Nexcella Presents NXC-201 Data at 65th American Society of Hematology (ASH) Annual Meeting in 9 Relapsed/Refractory AL Amyloidosis Patients


  • 100% overall response rate observed in relapsed/refractory AL Amyloidosis patients with median 6 lines of prior therapy
  • Updated results will be communicated at the presentation time December 10, 2023

LOS ANGELES, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (Nasdaq:IMMX) (“Nexcella”, “Company”, “We” or “Us”), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced that additional NXC-201 clinical data in relapsed/refractory AL Amyloidosis has been selected for oral presentation at the upcoming 65th American Society of Hematology (ASH) Annual Meeting to be held in San Diego, California, December 9-12, 2023.

“NXC-201 is the only CAR-T being studied as a treatment for AL amyloidosis patients who relapsed, or are refractory to, 4-drug combination daratumumab-CyBorD,” said Ilya Rachman, MD PhD, Executive Chairman of Nexcella. “NXC-201 attacks the root cause of AL Amyloidosis: disease-causing plasma cells, representing a potential one-time treatment option.”

“30,000 – 45,000 patients in the United States and Europe are living with AL Amyloidosis, for many of whom there are no additional approved treatment options beyond Dara-CyBorD,” said Gabriel Morris, President of Nexcella. “We are pleased to present our progress on advancing NXC-201 at the upcoming 65th annual ASH meeting in San Diego.” 

ASH Presentation Details (NXC-201 AL Amyloidosis):

Event65th ASH Annual Meeting and Exposition, San Diego, CA
Title“Feasibility of a Novel Academic Anti-BCMA Chimeric Antigen Receptor T-Cell (CART) (HBI0101) for the Treatment of Relapsed and Refractory AL Amyloidosis”
Presentation
Date/Time (Pacific Time)
  • Publication #538
  • Session Date: Sunday, December 10, 2023
  • Session Name: 654. MGUS, Amyloidosis and Other Non-Myeloma Plasma Cell Dyscrasias: Clinical and Epidemiological: From Light Chain to Fibril–Novel Diagnostics to Treatments for Amyloidosis
  • Session Time: 12:00 PM - 1:30 PM PT
  • Presentation Time: 12:45 PM PT

About NXC-201

NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis and relapsed/refractory multiple myeloma.

About NEXICART-1

NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2a, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI0101), in adults with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis.

The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the recommended Phase 2 dose (RP2D) and Phase 2 dose of NXC-201. The Phase 2 portion of the study will evaluate the efficacy and safety of NXC-201 in relapsed/refractory Multiple Myeloma according to the International Myeloma Working Group (IMWG) Uniform Response Criteria and in relapsed/refractory AL Amyloidosis according to consensus recommendations.

The Phase 1b portion of the ongoing Phase 1b/2a clinical trial has been successful in determining the recommended Phase 2 dose (RP2D) of 800 million CAR+T cells. Nexcella plans to submit an IND application to the FDA for a Phase 1b/2 of NXC-201 in relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis in order to expand the ongoing clinical trial to the U.S. The expected primary endpoint for the Phase 2 portion of the ongoing Phase 1b/2a clinical trial of NXC-201 in relapsed/refractory multiple myeloma is overall response rate and duration of response. Nexcella plans to submit data to the FDA in relapsed/refractory multiple myeloma once 100 patients are treated with NXC-201. The expected primary endpoint for NXC-201 in relapsed/refractory AL Amyloidosis is overall response rate. Nexcella plans to submit data to the FDA in relapsed/refractory AL amyloidosis once 30-40 patients are treated with NXC-201.

About AL Amyloidosis
AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow. Misfolded amyloid proteins produced by these cells cause a buildup of misfolded immunoglobulin proteins in and around tissues, nerves and organs, gradually affecting their function. This can cause progressive and widespread organ damage and high mortality rates.
AL amyloidosis affects roughly 30,000 – 45,000 patients in the U.S. and Europe, and it is estimated that there are approximately 3,000 – 4,000 new cases annually in the U.S. The estimated annual global incidence of AL Amyloidosis is ~15,000 patients. The Amyloidosis market was $3.6 billion in 2017, expected to reach $6 billion in 2025, according to Grand View Research.

About Nexcella, Inc.

Nexcella, Inc. is a Los Angeles, California based clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our lead candidate, next generation BCMA-targeted CAR-T NXC-201 for relapsed/refractory AL amyloidosis and relapsed/refractory multiple myeloma, has produced 100% and 95% response rates in each indication, respectively, as of July 17, 2023 across 72 patients. NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both multiple myeloma and AL Amyloidosis. We believe NXC-201 has potential to be the world’s first outpatient CAR-T. Our N-GENIUS platform allows us to discover, develop, and manufacture cutting-edge cell therapies for patients in need. To learn more about Nexcella, Inc. visit us at www.nexcella.com

Forward Looking Statements

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Contacts:

Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com

Company Contact
irteam@nexcella.com



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