Presentation at Society for Immunotherapy of Cancer (SITC) Annual Meeting
- 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
TEL AVIV, Israel, Nov. 07, 2024 (GLOBE NEWSWIRE) -- 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.
Favorable safety profile:
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.
Robust Proof-of-Mechanism:
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.
Initial signs of clinical activity:
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.
Presentation details are as follows:
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.”
About AM003
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.
About Aummune
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.
Contact:
Irit Carmi-Levy, Ph.D.
CEO and Chief Scientific Officer
Irit@Aummune.tech
1 https://clinicaltrials.gov/study/NCT06258330
2 https://www.linkedin.com/company/aummune/mycompany/
