Immix Biopharma, Inc. develops clinical-stage cell therapies focused on relapsed/refractory AL Amyloidosis, led by NXC-201, a sterically optimized BCMA-targeted CAR-T therapy. Company news commonly covers NXC-201 clinical data from the NEXICART-2 study, FDA designations such as Breakthrough Therapy, RMAT and orphan-drug status, and regulatory-development planning.
Updates also include equity financings, pre-funded warrants, private placements, investor-conference participation, and commercial and medical leadership additions tied to the company’s rare-disease oncology and hematology strategy.
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 16th 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.
Immix Biopharma (Nasdaq: IMMX) announced promising data from ongoing clinical trials for its CAR-T therapy NXC-201. In a Phase 1b study, NXC-201 demonstrated an 85% overall response rate (ORR) and 71% complete response (CR) in relapsed/refractory multiple myeloma patients. Additionally, it achieved a 100% CR and organ response rate in AL Amyloidosis patients. Notably, the therapy showed low toxicity, with a median CRS duration of just 2 days. Immix Biopharma has also established a subsidiary, Nexcella, Inc., to advance the development of NXC-201 and other therapies.
Immix Biopharma has successfully dosed its 15th patient in the ongoing Phase 1b/2a clinical trial of IMX-110, targeting advanced solid tumors. Clinical trial data is expected to be released rolling basis starting Q1 2023, with patient assessments every 8 weeks through CT scans. The trial includes both IMX-110 monotherapy and a combination treatment with Beigene/Novartis's anti-PD-1 tislelizumab. The FDA has granted orphan drug designation and rare pediatric disease designation for IMX-110, boosting its potential for expedited review upon market approval.
Immix Biopharma, Inc. (Nasdaq: IMMX) announced the completion of release testing and the shipment of GMP-manufactured batches of IMX-110 for clinical trial dosing. This innovative drug will be evaluated in two clinical trials, including IMX-110 monotherapy and a combination trial with BeiGene/Novartis anti-PD-1 tislelizumab for advanced solid tumors. The FDA has granted IMX-110 orphan drug and rare pediatric disease designations, facilitating expedited review processes. The company aims to release clinical data from these trials soon.
Immix Biopharma (Nasdaq: IMMX) has received IRB approval for enrolling pediatric patients in its IMX-110 clinical trial, crucial for FDA's Priority Review Voucher (PRV) approval. The PRV enables expedited review for new drug applications. Historically, these vouchers sell for $67 to $350 million. The company is focusing on treating pediatric rhabdomyosarcoma, a severe childhood cancer, and soft tissue sarcoma in adults. IMX-110 is part of ImmixBio's innovative Tissue-Specific Therapeutics platform, enhancing treatment efficacy by targeting tumor sites more effectively.