NIH Awards NeurOp $3.5 Million to Support Phase 1 Clinical Trial of NMDA Inhibitor NP10679
Monday, July 24, 2017 12:00 AM

NP10679 is in development to prevent brain ischemia during stroke or subarachnoid hemorrhage

NeurOp, Inc. today announced that it has received a $3.5 million award from the National Institute of Neurological Disorders and Stroke (NINDS), a division of the NIH, to begin clinical testing of the Company’s drug candidate NP10679, a GluN2B subunit-specific NMDA (N-methyl-D-aspartate) inhibitor. NeurOp is investigating NP10679 for the prevention of ischemic damage during a stroke or subarachnoid hemorrhage (SAH).

“We designed NP10679 with great care to incorporate the attributes we believe differentiate this molecule from other NMDA inhibitors in development,” said Barney Koszalka, PhD, NeurOp CEO. “For example, the binding of the molecule is enhanced in an acidic environment, a property other NMDA inhibitors lack. This property of pH dependence improves the chance of achieving efficacy at dose levels devoid of side effects. We would like to partner with a pharmaceutical company in future trials to fully explore this advantage in an array of disorders such as stroke, treatment-resistant depression and neuropathic pain.”

NP10679 is bioavailable by either the oral or IV route, and it will initially be evaluated in a Phase 1 study in healthy human volunteers by the IV route. The study is expected to start in early 2018. Pre-clinical studies have shown efficacy in treating complications associated with SAH. An IND for NP10679 was opened in 2016.

NeurOp’s Chief Scientific Officer, Robert Zaczek, PhD, added, “The safety profile of NP10679 allows for prophylactic use in patients at risk for an ischemic event, such as those suffering an SAH. This is important because extensive data has shown that early intervention is key for robust efficacy of neuroprotective therapy. Our prophylactic intervention strategy will place NP10679 at its site of action before an SAH-driven delayed cerebral ischemia event takes place. This eliminates the time-of-dosing caveat that might, in part, have led to previous failures of clinical tests involving glutamatergic agents in stroke and head trauma.”

Note: Research reported in this news release is supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health (NIH) under Award Number R44NS071657. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

About NeurOp
NeurOp, Inc. is an Atlanta-based biopharmaceutical company developing new medicines for central nervous system disorders, including depression, neuropathic pain, ischemia (stroke), schizophrenia and Parkinson’s disease. Its research targets specific subunits of neuronal NMDA receptors to identify and evaluate small molecule modulators for potential therapeutic benefit. Multi-year funding from the NIH supports the Company’s research and development programs for NP10679 for the prevention of ischemic damage during a stroke or subarachnoid hemorrhage. For more information, please visit www.neuropinc.com.

 
Skin Vaccination with Microneedle Patch, Influenza Fusion Protein Improves Efficacy of Seasonal Flu Vaccines, Study Finds
Wednesday, July 19, 2017 12:00 AM

ATLANTA—A boosting skin vaccination with a biodegradable microneedle patch and protein constructed from sequences of influenza virus subtypes could improve the effectiveness of conventional influenza vaccines, according to a study led by Georgia State University.

To increase the protection offered by standard influenza vaccines, Dr. Baozhong Wang’s group made a fusion protein (4M2e-tFliC) with four different sequences of M2e from four different influenza subtypes. M2e is a peptide, a compound of two or more amino acids linked in a chain, found among all influenza strains. The fusion protein also contains flagellin (FliC), a peptide found in nearly all bacteria with flagella (lash-like appendages) that acts as a strong catalyst when administered together with other antigens, or foreign substances that induce an immune response in the body.

The researchers condensed the protein into the microneedle patch through a collaboration with Dr. Mark R. Prausnitz of the Georgia Institute of Technology. The microneedle patch is generated from a biocompatible polymer, and the tiny needles arrayed on the patch dissolve and release vaccine into the skin rapidly.

