (646) 307-1963, using conference ID 5617240. A replay will be accessible on Gracell's investor relations webpage post-event.
The CAR-T cell therapy market is poised for significant growth, projected to reach a CAGR of 23% from 2022 to 2035. Over 970 therapies are currently approved or under development, with 25% in late-stage trials. The market's expansion is supported by substantial investments, totaling nearly USD 25 billion, primarily from US-based companies. Non-Hodgkin's lymphoma is expected to dominate the market, capturing 85% of target indications. The report highlights over 38,470 patients enrolled in around 750 clinical trials, indicating robust research and partnership activity.
Gracell Biotechnologies Inc. (NASDAQ: GRCL), a clinical-stage biopharmaceutical company focused on cancer cell therapies, announced its participation in two investor conferences. The Citi 2023 Virtual Oncology Leadership Summit includes a fireside chat on February 21, 2023, at 10:00 am ET. Additionally, Gracell will host a fireside chat at the H.C. Wainwright Cell Therapy Virtual Conference on February 28, 2023, at 9:30 am ET, followed by one-on-one meetings. Webcasts of both events will be available on their website for 90 days.
Gracell Biotechnologies Inc. (GRCL) has received clearance from China’s NMPA for its IND application for GC012F, a CAR-T therapy targeting relapsed/refractory multiple myeloma. This follows FDA clearance for trials in the U.S. The company aims to initiate a Phase 1/2 clinical trial in China in Q3 2023, with a similar trial in the U.S. set for Q2 2023. GC012F utilizes Gracell's FasTCAR platform, offering next-day manufacturing for enhanced accessibility. Previous data presented indicate a 100% minimal residual disease negativity rate in treated patients. Gracell is focused on advancing innovative cancer therapies.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) has received FDA clearance for its Investigational New Drug application, allowing it to initiate a Phase 1b/2 clinical trial for its CAR-T therapeutic candidate GC012F, targeting relapsed/refractory multiple myeloma (RRMM). This dual-targeting therapy, which addresses BCMA and CD19, has shown promising safety and efficacy in earlier studies, including a 100% minimal residual disease negativity rate. The U.S. trial is set to begin in Q2 2023, aiming to evaluate both safety and efficacy further. This milestone validates Gracell's FasTCAR platform and the potential of GC012F as a transformative cancer therapy.
Gracell Biotechnologies (NASDAQ: GRCL) has presented promising clinical data for its FasTCAR-enabled therapy, GC012F, targeting multiple myeloma at the 64th ASH Annual Meeting. In a Phase 1 trial, 16 high-risk, newly diagnosed multiple myeloma patients showed a 100% overall response rate (ORR) and 100% minimal residual disease (MRD) negativity. Additionally, 87.5% achieved stringent complete response (sCR) at a median follow-up of eight months. The therapy also exhibited a favorable safety profile, with only 25% experiencing mild cytokine release syndrome. These results indicate significant potential for GC012F in enhancing treatment outcomes.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced participation in two investor conferences. The Piper Sandler 34th Annual Healthcare Conference will take place on November 30, featuring a presentation at 4:00 pm ET and one-on-one meetings. The JMP Securities Hematology & Oncology Summit is scheduled for December 7 with a presentation at 10:00 am ET. Both events aim to enhance Gracell's outreach in the biopharmaceutical sector. A webcast of the chat will be available for 30 days post-event on their investor website.
Gracell Biotechnologies (NASDAQ: GRCL) reported its Q3 2022 financial results, highlighting significant advancements in its cancer treatment pipeline. The company plans to submit IND filings for its lead candidate, GC012F, targeting relapsed/refractory multiple myeloma, by year-end. Notable results from an ongoing trial show a 100% overall response rate (ORR) in newly diagnosed multiple myeloma patients. As of September 30, 2022, Gracell has $229.1 million in cash and equivalents, with a net loss of $24.2 million for the quarter due to increased R&D spending.
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