AIM ImmunoTech Inc. announced the publication of positive data from a Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer. The manuscript titled, “Phase I trial combining chemokine-targeting with loco-regional chemo-immunotherapy for recurrent, platinum-sensitive ovarian cancer shows induction of CXCR3 ligands and markers of type 1 immunity1” was published in the American Association for Cancer Research publication, Clinical Cancer Research. The Phase 1/2 study being conducted by the University of Pittsburgh School of Medicine is designed to evaluate the immunologic and potential clinical effectiveness of intensive locoregional sequential intraperitoneal (IP) cisplatin (IPC) with intravenous (iv) paclitaxel followed by peritoneal infusion of a chemokine modulatory (CKM) regimen composed of a cocktail of IP rintatolimod and interferon-alpha (IFNa) for patients with advanced stage ovarian cancer (III-IV) at primary neoadjuvant setting.

AIM ImmunoTech provided rintatolimod (Ampligen®, a dsRNA acting as TLR3 agonist), for the Phase 1/2 study. Twelve patients were enrolled in Phase 1 portion of the trial and were treated with IP cisplatin, IP Ampligen®, and oral celecoxib (COX-2 blocker). Patients in cohorts 2, 3 and 4 also received IP IFNa at 2, 6 and 18 million units, respectively.

The primary objectives of the study were to evaluate safety, identify Phase 2 recommended dose and characterize changes in the immune TME. Peritoneal resident cells and IP wash fluid were profiled via NanoString and Meso Scale Discovery (MSD) multiplex assay, respectively. Of the 12 patients enrolled in this Phase 1 trial, 9 (75%) were evaluable for safety, toxicity, and other endpoints.

The 3 non-evaluable patients did not complete at least 3 cycles, due to platinum hypersensitivity reactions or port complications. Overall, the regimen was well tolerated, apart from the highest dose of IFNa. Most common toxicities for all grades were anemia (58%), hypomagnesemia (50%), hyponatremia (41.7%), arthralgia (41.7%), and fatigue (41.7%).

There was one grade 4 hypomagnesemia (8.3%). Dose limiting toxicities of abdominal pain of grade 3 or more were noted in two patients who received 18MU IFNa (cohort 4). The Phase 2 recommended dose of IFNa was 6 million units every 3 weeks.

Median PFS was 8.4 (3-16.4) months. Median overall survival was 30 (8-66) months. The Company believes these survival outcome data provide an encouraging early signal.

Overall response rate was 55.6% and the disease control rate (DCR) was 77.8%, consistent with the expected platinum-sensitive response. Among responders, median duration of response was 11.7 (6-16.4) months.