AIM ImmunoTech Inc (NYSE:AIM) announced that Roswell Park Comprehensive Cancer Center has reported the complete topline data from its Phase 1 study evaluating Ampligen (rintatolimod) as a component of a Chemokine-Modulating (CKM) regimen for the treatment of early-stage triple-negative breast cancer (TNBC). 

The topline results from the Phase 1 study confirm the positive findings previously presented at the 2022 Society for Immunotherapy of Cancer 37th Annual Meeting in a poster presentation.

Complete topline results confirm that treatment was well tolerated, with promising clinical activity of pathologic complete response (pCR) + microinvasive residual disease (ypTmic) at 66%, comparable to pembrolizumab/neoadjuvant chemotherapy (NAC).

The results demonstrated that treatment was well-tolerated with mostly grade 1 or 2 treatment-related adverse events (TRAEs) without dose-limiting toxicities (DLTs) or delayed or immune-related toxicities. 

DLT was defined as grade 3 or higher toxicities within the first three weeks. Secondary endpoints included pCR rate where 5/9 (56%) of patients attained pCR, and one more attained ypTmic. 

Tumor and blood biomarkers were also analyzed in exploratory studies.

A Phase 2 study in early-stage TNBC is planned to determine if CKM, including Ampligen, may be a safe and effective alternative to pembrolizumab or pembrolizumab/NAC.

Price Action: AIM shares are up 6.26% at $0.62 on the last check Monday.