Arcellx
Arcellx, founded in December 2014, is a biotechnology company focused on developing cell therapy treatments for multiple myeloma, acute myeloid leukemia, myelodysplastic syndrome, and solid tumors. The company is headquartered in Rockville, MD, with an additional location in Redwood City, CA, and trades on the Nasdaq under the ticker symbol 'ACLX'.
Company History
Arcellx was founded in December 2014. After securing seed money in April 2015, the company began developing the D-Domain binding scaffold. In Winter 2016/2017, Arcellx secured Series A funding. Construction of its Gaithersburg facility began in September 2018. The company received IND approval from the FDA for anitocabtagene autoleucel in October 2019 and dosed the first patient in February 2020. Significant milestones include a Series C funding round in June 2021 and an initial public offering on the Nasdaq in February 2022 under the ticker symbol “ACLX.”
Lead Products and Technologies
Arcellx's lead product is anitocabtagene autoleucel (anito-cel), currently in a Phase 2 pivotal trial for relapsed or refractory multiple myeloma. Another key asset, ACLX-001, is in development for the same condition and entered a Phase 1 clinical trial in May 2022. ACLX-002 is an ARC-SparX platform cell therapy for relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The company utilizes the D-Domain technology, a fully synthetic binding agent with a hydrophobic core, as part of its ddCAR platform.
Clinical Trials and Studies
Arcellx's iMMagine-1 study (NCT05396885) is a Phase 2, open-label trial evaluating the efficacy and safety of anitocabtagene autoleucel in patients with relapsed or refractory multiple myeloma. The iMMagine-3 study is a global, Phase 3, randomized, open-label study designed to assess the safety and efficacy of the same product in a similar patient population. Data from the ongoing Phase 1 study of anitocabtagene autoleucel was presented at the ASH in December 2020 and the ASCO Annual Meeting in 2022.
Locations
Arcellx is headquartered in Rockville, MD, and has an additional location in Redwood City, CA. The construction of the Gaithersburg facility began in September 2018, reflecting the company's expansion and commitment to developing advanced cell therapies.
Research and Development
Arcellx is actively developing cell therapy treatments for cancers including multiple myeloma, acute myeloid leukemia, myelodysplastic syndrome, and solid tumors. Recent initiatives include identifying a second antigen target associated with AML/MDS and advancing preclinical development. Projects targeting hepatocellular carcinoma (HCC) and small cell lung cancer (SCLC) are also underway. The company’s ARC-SparX platform combines universal ARC-T and specialized SparX proteins to target and kill disease cells, while the ddCAR platform employs a novel D-Domain for targeted cell therapy.