Nexcella Enters US GMP Manufacturing Agreement to Expand Ongoing Phase 1b/2 Clinical Trial 

Nexcella, Inc. recently announced it has entered into a manufacturing agreement with a well-known United States Good Manufacturing Practice (GMP) cell therapy manufacturer that will supply a US Phase 1b/2 clinical trial of NXC-201 in relapsed/refractory multiple myeloma and AL amyloidosis. As Nexcella plans to expand the ongoing Israel trial to the US, it is necessary to demonstrate that clinical trial drug supply has been secured when submitting an Investigational New Drug (IND) application to the US FDA. This US manufacturing site is expected to supply NXC-201 material for the Phase 1b/2 clinical trial in the US following an IND submission to the FDA and approval.

Over the coming months, Nexcella plans to initiate a pre-IND meeting with the FDA, submit an IND application to the FDA, and obtain IND approval for a Phase 1b/2 of NXC-201 in relapsed/refractory multiple myeloma and AL amyloidosis. We believe recently reported Phase 1b clinical data from the ongoing clinical trial in Israel supports expanding the NXC-201 trial to the U.S.

As of the October 23, 2022 data cutoff, updated clinical data from the ongoing Phase 1b portion of the NEXICART-1 (NCT04720313) study of the novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 for the treatment of patients with relapsed or refractory multiple myeloma and light chain amyloidosis (AL) showed:

• Multiple Myeloma – 90% overall response rate (59% complete responses) for NXC-201 at the therapeutic dose in an ongoing 42-Patient Phase 1 expansion trial (Haematologica https://doi.org/10.3324/haematol.2022.281628, 5th European CAR-T cell meeting https://www.nexcella.com/publications/) in relapsed/refractory multiple myeloma. All patients treated with NXC-201 were triple-class refractory (to at least 1 immunomodulatory drug, 1 proteasome inhibitor and 1 anti-CD38 antibody)
• AL Amyloidosis – 100% organ response rate, 100% complete responses (MRD negativity 10^-5), published for NXC-201 in 5 relapsed/refractory patients (Clinical Cancer Research  https://doi.org/10.1158/1078-0432.CCR-22-0637, 5th European CAR-T cell meeting https://www.nexcella.com/publications/)
• The therapeutic dose of NXC-201 (800 million CAR+T cells) has already been established as the recommended Phase 2 dose (RP2D)

Additional information on NXC-201 clinical data as of October 23, 2022 is available here.

“We are excited about our progress toward bringing NXC-201 to US clinical sites. Securing clinical supply is a critical step in advancing NXC-201 toward a potential US regulatory submission. We believe NXC-201 could become a best-in-class therapy for patients suffering from AL amyloidosis and multiple myeloma,” said Gabriel Morris, President of Nexcella.

Ilya Rachman, MD, Executive Chairman of Nexcella, added “NXC-201 has a highly-differentiated, mild tolerability profile. We believe NXC-201 could be the world’s first outpatient CAR-T. We look forward to working with our partners at our new US manufacturing site as we further our plans to bring NXC-201 to US patients who need alternative treatments.”

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, all of which as of October 23, 2022 were triple-class refractory (to at least 1 immunomodulatory drug, 1 proteasome inhibitor and 1 anti-CD38 antibody).

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.

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. The design consists of a structurally differentiated CAR-T, with our proprietary BCMA-targeting CAR, which has demonstrated reduced toxicity in NEXICART-1, supporting investigating NXC-201 as an outpatient therapy.

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 34,470 patients in the US 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.

Nexcella, Inc., a subsidiary of Immix Biopharma, Inc (NASDAQ:IMMX), is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our N-GENIUS platform allows us to discover, develop, and manufacture cutting-edge cell therapies for patients in need. For more information, visit www.nexcella.com.