• Phase 1 trial is de­signed to val­i­date novel binding domain; first step in eval­u­ating Arcellx T cell ther­apy plat­form in the clinic
• Future trials will use Arcellx plat­form to direct T cell ac­­tiv­ity and target mul­ti­ple tumor an­ti­gens
• Therapy granted Fast Track Desig­na­tion for treat­ment of re­lapsed and re­frac­tory mul­ti­ple myeloma

Gaithersburg, MD (Press Release) – Arcellx to­day an­nounced that the first patient has been dosed with its engi­neered T cell ther­apy uti­liz­ing a novel deimmunized syn­thet­ic binding domain in the treat­ment of patients with re­lapsed and re­frac­tory mul­ti­ple myeloma. This first-in-human Phase 1 trial is the first in a series of clin­i­cal trials planned for efficient, stepwise devel­op­ment of the Arcellx ARC-T + sparX cell ther­apy plat­form, with BCMA as an initial target.

“Validating this novel binding domain facilitates sub­se­quent ARC-T + sparX trials in the in­ves­ti­ga­tion of titratable T cell ac­­tiv­ity and redirection to mul­ti­ple tumor an­ti­gens,” said Angela Shen, M.D., M.B.A., Chief Medical Officer at Arcellx.

“We be­lieve our novel binding domain serves as the foundation for a new class of thera­peutics,” stated David Hilbert, Ph.D., Pres­i­dent, Chief Executive Officer and Founder of Arcellx. “The ARC-T + sparX plat­form poten­tially offers mul­ti­ple ad­van­tages over existing cell ther­a­pies that could enable much broader access for patients being treated in academic med­i­cal centers as well as com­munity prac­tices.”

The FDA has granted the Arcellx ddBCMA cell ther­apy Fast Track Desig­na­tion for the treat­ment of re­lapsed and re­frac­tory mul­ti­ple myeloma. Fast Track is a process de­signed to facilitate the devel­op­ment and expedite the review of drugs in­tended to treat serious con­di­tions and that dem­onstrate, through clin­i­cal or pre­clin­i­cal data, the poten­tial to fill an unmet med­i­cal need.

About the Arcellx ddBCMA T Cell Therapy Phase 1 Trial

The open label Phase 1 trial is eval­u­ating an engi­neered T cell ther­apy that uses the com­pany’s novel syn­thet­ic binding domain in the treat­ment of patients with re­lapsed and re­frac­tory mul­ti­ple myeloma. In the trial, a patient’s T cells are engi­neered to express a re­cep­tor targeting the B-cell maturation an­ti­gen (BCMA) on the tumor cell surface using the novel binding domain. The binding domain, which is a deimmunized syn­thet­ic pro­tein, is a key component of the Arcellx ARC-T + sparX cell ther­apy plat­form. The Arcellx ddBCMA cell ther­apy has been granted Fast Track Desig­na­tion by the U.S. Food and Drug Admin­istra­tion (FDA). Additional in­for­ma­tion about the trial can be found at https://www.clinicaltrials.gov/ct2/show/NCT04155749.

About ARC-T + sparX Technology

Arcellx has devel­oped a novel pro­pri­e­tary plat­form in which ARC-T (Antigen Receptor Complex T cells) are con­trolled by the admin­istra­tion of a tumor-targeting pro­tein called a sparX (Soluble Protein Antigen-Receptor X-linker). A library of sparX pro­teins that recog­nizes dif­fer­en­t cell surface an­ti­gens are functional as monovalent, bivalent, or bispecific con­structs, and could poten­tially be admin­istered simultaneously or sequentially to address the in­her­ent heterogeneity of dis­eases such as cancer. The ARC-T cells can be readily silenced, activated and reprogrammed by sparX, allow­ing dose con­trol to minimize toxicities and mul­ti­ple an­ti­gen targeting to im­prove ef­fi­cacy and address relapse. The ARC-T + sparX thera­peutic plat­form is de­signed to poten­tially provide en­hanced ef­fi­cacy, safety, patient accessibility and efficiency of manu­fac­tur­ing rel­a­tive­ to existing cell ther­a­pies.

About Arcellx, Inc.

Arcellx is a clin­i­cal-stage bio­pharma­ceu­tical com­pany devoted to providing patients with superior immune cell ther­a­pies through scientific inno­va­tion and ac­cel­er­ated devel­op­ment of next-gener­a­tion tech­nology. Arcellx initially is devel­op­ing the ARC-T cell ther­a­pies for cancer in­di­ca­tions, and in the future, broader in­di­ca­tions, in­clud­ing auto­immune dis­ease. More in­for­ma­tion can be found at www.arcellx.com.

Source: Arcellx.