X4 Pharmaceuticals, Inc. (XFOR) stock prices were down by 8.40% as of the market closing on June 18th, 2021, bringing the price per share down to USD$7.42 at the end of the trading day.
Mavorixafor Clinical Trial
June 11th, 2021 saw the company announce positive preliminary efficacy and safety data from the ongoing Phase 1b clinical trial of movorixafor. The lead candidate was being administered in conjunction with ibrutinib to patients with Waldenstrom’s macroglobulinemia exhibiting MYD88 and CXCR4 mutations. The findings were published in a post at the European Hematology Association 2021 Annual Congress.
The promising results of the ongoing trial already exhibit robust decreases in IgM levels, despite still being in the low- to mid-dose ranges of the treatment. This crucial signal of clinical response shows the potential benefit of administering mavorixafor in combination with ibrutinib. The combined therapy has demonstrated adequate tolerability and promising results across various pharmacodynamic parameters, including increases in total hemoglobin and mobilization of white blood cells. Longer-term data and an expanded dataset from the trial are expected for later in the fiscal year 2021.
Scope of Trial
With ibrutinib having substantially addressed the treatment of Waldenstrom’s macroglobulinemia, the company continues to observe a significant unmet clinical need for patients with concurrent CXCR4 and MYD88 mutations. The encouraging preliminary safety and efficacy data from the ongoing combined treatment trials has significantly advanced treatment in this challenging patient population.
Details of the Trial
The Phase 1b clinical trial had 8 patients enrolled as of April 15th, 2021, with a median duration of treatment of 156 days. The data presenting primarily concerns patients from Cohort A, who were administered low- to mid-range doses of mavorixafor and ibrutinib. Four of the patients were treated for more than six 28-day cycles.
Reductions in serum IgM were reported by 100% of the patients that were a part of the trial, with none of them exhibiting a progression of the disease while undergoing treatment. All of the patients who exhibited below normal baseline hemoglobin level reported increases while being administered the treatment, with a median change in hemoglobin of more than 20 g/L. This closes the gap between patient’s and normal levels of hemoglobin, suggesting a reduction in cancer burden in the bone marrow.
Future Outlook for XFOR
Armed with the recent success of its clinical trial, XFOR is poised to continue its trajectory of success as it pushes its flagship treatment through to commercialization. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.
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