Immix Biopharma Inc Stock Price, News & Analysis

Immix Biopharma (NASDAQ: IMMX) has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for NXC-201, their sterically-optimized CAR-T therapy for relapsed/refractory AL Amyloidosis. This designation follows positive proof-of-concept U.S. clinical data from the NEXICART-2 trial.

The RMAT designation, granted to less than half of applications in the past eight years, potentially accelerates the path to market approval through frequent FDA interactions and routes to Accelerated Approval and Priority Review. NXC-201 is currently the only CAR-T therapy in development for AL Amyloidosis, addressing an area with no FDA-approved drugs.

The company reports accelerated enrollment in the NEXICART-2 study following successful completion of the safety run-in segment, with the next update planned for H1 2025.

Immix Biopharma (NASDAQ: IMMX) has successfully completed the six-patient Phase 1b safety run-in segment of its NEXICART-2 study for NXC-201, a CAR-T therapy targeting AL Amyloidosis. The trial, which evaluated three patients at 150 million CAR-T cells and three at 450 million cells, is now advancing to accelerated enrollment across U.S. study sites in January 2025.

The NEXICART-2 study consists of two segments: the completed six-patient safety run-in and a 34-patient dose expansion segment. NXC-201 is currently the only CAR-T therapy in development for AL Amyloidosis, a life-threatening disorder affecting approximately 33,000 patients in the U.S. The company previously announced positive data from the first four patients in December 2024 and expects to provide the next program update in Q1 2025.

Immix Biopharma (IMMX) reported positive initial clinical data from the first four patients in its NEXICART-2 U.S. trial of NXC-201 CAR-T therapy for relapsed/refractory AL Amyloidosis. All four patients normalized their disease markers within 30 days of treatment, with two achieving complete response (CR) and two showing bone marrow MRD negativity. The trial, which began enrollment in June 2024, is the only ongoing CAR-T clinical trial for AL Amyloidosis in the United States.

Patients received either 150 million (three patients) or 450 million (one patient) CAR+T cells. The treatment showed favorable tolerability with no severe adverse events, cytokine-release syndrome, and no neurotoxicity. The company plans to continue enrollment with interim data expected in Q2/Q3 2025 and final topline results in Q2/Q3 2026.

Immix Biopharma (IMMX) announced the publication of positive clinical results for its CAR-T cell therapy NXC-201 in the Journal of Clinical Oncology. The study, conducted outside the U.S., involved 16 patients with relapsed/refractory AL Amyloidosis who had received a median of 4 prior treatments. The therapy demonstrated a 75% complete response rate (12/16 patients) and showed a favorable safety profile in frail patients.

The company is currently conducting a U.S. trial focusing on patients with preserved heart function, excluding those with pre-existing heart failure. The U.S. multi-site trial, which began in mid-2024, is currently dosing at the expansion cohort level. Notably, there are currently no FDA-approved drugs for relapsed/refractory AL Amyloidosis.

Immix Biopharma (IMMX) has presented updated Phase 1/2 clinical data for NXC-201 in treating relapsed/refractory AL Amyloidosis at ASH 2024. The study showed a 75% complete response rate (12/16 patients) with a median of 4 prior therapy lines. The best responder maintained a complete response for 31.5 months ongoing.

Key results from 16 patients include: 94% overall response rate, 62% organ response rate, and favorable safety profile with no ICANS events. Patient characteristics showed 81% had cardiac involvement, 38% had NYHA stage 3/4 heart failure, and 31% had Mayo stage 3 AL amyloidosis. The treatment demonstrated manageable cytokine release syndrome with a median duration of 2 days.

Immix Biopharma (IMMX) has announced a conference call scheduled for Tuesday, December 10, 2024, at 4:30 p.m. Eastern Time. The call will feature company management providing updates on positive new developments regarding CAR-T NXC-201 in relapsed/refractory AL Amyloidosis.

The clinical-stage biopharmaceutical company, which focuses on developing cell therapies for AL Amyloidosis and select immune-mediated diseases, will host the call via Zoom. Following management's formal presentation, attendees will have the opportunity to participate in a question-and-answer session.

Immix Biopharma (IMMX) announced positive clinical data for NXC-201 in treating relapsed/refractory AL Amyloidosis patients, achieving a 75% complete response rate (12/16 patients) with median 4 prior lines of therapy. The data will be presented at the 66th American Society of Hematology (ASH) Annual Meeting in San Diego on December 9, 2024. NXC-201 is highlighted as the only CAR-T therapy in development for this condition, demonstrating promising results in this underserved patient population.

Immix Biopharma (IMMX) has advanced its CAR-T therapy NXC-201 to the expansion cohort dose level in the U.S. NEXICART-2 trial for AL Amyloidosis. The study is now dosing at 450 million NXC-201 CAR+T cells, following successful completion of the first cohort at 150 million cells. Both doses have previously produced complete responses in clinical studies.

NXC-201 is the only one-time CAR-T treatment being studied for relapsed/refractory AL Amyloidosis in U.S. clinical trials. The NEXICART-2 study, led by Memorial Sloan Kettering Cancer Center, aims to evaluate the safety and efficacy of NXC-201 in patients with adequate cardiac function who haven't received prior BCMA-targeted therapy.

Previous data from an ex-US study showed a 92% overall response rate and a 28.0 month duration of response. AL Amyloidosis, affecting approximately 33,000 patients in the U.S., currently has no FDA-approved drugs for relapsed/refractory cases.

Immix Biopharma (IMMX) has announced that Dr. Raymond Comenzo, an internationally recognized AL Amyloidosis expert, has joined the Scientific Advisory Board of its subsidiary Nexcella. Dr. Comenzo, Director of the Myeloma and Amyloid Program at Tufts Medical Center, is renowned for his pioneering work in developing consensus guidelines for clinical trials and response criteria in AL Amyloidosis. He was the senior author of the landmark Andromeda trial results, which led to the first FDA-approved therapy for AL amyloidosis.

Dr. Comenzo expressed excitement about joining Nexcella's efforts to advance CAR-T NXC-201 for treating relapsed/refractory AL Amyloidosis, an area with no currently approved drugs. Immix Biopharma's leadership believes Dr. Comenzo's expertise will greatly benefit their research and development efforts in this field.