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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) appointed Dr. Samuel Zhang as Chief Business Officer (CBO) on July 19, 2022. With over 20 years of biopharma experience, Dr. Zhang will lead global business development and corporate strategy, enhancing Gracell's operations. The leadership change aims to accelerate growth and advance Gracell's cell therapy pipeline, leveraging proprietary technologies for cancer treatment. Dr. Zhang previously held senior roles at major pharmaceutical firms, emphasizing his strategic expertise in business development and commercialization.
Gracell Biotechnologies (NASDAQ: GRCL) announced its participation in three investor conferences in June 2022, focused on advancing its innovative cell therapies for cancer treatment. Events include the Goldman Sachs Virtual Healthcare Corporate Day from June 20-24, the Truist Securities Cell Therapy Symposium in New York on June 28, and the Stifel 2022 Virtual Cell Therapy Summit panel discussion on June 30 at 11:30 am ET. Gracell aims to leverage its FasTCAR and TruUCAR technologies to improve CAR-T therapy outcomes, addressing challenges like manufacturing time and costs.
Gracell Biotechnologies presented updated clinical data for its dual-targeting CAR-T candidate, GC012F, at the EHA2022 Congress. The study focused on 29 relapsed/refractory multiple myeloma patients, achieving a 100% minimal residual disease negativity rate. The median duration of response was reported at 15.7 months. Additionally, interim results for GC012F in B-cell non-Hodgkin's lymphoma were shared. GC012F has shown a favorable safety profile, with no severe adverse events reported. The company continues to develop this promising therapy, aiming to address significant patient needs.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced a clinical update call on June 13 to follow the European Hematology Association 2022 Hybrid Congress. The call will highlight clinical data from three investigator-initiated trials for its treatments, GC012F and GC502, targeting conditions like multiple myeloma and B-cell malignancies. Key presentations include updated data from GC012F on June 5 and June 12, and initial data from GC502 on June 10. The company focuses on developing effective cell therapies to address limitations of conventional CAR-T treatments.
Gracell Biotechnologies (NASDAQ: GRCL) announced its participation in the 2022 ASCO Annual Meeting, presenting updated clinical data for its dual-targeting CAR-T candidate, GC012F, aimed at treating relapsed/refractory multiple myeloma (RRMM). The trial, utilizing Gracell's FasTCAR platform, involved 37 heavily pretreated RRMM patients, showing high response rates across various dose levels. Notably, all assessable patients achieved minimal residual disease negativity. Safety data indicated a mostly low-grade cytokine release syndrome profile, reinforcing the therapy's promise.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced participation in three investor conferences in June 2022. Highlights include:
- BTIG China Biotech Day: Fireside chat and one-on-one meetings on June 1.
- Jefferies Healthcare Conference: Fireside chat on June 10 at 9:00 a.m. ET; one-on-one meetings from June 8-10 in New York.
- Citi 3rd Pan-Asia Regional Investor Conference: One-on-one and small group meetings from June 8-10.
Gracell focuses on developing advanced cell therapies, targeting challenges of traditional CAR-T treatments.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced participation in three investor conferences in June 2022. Events include the BTIG China Biotech Day on June 1, and the Jefferies Healthcare Conference from June 8-10, featuring a fireside chat on June 10 at 9:00 a.m. ET. Additionally, Gracell will attend the Citi 3rd Pan-Asia Regional Investor Conference during the same dates. The company focuses on developing advanced cell therapies for cancer, utilizing innovative technology platforms to tackle challenges associated with conventional CAR-T therapies.
Gracell Biotechnologies (NASDAQ: GRCL) reported Q1 2022 results with a net loss of RMB158.6 million (US$25.0 million), up from RMB99.7 million year-over-year. Cash reserves stood at RMB1,694.7 million (US$267.3 million), funding operations into 2024. Key clinical updates include promising early data from the IIT of GC502 in relapsed/refractory B-ALL, showing 75% of patients achieving minimal residual disease negative complete response. The company plans to present further data on its CAR-T therapies at upcoming conferences and file INDs for GC012F in the second half of 2022.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced presentations at the EHA2022 Congress from June 9-12 in Vienna, showcasing clinical data for its CAR-T therapies, GC012F and GC502. GC012F, a dual-targeting candidate for B-cell non-Hodgkin's lymphoma and multiple myeloma, demonstrated promising early results, with all enrolled patients achieving complete responses after treatment. GC502, targeting B-cell acute lymphoblastic leukemia, showed similar positive results. The presentations highlight Gracell's innovative platforms, aiming to enhance treatment efficacy and patient access.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced participation in three investor conferences in May 2022. The events include the CICC Healthcare Industry Forum (May 9-13, 2022), the ICA 2nd Annual Asia Pacific Healthcare Conference (May 19-24, 2022), and the H.C. Wainwright Global Investment Conference (May 25-27, 2022). Gracell aims to showcase its advancements in cell therapies, particularly its FasTCAR and TruUCAR platforms. Presentations and one-on-one meetings will provide investors insights into Gracell's innovative pipeline.
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