Nexcella Completes Initial NXC-201 Engineering Batch at its U.S. CAR-T Manufacturing Site

Supports planned expansion of its ongoing NEXICART-1 (NCT04720313) NXC-201 CAR-T clinical trial to the U.S.

LOS ANGELES, July 10, 2023 (GLOBE NEWSWIRE) — Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), today announced the completion of its initial CAR-T NXC-201 engineering batch at its U.S. manufacturing site. This represents an important step forward in the planned U.S. expansion of the Company’s ongoing Phase 1b/2a NEXICART-1 (NCT04720313) study of its novel BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201.  This milestone is completed following the selection of a U.S. GMP manufacturer in February 2023 and commencement of U.S. engineering batches in May 2023.

“The completion of our first U.S. engineering batch is a significant step towards expanding our Phase 1b/2a NEXICART clinical trial to the United States as we work to bring NXC-201 to American patients in need,” said Ilya Rachman, M.D. Ph.D. Executive Chairman of Nexcella. “NXC-201 is the first CAR-T being developed in AL Amyloidosis. We believe that our 100% overall response rate in relapsed/refractory AL amyloidosis patients who have received a median 6 lines of therapies that failed to halt disease progression prior to receiving NXC-201 gives hope to AL amyloidosis patients with limited treatment options. In relapsed/refractory multiple myeloma, our NXC-201 92% overall response rate similarly could provide a viable option for patients with limited treatment options.”

“Today, 95% of U.S. medical centers are unable to offer CAR-T cell therapy. In the 5% of U.S medical centers that do offer CAR-T treatment, patients are hospitalized for a current market-standard 14 days,” said Gabriel Morris, President of Nexcella. “NXC-201 has been trialed in 58 patients, demonstrating a 1-2 day median side-effect duration and a median day 0-1 onset, which offers potential to reduce hospitalization costs up to 80%, and potentially enable dosing in the 95% of U.S. medical centers today unable to offer CAR-T cell therapy.”

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 multiple myeloma and relapsed/refractory AL amyloidosis across 58 patients.

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 plasma cells cause buildup 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 – 40,000 patients in total throughout the U.S. and Europe, and it is estimated that there are approximately 3,000 – 4,000 new cases of AL amyloidosis annually in the U.S. The 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 Multiple Myeloma

Multiple myeloma (“MM”) is an incurable blood cancer of plasma cells that starts in the bone marrow and is characterized by an excessive proliferation of these cells. Despite initial remission, unfortunately, most patients are likely to relapse. There are 35,730 patients in the United States diagnosed with MM each year. Prognosis for patients who do not respond to or relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents remains poor.

The $13.9 billion Multiple Myeloma market in 2017 is expected to reach $28.7 billion in 2027 according to Wilcock, et al. Nature Reviews.

About Nexcella, Inc.

Nexcella, Inc. is a Los Angeles, CA 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 multiple myeloma and relapsed/refractory AL amyloidosis has produced 92% and 100% response rates in each indication, respectively, as of February 9, 2023 across 58 patients. 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.

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