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 (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.
Immix Biopharma (Nasdaq: IMMX) has successfully completed Good Manufacturing Practice (GMP) manufacturing of IMX-110, a drug candidate for clinical trials. This scaled-up process will support two upcoming clinical trials: one for monotherapy in soft tissue sarcoma and another combining IMX-110 with BeiGene's anti-PD-1 tislelizumab for advanced solid tumors. The FDA has granted orphan drug and rare pediatric disease designations for IMX-110, enabling it to benefit from expedited review processes. The company aims to initiate these trials in 2022.
Immix Biopharma (Nasdaq: IMMX) announced promising interim results for IMX-110 from a Soft Tissue Sarcoma (STS) mice study. After one treatment cycle, IMX-110 demonstrated a 75% survival rate compared to 0% for Trabectedin, an FDA-approved drug. This positions IMX-110 favorably in a potential $3 billion STS market projected to reach $6.5 billion by 2030. CEO Ilya Rachman expressed optimism ahead of two clinical trials for IMX-110 set to begin in 2022.
Immix Biopharma (Nasdaq: IMMX) has authorized a $1 million stock buyback program to enhance shareholder value. The company, with approximately $18 million in cash and equivalents as of December 31, 2021, and 13.9 million shares outstanding, aims to execute purchases based on market conditions and regulatory considerations. CEO Ilya Rachman expressed confidence in reaching critical milestones with their lead asset, IMX-110, while emphasizing alignment with shareholder interests.
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