Chancellor Washington speaking at Four Points Innovation Announcement Celebration, March 2020

Duke & Deerfield Announce Four Points Innovation

(Durham, NC and New York, NY, December 18, 2019)—Duke University and Deerfield Management Company, a healthcare investment firm, today announced the creation of a major translational research collaboration. Spearheaded by Duke University’s Office of Licensing & Ventures (OLV), the alliance is expected to accelerate the preclinical development of new drugs for improved quality of life and cures for disease.

Four Points Innovation Logo

“This is an exciting day for Duke and the patients we serve,” said Mary E. Klotman, MD, Dean, Duke University School of Medicine and Vice Chancellor for Health Affairs. “This new partnership will help further Duke’s commitment to improving the lives of people in our own community and around the world by supporting and accelerating the translation of research into new therapies to treat and cure society’s most formidable healthcare challenges.”

By way of a newly launched company called Four Points Innovation, up to $130 million of initial funding will be made available by Deerfield to back the initiative for 10 years.  Deerfield also will provide development expertise in support of Duke’s innovative drug research across a span of high-need therapeutic areas, as well as those targeting patients who suffer from hard-to-treat and rare diseases.

A private company wholly owned by affiliates of Deerfield, Four Points Innovation will support Duke R&D projects throughout preclinical stages of drug discovery and development. Beginning approximately in March 2020, Duke researchers will have the ability to submit proposals on projects for consideration by a Four Points Innovation committee comprised of scientific leadership representing both Duke and Deerfield.

Accepted projects will include a development plan aimed at achieving Investigational New Drug (IND) readiness. Deerfield will provide funding and operational support for accepted projects, and successful projects that achieve IND-enabled status may be eligible for additional capital from Deerfield.

Duke’s Office of Licensing and Ventures broke previous records last year with 354 invention disclosures, 120 agreements, and 32 exclusive agreements. Duke faculty and staff formed sixteen new start-up companies during the year, bringing the university’s total to over 140 new companies. Over the last two years, 29 of the university’s 32 startups have chosen to stay in North Carolina.

“Duke University, with its vast research enterprise, world-class investigators and novel innovations, is a leader in biomedical discovery,” said James E. Flynn, Managing Partner at Deerfield Management. “We are excited about entering into this partnership with Duke, as we collectively seek to develop new medicines to save lives and address unmet medical needs.”

Under the terms of the agreement, Four Points Innovation would receive an option to license Four Points Innovation-funded intellectual property developed at Duke.

Computed axial tomography hospital room. Equipped oncology diagnosis area

Positive Clinical Trials & $10.7M Investment for Polarean Paves Way for NDA

In March, Polarean Imaging, a medical imaging technology company, raised $10.7M after seeing success with their Phase III trials in January.

Polarean said the two phase III clinical trials “validated the belief” that its technology allows doctors and surgeons to visualise aspects of lung function that have gone undetected using traditional magnetic resonances imaging (MRI) techniques.

The North Carolina-based company said the extra cash would strengthen its balance sheet while it prepares for the new drug application (NDA) for its hyperpolarised 129-Xenon gas MRI technique, which is planned for submission to the US Food & Drug Administration during the third quarter of the year.

Polarean designs and manufactures equipment for the production of hyperpolarized xenon or helium gas.

polarean gas shown in lungs

When used in conjunction with MRI, these gases offer a fundamentally new and non-invasive functional imaging platform. By inhaling and holding a small amount of the gas for just a few seconds, the patient is able to create a much stronger MRI signal, providing doctors with multiple images of lung structure and function.

Current investigational uses include identifying early diagnoses of respiratory diseases as well as monitoring progression and therapeutic response. In addition, xenon gas exhibits solubility and signal properties that enable it to be imaged within other tissues and organs.

Polarean said the new funds will be used to support the preparation and submission of the NDA, the initial preparation for commercial launch following submission of the NDA, and to provide additional working capital to build and sell additional polarisers.

Polarean’s Richard Hullihen said in June they’re targeting the third quarter of 2020 to submit an NDA for its drug-device combination.

FDA sign

Viela Bio Announces U.S. FDA Approval of UPLIZNA™

Viela Bio (Nasdaq:VIE) announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNATM (inebilizumab-cdon) for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-AQP4 antibody positive as a twice-a-year maintenance regimen following initial doses. Approximately 80%1 of all patients with NMOSD test positive for anti-AQP4 antibodies.

vielabio logo

“NMOSD is an extremely challenging disease to treat. Patients experience unpredictable attacks that can lead to permanent disability from blindness and paralysis. In addition, each subsequent attack may result in a cumulative worsening of disability. In the pivotal N-MOmentum trial, UPLIZNATM—a humanized CD19-directed monoclonal antibody—significantly reduced the risk of attacks and also reduced hospitalizations when given as a monotherapy,” said Bruce Cree, M.D., Ph.D., MAS, the lead investigator for the N-MOmentum trial and Professor of Clinical Neurology at the University of California San Francisco Weill Institute for Neurosciences. “UPLIZNATM is an important new treatment option that provides prescribing physicians and patients living with NMOSD a therapy with proven efficacy, a favorable safety profile and a twice-a-year maintenance dosing schedule.”

