This was reported by Spanish clinicians at the ESMO congress held in Munich at the end of October. The preparation and financing of the study was also carried out with funds from the BMBF's Spinnovator programme.

Despite major advances in cancer therapy in recent years - especially due to immune oncology - there is still an urgent medical need for new therapeutic concepts in the treatment of metastasizing tumours. A promising approach uses peptides that intervene in central signalling pathways of tumour growth, inhibit the formation of new tumours and block the migration of cancer cells and their invasion into other organs without significantly affecting other cell types or organs. This approach is also being pursued by amcure, which was founded in 2012 by the Karlsruhe Institute of Technology (KIT) with peptide-based drugs.

The preclinical development of the active substance AMC303 was started in 2014 - also with support from the BMBF's spinnovator programme. The molecule binds to the surface molecule CD44v6, which plays an important role in many tumour types - especially in the spread and development of metastases. In some tumours, a high expression of CD44v6 on the tumour cells indicates a poor prognosis. The blocking of this surface molecule with amcure's compound could open up completely new long-term applications in the treatment of metastatic cancers such as pancreatic cancer, head and neck cancer, gastric cancer, colorectal cancer, breast cancer and lung cancer.

Since October 2016, AMC303 has been tested for its tolerability profile in a first clinical trial at three European cancer centres in Belgium and Spain - and is now convincing with initial positive data. The results presented at the European Society of European Oncology (ESMO) Congress in Munich at the end of October show that the substance is well tolerated in 27 patients with a total of 11 different types of cancer. "AMC303 was well tolerated by various cancer patient groups who had already undergone various other treatments. The side effects were temporary and manageable. Thus, AMC303 has the potential to become a safe therapeutic option," said Emiliano Calvo, lead investigator of the study at Hospital Madrid Norte Sanchinarro and director of the START Madrid-CIOCC Early Phase Clinical Drug Development Program. "These encouraging data support the continuation of the study," highlighted Klaus Dembowsky, Managing Director of amcure GmbH.

The study was designed to include a variety of tumour types in the first part and a tumour type-specific extension cohort in the recommended dose for a subsequent Phase 2 study in the second part. In the second part, patients with a moderate to high expression of the target molecule CD44v6 will be treated in four specific tumour types of squamous cell carcinoma. The company expects to present further results from the study in 2019.

The development of the active substance AMC303 and the ongoing clinical study have been supported since 2014 with the help of investors (Series A in May 2014 for EUR 3.7 million, Series B in December 2016 for EUR 6 million) and funds from the BMBF's Spinnovator program totalling EUR 4.2 million. The investors of amcure GmbH, led by LBBW Venture Capital, include KfW, MBG Mittelständische Beteiligungsgesellschaft Baden-Württemberg, S-Kap Unternehmensbeteiligung, KIT and private investors. Including public subsidies, amcure has thus raised a total of EUR 13.9 million to date.