AIM ImmunoTech Inc AIM has announced the presentation of positive data from a Phase 1 study of Ampligen in metastatic triple-negative breast cancer.
- The pre-determined primary efficacy endpoint was met (increase in CD8⍺ in TME).
- A uniform increase of immune markers upon treatment was observed: CD8⍺ mRNA (6.1-fold), GZMB mRNA (3.5-fold), ratios of CD8⍺/FOXP3 and GZMB/FOXP3 (5.7-fold) and 7.6-fold respectively), thus successfully meeting the pre-determined primary endpoint in the study (increase in CD8⍺ in TME).
- Also Read: FDA Removes Clinical Hold On AIM ImmunoTech's Mid-Stage Ampligen Trial In Pancreatic Cancer.
- In addition, an increase in CTL attractants CXCL10 (2.6-fold) and CCL5 (3.3-fold) was observed. In contrast, Treg marker FOXP3 or Treg attractants CCL22 or CXCL12 were not enhanced.
- Three patients had stable disease lasting 2.4, 2.5, and 3.8 months as data cut off on September 1, 2021.
- An additional patient (non-evaluable) had a partial response (breast tumor autoamputation) with massive tumor necrosis in the post-CKM biopsy.
- Price Action: AIM shares are up 12% at $1.21 during the premarket session on the last check Monday.
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