Herantis Pharma Granted A U.S. Patent On Therapeutic Use Of MANF

Published: May 23, 2017

Herantis Pharma granted a U.S. patent on therapeutic use of MANF

Herantis Pharma Plc
Company release 23 May 2017 at 9:00 am

The United States Patent and Trademark Office ("USPTO") has issued to Herantis Pharma Plc ("Herantis") a patent titled "Neurotrophic factor MANF and uses thereof". The patent number 9,592,270 is for the use of MANF, or mesencephalic astrocyte-derived neurotrophic factor, for the treatment of neurological diseases including Parkinson's disease, epilepsy, and ischemic brain injury.

"MANF is the only known neurotrophic and neuroprotective factor similar to our drug candidate CDNF, which is now entering clinical development", explains Henri Huttunen, Chief Scientific Officer of Herantis. "Scientific research has revealed that despite their resemblance both CDNF and MANF have unique features that make them very interesting drug candidates for slightly different target diseases. We are currently developing CDNF for the treatment of Parkinson's disease, and this new patent also strengthens our patent portfolio in that specific field."

Based on published scientific data CDNF and MANF form a novel family of neurotrophic factors ("NTFs") that are clearly distinct from conventional NTFs. In addition to their neurotrophic activity they for instance protect cells generally from endoplasmic reticulum stress, a condition linked to several neurodegenerative and other chronic diseases. The granted MANF patent as well as the CDNF patents previously granted to Herantis are based on scientific research at the Institute of Biotechnology at the University of Helsinki lead by professor Mart Saarma.

Herantis has previously received regulatory approvals in Sweden to start its first-in-human clinical study with CDNF in Parkinson's disease. The clinical study, funded by the European Union, intends to recruit 18 patients with Parkinson's disease and aims at developing a therapy whose efficacy goes clearly beyond the current state-of-the-art treatments. Herantis will inform separately if it launches formal drug development of MANF.

Further information:

Herantis Pharma Plc, Pekka Simula, CEO, telephone: +358 40 7300 445
Company web site: www.herantis.com
Certified Advisor: UB Securities Ltd, telephone: +358 9 25 380 225

About Parkinson's disease

Parkinson's disease (PD) is a slowly progressing neurodegenerative disease caused by the death of dopaminergic neurons in the midbrains. Common first motor symptoms of the disease include tremors, rigidity and slowness of movement. While the motor symptoms can be treated with medication the disease progression cannot be prevented, and the benefits of medication may be lost with disease progression or side effects can become unmanageable. In addition, PD may cause non-motor symptoms such as sleep problems, depression, and anxiety, which are not alleviated by current Parkinson's drugs. Estimated 7 million people worldwide have Parkinson's disease.

About CDNF

CDNF, or Cerebral Dopamine Neurotrophic Factor, is an endoplasmic reticulum located and secreted protein with neuroprotective and neurorestorative properties, patented worldwide by Herantis. Encouraged by strong preclinical proof-of-concept Herantis is launching a first-in-human, randomized Phase 1-2 clinical study with CDNF for the treatment of Parkinson's disease in 1H/2017. The clinical study has received funding from the European Union's research and innovation program Horizon 2020 under grant agreement number 732386.

In preclinical studies including chronic toxicology studies, CDNF administration has been safe; CDNF has protected and regenerated midbrain dopamine-generating cells suggesting a potential for disease modification of PD; it has also shown efficacy in non-motor symptoms in PD. In an ALS disease model CDNF has significantly increased survival and reduced symptoms. This suggests the potential to address unmet clinical needs in both PD and ALS. CDNF drug development is based on research at the Institute of Biotechnology at the University of Helsinki, lead by professor Mart Saarma.

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 for breakthrough in unmet clinical needs. Our first-in-class assets are based on globally leading scientific research in their fields: CDNF for disease modification in neurodegenerative diseases, primarily Parkinson's and ALS; and Lymfactin® for 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.

Distribution:

Nasdaq Helsinki
Main media
www.herantis.com

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