Three Cancer Drug Trials Advance: AIM Plans Phase 3, Innovent Doses First Patient

AIM ImmunoTech Inc. (NYSE American: AIM) announced an agreement with the PPD clinical research business of Thermo Fisher Scientific to design the company's anticipated Phase 3 clinical trial in the use of Ampligen in the treatment of late-stage pancreatic cancer. The ongoing Phase 2 DURIPANC clinical trial of Ampligen and AstraZeneca's durvalumab in the treatment of late-stage pancreatic cancer is producing promising results.

Based on the success so far, as well as anticipated final patient enrollment later this year, the company's scientific team will work closely with Thermo Fisher's experts in the design of a Phase 3 study. AIM has thus far reported positive progress in Progression-Free Survival (PFS), Overall Survival (OS) and safety in the DURIPANC study, which is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center in the Netherlands.

Ampligen is a dsRNA and highly selective TLR3 agonist immuno-modulator that has shown broad-spectrum activity in clinical trials.

Separately, Innovent Biologics, Inc. announced that the first participant has been successfully dosed in the pivotal phase 3 clinical study (HeriCare-Breast01). The trial is evaluating IBI354 (HER2 Monoclonal Antibody-Camptothecin Derivative Conjugate, HER2 ADC) as a first-line treatment for patients with unresectable locally advanced or metastatic HER2-positive breast cancer.

HeriCare-Breast01 (NCT07377643) is a multicenter, randomized, open-label, active-controlled study designed to evaluate the safety and efficacy of IBI354, with or without pertuzumab, compared with the current standard-of-care, paclitaxel plus trastuzumab and pertuzumab (THP). The primary endpoint is progression-free survival (PFS).

In a multicenter phase 1/2 study in participants with advanced solid tumours, a total of 88 participants with HER2-positive breast cancer were enrolled (the median prior treatment lines was 4) and were treated with 6-15 mg/kg doses of IBI354. As of March 24, 2025, the overall confirmed objective response rate (cORR) was 59.1% and the disease control rate (DCR) was 90.9%. Among them, ORR reached 72.4% and DCR reached 89.7% in 29 breast cancer participants treated with 9mg/kg Q3W.

The median follow-up time of 9mg/kg Q3W dose group was 13.6 months as of the cut-off date, and progression-free survival (PFS) was 14.1 month (95%CI: 8.3, NC). IBI354 also demonstrated an excellent safety profile in this Phase 1/2 clinical study (n=368). No DLT was occurred up to 18mg/kg dose group. The overall incidence of grade 3 or higher treatment-related adverse events (TRAEs) in 9mg/kg Q3W dose group was 21.0%, the incidence of TRAEs leading to dose interruption was 9.9%, the incidence of TRAEs leading to dose reduction was 1.2%, the overall incidence of TRAEs leading to discontinuation was 1.2%, and no TRAE leading to death reported.

The most common TRAEs are white blood cell count decreased, nausea and anemia. The incidence of interstitial lung disease was only 1.2%, all were grade 1. IBI354 has two pivotal phase 3 trials ongoing (HeriCare-Ovarian01, HeriCare-Breast01), which holds potential to deliver a new generation of ADC therapies characterized by "high potency and low-toxicity".

Breast cancer is one of the most common cancers among women worldwide. Approximately 1.3 million women are diagnosed with breast cancer each year, and about 30% of them develop locally advanced or metastatic breast cancer.