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) reported positive initial clinical data from the first four patients in its NEXICART-2 U.S. trial of NXC-201 CAR-T therapy for relapsed/refractory AL Amyloidosis. All four patients normalized their disease markers within 30 days of treatment, with two achieving complete response (CR) and two showing bone marrow MRD negativity. The trial, which began enrollment in June 2024, is the only ongoing CAR-T clinical trial for AL Amyloidosis in the United States.
Patients received either 150 million (three patients) or 450 million (one patient) CAR+T cells. The treatment showed favorable tolerability with no severe adverse events, cytokine-release syndrome, and no neurotoxicity. The company plans to continue enrollment with interim data expected in Q2/Q3 2025 and final topline results in Q2/Q3 2026.
Immix Biopharma (IMMX) announced the publication of positive clinical results for its CAR-T cell therapy NXC-201 in the Journal of Clinical Oncology. The study, conducted outside the U.S., involved 16 patients with relapsed/refractory AL Amyloidosis who had received a median of 4 prior treatments. The therapy demonstrated a 75% complete response rate (12/16 patients) and showed a favorable safety profile in frail patients.
The company is currently conducting a U.S. trial focusing on patients with preserved heart function, excluding those with pre-existing heart failure. The U.S. multi-site trial, which began in mid-2024, is currently dosing at the expansion cohort level. Notably, there are currently no FDA-approved drugs for relapsed/refractory AL Amyloidosis.
Immix Biopharma (IMMX) has presented updated Phase 1/2 clinical data for NXC-201 in treating relapsed/refractory AL Amyloidosis at ASH 2024. The study showed a 75% complete response rate (12/16 patients) with a median of 4 prior therapy lines. The best responder maintained a complete response for 31.5 months ongoing.
Key results from 16 patients include: 94% overall response rate, 62% organ response rate, and favorable safety profile with no ICANS events. Patient characteristics showed 81% had cardiac involvement, 38% had NYHA stage 3/4 heart failure, and 31% had Mayo stage 3 AL amyloidosis. The treatment demonstrated manageable cytokine release syndrome with a median duration of 2 days.
Immix Biopharma (IMMX) has announced a conference call scheduled for Tuesday, December 10, 2024, at 4:30 p.m. Eastern Time. The call will feature company management providing updates on positive new developments regarding CAR-T NXC-201 in relapsed/refractory AL Amyloidosis.
The clinical-stage biopharmaceutical company, which focuses on developing cell therapies for AL Amyloidosis and select immune-mediated diseases, will host the call via Zoom. Following management's formal presentation, attendees will have the opportunity to participate in a question-and-answer session.
Immix Biopharma (IMMX) announced positive clinical data for NXC-201 in treating relapsed/refractory AL Amyloidosis patients, achieving a 75% complete response rate (12/16 patients) with median 4 prior lines of therapy. The data will be presented at the 66th American Society of Hematology (ASH) Annual Meeting in San Diego on December 9, 2024. NXC-201 is highlighted as the only CAR-T therapy in development for this condition, demonstrating promising results in this underserved patient population.
Immix Biopharma (IMMX) has advanced its CAR-T therapy NXC-201 to the expansion cohort dose level in the U.S. NEXICART-2 trial for AL Amyloidosis. The study is now dosing at 450 million NXC-201 CAR+T cells, following successful completion of the first cohort at 150 million cells. Both doses have previously produced complete responses in clinical studies.
NXC-201 is the only one-time CAR-T treatment being studied for relapsed/refractory AL Amyloidosis in U.S. clinical trials. The NEXICART-2 study, led by Memorial Sloan Kettering Cancer Center, aims to evaluate the safety and efficacy of NXC-201 in patients with adequate cardiac function who haven't received prior BCMA-targeted therapy.
Previous data from an ex-US study showed a 92% overall response rate and a 28.0 month duration of response. AL Amyloidosis, affecting approximately 33,000 patients in the U.S., currently has no FDA-approved drugs for relapsed/refractory cases.
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.
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