New Cytokine Network Can Repair Tissue Damage In The Intestine, Study Finds
Monday, May 21, 2018 09:45 AM

A new group of proteins called cytokines, critical for antimicrobial activity and repairing the damaged intestinal tissue found in inflammatory bowel disease (IBD), has been discovered by researchers in a study led by Georgia State University.

The research team examined acute intestinal disease in the colons of mice and found a specific network of proinflammatory cytokines was activated in response to intestinal barrier damage and instrumental in repairing the damaged tissue. Cytokines are small proteins that are produced in response to microbial threat and aid in the recruitment and activation of immune cells to protect the host. The findings, which have potential implications for the treatment of intestinal inflammatory conditions, are published in the journal Proceedings of the National Academy of Sciences.

In the intestine, cells form a physical barrier that separates the body cavity from the outside environment and protects the host from microorganisms. However, damage to this barrier can activate immune cells, which promote repair and resolve inflammation. If the damage persists or repair processes are ineffective, chronic intestinal inflammation occurs, as found in human IBD, resulting in abdominal pain, persistent diarrhea, rectal bleeding and other symptoms.

“In this manuscript, we identified a novel cytokine network involving IL-36γ, IL-23 and IL-22 as being involved in the repair of intestinal damage and inflammation,” said Dr. Timothy Denning, lead author of the study and professor and associate director of the Institute for Biomedical Sciences at Georgia State. “I think what is very intriguing about this finding is that inflammation is often viewed in the context of being bad, but it is in fact a physiologic response to damage, injury and infection.

“The real key to inflammation is how to control it. In our study, we found this specific cytokine network was critical for tissue repair, but some of these same factors are being targeted in clinical trials for IBD. This entire cytokine axis is likely beneficial for host protection, but if it goes uncontrolled for too long, which is often seen in chronic diseases like IBD, they could then be pathogenic. So the key is understanding when and how to regulate these cytokines networks for the benefit of human health.”

Another key finding was that IL-36γ induces IL-23, linking them in the repair of acute intestinal barrier damage. In the study, mice that did not have the gene for IL-36γ or IL-36 receptor could not recover from acute intestinal damage, but treating mice with IL-23 helped the mice to resolve the damage. The study also revealed that IL-23 serves as a key intermediary between IL-36γ and IL-22. This shows that IL-23 can be beneficial and part of a network that is instrumental in tissue protection and intestinal barrier repair. Importantly, clinical trials that target and block IL-23 to treat Crohn’s disease and ulcerative colitis, two major types of IBD, are getting promising outcomes, highlighting the importance of context-dependent effects of these factors.

Therefore, one has to be cautioned against classifying this cytokine pathway as exclusively beneficial or deleterious. Instead, critical details such as where these cytokines are produced, and the level and duration of expression, are central to understanding their function, Denning said.

“What we are showing is that for early stages and acute stages of disease, these factors can actually be protective, whereas others are finding that in chronic diseases, these factors can be pathogenic,” Denning said. “Having a clear appreciation for that will afford the ability to manipulate these cytokines during specific phases of disease for the optimal therapeutic benefit.”

It is also important to understand how blocking these cytokines, which can be beneficial if they are at high levels for a long period of time, may impair repair processes, he said.

Co-authors of the study include Drs. Andrew T. Gewirtz, Didier Merlin, Oscar Medina-Contreras, Duke Geem, Akihito Harusato, Estera Maxim, Hirohito Abo and Vu L. Ngo of Georgia State and Dr. Asma Nusrat of the University of Michigan.

The study was funded by the National Institutes of Health and the Crohn’s and Colitis Foundation.

To read the study, visit http://www.pnas.org/content/early/2018/05/11/1718902115.

 
Researchers Develop New Chemistry To Make Smart Drugs Smarter
Written by LaTina Emerson   
Monday, May 21, 2018 09:43 AM

A method to activate targeted drugs, or smart drugs, only at the selected site of action, an approach that improves the drug’s therapeutic effect and minimizes side effects, has been developed in a study led by Georgia State University.