NMOSD is a rare, severe, neuroinflammatory autoimmune disease that attacks the optic nerve, spinal cord and brain stem. In addition to potentially irreversible blindness and paralysis, patients may also experience loss of sensation, bladder and bowel dysfunction, nerve pain and respiratory failure. It is estimated that there are approximately 10,000 people in the U.S. suffering from NMOSD2. Multiple lines of evidence suggest that NMOSD is a B-cell-mediated disorder.

“As an organization that understands and represents the struggle of patients and their loved ones affected by NMOSD, we are pleased that now there is another treatment option that could reduce their attacks, which can lead to devastating and irreversible disability,” said Victoria Jackson, co-founder of the Guthy-Jackson Charitable Foundation, a non-profit organization dedicated to funding research and raising awareness about NMOSD. “We have been proud to partner with Viela Bio and congratulate them and the NMOSD community on this important milestone.”

 

Read the full story here

[Originally posted by GlobeNewswire — June 11, 2020]

paddy rice field with cloud background

Upstream Biotechnology

MANAGEMENT: Peter Alexander
DUKE INVENTOR: Xinnian Dong

Upstream Biotechnology uses patented technology to develop broad-spectrum disease-resistant crops to eliminate pesticide use, reduce production costs, and increase crop yield.

This novel method alters upstream DNA sequences to turn on a defensive gene while also using newly discovered sequence elements called upstream open reading frames (uORFs). The technology might also be used to produce various therapeutic proteins in plants.

Upstream Biotechnology

THE PROBLEM:

Rice is one of the most important staple crops, responsible for providing over 1/5 of the calories consumed by humans worldwide. Diseases caused by bacterial or fungal pathogens present a significant problem and can result in the loss of 80% or more of a rice crop.

George Green speaking to guest at Invented at Duke 2019Although there is a long history of research into engineering disease-resistant plants, a practical application for using these methods in crops results in lower crop yield as the plant is diverting its energy to maintaining a constant active defense.

“Immunity is a double-edged sword, ” said study co-author Xinnian Dong, professor of biology at Duke and lead investigator of the study. “There is often a tradeoff between growth and defense because defense proteins are not only toxic to pathogens but also harmful to self when overexpressed,” Dong elaborated. “This is a major challenge in engineering disease resistance for agricultural use because the ultimate goal is to protect the yield.”

THE SOLUTION

Previous studies have focused on altering the coding sequence or upstream DNA sequence elements of a gene. These upstream DNA elements are known as promoters, and they act as switches that turn on or off a gene’s expression. This is the first step of a gene’s synthesis into its protein product, known as transcription.

By attaching a promoter that gives an “on” signal to a defense gene, a plant can be engineered to be highly resistant to pathogens, though at a cost to growth and yield. These costs can be partially alleviated by attaching the defense gene to a “pathogen-specific” promoter that turns on in the presence of pathogen attack.

To further alleviate the negative effects of active defense, the Dong group sought to add an additional layer of control. They turned newly discovered sequence elements, called upstream open reading frames (uORFs), to help address this problem. These sequence elements act on the intermediate of a gene, or messenger (RNA, a molecule similar to DNA) to govern its “translation” into the final protein product. A recent study by the Dong lab in an accompanying paper in Nature has identified many of these elements that respond in a pathogen-inducible manner.

The Dong group hypothesized that adding this pathogen-inducible translational regulation would result in a tighter control of defense protein expression and minimize the lost yield associated with enhanced disease resistance.

THE IMPLEMENTATION

The Dong group then sought to apply these findings to engineer disease-resistant rice, as it is one of the world’s most important crops. They created transgenic rice lines containing the transcriptional/translational cassette driving expression of another potent “immune activator” gene called AtNPR1. This gene was chosen as it has been found to confer broad spectrum pathogen resistance in a wide variety of crop species, including rice, citrus, apple and wheat.

The transgenic rice lines containing the transcriptional/translational cassette were infected with bacterial/fungal pathogens that cause three major rice diseases — rice  blight, leaf streak, and fungal blast. These showed high resistance to all three pathogens, indicating broad spectrum resistance could be achieved. Importantly, when grown in the field, their yield — both in terms of grain quantity and quality per plant — was almost unaffected. These results indicate a great potential for agricultural applications.

This strategy is the first known use of adding translational control for the engineering of disease-resistant crops with minimal yield costs. It has many advantages, as it is broadly applicable to a variety of crop species against many pathogens. Since this strategy involves activating the plants’ endogenous defenses, it may also reduce the use of pesticides on crops and hence protect the environment.

A rice leaf exhibiting typical watermark lesions associated with sheath blight disease By Peggy Greb, USDA Agricultural Research Service - USDA Agricultural Research Service, Image Number D1769-1
blueprints of xray technology

Quadridox


DUKE INVENTORS: Joel Greenberg, Michael Gehm

quadridox.com

Quadridox provides design, development, and analysis of sensing and measurement systems to commercial and government agencies in the security, medical, and commercial spaces.