The study found mice receiving a conventional inactivated vaccine, a vaccine consisting of pathogens grown in culture and then killed, followed by a skin-applied dissolving 4M2e-tFliC microneedle patch boost could better maintain the humoral immunity antibody response against influenza virus infection compared to when they received the conventional vaccine alone. The findings, published in the Journal of Controlled Release, offer a new perspective for universal influenza vaccines.

“Our study demonstrates that M2e-based vaccines greatly improve immune responses and strengthen protective functions against influenza virus infection,” said Wang, associate professor in the Institute for Biomedical Sciences at Georgia State. “We found that a skin-applied 4M2e-tFliC microneedle patch boosted immunization to seasonal vaccine recipients and may be a rapid approach to increasing the protective efficacy of seasonal vaccines in response to influenza virus challenges. Thus, the M2e antigen is a promising candidate for the development of universal influenza vaccines.”

Influenza virus is one of the most serious respiratory pathogens affecting humans and causes about five million illnesses and 250,000 to 500,000 deaths each year worldwide. It’s estimated that a sudden emergence of an influenza pandemic could kill about 60 million people globally.

Vaccination is an effective method to prevent influenza virus infection, but circulating viruses can rapidly undergo antigenic changes, or small changes in the genes of influenza viruses that happen over time as the virus replicates, that can reduce or eliminate the efficacy of seasonal flu vaccines. To combat an influenza pandemic caused by antigenic drift, a fast, cost-efficient vaccination method is required to provide broader cross-protection against seasonal and pandemic influenza virus infection and promote long-term immunity.

The biodegradable microneedle patch, which is designed to deliver vaccines into the epidermis and dermis of the skin, is a novel technology for vaccine delivery and could improve the vaccine’s ability to provoke an immune response in the body. The skin is a potent site for vaccination because it has an abundance of blood vessels and lymphatic vessels, as well as many different immune cell types. Also, many cells in skin express TLR5, a receptor for FliC that activates the innate immune system. Combining the skin delivery of the M2e antigen with tFliC as a catalyst creates a strong synergy.

In this study, mice were immunized with inactivated influenza vaccines, and four weeks later they were given one of the following boosting immunizations: intramuscular injection of 4M2e-tFliC fusion protein, microneedle patch skin vaccination of 4M2e-tFliC or a placebo microneedle patch without the antigen.

The researchers tested whether a 4M2e-tFliC boosting immunization could affect the immune responses induced by inactivated influenza vaccines. The mice were challenged with H1N1 and H3N2 influenza viruses and monitored daily for body weight changes and survival over 14 days. The levels of influenza virus titers in the lungs of animals whose bodies had built up antibodies against influenza virus were measured, and samples of blood, lungs, spleens and bone marrow were collected and processed.

Mice that received the microneedle patch boost showed significantly enhanced survival and cellular immune responses. The results also indicated skin vaccination with 4M2e-tFliC aided a long-term antibody-mediated immunity.

Co-authors of the study include Drs. Wandi Zhu, Chao Wang, Yuan Luo, Gilbert X. Gonzalez and Teena Mohan of Georgia State and Drs. Winston Pewin and Mark R. Prausnitz of the Georgia Institute of Technology.

The study is funded for $2.6 million by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health. Wang is the principal investigator.

To read the study, visit http://www.sciencedirect.com/science/article/pii/S0168365917306806.

 
Tech Square Labs scores $1 million from Invest Georgia
Thursday, July 13, 2017 12:00 AM

Atlanta-based Tech Square Labs Fund has received a $1 million investment from Invest Georgia, a state-run venture capital fund.

The $25 million Tech Square Labs Fund has made 12 investments so far, totaling $4 million. Investors in the fund include family offices and high net worth individuals. Invest Georgia is the first institutional money in the fund.

Tech Square Labs was launched by a duo of serial entrepreneurs Paul Judge and Allen Nance. The venture, which operates out of a 15,000-square-foot former Office Depot building at Tech Square, aims to build the next generation of information security, marketing automation, and business-to-consumer (B2C) companies.

The General Assembly created Invest Georgia back in 2013, an initiative of Lt. Gov. Casey Cagle, to boost investment in Georgia-based growth and early-stage companies.

