AIM ImmunoTech Inc (NYSE:AIM) has revealed positive data evaluating Ampligen (rintatolimod) as a component of a regimen for the treatment of early-stage triple negative breast cancer.
Led by by Roswell Park Comprehensive Cancer Center medical oncologist Dr Shipra Gandhi, the data will be presented in a poster presentation at the Society for Immunotherapy of Cancer 37th annual meeting being held virtually and in Boston, Massachusetts from November 8 to 12, 2022.
The research was led by Gandhi, a physician scientist who is assistant professor of Oncology at Roswell Park, in collaboration with senior investigator Dr Pawel Kalinski, chair of Immunology and senior vice president for Team Science at Roswell Park, according to AIM ImmunoTech.
Ampligen is the Ocala, Florida-based company’s dsRNA product candidate being developed for cancers, viral diseases and disorders of the immune system.
Triple negative breast cancer accounts for between 10% and 15% of breast cancers, tends to grow faster, has fewer treatment options and worse outcomes, according to the American Cancer Society.
Guided by the preclinical data, Roswell Park proposed this chemokine modulatory regimen (CKM) regimen, which combines AIM ImmunoTech’s Ampligen (rintatolimod), which is a TLR3 agonist, interferon-α2b and celecoxib (a COX-2 inhibitor), as an approach for selectively inducing cytotoxic T-lymphocytes (CTL)-attractants but decreasing Treg-attractants.
According to the company, the Roswell Park researchers hypothesized that the combination of CKM with chemotherapy can promote CTL infiltration and result in higher pathological complete response.
AIM ImmunoTech CEO Thomas K Equels said that building off of the previously developed chemokine modulatory regimen combining interferon-α with TLR3 agonist Ampligen, and the evaluation Roswell Park presented earlier this year at AACR, the company remains encouraged by Ampligen’s demonstrated potential to enhance the effectiveness of taxane-based chemotherapy of breast cancer and potentially other diseases.
“Ampligen has continued to demonstrate its potential to deliver promising clinical activity in an area where there remain significant immune-related permanent toxicities with the current standard of care. We are pleased with these additional data and look forward to continued evaluation of Ampligen’s potential,” Equels said in a statement.
In a Phase 1 study, nine patients with stage one to three triple negative breast cancer (TNBC), with a median age of 47 years, were treated with paclitaxel 80 mg/m2 administered by IV weekly for 12 weeks and CKM for the first three weeks, including Ampligen 200 mg daily and oral celecoxib 200 mg twice daily for the first three days, the company said.
Interferon-α2b was administered in an accelerated dose-escalation at zero or five million units (MU)/m2 – dose levels (DL) 1, 2 respectively – in the first two patients; 10 MU/m2 (DL 3) in four patients and 20 MU/ m2 (DL 4) in three patients.
CKM/paclitaxel was followed by standard dose-dense doxorubicin and cyclophosphamide (AC) and surgery. Dose-limiting toxicity (DLT) was defined as grade 3 or higher toxicities within the first three weeks. The primary endpoint was safety and tolerability. Secondary endpoints included polymerase chain reaction (pCR) rate. Tumor and blood biomarkers were analyzed in exploratory studies, according to AIM ImmunoTech.
The results of the study demonstrated that treatment was well-tolerated with mostly grade one or two treatment-related adverse events (TRAEs) without dose-limiting toxicity or delayed or immune-related toxicities.
Grade 3 TRAEs included neutropenia (three of nine) attributed to CKM (one out of nine) or paclitaxel (three of nine), pneumonia (one of nine) and anemia (one of nine) attributed to AC.
Additional pneumonia and skin squamous cell carcinoma in situ were observed, unrelated to study treatment. Paclitaxel- or AC-related toxicities were not higher than expected. Five of nine (56%) of patients attained pCR and one more patient attained ypTmic. CTL marker CD8α was selectively elevated in post-CKM tumor biopsies (five patients at DL3 and four) but decreased in the post-CKM blood, according to AIM ImmunoTech.
Roswell Park Comprehensive Cancer Center was founded by Dr Roswell Park in 1898, and is the only National Cancer Institute-designated comprehensive cancer centre in upstate New York.
According to AIM Immunotech, Ampligen is also being used to treat pancreatic cancer patients in an early access program approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center. Additionally, Ampligen is also approved in Argentina for the treatment of severe chronic fatigue syndrome and is currently being evaluated in COVID-19, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-COVID conditions.
Contact the author at susie@proactiveinvestors.com