23 October 2018 - - German biopharmaceutical company amcure has presented clinical trial data from its lead oncology drug candidate, AMC303, at the European Society for Medical Oncology Congress in Munich, the company said.

The data presented on Sunday, 21 October in a proffered oral presentation demonstrated the favorable safety profile of AMC303. The company is currently conducting a Phase 1b expansion cohort and expects to publish updates from the study in 2019.

AMC303 is a cyclic peptide targeting CD44v6, a key cell membrane protein in pathways of several receptor-tyrosine kinases, such as c-MET, VEGFR-2 and RON.

This approach provides a potential novel mechanism for the treatment of patients with advanced and solid tumors that have already begun to spread throughout the body.

Trial results presented at ESMO 2018 have shown the compound to be well-tolerated in 27 patients with a total of 11 different cancer types, with a favourable PK profile.

No related serious adverse events were reported, and most frequently reported related events were infusion related reactions and hypersensitivity (grade 1-2, in 22% of patients), followed by nausea, diarrhea and fatigue.

The trial, conducted in Belgium and Spain, is designed to assess the safety, tolerability and pharmacokinetics of multiple and increasing doses of AMC303 as monotherapy in patients with advanced metastatic malignant solid tumors of epithelial origin.

In addition, the study includes a comprehensive biomarker program. The study was designed to include a broad variety of tumor types in the first part of the study irrespective of the target expression and a tumor type-specific expansion cohort at the recommended dose for a subsequent Phase 2 study.

With the expansion cohort, amcure focuses its patient selection on patients with a moderate to high expression of the target molecule CD44v6 in four specific tumor types of squamous tumors: head and neck squamous cell carcinoma (HNSCC), squamous non-small-cell lung carcinoma (NSCLC), esophageal and cervical tumors.

Amcure's lead compound, AMC303, is being developed as a potential treatment for patients with advanced and metastatic epithelial tumors, e.g. pancreatic cancer, head and neck cancer, gastric cancer, colorectal cancer, breast cancer and lung cancer.

AMC303 has a high specificity for inhibiting CD44v6, a co-receptor required for signaling through multiple cellular pathways (c-Met, VEGFR-2, RON) involved in tumor growth, angiogenesis and the development and regression of metastases. AMC303 has demonstrated strong effects in various in vitro and in vivo assays.

Amcure GmbH is a spin-off from the Karlsruhe Institute of Technology established in 2012.

The company develops peptide-based compounds for the treatment of highly metastatic forms of cancer. amcure's most advanced development candidate, AMC303, has entered clinical development and has demonstrated in in vivo animal proof-of-concept studies a high efficacy against different types of epithelial cancers.

amcure is supported by a grant from the German Federal Ministry of Education and Research.