The VC fund was allocated $20 million out of an allowed $100 million to date from the state.

Earlier this year, Invest Georgia plowed $3.25 million into Mosley Ventures. The $31 million Mosley Ventures fund has invested in nearly 20 companies since launching four years ago. The fund invests in seed-and-early stage companies in cybersecurity, digital media, machine learning and mobility.

In 2015, Invest Georgia invested $3 million in TTV Capital IV, a financial services-focused venture capital fund.

 
AdvaMed Urges House Passage of MDUFA Reauthorization Bill
Tuesday, July 11, 2017 12:00 AM

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker regarding the planned vote in the U.S. House on the FDA Reauthorization Act of 2017:

"AdvaMed is pleased the full House will be taking up the FDA Reauthorization Act this week. Passage of this legislation will help patients everywhere as it will bring us one step closer to helping FDA fulfill its crucial mission to ensure the availability of safe and effective medical devices and diagnostics.

"The robust performance goals, process improvements, increased accountability and additional resources built into the new user fee agreement mean that patients will benefit from more timely access to the latest medical innovations and companies will benefit from greater certainty as they plan for the next-generation of advancements.

"We encourage members of the House to vote in favor of this important legislation and urge their Senate colleagues to follow suit as soon as possible."

 
Medical device company raises $12.3 million, plans move to Atlanta
Tuesday, July 11, 2017 12:00 AM

Dune Medical Devices, a metro Philadelphia-based company dedicated to identifying microscopic residual cancer, is moving its U.S. headquarters to Atlanta.

The company also closed a $12.3 million funding round on July 6. Investors included Canepa Healthcare, ATON Partners and the Kraft Group.

Dune's MarginProbe System is used during breast cancer lumpectomy procedures to test whether the surgery has removed all the cancerous cells.

Typically, women must wait at least five to seven days after the procedure to see if physicians "got it all," and currently 20 to 30 percent of those who undergo lumpectomies will need a second surgery.

"That's really the challenge that's out there, and it's a huge cost to the health-care system as well as a pretty big stress to the patient," said Lori Chmura, CEO of Dune Medical Devices. "It's really important to get all the cancer out the first time."

MarginProbe has shown to reduce re-excision rates up to 79 percent. The U.S. Food and Drug Administration approved the device in 2012, and it already has been used on 10,000 patients.

MarginProbe uses a proprietary radiofrequency spectroscopy platform that also has potential to be applied to a variety of other cancers.

"It essentially uses radio frequency fields to reflect what the differences are between cancer and non-cancer," Chmura said. "."[The device] looks like a pen. You put it up to the tissue once the specimen is removed and the system acquires and delivers a signal that says whether it's cancerous or not."

Dune's technology has attracted attention worldwide, and last year it received a grant of three million euros from EU Horizon 2020 to continue developing the technology.

"Our goal is to make this a standard of care in breast conservation surgery," Chmura said. "We're in the process right now of developing technology to be able to detect microscopic residual cancer for other types of cancer as well."

After breast cancer, Dune will focus on prostate cancer. The company's goal is to expand MarginProbe's capabilities to endoscopic, laparoscopic and robotic surgeries for cancers like pancreatic, lung, gastrointestinal and colon cancers.

Originally founded in Israel, Dune is in the process of moving its U.S. headquarters from metro Philadelphia to Alpharetta, where it has leased office space on Windward Parkway. The office will start with five to seven full-time employees and grow with time, Chmura said.

"Atlanta has shown to be very open to working with Israeli startup companies, which is important to us," Chmura said. "We are moving our headquarters to Alpharetta to really capitalize on the health IT market as well as the benefits of [the Southeastern Medical Device Association, located in Norcross, Ga.], the Global Center for Medical Innovation and some of the other great medical device organizations in Atlanta."

 

Source: https://www.bizjournals.com/atlanta/news/2017/07/11/medical-device-company-raises-12-3-million-plans.html?ana=e_du_prem#i1

 
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