Aummune Ltd.

AM003 is a first-in-class functional oligonucleotide in development for the treatment of solid tumors First –in-human, monotherapy dose-escalation Phase 1 trial has been successfully completed The study met its primary endpoint of safety and tolerability Nov. 07, 2024 -- Aummune, a clinical –stage biopharmaceutical company developing a unique class of oligonucleotide drugs to treat solid tumors, announced today the completion of a Phase 1 trial of its proprietary investigational product AM003, a unique individualized immunotherapy designed to directly induce tumor cell death as well as to stimulate an anti-tumor immune response. A first-in-human open-label, dose-escalation study was conducted to evaluate the safety and tolerability of AM003 as a monotherapy, as well as to explore its anti-tumor activity when administered locally to solid tumors.1 A total of 12 patients were enrolled in the study, representing a diverse array of indications, including pancreatic, ovarian, lung, head & neck cancers and sarcomas. Notably, two-thirds of the participants had received at least three lines of prior therapy before being treated with AM003. All three planned dose levels of AM003 were successfully administered to 12 patients. The study met its primary endpoint of safety and tolerability, with no dose-limiting toxicities (DLTs) observed. Most adverse events (AEs) reported were mild to moderate, and clinically manageable. Additionally, no cytokine-related adverse events were recorded. The Data and Safety Monitoring Board (DSMB) cleared all three dose levels and recommended the continuation of the trial. Immune stimulation of circulating T cells and antigen presenting cells (APCs) was demonstrated in the majority of patients. Furthermore, an increase in effector T cells was observed in tumor tissues following treatment. Radiological assessments indicated that 3 out of 11 evaluable patients (27%) achieved best overall response of stable disease (SD). Additionally, a total of 13 lesions injected with AM003 were assessed, with 3 (23%) showing a decrease in size of ≥ 40%. These findings will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting Conference, taking place in Houston, Texas. Abstract#: 610 Title: “Safety and Efficacy of AM003, a First-in-Class Individualized Immunotherapy, in a Basket of Advanced Solid Tumors: Results from a Phase 1 Study” Poster Session Date: November 9, 2024 “Immunotherapy and personalized therapy has transformed cancer treatment. However, there is still a dire need for new innovative therapies. We believe that AM003 — as a new class of individualized immunotherapy — holds a great potential for patients with solid tumors,” said Fredric Price, Chairman of Aummune. Irit Carmi-Levy, PhD, CEO of Aummune, added, “Based on the results of the Phase 1 trial, Aummune plans to initiate a Phase 2 trial to evaluate AM003 safety and efficacy in combination with a checkpoint inhibitor in patients with advanced/metastatic solid tumors.” AM003 is a first-in-class multimodal, tumoricidal oligonucleotide - an individualized approach coupled with immunotherapy to yield a multi-faceted treatment. In preclinical studies, AM003 demonstrated potency and selectivity in numerous human tumor-derived 3D cultures, showed no overt toxicity in non-human primates, and showed safety and efficacy in murine models of solid tumors. Aummune is a biotechnology company dedicated to developing a irst-in-class therapy for solid tumors, coupling tumoricidal oligonucleotides with immune-stimulating mechanisms. The company is using its platform to build a pipeline of novel oligonucleotide-based therapies. Learn more by visiting www.aummune.com or follow us on LinkedIn2. 1 https://clinicaltrials.gov/study/NCT06258330 2 https://www.linkedin.com/company/aummune/mycompany/ The content above comes from the network. if any infringement, please contact us to modify.