Smart drugs, developed to improve the delivery problems of pharmaceutical drugs, are like guided missiles with warheads. They need a targeting molecule to guide pharmaceutical drug molecules to the desired site of action and a trigger to “drop the bomb” or release or activate the drug. In chemistry terms, such smart drugs are conjugates, or links, between a targeting molecule and a drug molecule.

For the most part, the issue of guiding and enriching such smart drugs to the desired site of action has been resolved. An example is the use of antibody-drug conjugates, an emerging class of cancer treatment that targets the delivery of drugs to cancer cells. However, the issue of when and how to trigger drug release, particularly at a sufficiently high concentration, has been a challenging task.

This study introduces new chemistry and a new concept to allow for “enrichment-triggered activation” of the drug molecule after delivering the smart drug to the desired site of action. The study tested doxorubicin, an anti-cancer drug, and carbon monoxide, an anti-inflammatory agent, using this delivery method and found the targeted approach effectively treated diseases such as acute liver injury in mice and cancer in cell culture. The researchers linked the active drug to a targeting molecule and then triggered the release of the drug at the desired site of action. The findings are published in the journal Nature Chemistry.

“The general idea is we have a targeting molecule that is conjugated to a payload (pharmaceutical drug molecule), and in between, there’s a linker,” said Dr. Binghe Wang, Regents’ Professor of Chemistry and director of the Center for Diagnostics & Therapeutics at Georgia State, a Georgia Research Alliance Eminent Scholar in Drug Discovery and a Georgia Cancer Coalition Distinguished Cancer Scholar. “The entire purpose of this is to enrich drug concentration at the site of action. This allows a higher concentration of the drug at the site of action, but minimizes the concentration elsewhere. Essentially, it’s almost like a guided missile.

“What we have developed is an approach called enrichment-triggered prodrug activation. Most other chemical approaches rely on some kind of linker chemistry that is not specific enough or there’s a premature release in the general circulation. What we have essentially is a way to control release once the concentration of the drug reaches a certain level. Let’s say you have someone who has prostate cancer. If the drug concentration at the prostate can be a hundredfold higher than the concentration in the bloodstream, chances are you can probably kill all the cancer cells without causing all these side effects.”

In this study, the researchers used this targeted drug delivery approach to administer carbon monoxide to mice and treat acute liver injury. They saw a very potent effect, maybe 10 to 30 times more effective than traditional drug delivery, Wang said. They also tested the anti-cancer drug doxorubicin in cell culture.

They found it’s necessary to use a very stable linker to connect the targeted molecule and active drug so the linker can remain steady as it circulates in the bloodstream. They also needed to trigger a mechanism to release the drug at a desired site of action.

“The linker chemistry design has been very tricky,” Wang said. “There’s a lot of effort that went into it. What we have is something very unique in the sense that we have designed an approach that is not based on typical chemistry. When the (drug) concentration reaches a certain level, then it will automatically start releasing very quickly.”

While this study’s targeted drug delivery approach resembles that of antibody-drug conjugates, which target an antibody (a protein that recognizes foreign substances) on the surface of cancer cells, the current approach doesn’t require having antibodies.

“There are many other molecules that one can use to target different kinds of tissues, diseased organs or sites,” Wang said.

This approach is also not limited to the cell surface, as used in antibody-drug conjugate delivery, because small molecules are used for targeting and cleaving the drug from the targeting molecule.

Co-authors of the study include Drs. Yueqin Zheng, Xingyue Ji, Bingchen Yu, Kaili Ji, Mengyuan Zhu, Manjusha Roy Choudhury, Ladie Kimberly C. De La Cruz, Vayou Chittavong, Zhixiang Pan and Zhengnan Yuan of Georgia State; and David Gallo, Eva Csizmadia and Leo E. Otterbein of Harvard Medical School.

To read the study, visit https://www.nature.com/articles/s41557-018-0055-2.

