Immix Biopharma Expands NEXICART-2 Trial with New Sites
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Immix Biopharma Expands Clinical Trial Sites for NEXICART-2
Immix Biopharma, Inc. (Nasdaq: IMMX), a clinical-stage biopharmaceutical company, has announced significant developments regarding its NEXICART-2 clinical trial focusing on relapsed/refractory AL Amyloidosis. This expansion is crucial for improving patient access and enrollment in a study that aims to evaluate the safety and efficacy of CAR-T therapy, specifically CAR-T NXC-201.
New Clinical Trial Sites
The recent addition of clinical trial sites will enhance the opportunities for patient participation across the U.S. Notable locations such as Cleveland Clinic, UC Davis, and Sutter Health have been included in the trial. The lead institution, Memorial Sloan Kettering Cancer Center (MSKCC), continues to spearhead this effort, ensuring a robust foundation for the study.
Positive Data from Previous Studies
Recent findings from the ex-U.S. clinical trial, presented at the American Society of Gene and Cell Therapy (ASGCT) 2024, highlighted an impressive 92% overall response rate for patients undergoing treatment. This data reinforces the potential of CAR-T NXC-201 in this therapeutic area, marking a significant milestone for Immix Biopharma's innovative approach to treating AL amyloidosis.
Overview of the NEXICART-2 Study
The NEXICART-2 study (NCT06097832) is designed as an open-label, single-arm trial aimed at evaluating CAR-T NXC-201’s effectiveness in patients suffering from relapsed/refractory AL Amyloidosis. Targeting patients who possess adequate cardiac function and have not been previously treated with BCMA-targeted therapy, the study will enroll up to 40 participants. This new trial design incorporates a safety run-in phase to ensure patient safety across varying doses of CAR-T cells.
Expected Outcomes of the Clinical Trial
In NEXICART-2, complete response rates and overall response rates are the primary endpoints, which are critical metrics in the assessment of treatment efficacy. The trial seeks to validate earlier findings by further exploring the impact of escalating doses of CAR-T NXC-201 throughout the patient cohort.
Details on NXC-201
NXC-201 is the leading candidate in Immix Biopharma's portfolio, representing a breakthrough in CAR-T therapies specifically targeting AL amyloidosis. The therapy has been specifically engineered for steric optimization to enhance its effectiveness and minimize potential adverse effects. Initial results from the Phase 1b/2 ex-U.S. study have indicated a significant safety profile, lacking any recorded neurotoxicity among treated patients.
Market Significance of AL Amyloidosis
AL amyloidosis presents a considerable challenge in healthcare, characterized by the abnormal accumulation of amyloid proteins that can lead to organ dysfunction and increased mortality. Recent estimates indicate that the prevalence of relapsed/refractory AL amyloidosis is on the rise, projected to affect approximately 33,277 individuals. The market for treatments targeting AL amyloidosis was valued at $3.6 billion and is expected to see sustained growth, potentially reaching $6 billion in the coming years.
About Immix Biopharma, Inc.
Immix Biopharma, Inc. is at the forefront of developing innovative cell therapies for AL amyloidosis and other immune-mediated diseases. The company continues to advance its clinical programs, particularly NXC-201, which has gained Orphan Drug Designation from both the FDA and the EMA, underscoring its potential in addressing unmet medical needs.
Contact Information
For more information about Immix Biopharma and its clinical trials, individuals can reach out to Mike Moyer at LifeSci Advisors via email at mmoyer@lifesciadvisors.com or directly contact the company's investor relations team at irteam@immixbio.com.
Frequently Asked Questions
What is the purpose of the NEXICART-2 trial?
The NEXICART-2 trial aims to evaluate the safety and efficacy of the CAR-T NXC-201 therapy in patients with relapsed/refractory AL amyloidosis.
How many patients will be enrolled in the NEXICART-2 study?
Up to 40 patients with adequate cardiac function who have not been previously treated with BCMA-targeted therapy will be enrolled.
What results were reported from the ASGCT 2024 regarding CAR-T NXC-201?
The ASGCT 2024 presented data indicating a remarkable 92% overall response rate for patients treated with CAR-T NXC-201.
What are the primary endpoints of the trial?
The primary endpoints include the complete response rate and overall response rate, critical for determining the treatment's success.
What is the significance of Orphan Drug Designation for NXC-201?
Orphan Drug Designation enhances the development of NXC-201, providing benefits like market exclusivity and incentives to promote research on conditions with limited treatment options.
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