Nexcella Announces 72-Patient NXC-201 Clinical Data at the IMS 20th Annual Meeting, 95% Overall Response Rate in Multiple Myeloma

• 95% overall response rate observed in relapsed/refractory multiple myeloma patients not previously treated with BCMA-targeted therapy. Median progression free survival (mPFS) was 12.9 months as of the July 17, 2023 data cut-off
• 90% overall response rate observed in relapsed/refractory multiple myeloma at the therapeutic dose including patients with, and without prior BCMA-targeted therapy
• Class-Leading Response Rate in BCMA-exposed patients (frequently excluded from BCMA CAR-T clinical trials) has the potential to meet an important market need
• Nexcella plans to submit a BLA for FDA approval in multiple myeloma once 100 patients are treated with NXC-201
• The expected primary endpoints for NXC-201 in relapsed/refractory multiple myeloma are overall response rate and duration of response

LOS ANGELES, Oct. 02, 2023 (GLOBE NEWSWIRE) -- Nexcella Inc. (“Nexcella”, “Company”, “We” or “Us”) today announced the presentation of updated data from the ongoing Phase 1b/2 NEXICART-1 (NCT04720313) study of its novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201. The updated dataset consists of 63 multiple myeloma patients (including data on 13 new patients and continued follow-up data on 50 previously enrolled patients), at a poster presentation at the 20th International Myeloma Society Annual Meeting in Athens, Greece on September 27-30, 2023 (72 patient count includes 9 AL Amyloidosis patients which will be announced separately).

“We continue to be very encouraged by NXC-201 clinical results,” said Polina Stepensky, M.D., Director of the Hadassah Medical Organization’s Department of Bone Marrow Transplantation and Immunotherapy for Adults and Children, and principal study investigator. “We feel these overall response rate data are compelling as 72% was the overall response rate reported for ABECMA from its pivotal 100-patient KarMMa trial in relapsed/refractory multiple myeloma. Additionally, we believe NXC-201 has demonstrated promise in the rapidly growing segment of BCMA-exposed relapsed/refractory multiple myeloma patients who are frequently excluded from CAR-T clinical trials.”

Updated clinical data in 63 patients from the ongoing NEXICART-1 (NCT04720313) study of NXC-201 for the treatment of relapsed/refractory multiple myeloma are as of the July 17, 2023 data cut-off. Median follow-up was 11.9 months (range: 0.6-19.0 months). NXC-201 clinical data showed:

• 95% overall response rate (36 of 38 patients at the therapeutic dose of 800 million CAR+T cells) in relapsed/refractory multiple myeloma who were not exposed to prior BCMA-targeted therapy, producing a median progression free survival (mPFS) of 12.9 months
• 90% overall response rate (45 of 50 patients at the therapeutic dose of 800 million CAR+T cells) in relapsed/refractory multiple myeloma (including patients with, and without prior BCMA-targeted therapy)
• 58% complete response rate (29 out of 50 patients at the therapeutic dose of 800 million CAR+T cells) (including patients with, and without prior BCMA-targeted therapy)
• Prior NXC-201 dose escalation levels included: 150 x 10⁶ (n=6), 450 x 10⁶ (n=7), and 800 x 10⁶ (n=50) CAR+T cells. The overall response rates for each dose level were: 50%, 86%, and 90%, respectively
• Favorable NXC-201 safety data support the potential for NXC-201, if ultimately approved, to reduce hospitalization, with an opportunity for use as outpatient CAR-T cell therapy, potentially reducing related hospitalization costs by up to 80%

“We continue on our path toward developing NXC-201 as a differentiated CAR-T therapy,” said Gabriel Morris, President of Nexcella. “The waiting lists at major academic medical centers in the United States for multiple myeloma CAR-Ts reflect unmet medical need. We believe that NXC-201 could provide patients, especially those exposed to a prior BCMA-targeted therapy, with an important treatment option and we look forward to next steps in our clinical program, led by our US IND filing, planned for Q4 2023.”

“We are pleased to report on the consistent positive overall response rate and follow-up data from our 63-patient cohort at IMS,” said Ilya Rachman, M.D. Ph.D., Executive Chairman of Nexcella. “Industry data suggest that 95% of US medical centers do not offer CAR-T today due to its severe side effect profile. Favorable tolerability observed to date for NXC-201 suggest that, if approved, it could substantially reduce hospitalization from current practice and be largely used in an outpatient setting. This could meaningfully reduce hospital costs and enable NXC-201 CAR-T therapy to be widely adopted.”

The 20^th IMS multiple myeloma poster can be accessed on the Nexcella corporate website at this link: https://nexcella.com/publications/

Nexcella Announces 72-Patient NXC-201 Clinical Data at the IMS 20th Annual Meeting, 95% Overall Response Rate in Multiple Myeloma

Poster Presentation:

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 with endpoints of overall survival, progression-free survival and response rates according to International Myeloma Working Group (IMWG) Uniform Response Criteria.

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. The expected primary endpoints for the Phase 2 portion of the ongoing Phase 1b/2a clinical trial of NXC-201 in relapsed/refractory multiple myeloma are overall response rate and duration of response. Nexcella plans to submit data to the FDA in 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 AL amyloidosis once 30-40 patients are treated with NXC-201.

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 or refractory multiple myeloma and AL amyloidosis.

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, 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 multiple myeloma and relapsed/refractory AL amyloidosis, has produced 95% and 100% 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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Investor Contact
Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com

Company Contact
irteam@nexcella.com

Attachment

• Nexcella Announces 72-Patient NXC-201 Clinical Data at the IMS 20th Annual Meeting, 95% Overall Response Rate in Multiple Myeloma

Nexcella Announces 72-Patient NXC-201 Clinical Data at the IMS 20th Annual Meeting, 95% Overall Response Rate in Multiple Myeloma

Nexcella Announces 72-Patient NXC-201 Clinical Data at the IMS 20th Annual Meeting, 95% Overall Response Rate in Multiple Myeloma