 
Nutriband Inc. Acquires 4P Therapeutics Inc.
Written by Nutriband Inc.   
Monday, May 21, 2018 09:27 AM

Nutriband Inc. (OTC: NTRB), a Nevada Corporation, is pleased to announce the acquisition of 4P Therapeutics Inc. on April 5, 2018

Nutriband has acquired 100% interest in 4P Therapeutics for a total of $1,900,000 payable in both company stock and cash.  4P Therapeutics will receive 250,000 shares of common stock and a cash amount of $400,000.  Steven Damon, CEO of 4P Therapeutics, has been appointed to the Nutriband Inc. Board of Directors.  

4P Therapeutics will now become the Pharmaceutical and Development arm of Nutriband Inc. with a specific focus on Transdermal and Topical Technologies, prescription drugs and clinical development.

Included in the acquisition of 4P's IP Portfolio is Defent™ abuse deterrent patch technology, an opioid abuse deterrent platform for the transdermal delivery of opioid-based medications. Defent™ lowers the risk of abuse and misuse, creating a safer treatment for patients.

Nutriband has also acquired 4P's Exenatide transdermal delivery system, currently in Phase I clinical development.  If successfully taken through Phase III and to commercialization, it will compete with injectable Exenatide such as Byetta® and Bydureon® by providing an injection free alternative for patients with type II diabetes.

A Full Pipeline of drugs and technology can be found on 4P's website http://www.4ptherapeutics.com/.

4P Therapeutics is a private company focused on the research and development of novel drug delivery technologies and therapeutics. 4P develops products that meet the needs of patients, physicians and payers. The company has capabilities for developing pharmaceutical products ranging from pre-clinical testing to clinical manufacturing and early stage clinical development (Phase I/II). A key company focus and area of expertise is in the development of transdermal products for currently injected compounds, including proteins, peptides, macromolecules and biologics. Transdermal delivery of commercially available drugs or biologics that are typically delivered via injection has the potential to improve safety, efficacy and therapeutic outcomes associated with these treatments.

Nutriband Inc. appointed Steven Damon to its Board of Directors.  Steven Damon has over 30 years of experience with various business roles in the medical and pharmaceutical industries. As well as founding 4P Therapeutics, Steven also maintains an executive leadership role as Vice President for Business and Commercial Development with Femasys an Atlanta based women's health care medtech company.  In addition, he serves on the boards of Micron Biomedical, Carmel Bioscience, Temple Therapeutics and Georgia BIO. He actively consults with various companies on strategy, financing and M&A. 

Before founding 4P Therapeutics, Steven led the Business Development team at Atlanta based Altea Therapeutics as the company's Senior Vice President of Business Development.  He founded and was President of Absorbable Polymers International a Birmingham, Alabama company. He was an Executive Director at DURECT Corporation in Cupertino California where he led Business Development activities and was responsible for the ALZET research drug delivery pump business.  Steve started his life science career with Kimberly-Clark Healthcare (now Halyard Healthcare) with lead responsibilities for commercial development of the healthcare business in Europe and the acquisitions of a number of life science companies and products. Additional activities include industry related speaking engagements, publications and committee participation. Steven has been a long time mentor for the Emory and Georgia Tech Ti:GER program and also participates in other GT student mentoring programs.

Nutriband Inc. appointed Alan Smith Ph.D. as Head of Regulatory and Clinical Operations. Alan Smith, Ph.D., co-founded 4P Therapeutics in 2011 and serves as Vice President, Clinical, Regulatory, Quality, and Operations. Previously, he was with Altea Therapeutics, most recently serving as Vice President, Product Development and Head of Clinical R&D, Regulatory Affairs, and Project Management. At Altea, he led major research and development programs with pharmaceutical companies such as Eli Lilly, Amylin, Hospira, Elan, and Novartis. He joined Altea as one of the first employees and spent 12 years growing its multidisciplinary drug delivery research and development organization.

