Immix Biopharma, Inc. - IMMX STOCK NEWS

Nexcella, a subsidiary of Immix Biopharma (NASDAQ: IMMX), announced the successful dosing of 50 patients with its CAR-T therapy NXC-201 in an ongoing Phase 1b/2a trial targeting relapsed/refractory multiple myeloma and AL amyloidosis. Enrollment continues robustly at 5 patients monthly, with a goal of 100 total patients for U.S. FDA BLA approval. Nexcella plans to present data from this 50-patient cohort later this year at a scientific forum. The therapy demonstrated a 90% overall response rate in multiple myeloma cases, highlighting its potential as an outpatient treatment with reduced toxicity, enhancing its market competitiveness in effective cancer therapies.

Nexcella, Inc. has entered into a manufacturing agreement with a U.S. GMP cell therapy manufacturer to supply clinical trial material for NXC-201, targeting relapsed or refractory multiple myeloma and AL amyloidosis. This marks a significant step toward expanding the ongoing trial in Israel to the U.S. According to recent Phase 1b data, NXC-201 demonstrated a 90% overall response rate in multiple myeloma cases and a 100% organ response rate in AL amyloidosis patients. Nexcella plans to initiate a pre-IND meeting with the FDA, with hopes of submitting an IND application soon. They believe NXC-201 could be a groundbreaking outpatient CAR-T therapy.

Nexcella, a subsidiary of Immix Biopharma (NASDAQ: IMMX), presented promising interim Phase 1 data for NXC-201 in treating relapsed or refractory multiple myeloma. As of October 23, 2022, from 42 evaluable patients, the therapy achieved a 90% overall response rate (ORR) among 29 patients receiving a therapeutic dose of 800 million CAR+T cells, with 59% attaining complete responses. The therapy demonstrated manageable cytokine release syndrome (CRS) and no neurotoxicity. The recommended Phase 2 dose has been established, supporting NXC-201 as a potential outpatient CAR-T therapy, with plans to submit a BLA by mid-2025.

Immix Biopharma (Nasdaq: IMMX) announced the dosing of the first two patients in its Phase 1b/2a clinical trial of IMX-110 combined with Beigene/Novartis anti-PD-1 Tislelizumab for advanced solid tumors. This innovative combination aims to convert immunologically 'cold' tumors into 'hot' ones, potentially enhancing treatment response. Initial data is expected in the first half of 2023. IMX-110 has received orphan drug designation for soft tissue sarcoma and rare pediatric disease designation for rhabdomyosarcoma, enabling fast track review by the FDA, which may expedite its path to market.

Immix Biopharma (Nasdaq: IMMX) has successfully dosed its 17th patient in the ongoing Phase 1b/2a clinical trial of IMX-110. Positive safety data has allowed for the continued dosing of previously enrolled patients. Clinical data is expected to be released on a rolling basis starting in Q1 2023, with patients undergoing CT scans every 8 weeks to monitor tumor response. IMX-110 has received FDA orphan drug designation for soft tissue sarcoma and rare pediatric disease designation for rhabdomyosarcoma, enabling potential fast-track review and a priority review voucher upon marketing approval.

Nexcella, a subsidiary of Immix Biopharma (Nasdaq: IMMX), reported that its NXC-201 treatment achieved a 100% complete response rate in six relapsed/refractory AL amyloidosis patients. Clinical data published in December 2022 indicated a 100% organ response rate and a significant mean reduction of 65% (2,656 pg/mL) in NT-proBNP from baseline. No grade 4 Cytokine Release Syndrome (CRS) or neurotoxicity was observed, with low-grade CRS lasting a median of 2 days. This positions NXC-201 as a potential first outpatient CAR-T therapy for AL amyloidosis and similar conditions.

Nexcella, Inc., a subsidiary of Immix Biopharma (Nasdaq: IMMX), announced updated clinical data for its CAR-T therapy NXC-201, targeting multiple myeloma and AL amyloidosis. The data will be presented at the 5th Annual European CAR T-cell Meeting in Rotterdam from February 9-11, 2023. Initial trials showed an 85% overall response rate and 71% complete response rate among 20 patients with relapsed/refractory multiple myeloma. NXC-201 also achieved a 100% overall response rate in AL amyloidosis patients, with no observed neurotoxicity, highlighting its potential as an outpatient CAR-T therapy.

Immix Biopharma, Inc. (Nasdaq: IMMX) announced the dosing of the 16^th patient in its ongoing Phase 1b/2a clinical trial for IMX-110, targeting advanced solid tumors. The second patient was dosed in December 2022, with results expected in Q1 2023. IMX-110 has received orphan drug designation for soft tissue sarcoma and rare pediatric disease designation for rhabdomyosarcoma, enabling fast track review by the FDA. The trial aims to evaluate tumor response, with CT scans occurring every 8 weeks after dosing.

Immix Biopharma (Nasdaq: IMMX) has shipped GMP-manufactured Tislelizumab to commence a clinical trial evaluating the combination with IMX-110 in advanced solid tumors. This follows the release of IMX-110 on December 12, 2022. Clinical data is expected to be reported beginning in Q1 2023, with patients undergoing CT scans every 8 weeks. The FDA has granted orphan drug designation for IMX-110 for soft tissue sarcoma and rare pediatric disease designation for rhabdomyosarcoma, potentially facilitating fast-track and priority review processes.