On April 15, 2024 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us" or "IMMX"), a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and other autoimmune diseases, reported that updated NXC-201 clinical data has been selected for presentation at the upcoming 27th Annual Meeting of The American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) to be held in Baltimore May 7-11, 2024 (Press release, Immix Biopharma, APR 15, 2024, View Source [SID1234642069]).

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"We are delighted to present continued clinical progress developing what we believe is the only CAR-T in AL Amyloidosis at the upcoming 27th Annual Meeting of The American Society of Gene & Cell Therapy," 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 for the NEXICART-1 Phase 1b/2a clinical trial of NXC-201. "A potential one-time treatment such as CAR-T NXC-201 for relapsed/refractory AL amyloidosis patients would be a welcome option for this devastating disease."

Oral Presentation:

Title: "Academic BCMA-CART cells (HBI0101), a promising approach for the treatment of LC Amyloidosis"

Oral Presentation Date/Time: Friday May 10, 2024 8:45 am – 9:00am Eastern Time
Event: 27th Annual Meeting of The American Society of Gene and Cell Therapy, Baltimore, MD

Session Title: Late-Breaking Abstracts II

Location: Baltimore Convention Center, Baltimore, MD

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 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.

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

About NXC-201

We believe NXC-201 (formerly HBI0101) is the only "Single-Day CRS" CAR-T cell therapy that is uniquely suited to target AL Amyloidosis and other autoimmune diseases. It is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis, and expanding into other autoimmune indications. These trials build on a robust NXC-201 clinical dataset initiated in February 2021. NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma, and awarded EU ODD by the EMA in AL Amyloidosis.

About AL Amyloidosis

AL amyloidosis is a 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.

U.S. observed prevalence of relapsed/refractory AL Amyloidosis is growing 12% per year according to Staron, et al Blood Cancer Journal, estimated to reach 33,277 patients in 2024. The Amyloidosis market was $3.6 billion in 2017, expected to reach $6 billion in 2025, according to Grand View Research.