Dr. Smith has 20 years of experience in the research and development of drug and biologic delivery systems, diagnostics and medical devices for treatment and management of diabetes, chronic pain and cardiovascular disease. Prior to joining Altea Therapeutics, he led the development of transdermal glucose monitoring systems at SpectRx, Inc., a publicly traded noninvasive diagnostics company. Dr. Smith received Ph.D. and M.S. degrees in Biomedical Engineering from Rutgers University and the University of Medicine and Dentistry of New Jersey. He currently serves on the Editorial Advisory Board of Expert Opinion on Drug Delivery.

Nutriband Inc.

Nutriband is a unique, result's driven, health and pharmaceutical Company based in Orlando Florida.  Unlike traditional health product companies, Nutriband found its start by spotting and targeting a gross and virtually unexplored niche in the market through its method of ingredient delivery. All Nutriband products are based around the science of transdermal / Topical technologies.

http://www.nutriband.com/

 
Dune Medical Sets the Stage for Growth, Naming Alan Bond Chief Financial Officer
Written by Metro Atlanta   
Monday, May 21, 2018 09:26 AM

Dune Medical Devices has appointed Alan Bond as Chief Financial Officer. Bond is a veteran financial executive with an extensive record of developing and implementing strategy, and driving revenue and profitability in the medical device industry. Bond joins the Dune Atlanta office after years with McKesson and Given Imaging.

“Alan has experience in both large and small organizations during times where the companies were undergoing significant strategic changes and acquisitions,” says Lori Chmura, CEO of Dune Medical. “His experience in driving organizational performance will add significantly to Dune Medical’s capability to manage new growth, and we are pleased to add him to our distinguished team.”

Dune Medical Devices’ proprietary tissue characterization technology utilizing Radiofrequency (RF) Spectroscopy, is a ground-breaking solution to identifying microscopic residual cancer at the surface of the tissue to give surgeons another tool to help identify all the cancerous tissue in the operating room. Dune’s first medical device, the MarginProbe System, achieved FDA approval in 2013 for use in breast cancer lumpectomy procedures. Numerous peer reviewed publications have demonstrated a 50 - 79% reduction in re-excision with the use of MarginProbe.

“Breast conservation surgery is a first line surgical modality for most women facing a breast cancer diagnosis and MarginProbe improves the effectiveness and outcome of the surgery,” says Bond. “I look forward to playing an important role in optimizing Dune’s organizational performance and bringing a strategic focus as we expand our revolutionary technology platform to the diagnosis, surgery and therapy of other cancers.”

 
BIO Statement on Trump Administration’s Plan to Lower Drug Costs
Written by Brian Newell   
Wednesday, May 16, 2018 09:30 AM

BIO President and CEO Jim Greenwood issued the following statement after President Trump announced his administration’s plan to lower prescription drug costs:

“The men and women of the biopharmaceutical industry work every day to help cure disease and improve the lives of patients. Our country leads the world in the discovery of new treatments because of gifted researchers, dedicated entrepreneurs and a competitive marketplace that recognizes the inherent risks of biomedical innovation. But developing cures and treatments is not enough. These advances in medicine must also be accessible and affordable for patients.

“Today the president outlined some of the financial challenges patients face at the pharmacy counter. We look forward to working with the administration on solutions that help provide all patients access to prescription drugs with out-of-pocket costs they can afford. However, we have concerns that some of the ideas proposed today could, if adopted, hurt patient access to the medicines they need today and the future cures and treatments they’re desperately waiting for America’s biopharmaceutical innovators to discover.

“BIO represents an industry with the power to save lives and save money in other parts of the health care system. As more information about the administration’s proposals is released in the coming days and weeks, we will carefully review the details. We will work to ensure that these proposals lower costs for patients, support continued innovation, address the practices of foreign governments that undervalue innovative medicines, and do nothing to hurt small companies who are the backbone of biomedical innovation.” 

For more information about prescription drug costs, visit DrugCostFacts.org.

About BIO

BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO's blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.

 
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