Immix Biopharma

Immix Biopharma announced the first patient dosed in the U.S. NEXICART-2 trial for NXC-201, a CAR-T therapy targeting relapsed/refractory AL Amyloidosis, showing a 92% response rate in ex-U.S. trials. The study aims to evaluate safety and efficacy, with potential to become a first-in-class therapy.

Immix Biopharma initiated the U.S. NEXICART-2 trial for NXC-201, a CAR-T therapy targeting relapsed/refractory AL Amyloidosis, following a 92% response rate in ex-U.S. trials. The study aims to evaluate safety and efficacy, with the first patient dosed at MSKCC, aligning with mid-2024 guidance.

Immix Biopharma announced the first patient dosed in the U.S. NEXICART-2 trial for NXC-201, a CAR-T therapy targeting relapsed/refractory AL Amyloidosis. The trial follows positive ex-U.S. data showing a 92% response rate. NXC-201 aims to be a first-in-class therapy for this condition, with no current approved treatments.

Immix Biopharma's NXC-201 received EU Orphan Drug Designation, offering 10 years market exclusivity, reduced fees, and centralized authorization. Aimed at treating multiple myeloma, it highlights potential for frail patients. NXC-201's 'Single Day CRS' profile may benefit relapsed/refractory patients, expanding into autoimmune diseases.

Nexcella, an Immix Biopharma subsidiary, is on track to dose relapsed/refractory AL Amyloidosis patients with CAR-T NXC-201 in mid-2024 at U.S. sites, including New York City. The NEXICART-2 trial aims to enroll 40 patients over 18 months, focusing on safety and efficacy. NXC-201 has FDA and EMA Orphan Drug Designation.

Immix Biopharma announced Memorial Sloan Kettering Cancer Center as the lead site for its NXC-201 clinical trial targeting relapsed/refractory AL Amyloidosis. NXC-201, a CAR-T cell therapy, is undergoing a Phase 1b trial to assess its safety and efficacy, with potential to revolutionize treatment for AL Amyloidosis and other autoimmune diseases.

Immix Biopharma to host a virtual KOL event on Nov 29, 2023, discussing NXC-201, a BCMA-targeted CAR-T cell therapy for R/R AL amyloidosis and R/R multiple myeloma. NXC-201 showed 100% and 95% overall response rates in respective conditions. It received FDA Orphan Drug Designation and IND clearance for U.S. dosing.

Immix Biopharma's NXC-201, a BCMA CAR-T cell therapy, has received FDA IND clearance, enabling U.S. expansion of NEXICART-2 studies for relapsed/refractory AL Amyloidosis. With 72 patients dosed ex-U.S., showing 100% response in AL Amyloidosis and 95% in multiple myeloma, the therapy also eyes autoimmune indications expansion.

Immix Biopharma completed its 3rd engineering batch of NXC-201, a BCMA-targeted CAR-T cell therapy, at its California facility, marking a milestone for U.S. manufacturing capability. NXC-201, with a 100% response rate in AL Amyloidosis patients, aims to expand CAR-T therapy access, potentially becoming the first outpatient CAR-T.

FDA grants Orphan Drug Designation to Immix Biopharma's NXC-201 for AL Amyloidosis, offering 7 years market exclusivity, tax credits, and fee waivers. NXC-201, a CAR-T cell therapy, shows promise in Phase 1b/2a trials with a 100% hematologic response rate. AL Amyloidosis affects 30,000-40,000 in the U.S. and Europe, with a market projected to grow from $3.6 billion in 2017 to $6 billion by 2025.