29 July 2021 - - Germany-based immunotherapies developer DiosCURE Therapeutics SE has signed an exclusive licensing agreement with the research and invention parties University of Bonn, University Hospital Bonn, Scripps Research and Macrostruct Holding and Consulting AB, for a suite of intellectual property, including the single-domain antibodies, DIOS-202, DIOS-203 and DIOS-301, currently in preclinical development as a potential differentiated, highly-efficacious therapy against SARS-CoV-2, the company said.

Under the terms of the agreement, DiosCURE is the exclusive, worldwide licensor for the lead drug candidates DIOS-202, DIOS-203 and DIOS-301 and has prioritized access to all future candidates resulting from the research collaboration.

DIOS-202, DIOS-203 and DIOS-301 are multivalent single-chain antibodies with unique molecular modes-of-action to inactivate SARS-CoV-2 virions.

The company's lead candidates, DIOS-202, DIOS-203 and DIOS-301, are synergistic combinations of single-domain antibodies derived from camelid heavy chain-only antibodies.

Based on detailed structural information of the antibodies' interaction with its viral target protein, these multivalent constructs have an up to 100-fold higher neutralizing activity due to their high avidity and by binding two different epitopes of the spike protein.

The unique mechanism of action of DIOS-202, DIOS-203 and DIOS-301, irreversibly inactivates SARS-CoV-2 and therefore suppresses the emergence of escape mutants, which represents an increasing risk in the ongoing SARS-CoV-2 pandemic.

Those new promising antibodies against SARS-CoV-2 were identified and further developed by an international research team led by the University of Bonn.

As the IP Service Provider of the University of Bonn, PROvendis GmbH negotiated the commercialization contract with DiosCURE. The discovery and promising early preclinical data were published in an article in Science on January 12, 2021.

Lead asset DIOS-203 is currently advancing through late-stage preclinical development and the company is ramping up to initiate a Phase I dose escalation trial in healthy volunteers to assess safety and tolerability of DIOS-203 upon completion.

The lead candidates are expected to be highly efficacious, well-tolerated, cost-efficient in production and are amenable to a range of clinical applications.

As immunotherapies, DIOS-202, DIOS-203 and DIOS-301 are suitable as prophylactic as well as treatment for infected patients to avoid severe COVID-19 disease.

DiosCURE is developing next-generation immunotherapies focused on a novel approach against SARS-CoV-2.

The company's proprietary bi- and trivalent variable domains of heavy chain-only antibodies are synergistic combinations of single-domain antibodies, constructed following structural information and optimized for potency as well as their potential to avoid the emergence of escape mutants.

DiosCURE designed lead candidates that target two different epitopes of the SARS-CoV-2 spike protein with the potential to be highly efficacious, well-tolerated and manufactured at a large-scale standardized process.