Aummune Reports Phase 1 Results for AM003 Immunotherapy in Solid Tumors

Aummune, a clinical-stage biopharmaceutical firm, has announced the successful completion of a Phase 1 clinical trial for its experimental drug AM003. This drug, an innovative immunotherapy, is designed to both directly kill tumor cells and stimulate the body's immune response against tumors.

The trial, which was the first to test AM003 in humans, aimed to assess the safety and tolerability of the drug when used as a standalone therapy. It also sought to explore its effects on tumor activity when delivered directly to solid tumors. The study involved 12 patients with various types of cancer, including pancreatic, ovarian, lung, head and neck cancers, and sarcomas. Significant to note, two-thirds of these patients had previously undergone at least three different treatments before participating in this study.

During the trial, AM003 was administered at three different dose levels to all 12 participants. The trial achieved its primary goal of establishing the drug's safety and tolerability, with no significant toxicities observed. Adverse events reported were mostly mild to moderate and were clinically manageable. Importantly, there were no adverse events related to cytokines. The Data and Safety Monitoring Board (DSMB) reviewed the data and approved all three dose levels, recommending that the trial proceed.

The trial also demonstrated immune system activation, with most patients showing immune stimulation of circulating T cells and antigen-presenting cells (APCs). Additionally, an increase in effector T cells was noted in tumor tissues post-treatment. Radiological evaluations revealed that out of 11 patients who could be evaluated, three achieved a stable disease state. Moreover, among the 13 lesions treated with AM003, three showed a reduction in size by 40% or more.

These results are set to be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in Houston, Texas. The presentation will cover the safety and efficacy of AM003 in treating various advanced solid tumors, based on the findings from this Phase 1 study.

Fredric Price, Chairman of Aummune, expressed optimism about AM003, stating that it represents a significant advancement in personalized cancer therapy. He emphasized the need for innovative therapies and suggested that AM003 has great potential for patients with solid tumors.

Aummune's CEO, Dr. Irit Carmi-Levy, also highlighted the company's future plans. Following the promising results from this Phase 1 trial, Aummune intends to start a Phase 2 trial. This next phase will evaluate the safety and efficacy of AM003 when used in combination with a checkpoint inhibitor in patients with advanced or metastatic solid tumors.

In preclinical studies, AM003 has shown effectiveness and selectivity in various human tumor-derived 3D cultures and demonstrated safety in non-human primates. It has also proven safe and effective in murine models of solid tumors.

Aummune remains focused on developing first-in-class therapies for solid tumors, leveraging tumoricidal oligonucleotides combined with immune-stimulating mechanisms. The company continues to build a pipeline of novel oligonucleotide-based treatments aimed at providing new hope for cancer patients.