Nexcella Announces Positive 58-Patient NXC- 201 Clinical Data: 100% Overall Response Rate in light chain (AL) Amyloidosis; 92% Overall Response Rate in Multiple Myeloma at the EBMT 49th Annual Meeting in Paris

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The dataset represents 8 new evaluable patients in multiple myeloma and 3 new evaluable patients in light chain (AL) amyloidosis (paper and poster publications www.nexcella.com/publications ).

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Wednesday, April 26, 2023
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EBMT, Haematologica, Hematopoietic stem cell transplantation, Blood, Hospital, Multiple myeloma, AL amyloidosis, Clinical Cancer Research, Hope, Clinical data management system, Hadassah Medical Center, February 9–11, 2017 North American blizzard, Patient, Data, European, CEST, Paper, LOS, Liver, European Society for Medical Oncology, FDA, Safety, IND, BLA, CART, BCMA, Pharmaceutical industry, Semiconductor, Agrochemical, Vaccine, Nursing, Immunotherapy, Amyloidosis
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LOS ANGELES, CA, US, UNITED STATES, AL, PARIS, FRANCE
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NEXCELLA, NEXCELLA, INC., NEXICART-1, NXC-201, MULTIPLE MYELOMA, AL AMYLOYDOSIS
Summary
Key Points: 
  • The dataset represents 8 new evaluable patients in multiple myeloma and 3 new evaluable patients in light chain (AL) amyloidosis (paper and poster publications www.nexcella.com/publications ).
  • The new data are being presented during a poster presentation at the European Society for Blood and Marrow Transplantation 49th Annual Meeting in Paris, France, April 23-26.
  • “In multiple myeloma, these data are compelling as the overall response rate for ABECMA was 72% in its pivotal KarMMa trial with 100 patients in relapsed or refractory multiple myeloma.
  • Nexcella plans to submit data to the FDA in AL amyloidosis once 30-40 patients are treated with NXC-201.



Multiple Myeloma

  • 92% was the overall response rate produced by NXC-201 in relapsed/refractory multiple myeloma patients treated at the therapeutic dose of 800 million CAR+T cells in its ongoing phase 1b/2a NEXICART-1 clinical trial (NCT04720313) who were not exposed to prior BCMA-targeted therapy, producing a median progression free survival (mPFS) of 12.3 months as of the February 9, 2023 data cutoff
  • 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
  • Nexcella plans to submit a BLA for FDA approval in multiple myeloma once 100 patients are treated with NXC-201
  • The expected primary endpoint for NXC-201 in relapsed/refractory multiple myeloma is overall response rate

AL Amyloidosis

  • 100% (8/8) was the overall response rate produced by NXC-201 in 8 light chain (AL) amyloidosis patients in our ongoing phase 1b/2a NEXICART-1 clinical trial (NCT04720313)
  • The Amyloidosis market was $3.6 billion in 2017, expected to reach $6 billion in 2025, according to Grand View Research
  • The expected primary endpoint for a pivotal study of NXC-201 in relapsed/refractory AL Amyloidosis is overall response rate
  • Nexcella plans to submit a BLA for FDA approval in AL amyloidosis once 30-40 patients are treated with NXC-201

Nexcella Announces Positive 58-Patient NXC-201 Clinical Data: 100% Overall Response Rate in light chain (AL) Amyloidosis; 92% Overall Response Rate in Multiple Myeloma at the EBMT 49th Annual Meeting in Paris


Nexcella, Inc. www.nexcella.com

LOS ANGELES, April 26, 2023 (GLOBE NEWSWIRE) -- Nexcella Inc. (“Nexcella”, “Company”, “We” or “Us”), today announced new positive clinical data from its ongoing Phase 1b/2 NEXICART-1 (NCT04720313) study of its novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 for the treatment of patients with relapsed or refractory light chain (AL) amyloidosis and multiple myeloma. The dataset represents 8 new evaluable patients in multiple myeloma and 3 new evaluable patients in light chain (AL) amyloidosis (paper and poster publications www.nexcella.com/publications). The new data are being presented during a poster presentation at the European Society for Blood and Marrow Transplantation 49th Annual Meeting in Paris, France, April 23-26.

"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. “In multiple myeloma, these data are compelling as the overall response rate for ABECMA was 72% in its pivotal KarMMa trial with 100 patients in relapsed or refractory multiple myeloma. In AL Amyloidosis, NXC-201’s very promising response could offer hope to patients who have already been treated with a 4-drug standard-of-care combination incorporating DARZALEX.  In particular, NXC-201 may offer a valuable option for both multiple myeloma and AL amyloidosis patients who have progressed on standards of care.”

