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.
Immix Biopharma (IMMX) has announced that Dr. Raymond Comenzo, an internationally recognized AL Amyloidosis expert, has joined the Scientific Advisory Board of its subsidiary Nexcella. Dr. Comenzo, Director of the Myeloma and Amyloid Program at Tufts Medical Center, is renowned for his pioneering work in developing consensus guidelines for clinical trials and response criteria in AL Amyloidosis. He was the senior author of the landmark Andromeda trial results, which led to the first FDA-approved therapy for AL amyloidosis.
Dr. Comenzo expressed excitement about joining Nexcella's efforts to advance CAR-T NXC-201 for treating relapsed/refractory AL Amyloidosis, an area with no currently approved drugs. Immix Biopharma's leadership believes Dr. Comenzo's expertise will greatly benefit their research and development efforts in this field.
Immix Biopharma (NASDAQ: IMMX) has expanded its U.S. clinical trial sites for the NEXICART-2 study, evaluating CAR-T NXC-201 in relapsed/refractory AL Amyloidosis patients. New sites include Cleveland Clinic, UC Davis, and Sutter Health, joining lead site Memorial Sloan Kettering Cancer Center. This expansion aims to increase patient access and enrollment opportunities across the U.S.
The study builds on positive data from the ex-U.S. NEXICART-1 trial, which showed a 92% overall response rate in relapsed/refractory AL Amyloidosis patients. NXC-201 is currently the only CAR-T therapy in development for AL Amyloidosis. The expansion supports upcoming interim and final read-outs of NEXICART-2, as Immix Biopharma continues its mission to advance treatment options for this patient population.
Immix Biopharma (Nasdaq: IMMX) has been awarded an $8 million CLIN2 grant from the California Institute for Regenerative Medicine (CIRM) to support the clinical development of NXC-201, a CAR-T cell therapy for relapsed/refractory AL Amyloidosis. The funding will be used for the NEXICART-2 U.S. clinical trial, which aims to evaluate the safety and efficacy of NXC-201 in patients with adequate cardiac function who have not received prior BCMA-targeted therapy.
The decision follows promising results from the ex-U.S. NEXICART-1 study, which showed a 92% overall response rate in relapsed/refractory AL Amyloidosis patients. NXC-201 is currently the only CAR-T therapy in development for AL Amyloidosis, a rare disease with treatment options. The therapy's potential has been recognized in a recent New England Journal of Medicine review article.
Immix Biopharma has dosed the first patient in its U.S. NEXICART-2 trial for AL Amyloidosis at Memorial Sloan Kettering Cancer Center. The trial aims to assess the safety and efficacy of NXC-201, a BCMA-targeted CAR-T cell therapy, in patients with relapsed or refractory AL Amyloidosis. This follows positive results from the ex-U.S. NEXICART-1 trial, which showed a 92% overall response rate. The trial's initiation is in line with Immix Biopharma's mid-2024 guidance. NXC-201 could become a first-in-class treatment for AL Amyloidosis, with no approved drugs currently available for relapsed cases.
Immix Biopharma, a clinical-stage biopharmaceutical company, announced their participation in the Stifel 2024 Cell Therapy Forum on July 9, 2024. The event will be held virtually, where Immix Biopharma will present and host institutional investor meetings. The company specializes in developing cell therapies for autoimmune diseases and aims to engage with institutional investors during this forum to discuss their advancements and business strategies.
Immix Biopharma, Inc. announced positive clinical data for NXC-201 in treating relapsed/refractory AL Amyloidosis patients, showcasing a 92% overall response rate with 75% complete responders. The impressive response rates and durability of the treatment highlight its potential as a new option for patients. The company plans to proceed with the NEXICART-2 clinical trial in mid-2024 based on the positive outcomes of the NEXICART-1 study.
Immix Biopharma, Inc. has been granted European Orphan Drug Designation for NXC-201 in the treatment of multiple myeloma, providing 10 years of market exclusivity, access to centralized authorization procedure, and reduced fees for various applications. The Company aims to address unmet medical needs in frail patients with relapsed/refractory multiple myeloma, with potential benefits in terms of tolerability and clinical impact. The designation signifies recognition of the therapy's potential for this patient population, opening up opportunities for further development.
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