3 April 2018 • State Grant to Fund Clinical Trials Through Pittsburgh-Israeli Collaboration

PITTSBURGH — Noveome Biotherapeutics, Inc. has been awarded a significant grant from the Commonwealth of Pennsylvania to begin clinical trials for eye and brain diseases.

The $500,000 grant comes from the Pennsylvania Department of Health. The clinical trials will focus on potential remedies for currently untreatable back of the eye conditions including glaucoma and optic neuritis, and for a type of brain damage known as chronic traumatic encephalopathy, or CTE.

Pittsburgh-based Noveome intends to conduct the trials in collaboration with SipNose, Ltd. of Yokneam, Israel. Noveome has developed a proprietary product, called ST266, for healing damaged or diseased tissue. SipNose has developed a unique device that can deliver ST266 non-invasively through the nose to protect nerves in the affected areas of the eye or brain.

The two companies entered into a formal collaboration agreement last month for using ST266 with the nasal device. They have already completed preclinical studies. A Phase 1 clinical safety trial is scheduled to begin later this year.

Their collaboration comes at the same time that Pennsylvania has been seeking to promote more research and development projects involving local and Israeli companies. The Commonwealth and the State of Israel just signed an Agreement on Cooperation in Research, Development and Technological Innovation in November 2017.

“It is very timely and exciting to have an established Pittsburgh biotech company and an innovative Israeli company collaborating on this critical life sciences project,” said Dennis M. Davin, Secretary of the Pennsylvania Department of Community and Economic Development.

Marc Zucker, Chairman, Pennsylvania Jewish Coalition, commented, “The Pennsylvania Jewish Coalition worked tirelessly last year to consummate a memorandum of understanding between Israel and the Commonwealth of Pennsylvania. This latest development demonstrates how businesses in Israel and Pennsylvania, when given the opportunity, can build bridges of understanding and mutual cooperation, for the benefit of all concerned.” For several years, his organization and others have been working with the Commonwealth and the Israeli Consulate’s office to encourage such joint ventures.

Jeff Finkelstein, President of the Jewish Federation of Pittsburgh echoed, “Pittsburgh and Israel have many connections through technology and medical companies that employ experts across countries. This development attests to the growth potential for partnerships between the thriving tech community in Pittsburgh and the ‘startup nation’ of Israel.”

The Diseases and Potential Treatment

Intranasal ST266 will be used for diseases of the nerve that connects the eye to the brain including glaucoma and multiple sclerosis (MS). Glaucoma damages the optic nerve and is a leading cause of blindness for people over 60 years old. Current treatments slow the nerve damage, but do not prevent it. With MS, the body’s immune system attacks the protective sheath covering the optic nerve resulting in optic neuritis. Optic neuritis is often the first symptom associated with MS. There is no treatment for this MS related eye condition.

Intranasal ST266 will also be tested as a treatment for chronic traumatic encephalopathy (CTE). CTE is a degenerative disease usually caused by repeated head injuries. Most documented cases occur in athletes involved in contact sports and in combat injuries. Symptoms may range from headaches and dizziness, to changes in mood and behavior, and in some cases, dementia and even suicide. Autopsies have revealed a buildup of tau proteins that have damaged the brain tissue.

In all of these indications, Noveome’s ST266 will be tested for its ability to control inflammation, protect and resuscitate nerve cells, and speed impaired healing. ST266 is a complex solution of molecules secreted from novel cells grown using Noveome’s proprietary process. Unlike a single drug used for a single target, ST266 contains such a complex combination of biologically active molecules that it may be useful for treating many different diseases and conditions.

“We are confident that we will be successful in delivering ST266 directly to the back of the eye and brain,” said William J. Golden, Founder, Chairman and CEO at Noveome. “Combining our product with SipNose’s innovative medical device represents a revolutionary approach to non-invasively treat currently untreatable medical conditions.”

Noveome has already treated 233 subjects with ST266 in eight clinical trials in other indications. It was found to be well-tolerated and there were no drug-related adverse events reported, attesting to its strong safety profile.

A Common Connection Leads to Collaboration

Noveome’s collaboration with SipNose was initiated by Dr. Larry Brown, CSO of Noveome, and Dr. Iris Shichor, CEO of SipNose. They met through the Massachusetts Institute of Technology, where both studied under Dr. Robert Langer, a distinguished Institute Professor and a member of Noveome’s Board of Directors.

Dr. Langer commented, “I am always heartened when my prior students join forces by innovating new and exciting approaches to address untreatable conditions such as optic neuropathies and brain diseases.”

About Noveome

Noveome is a clinical stage company focused on breakthrough therapies for the regenerative repair of inflamed or damaged tissues. The company, formerly called Stemnion, Inc., is located in the heart of Pittsburgh’s riverfront Technology Center. The company originally received seed money from UPMC Enterprises, University of Pittsburgh and Carnegie Mellon University when it was founded in 2000. To date, Noveome has received $109 million in research funding from the U.S. Department of Defense. Noveome is passionate about growing its business in Allegheny County and helping the region to become a world leader in biotechnology research and development. www.noveome.com

About SipNose

Founded in Yokneam, Israel in 2011, SipNose is a medical device company that has developed an innovative targeted intranasal delivery device for non-invasively delivering medicines to the brain. SipNose is developing novel applications for unmet need clinical conditions through its collaborations with pharmaceutical companies and academia leaders.

Contacts
Noveome Biotherapeutics, Inc.
Gail Kempler, Ph.D., (412) 402-9914
Director, Investor Relations
gkempler@noveome.com

SipNose, Ltd.
Eric Keller, (703) 624-2024
Director of Business Development
eric@sipnose.com

Media Inquiries:
Rich Creehan
(412) 341-1607
creehanmedia@gmail.com