Herantis Pharma initiates non-invasive CDNF development program, announces licensing agreement with University of Helsinki

ESPOO, Finland I July 6, 2018 I Herantis Pharma Plc ("Herantis") announced today the initiation of a non-invasive CDNF development program to broaden the application of CDNF in Parkinson's disease and potentially other neurodegenerative disorders. In conjunction, Herantis and the University of Helsinki have signed a licensing agreement granting Herantis worldwide, exclusive rights for the therapeutic application of a non-invasive CDNF approach based on a modification of the natural CDNF.

Herantis is currently evaluating natural CDNF in a Phase 1-2 clinical study at three European university hospitals. In the study, CDNF is injected directly into the brain using a delivery system suited for Parkinson's disease patients.  Building on Herantis' drug development expertise, the company will advance also the non-invasive CDNF to translate the new discoveries into clinical programs.

"Non-invasive CDNF is an important expansion to our existing patent estate and strengthens the profile and value of our CDNF program. Our focus as a company is to develop our unique clinical assets for patients in need. Identifying innovative opportunities to improve the technology and expand the application potential is part of our core strategy," said Pekka Simula, Herantis' CEO. "Based on broad and robust preclinical data, we believe CDNF can make a significant difference in the treatment of Parkinson's disease and we look forward to exploring the new possibilities a non-invasive administration could offer to provide the best product for the benefit of patients."

CDNF is a potent neuroprotective factor that promotes neuronal survival. In preclinical proof-of-concept studies CDNF has demonstrated beneficial effects in Parkinson's disease alleviating both motor and non-motor symptoms and stopping disease progression.

"We have previously shown that CDNF protects and recovers neurons from degeneration, neuroinflammation and endoplasmic reticulum stress, critical contributors to many neurodegenerative diseases," explained professor Mart Saarma of the Institute of Biotechnology, HiLIFE, University of Helsinki, a world leading expert in neuronal survival and neurotrophic factor research. "It is exciting to see the progress Pekka and his team have made in translating our findings into an investigational product and bringing it to Parkinson's patients. Our recent discoveries provide an opportunity to target numerous indications beyond Parkinson's with simpler administration and broader distribution while maintaining the full potential of CDNF and I look forward to supporting the company in its development efforts."

Herantis' non-invasive CDNF development program is currently in discovery stage. Target indications for possible future clinical development have not been disclosed.

About CDNF

CDNF is a novel drug candidate for the treatment of neurodegenerative diseases. Naturally present in the human blood circulation and cerebrospinal fluid, CDNF is a protein with neuroprotective and neurorestorative properties, patented internationally by Herantis. Encouraged by strong preclinical proof-of-concept Herantis has launched a first-in-human, randomized Phase 1-2 clinical study with CDNF in the treatment of Parkinson's disease (PD). The clinical study has received funding from the European Union's research and innovation program Horizon 2020 under grant agreement number 732386.

CDNF administration has been safe in preclinical studies and in first clinical treatments. In disease models, CDNF has protected and regenerated dopamine-generating cells in the midbrain suggesting potential for disease modification of PD. It has also shown efficacy in non-motor symptoms of PD. CDNF drug development is based on research at the Institute of Biotechnology, University of Helsinki, led by professor Mart Saarma. An introductory CDNF video is available on Herantis' website at  http://herantis.com/media/videos/

About drug development in general

Drug development projects can usually be divided in two stages: The preclinical stage, and the clinical stage involving human subjects. The clinical stage can be further broken in three formal phases. Phase 1 clinical studies assess the safety of a drug candidate in human subjects. In Phase 2, the optimal dosing and possible efficacy in the treatment of a particular disease is studied. Phase 3 studies finally aim to establish a statistical proof of safety and efficacy of the drug candidate in typically hundreds or thousands of patients for market approval. Drug development can take 10-15 years from the first preclinical studies to market approval.

About Herantis Pharma Plc

Herantis Pharma Plc is an innovative drug development company focused on regenerative medicine and unmet clinical needs. Our clinical stage assets CDNF and Lymfactin® are based on globally leading scientific research in their fields. They both aim at breakthrough in the treatment of severe diseases: CDNF in neurodegenerative diseases such as Parkinson's disease; and Lymfactin® in breast cancer associated lymphedema with potential also in other lymphedemas. The shares of Herantis are listed on the First North Finland marketplace run by Nasdaq Helsinki stock exchange.

SOURCE: Herantis Pharma

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