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Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced the enrollment of the first patient in the pivotal Phase 1/2 clinical study of GC007g, an allogeneic CAR-T therapy targeting B-cell acute lymphoblastic leukemia (B-ALL). Approved by China's NMPA, this study focuses on the safety and efficacy of GC007g in relapsed/refractory B-ALL patients. Dr. Martina Sersch emphasized the therapy's potential for patients not eligible for standard care. GC007g was previously studied in a completed trial in China using HLA-matched donor T-cells.
Gracell Biotechnologies (NASDAQ: GRCL) announced its participation in the 2021 Virtual Wells Fargo Biotech Corporate Access Day, scheduled for April 6, 2021. The event will feature one-on-one and small group meetings with key management including Dr. William (Wei) Cao, Dr. Martina Sersch, and Dr. Kevin Xie. Gracell focuses on developing affordable cell therapies using its advanced FasTCAR and TruUCAR technology platforms, aiming to address challenges in conventional CAR-T therapies. For more details, attendees are advised to contact their Wells Fargo representative.
Gracell Biotechnologies reported significant milestones, including a successful IPO that raised approximately $220 million. Their lead CAR-T candidate, GC012F, has shown promising results in treating multiple myeloma, with an overall response rate of 93.8% among high-risk patients. Additionally, the company received IND approval for GC019F for B-ALL treatments and plans to expand R&D operations in the U.S. and China. Despite increased expenses, including a net loss of $42.1 million for 2020, Gracell is well-positioned to advance its clinical programs and expand its manufacturing capabilities.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) announced it will release its financial results for Q4 and fiscal year 2020 on March 9, 2021, after U.S. market close. The management will hold a conference call on March 10, 2021, at 8:00 a.m. ET to discuss these results and recent business developments. Investors can access a replay of the webcast on Gracell's investor relations website for 90 days. The company focuses on developing innovative cell therapies through its FasTCAR and TruUCAR platforms, addressing challenges in the CAR-T therapy industry.
Gracell Biotechnologies (NASDAQ: GRCL) announced the approval of an investigational new drug (IND) application by China's National Medical Products Administration (NMPA) for its innovative CAR-T therapy, GC019F, targeting relapsed or refractory adult B-cell acute lymphoblastic leukemia (B-ALL). This therapy utilizes Gracell's FasTCAR technology, reducing the manufacturing time from weeks to just 22-36 hours, enhancing efficiency and accessibility. The IND approval marks a significant milestone in expanding treatment options for B-ALL patients in China, addressing a critical unmet medical need.
Gracell Biotechnologies Inc. (NASDAQ: GRCL) has received a Medical Products Manufacturing Certificate from the Jiangsu Medical Products Administration, awarded on January 4, 2021. This certificate confirms that its Suzhou facility complies with Good Manufacturing Practice (GMP) standards for CAR-T cell therapy production. Gracell is among five companies in China to achieve this certification, enhancing its ability to advance clinical programs, including FasTCAR-T therapies, aimed at transforming cancer treatment.
Gracell Biotechnologies has received approval from China's National Medical Products Administration (NMPA) for a pivotal seamless Phase 1/2 clinical trial for its allogeneic CAR-T therapy, GC007g. This therapy targets B-cell acute lymphoblastic leukemia (B-ALL) patients, particularly those who have relapsed post-allogeneic transplant. The trial approval, granted on December 24, 2020, is a significant milestone, potentially accelerating the development of this treatment option in China, addressing a critical need in cancer therapy.
Gracell Biotechnologies Inc. (NASDAQ:GRCL) has priced its initial public offering (IPO) at US$19.00 per American Depositary Share (ADS), raising approximately US$209.0 million in gross proceeds. The offering involves 11,000,000 ADSs, with an option for underwriters to purchase an additional 1,650,000 ADSs. Trading on Nasdaq is expected to commence on January 8, 2021, with the offering closing anticipated by January 12, 2021. The funds raised will support Gracell's innovative cell therapy development.