As of the February 9, 2023 data cutoff, updated clinical data in 58 patients from the ongoing NEXICART-1 (NCT04720313) study of the novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 for the treatment of relapsed or refractory multiple myeloma and light chain amyloidosis (AL) was presented. At all doses of NXC-201 across 50 patients, median follow-up was 5.7 months (range: 0.6-17.5 months). NXC-201 clinical data showed:

Multiple Myeloma

  • 92% was the overall response rate produced by NXC-201 in relapsed/refractory multiple myeloma patients treated at the therapeutic dose of 800 million CAR+T cells in its ongoing phase 1b/2a NEXICART-1 clinical trial (NCT04720313) who were not exposed to prior BCMA-targeted therapy, producing a median progression free survival (mPFS) of 12.3 months
  • 87% overall response rate (32 of 37 patients at the therapeutic dose of 800 million CAR+T cells) was observed in NEXICART-1 (NCT04720313) trial in relapsed/refractory multiple myeloma (including both patients with and without prior BCMA-targeted therapy) (Haematologica, 5th European CAR-T cell meeting, 49th EBMT meeting https://www.nexcella.com/publications/)
  • 57% complete response rate (21 out of 37 patients at the therapeutic dose of 800 million CAR+T cells) (including both patients with and without prior BCMA-targeted therapy)
  • 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
  • The expected primary endpoint for NXC-201 in relapsed/refractory multiple myeloma is overall response rate and duration of response
  • Additionally, favorable NXC-201 safety data support investigating NXC-201 as the first potential outpatient CAR-T cell therapy, potentially reducing NXC-201 CAR-T-related hospitalization costs by up to 80%
  • Nexcella plans to submit for FDA approval in multiple myeloma once 100 patients are treated with NXC-201

AL Amyloidosis

  • 100% (8/8) overall response rate, 71% organ response rate (cardiac, renal, liver), 63% complete hematologic response rate (minimum residual disease negativity 10-5), for NXC-201 in 8 relapsed/refractory AL Amyloidosis patients in our ongoing phase 1b/2a NEXICART-1 clinical trial (NCT04720313) (Clinical Cancer Research, 5th European CAR-T cell meeting, 49th EBMT meeting https://www.nexcella.com/publications/)
  • The Amyloidosis market was $3.6 billion in 2017, expected to reach $6 billion in 2025, according to Grand View Research
  • The expected primary endpoint for NXC-201 in relapsed/refractory AL Amyloidosis is overall response rate
  • Nexcella plans to submit for FDA approval in AL amyloidosis once 30-40 patients are treated with NXC-201

"We continue on our path toward 100 patients treated with NXC-201 and a planned BLA submission to the FDA for approval of NXC-201,” said Gabriel Morris, President of Nexcella. “The waiting lists at major academic medical centers in the United States for multiple myeloma CAR-Ts reflect the potential demand for NXC-201.”

“95% of US medical centers cannot offer CAR-T today due to their severe side effect profile,” said Ilya Rachman, M.D., Executive Chairman of Nexcella. “Favorable NXC-201 tolerability could result in not only a 3-day hospital stay instead of the CAR-T standard 14-day hospital stay, but also enable NXC-201 to be delivered in the 95% of US medical centers that cannot offer CAR-Ts today, potentially reducing hospitalization costs by up to 80%.”

The 49th EBMT poster can be accessed on the Nexcella corporate website at this link: https://www.nexcella.com/publications/

Poster Presentation:

Title: “Point-of-care CART manufacture and delivery for the treatment of multiple myeloma and AL amyloidosis: the experience of Hadassah Medical Center”

Event: European Society for Blood and Marrow Transplantation 49th Annual Meeting

Dates: April 23-26, 2023

Location: Palais des Congrès de Paris, 2 Pl. de la Prte Maillot, 75017 Paris, France

Times: Sunday, April 23 08:30 – 19:20 CEST / Monday, April 24 09:00 – 18:00 CEST / Tuesday, April 25 09:00 – 18:00 CEST / Wednesday, April 26 08:30 – 14:15 CEST

The Phase 1b portion of the ongoing Phase 1b/2 clinical trial has been successful in determining the recommended Phase 2 dose (RP2D) of 800 million CAR+T cells. Over the coming months, Nexcella plans to submit an IND application to the FDA for a Phase 1b/2 of NXC-201 in relapsed/refractory multiple myeloma and AL amyloidosis in order to expand the ongoing clinical to the U.S. The expected primary endpoint for the Phase 2 portion of the ongoing Phase 1b/2 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 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 NEXICART-1
NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI0101), in adults with relapsed or refractory multiple myeloma and AL amyloidosis.
The primary objective of the Phase 1b portion of the study, is to characterize the safety and confirm the Maximally Tolerated Dose (MTD) 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.

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.

About AL Amyloydosis
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. 

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 multiple myeloma and 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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