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) is a clinical-stage biopharmaceutical company leading the way in the development of innovative cell therapies for autoimmune diseases and hematologic malignancies. The company's flagship product, NXC-201, is a next-generation CAR-T cell therapy designed to treat relapsed/refractory AL Amyloidosis and multiple myeloma. NXC-201 stands out due to its potential to be the world’s first 'Single-Day CRS' CAR-T, offering rapid treatment and the prospect of quick patient recovery.
Immix Biopharma leverages its proprietary TME Normalization Technology to develop Tissue-Specific Therapeutics (TSTx) that precisely target cancerous tissues while minimizing systemic side effects. Their leading projects include the NEXICART-1 and NEXICART-2 clinical trials, which are currently testing the efficacy and safety of NXC-201 in patients with relapsed/refractory conditions.
In recent developments, Immix Biopharma has received multiple Orphan Drug Designations (ODD) from both the FDA and the European Medicines Agency (EMA) for NXC-201 in treating AL Amyloidosis and multiple myeloma. This designation provides significant regulatory and financial incentives, highlighting the therapy's potential impact on these challenging diseases.
Immix Biopharma's IMX-110 is another key product in its pipeline, aimed at treating soft tissue sarcoma. Currently under evaluation in Phase 1b/2a trials, IMX-110 has already been granted Orphan Drug and Rare Pediatric Disease Designations by the FDA, underscoring its potential for treating rare cancers.
The company has made significant strides over the past year, including receiving FDA investigational new drug clearance for NXC-201, advancing ongoing clinical trials, and forming strategic partnerships with leading research institutions such as Memorial Sloan Kettering Cancer Center. Their commitment to pioneering cell therapies is further evidenced by their recent awareness campaign, Be Proactive in AL™, aimed at improving the diagnosis and treatment of AL Amyloidosis.
With a robust clinical dataset and strong regulatory support, Immix Biopharma is well-positioned to bring transformative therapies to market, addressing unmet medical needs in autoimmune diseases and cancer. For more information, please visit www.immixbio.com.
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 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.
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