AM003 / Aummune - LARVOL DELTA

AM003-FIH-001: Study of AM003 in Patients With Locally Advanced and Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Aummune Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Jan 2025 ➔ Oct 2024

Trial completion • Trial completion date • Oncology • Solid Tumor

Safety and efficacy of AM003, a first-in-class individualized immunotherapy, in a basket of advanced solid tumors: results from a phase1 study (SITC 2024) - P1 | "Ethics Approval The study was approved by all relevant LECs and regulatory authorities. All study participants gave informed consent prior to enrollment."

Clinical • IO biomarker • Metastases • P1 data • Oncology • Solid Tumor

Aummune Announces Results from Phase 1 Trial of its Novel AM003 Immunotherapy for the Treatment of Solid Tumors (GlobeNewswire) - P1 | N=12 | NCT06258330 | Sponsor: Aummune Ltd. | "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....Immune stimulation of circulating T cells and antigen presenting cells (APCs) was demonstrated in the majority of patients....Radiological assessments indicated that 3 out of 11 evaluable patients (27%) achieved best overall response of stable disease (SD)."

P1 data • Oncology • Solid Tumor

AM003-FIH-001: Study of AM003 in Patients With Locally Advanced and Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Aummune Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2024 ➔ Jan 2025

Enrollment closed • Metastases • Trial completion date • Oncology • Solid Tumor

Phase 1 study of AM003, a novel individualized immunotherapy, in a basket of advanced solid tumors. (ASCO 2024) - "The DSMB last reviewed the escalation data in January 2024 and concluded that the trial can continue as planned. Enrollment of 136mg dose expansion is ongoing and completion of the trial will be mid 2024."

Clinical • IO biomarker • Metastases • P1 data • Oncology • Solid Tumor

Aummune’s Poster at ASCO 2024 to Highlight Ongoing Phase 1 Trial for AM003 (GlobeNewswire) - "Aummune...announced today that an abstract of the Company’s Phase 1 trial of its proprietary, investigational product AM003 will be presented on June 1, 2024, at the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO2024) taking place in Chicago, Illinois....The study has completed accrual and topline results are expected in Q3 2024..."

P1 data • Oncology • Solid Tumor

A Novel CpG motif Introduced into a Bispecifc AM003 Compound for the Treatment of Solid Tumors (SITC 2022) - "Aummune has initiated a first-in-human clinical study of AM003 in subjects with solid tumors. TLV medical center ethics committee TLVMC – IL – 2205 – 113 – 5 (Animals study) Helsinki approval number 0297-15-TLV (Buffy coat)"

IO biomarker • Oncology • Solid Tumor • CD4 • CD8 • IFNG • TNFA