AMC303 / amcure, Hinova Pharma - LARVOL DELTA

Peptide-based inhibition of CD44v6 renders liver carcinomas more susceptible to therapeutic intervention. (PubMed, J Mol Med (Berl)) - "Furthermore, we used AMC303, a peptide inhibitor that specifically binds to CD44v6, to investigate the consequences of CD44v6 inhibition in liver cancer and its impact on combination therapies...Inhibition of CD44v6 increases the efficacy of TKI/chemotherapeutics in cell lines and organoids generated from liver carcinoma. CD44v6 inhibition renders liver carcinomas more susceptible to therapeutic intervention, thereby representing a promising target for cotreatment strategies."

Journal • Hepatology • Liver Cancer • Oncology • Solid Tumor

Characterizing and targeting CD44v6+ cells in liver carcinoma (EASL-ILC 2022) - "With this study, we aim to target CD44v6 in primary human liver cancer cell lines by using an inhibitor, AMC303, and observe the effects of CD44v6 inhibition on proliferation, migration, invasion and EMT... Inhibition of CD44v6 in liver carcinoma cell lines led to a reduction in chemotaxis and migration. In conclusion, CD44v6 appears to be a promising targetable candidate in liver cancer."

Colorectal Cancer • Fibrosis • Gastrointestinal Cancer • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cancer • Liver Cirrhosis • Oncology • Pancreatic Cancer • Solid Tumor • CD44 • LYVE1 • SOX9 • TP53

First-in-Human, First-in-Class study of the CD44v6 inhibitor AMC303 as monotherapy in patients with advanced epithelial tumors (ESMO 2018) - P1; "AMC303 was demonstrated to be well-tolerated with a favorable PK profile. Part 2 is designed to test anti-tumor activity, including patients with high expression of CD44v6 in specific tumor types."

Clinical • Monotherapy • P1 data • Colorectal Cancer

A Safety and Pharmacokinetic Phase I/Ib Study of AMC303 in Patients With Solid Tumours (clinicaltrials.gov) - P1; N=55; Completed; Sponsor: amcure GmbH; Active, not recruiting ➔ Completed; Trial completion date: Feb 2021 ➔ May 2021

Clinical • Monotherapy • Trial completion • Trial completion date • Gastrointestinal Cancer • Oncology • Solid Tumor

A Safety and Pharmacokinetic Phase I/Ib Study of AMC303 in Patients With Solid Tumours (clinicaltrials.gov) - P1; N=55; Active, not recruiting; Sponsor: amcure GmbH; Trial completion date: Sep 2020 ➔ Feb 2021

Clinical • Monotherapy • Trial completion date • Gastrointestinal Cancer • Oncology • Solid Tumor

"#Amcure and #HinovaPharmaceuticals enter into an exclusive license agreement for the development, manufacturing and commercialization of #AMC303 in #Oncology in the Greater China region https://t.co/wfL9JT4EJh" (@1stOncology)

M&A • Oncology

A Safety and Pharmacokinetic Phase I/Ib Study of AMC303 in Patients With Solid Tumours (clinicaltrials.gov) - P1; N=55; Active, not recruiting; Sponsor: amcure GmbH; Recruiting ➔ Active, not recruiting; Trial completion date: Sep 2019 ➔ Sep 2020; Trial primary completion date: Jul 2019 ➔ Jul 2020

Clinical • Enrollment closed • Monotherapy • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Oncology • Solid Tumor

AMC303 inhibits tumor growth and metastasis in animal models by targeting CD44v6, a co-receptor of multiple oncogenic receptor tyrosine kinases (AACR 2019) - "AMC303 inhibits c-MET in vitro in a ligand-dependent fashion and in vivo significantly improved overall survival in an orthotopic pancreatic xenograft mouse tumor model. AMC303 effectively attenuated both primary and metastatic tumor growth by increasing apoptosis, reduction of angiogenesis and vascular normalization. These findings demonstrate the benefit of targeting multiple oncogenic RTK signaling pathways by AMC303."

Preclinical