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amcure Announces First Patient Dosed with AMC303 in Phase Ib Extension Cohort Based on Positive Safety Results


Top-line Results of Dose-Escalation Part to be Presented at ESMO 2018

amcure, a biopharmaceutical company developing first-in-class cancer
therapeutics, announced today the dosing of the first patient in the
extension cohort of its ongoing phase I/Ib study evaluating AMC303,
amcure's lead compound. The decision to move into the second part of the
clinical trial protocol was based on positive safety and pharmacokinetic
data obtained in the dose escalation part and a recommendation by the
data safety monitoring board. amcure will present top-line data from the
dose-escalation part of the trial in an oral presentation at the
European Society for Medical Oncology (ESMO) Congress, October 19-23 in

AMC303 targets CD44v6, a key cell membrane molecule in pathways of
several receptor-tyrosine-kinases, such as c-MET, VEGFR-2 and RON, which
are involved in tumor growth and metastases. 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.

The current study, which is being 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. The
study also includes a comprehensive biomarker program. With the
extension cohort, amcure is focusing 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.

"Our Phase I/Ib study with AMC303 is progressing as planned,
demonstrating the safety and linear pharmacokinetic properties in a
heavily pre-treated patient population. As drug combinations become
increasingly the standard in today's oncology practice, having a safe
therapeutic option with a unique and additive mechanism of action would
be an attractive asset. We look forward to continuing the development of
AMC303 towards this goal with more preclinical data on the drug's
potential and on CD44v6's disease biology and first clinical data being
presented at the upcoming ESMO congress," said Klaus Dembowsky, CEO of
amcure GmbH.

For more information on the trial please visit

About AMC303

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.

About amcure

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

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