2018

24 May 2018 • Study Advances Novel Treatment for Damaged Optic Nerve

Preclinical Data Suggests Use Beyond Conditions of the Eye

PITTSBURGH – May 24, 2018 – A newly published scientific study has demonstrated that damage to the optic nerve can be significantly reduced, with the potential for improved visual function, when treated with ST266, the lead product of Noveome Biotherapeutics, Inc.

The preclinical study involved animals with a crushed optic nerve, a condition humans can experience through head injury or eye disease.

Currently there are no existing treatments to lessen or reverse damage and vision loss resulting from optic nerve trauma, and no existing methods are able to restore the function of the optic nerve.

The research was conducted in collaboration with Kenneth S. Shindler, M.D., Ph.D., a professor of Ophthalmology in the Perelman School of Medicine at the University of Pennsylvania.

The findings were published this week in Investigative Ophthalmology and Visual Science in an article titled, “RGC Neuroprotection Following Optic Nerve Trauma Mediated by Intranasal Delivery of Amnion Cell Secretome.” http://iovs.arvojournals.org/article.aspx?articleid=2681860

“These results offer hope for this untreatable cause of permanent vision loss,” said Dr. Shindler. “Further testing and development of this novel therapy may provide an opportunity to reduce future vision loss and neurologic disability in a host of diseases that currently have little or no treatment options.”

Wider Implications

ST266 is a rich, complex solution of biologically active molecules secreted from Noveome’s proprietary cells. Instead of a single drug and target, ST266 targets numerous pathways involved in the regenerative repair of inflamed or damaged tissues.

In the study, Dr. Shindler administered ST266 non-invasively through the nasal passages such that the ST266 reached the olfactory nerve in the back of the nose. This method allows ST266 to be delivered directly to the optic nerve and brain, a different route than traditional intranasal delivery that requires absorption of drugs through nasal tissue into the bloodstream.

Dr. Shindler found that ST266 significantly reduced damage to the optic nerve, as measured by a standard vision test called optokinetic response (OKR). Furthermore, showing a trend toward improved visual function and more active nerve cells, ST266 increased survival of the retinal ganglion cells (RGCs) that transmit visual signals from the eye to the brain.

Noveome’s Chief Scientific Officer, Larry R. Brown, Sc.D., sees even greater possibilities for delivery of ST266 based on these results. “These promising results reinforce the multifaceted potential of targeted ST266 in multiple neurodegenerative conditions of the brain including traumatic brain injury, chronic traumatic encephalopathy, or diseases such as Alzheimer’s Disease, Parkinson’s Disease, amyotrophic lateral sclerosis and stroke,” said Dr. Brown.

The model used in this study is particularly useful for testing therapies for glaucoma, where increased eye pressure can damage the optic nerve, and for vision problems that afflict a majority of military service personnel who have been diagnosed with traumatic brain injury. Both glaucoma and traumatic optic nerve injury can lead to severe or even permanent vision loss.

Later this year, Noveome plans to begin a Phase 1 clinical human safety trial for targeted delivery of ST266 deep into the nasal passages, in collaboration with the Israeli medical device maker SipNose and through funding provided by the Commonwealth of Pennsylvania.

Editor’s Note: Shindler has served as a scientific advisory board member and consultant to Noveome and has received funds from Noveome for his consulting services. In addition, Noveome has provided unrestricted funds to Penn to support research in Shindler’s laboratory.

About ST266

ST266 is a novel secretome developed and manufactured by Noveome in its GMP manufacturing facility in Pittsburgh, Pennsylvania. In multiple preclinical studies, ST266 has demonstrated unique attributes of modulating inflammation, restoring nerve function, speeding impaired wound healing, and restoring cellular homeostasis, indicating that it can be applied across a wide range of disease indications to improve patient outcomes. Noveome has already treated 233 subjects with ST266 in eight clinical trials in various indications. It was found to be well-tolerated and there were no drug-related adverse events reported, attesting to its strong safety profile. Previous studies using an optic neuritis model were reported in Scientific Reports volume 7, Article number: 41768 (2017).

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 received seed money from UPMC Enterprises, University of Pittsburgh and Carnegie Mellon University when it was founded in 2000. To date, Noveome has received $114 million in research funding, primarily from the U.S. Department of Defense as well as other state and county government agencies. 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.

###

CONTACT:

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

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

27 April 2018 • Patrick Welch Elected to Noveome Board of Directors

PITTSBURGH — Noveome Biotherapeutics, Inc. has named a veteran executive in pharmaceutical marketing and sales, Patrick Welch, to a new seat on its Board of Directors.

Welch brings to Noveome his expertise gained in more than three decades in the pharmaceutical industry and healthcare management consulting. He spent 27 years at Allergan, Inc., the global pharmaceutical company, serving as a vice-president managing various corporate marketing operations in both the U.S. and Asia. Currently, Welch is president of Loudon, Tennessee-based WeGo Consulting, LLC, which he founded in 2014.

“Pat is an ideal individual to join the Noveome board, as he has an outstanding track record for pre-approval planning, sales and marketing of drugs for complex eye diseases,” said William J. Golden, Noveome’s founder and board chairman. “We are extremely pleased to have him at this critical point in Noveome’s development.”

Noveome recently announced plans to begin clinical trials on its product, ST266, for the treatment of currently untreatable diseases of the brain and eye. ST266 is a complex solution of molecules secreted from novel cells grown using Noveome’s proprietary process. It is being tested for its ability to safely control inflammation, protect and resuscitate nerve cells, and speed healing. To date the company has raised $114 million for research and manufacturing from the U.S. Department of Defense and other state and county government agencies.

“I am honored to join the Noveome Board of Directors and look forward to working with its distinguished members to help guide development, sales and marketing of the company’s promising drug candidate ST266,” said Welch.

Several of Welch’s accomplishments at Allergan relate directly to Noveome’s current focus on optic nerve disease. He was vice-president overseeing Allergan’s US Retina business unit. Previously, he directed Allergan’s entire Glaucoma portfolio, and managed the pre-approval planning for the drug RESTASIS® for treating dry eye (Allergan’s most successful eye drug) and LUMIGAN® for high eye pressure. Beyond ophthalmology, he was involved in Allergan operations concerning medical dermatology, neuroscience, healthcare reimbursement, and government affairs. He was a vice-president and general manager for Allergan Korea, and managing director for Asia.

About Noveome Biotherapeutics, Inc.

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.

Contacts

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

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

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