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Aummune Announces Results from Phase 1 Trial of its Novel AM003 Immunotherapy for the Treatment of Solid Tumors

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/


By: GlobeNewswire - 07 Nov 2024
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