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Immix Biopharma Announces Positive NXC-201 Clinical Results at ASGCT: 100% Overall Response Rate in DARZALEX-Relapsed/Refractory AL Amyloidosis with Zero ICANs in Ongoing NEXICART-1 Phase 1b/2a Clinical Trial

2023-05-22

研发

细胞疗法快速通道临床结果孤儿药免疫疗法

8 AL Amyloidosis patients relapsed/refractory to DARZALEX®-based regimens were treated with CAR-T NXC-201

100% (8/8) overall response rate and 63% (5/8) complete response (MRD 10-5) was demonstrated by NXC-201 with zero ICANs, zero grade 4 CRS

62% (5/8) had NYHA classification III or IV heart failure prior to treatment with NXC-201

Best responder duration of response was 16.5 months with response ongoing as of the data cutoff date of May 11, 2023

Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us”), today announced updated AL Amyloidosis clinical data from its ongoing Phase 1b/2a 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 multiple myeloma and light chain (AL) amyloidosis. Additional NXC-201 clinical data was presented on eight DARZALEX ® (daratumumab) relapsed or refractory AL amyloidosis patients. The new data are being presented during a late-breaking oral presentation at the 26th Annual Meeting of The American Society of Gene and Cell Therapy (ASGCT) in Los Angeles on May 19, 2023.

“We continue to be very encouraged by NXC-201,” 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 AL amyloidosis, these data are compelling as recent trials demonstrate an overall response rate of 55% for DARZALEX-relapsed or refractory AL amyloidosis patients receiving investigator’s choice. Importantly, NXC-201 may offer a valuable option for the increasing number of AL amyloidosis patients who have progressed on DARZALEX-based standards of care.”

Immix Biopharma Announces Positive NXC-201 Clinical Results at ASGCT: 100% Overall Response Rate in DARZALEX-Relapsed/Refractory AL Amyloidosis with Zero ICANs in Ongoing NEXICART-1 Phase 1b/2a Clinical Trial

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Immix Biopharma, Inc. (Nasdaq:IMMX)

Data were presented from eight patients in the ongoing Phase 1b/2a NEXICART-1 study of NXC-201 (formerly HBI0101), a novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy for the treatment of relapsed/refractory multiple myeloma and DARZALEX relapsed/refractory light chain (AL) amyloidosis patients. AL amyloidosis patients were infused with CAR+T cells at doses ranging from 150x106 to 800x106. This is the largest cohort of AL amyloidosis patients treated with a BCMA CAR-T therapy to-date. Of the patients treated, 62% (5/8) had NYHA classification III or IV heart failure prior to treatment. The highlights of the data presented include the following:

Overall response rate of 100% (8/8)HBI0101 BCMA

Complete response rate of 63% (5/8) (MRD 10-5)

Organ response rate of 75% (6/8)

Zero grade 4 cytokine release syndrome (CRS) events were reported

The best respcytokine release syndromeesponse of 16.5 months as of the data cutoff of May 11, 2023, with response ongoing

Rapid organ response is believed to be related to fast reduction of free light chain toxicity

Data demonstrates that BCMA CAR-T therapy is well tolerated and potentially efficacious for the treatment of advanced, relapsed/refractory AL amyloidosis

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 or refractory multiple myeloma and 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. 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 ongoinMyelomacal 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 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 multiple myeloma

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 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 Nexcella, Inc.

Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. (Nasdaq:IMMX), 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.

About Immix Biopharma, Inc. Nexcella, Inc.

Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company pioneering a novel class of Tissue-Specific Therapeutics (TSTx) targeting oncology and immuno-dysregulated diseases. Our lead asset is IMX-110, currently in Phase 1b/2a clinical trials as a monotherapy and in its IMMINENT-01 combination clinical trial with BeiGene’s anti-PD-1, tisleilizumab, for which patient dosing begin in Feb 2023. IMX-110 holds orphan drug designation (ODD) by the FDA for soft tissue sarcoma, and has received Rare Pediatric Disease Designation (RPDD) by the FDA the treatment of rhabdomyosarcoma, a life-threatening form of cancer in children. RPDD qualifies ImmixBio to receive fast track review and a priority review voucher (PRV) at the time of marketing approval of IMX-110. Additionally, ImmixBio subsidiary Nexcella, Inc, developing CAR-T NXC-201 for multiple myeloma and AL amyloidosis, with 92% and 100% response rates in each indication, respectively, as of February 9, 2023. Learn more at www.immixbio.com.