LOS ANGELES - Immix Biopharma, Inc. (NASDAQ:IMMX), a clinical-stage biopharmaceutical company with a market capitalization of $56 million, has announced that the Journal of Clinical Oncology published clinical results of its novel CAR-T cell therapy, NXC-201, for the treatment of relapsed/refractory AL Amyloidosis. The company's stock has seen significant volatility, having declined over 70% in the past year according to InvestingPro data. The study, NEXICART-1, involved 16 patients who had previously undergone a median of four lines of therapy. The data showed a 75% complete response rate, with a favorable safety profile noted in this patient population.
The NEXICART-1 trial, conducted outside the United States, is the first clinical trial of NXC-201 for this condition. The therapy has been designed to target B-cell maturation antigen (BCMA) and has shown no neurotoxicity and a short duration of cytokine release syndrome (CRS), suggesting a safe profile for further clinical development.
Building on these ex-U.S. results, Immix Biopharma's ongoing U.S. trial, NEXICART-2, is focused on patients with preserved heart function, excluding those with pre-existing heart failure. The U.S. trial began in mid-2024 and is currently dosing patients at the expansion cohort dose level. InvestingPro analysis shows the company maintains a healthy current ratio of 3.47, indicating strong ability to fund its ongoing clinical programs. Get access to 8 more exclusive ProTips and comprehensive financial metrics with InvestingPro.
The NEXICART-2 trial aims to enroll 40 patients and will evaluate the safety and efficacy of two dose levels of NXC-201 that have previously shown complete responses in the NEXICART-1 study. The primary endpoints are complete response rate and overall response rate.
NXC-201 has received Orphan Drug Designation in AL Amyloidosis by both the US FDA and the EU EMA, indicating its potential as a treatment for this rare disease. AL amyloidosis is characterized by the build-up of misfolded amyloid proteins in organs, leading to organ failure and high mortality rates. The prevalence of relapsed/refractory AL Amyloidosis in the U.S. is estimated to be growing annually, with the market expected to reach $6 billion by 2025.
Immix Biopharma's announcement is based on a press release statement and contains forward-looking statements regarding the potential benefits and clinical trial outcomes of CAR-T NXC-201. The company emphasizes that actual results may differ and that the ongoing clinical trials are crucial for determining the therapy's efficacy and safety. Analysts maintain a positive outlook, with a consensus target price of $7 per share, though InvestingPro's Fair Value analysis suggests the stock is currently overvalued.
In other recent news, Immix Biopharma has reported promising results from its Phase 1/2 clinical trial for CAR-T therapy NXC-201, showing a 75% complete response rate in relapsed/refractory AL Amyloidosis patients. This development comes alongside the company's expansion of its U.S. Phase 1b/2 study of CAR-T therapy NXC-201 to include three new clinical trial sites. H.C. Wainwright has maintained a Buy rating for Immix, highlighting the trials' progress and the potential of NXC-201.
Dr. Raymond (NS:RYMD) Comenzo, a renowned AL Amyloidosis expert, has joined the Scientific Advisory Board of Immix Biopharma's subsidiary Nexcella, expected to bolster the company's development of advanced treatments for AL Amyloidosis. Furthermore, Immix Biopharma has appointed Crowe LLP as its new auditor and received an orphan drug designation from the European Commission for NXC-201.
These recent developments highlight Immix Biopharma's ongoing efforts in the biopharmaceutical industry, with a focus on clinical trials and expanding its presence in the oncology sector. However, it is important to note that these statements are subject to risks and uncertainties, and actual results may differ materially from those projected.
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