LOS ANGELES - Immix Biopharma, Inc. (NASDAQ:IMMX), a clinical-stage biopharmaceutical company with a market capitalization of approximately $70 million, announced updated Phase 1/2 clinical data for its CAR-T therapy NXC-201, showing a 75% complete response rate in relapsed/refractory AL Amyloidosis patients. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 3.47, indicating robust short-term financial stability. The data, presented at the 66th American Society of Hematology Annual Meeting, indicated a best responder duration of response of 31.5 months, ongoing as of December 9, 2024.
The study involved 16 patients who had relapsed or were refractory to a median of four lines of prior therapy. These patients received varying doses of CAR+T cells, with the majority receiving the highest dose. Safety and efficacy data revealed an overall response rate of 94%, with a complete response rate of 75%. While the clinical results are promising, InvestingPro analysis reveals that the company is currently burning through cash rapidly, though it maintains more cash than debt on its balance sheet. InvestingPro subscribers have access to 8 additional key insights about IMMX's financial health. Additionally, an organ response rate of 62% was observed in evaluable patients. Notably, there were no cases of immune effector cell-associated neurotoxicity syndrome (ICANS), and the median duration of cytokine release syndrome (CRS) was two days.
Ilya Rachman, M.D., Ph.D., CEO of Immix Biopharma, expressed optimism about the high percentage of complete responders and the therapy's tolerability profile, emphasizing the significance for patients with relapsed/refractory AL Amyloidosis, a condition currently without FDA-approved drugs.
The company is looking forward to advancing this therapy to U.S. patients, as stated by CFO Gabriel Morris. The NXC-201 therapy has received Orphan Drug Designation in AL Amyloidosis by the US FDA and the EU EMA.
AL amyloidosis is a rare disease caused by misfolded amyloid proteins produced by abnormal plasma cells, leading to organ damage and high mortality rates. The estimated prevalence of relapsed/refractory AL Amyloidosis in the U.S. is growing, with a market expected to reach $6 billion by 2025. Despite the significant market opportunity, IMMX shares have seen a -63% year-to-date return, though analysts maintain a $7 price target, suggesting potential upside from the current $2.33 trading price.
This report is based on a press release statement from Immix Biopharma, Inc. The company's forward-looking statements highlight the potential benefits of NXC-201 and the anticipated clinical trials. However, these statements are not guarantees of future performance and are subject to risks and uncertainties.
In other recent news, Immix Biopharma has made significant strides in its clinical trials, particularly the NEXICART-2 trial. H.C. Wainwright has maintained a Buy rating for Immix, highlighting the trial's progress and the potential of NXC-201, a CAR-T cell therapy. The NEXICART-2 trial has advanced to a new phase with dosing at 450M NXC-201 CAR+T cells, following the successful completion of the first cohort.
Simultaneously, Immix Biopharma has expanded its U.S. Phase 1b/2 study of CAR-T therapy NXC-201 to include three new clinical trial sites. The expansion is a recent development, building on the promising results from the ex-U.S. study NEXICART-1.
Another key development is the addition of Dr. Raymond (NS:RYMD) Comenzo, a renowned AL Amyloidosis expert, to the Scientific Advisory Board of its subsidiary Nexcella. This is 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. The company is also progressing with its Phase III investigational product, RenovoGem™. These developments underscore Immix Biopharma's ongoing efforts in the biopharmaceutical industry.
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