AMXI-5001 / AtlasMedx - LARVOL DELTA

ATLAS-101: A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies (clinicaltrials.gov) - P1/2 | N=122 | Recruiting | Sponsor: AtlasMedx, Incorporated | Active, not recruiting ➔ Recruiting | Trial completion date: Jan 2025 ➔ Oct 2026 | Trial primary completion date: Jan 2025 ➔ Aug 2026

Enrollment open • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Genito-urinary Cancer • Hepatology • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor

A phase I/II, open label, multi-center, non-randomized dose escalation and dose expansion study of AMXI-5001 in patients with advanced malignancies (ESMO 2024) - P1/2 | "The dose expansion phase's primary endpoint is the preliminary efficacy. The secondary endpoint is to characterize the safety and tolerability further."

Clinical • Metastases • P1/2 data • Oncology • BRCA1 • BRCA2 • HRD

A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies (clinicaltrials.gov) - P1/2 | N=122 | Active, not recruiting | Sponsor: AtlasMedx, Incorporated | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatology • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor

Novel dual action PARP and microtubule polymerization inhibitor AMXI-5001 powerfully inhibits growth of esophageal carcinoma both alone and in combination with radiotherapy. (PubMed, Am J Cancer Res) - "We found that AMXI-5001 was the most potent growth inhibitor of 8 out of 9 different esophageal carcinoma cell lines compared to other clinically available PARP inhibitors, Olaparib, Niraparib, Rucaparib, and Talazoparib...To further assess AMXI-5001's potential as a therapeutic for esophageal carcinoma we evaluated the effect of AMXI-5001 in combination with standard chemotherapy agents, Cisplatin and 5 Fluorouracil...Compared to vehicle control, and those treated with either AMXI-5001 alone or radiation alone, mice treated with both AMXI-5001 and radiation had significant tumor response. In conclusion, AMXI-5001 is an orally bioavailable dual-action PARP and microtubule polymerization inhibitor that holds promise in the treatment of esophageal carcinoma."

Combination therapy • Journal • Esophageal Cancer • Gastrointestinal Cancer • Oncology

A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies (clinicaltrials.gov) - P1/2 | N=122 | Recruiting | Sponsor: AtlasMedx, Incorporated | N=80 ➔ 122 | Trial completion date: Jan 2023 ➔ Jan 2025 | Trial primary completion date: Jan 2023 ➔ Jan 2025

Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatology • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor

AMXI-5001, a novel dual parp1/2 and microtubule polymerization inhibitor for the treatment of human cancers. (PubMed, Am J Cancer Res) - "AMXI-5001 demonstrates comparable IC50 inhibition against PARP and microtubule polymerization as clinical PARP inhibitors (Olaparib, Rucaparib, Niraparib, and Talazoparib) and the potent polymerization inhibitor (Vinblastine), respectively. AMXI-5001 resulted in superior anti-tumor effects compared to either single agent (PARP or microtubule) inhibitor or combination with both agents. AMXI-5001 will enter clinical trial testing soon and represents a promising, novel first in class dual PARP1/2 and microtubule polymerization inhibitor that delivers continuous and synchronous one-two punch cancer therapy with one molecule."

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • PARP1

A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies (clinicaltrials.gov) - P1/2; N=80; Recruiting; Sponsor: AtlasMedx, Incorporated

Clinical • New P1/2 trial • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor