Welcome to our dedicated page for Immix Biopharma news (Ticker: IMMX), a resource for investors and traders seeking the latest updates and insights on Immix Biopharma stock.
Immix Biopharma, Inc. (Nasdaq: IMMX) generates a steady flow of news as a clinical-stage biopharmaceutical company advancing cell therapies for relapsed/refractory AL amyloidosis and other serious diseases. The company describes itself as a global leader in this rare blood disorder, and its news coverage reflects progress in clinical development, regulatory interactions, capital formation and corporate governance.
Many Immix Biopharma news items focus on its lead BCMA-targeted CAR-T cell therapy, NXC-201, and the ongoing NEXICART-2 clinical trial in relapsed/refractory AL amyloidosis. Press releases highlight interim and Phase 2 results, including complete response rates, organ responses and safety observations, as well as the selection of NXC-201 data for oral presentations at major conferences such as ASH and ASCO. The company also reports on regulatory designations for NXC-201, including RMAT and Orphan Drug Designation from U.S. and European authorities.
Investors following IMMX news will also see announcements about equity financings, including registered underwritten offerings and private placements of common stock and warrants, together with stated uses of proceeds for NXC-201 development and general corporate purposes. Additional coverage includes board and management changes, such as the appointment of experienced biotechnology leaders to the board of directors and the addition of a Chief Commercial Officer to prepare for potential commercialization of NXC-201.
This news page aggregates company press releases and related updates so readers can track Immix Biopharma’s clinical milestones, financing activities, conference presentations and strategic appointments over time.
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.
Immix Biopharma, Inc. (Nasdaq: IMMX) announced that CEO Ilya Rachman and CFO Gabriel Morris will present a company overview at the ThinkEquity Conference on October 26, 2022, at 2:00 PM ET. The presentation will highlight milestones achieved to kick off two clinical trials for IMX-110, which is currently in Phase 1b/2a trials with orphan drug designation for soft tissue sarcoma and Rare Pediatric Disease Designation for rhabdomyosarcoma. Expectations are for clinical trial data to be released in Q1 2023.
Immix Biopharma (Nasdaq: IMMX) has expanded its clinical trial consortium by adding four additional oncology sites to enhance the testing of its drug IMX-110 for soft tissue sarcoma. The lead site in California has historically enrolled 2-3 patients monthly. As part of the trial, patients will receive CT scans every eight weeks to monitor tumor response, with data release commencing in Q1 2023. The FDA has granted orphan drug designation and rare pediatric disease designation for IMX-110, enabling potential fast track and priority review upon marketing approval.
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