They were recently asked by the Department of Homeland Security (DHS) to develop a new type of X-ray scanner that combines the best features of two technologies: the ability to detect not just the 3D shape of an object but also its molecular composition. The resulting device could one day become standard in airports the world over.

Quadridox logo

Grid Therapeutics Announces 1st Patient in Phase 1 Study

Grid Therapeutics, LLC, a clinical-stage biotechnology company developing a first-in-class, novel, human-derived targeted immunotherapy for solid tumors, today announced that the first patient has been dosed in a Phase 1/2 study of GT103 in patients with refractory NSCLC. The study is initially being conducted at the Duke University Medical Center.

Grid Therapeutics Logo

“Today’s announcement marks the first time a therapeutic antibody derived from single B cells of cancer patients, and the first IgG3 subclass, has advanced to the clinic,” said Dr. Edward Patz Jr., M.D., Chief Executive Officer of Grid, and the James and Alice Chen Professor of Radiology, Professor in Pharmacology and Cancer Biology at Duke University School of Medicine. “Initiation of this study is a significant milestone for Grid, as we believe our unique strategy will transform cancer therapy.”

The Phase 1 segment of this trial will generate important data about the safety and tolerability of GT103, which targets complement factor H, a protein that protects tumor cells from complement lysis. The Phase 2 segment will be performed in combination with a checkpoint inhibitor, as recent pre-clinical data shows GT103 modulates the adaptive immune response and may potentiate current immune-oncology therapy.

Paolo Paoletti, Grid Board member and Chief Executive Officer of GammaDelta Therapeutics, stated, “This is an exciting and pioneering approach to a highly prevalent and intractable cancer, which currently has a very poor prognosis despite best available treatments.”

This trial is also designed to validate Grid’s innovative platform for the rapid development of additional therapeutic antibodies for the treatment of multiple forms of cancer.

Read the full story here

[Originally posted by BusinessWire — June 24, 2020]

AR Brain model app in use

From Campus to Commercialization: Celebrating Duke’s Novel Innovations

Celebrating its 3rd year, “Invented at Duke” showcased 13 companies and early technologies from across campus illustrating how Duke is leading the way in transferring innovations to society.  This year, 350 students, faculty, staff, alumni, investors, and members of the local community came to see how Duke is translating research into impactful innovations.

This annual event, co-hosted by Duke’s Office of Licensing and Ventures (OLV) and Duke’s Innovation & Entrepreneurship Initiative (I&E), aims to celebrate and promote the diverse accomplishments of Duke innovators and entrepreneurs. Showcasing technologies, inventions, and novel ideas coming out of Duke help to illustrates the breadth of Duke discoveries and innovations while encouraging others to develop ideas of their own.

“We are absolutely committed to Durham and have had to fight really, really hard against the demands of our investors to actually stay here,” Jantz said.

Guest speaker Derek Jantz, CSO of Duke start-up Precision BioSciences, talked about his company’s journey from start-up to going public this past year. He shared some of the company’s challenges—namely, being embroiled in an intellectual property lawsuit for five years which the company ultimately won—and its triumphs, such as beginning clinical trials with its first cancer patient. He also discussed the company’s decision to remain in the Triangle despite investor pressure to move to more established innovation hubs.

“We are absolutely committed to Durham and have had to fight really, really hard against the demands of our investors to actually stay here,” Jantz said. “They want us to move to Cambridge or San Francisco, and we’ve said no, we’re staying in Durham. And the reason for that is, we like Duke and absolutely love this city and would like nothing more than to do everything we can to help Durham become a major hub of innovation and entrepreneurship.”

This year, the event also highlighted Duke’s innovation and entrepreneurship resources. From funding resources to incubators to oversight, more than 15 Featured Resources were on display providing guidance and facilitating discussions among Duke inventors and the broader Duke community.

“This event really highlights the breadth and depth of Duke’s innovation community,” said Jon Fjeld, director of Duke’s Innovation & Entrepreneurship Initiative. “It’s inspirational to see innovations coming from across the university, from the School of Medicine and the Office of Information Technology all the way to undergraduate engineers and even an invention by a dance faculty member. It’s also rewarding to see how many resources and collaborations at Duke play a role in helping to move ideas and innovations out into the world.”

OLV is responsible for handling all intellectual property (inventions) for Duke employees. “We work with researchers early on to identify promising ideas, decide the best way to protect the inventions, work with them to find the best partner, negotiate the deals, collect and distribute revenues, and sometimes handle litigation,” said Robin Rasor, Executive Director of OLV.

16 new start-up companies were added this year to the growing list formed from Duke research–bringing Duke’s overall start-up total to 142. 14 of this year’s 16 are staying in North Carolina, with 29 of 32 total start-ups remaining in the Triangle over the past two years. This year OLV broke previous records with 354 invention disclosures, 120 agreements, and 32 exclusive agreements. 91 US patents were issued this year as well.

Barry Meyers, Ed Field, and Tarun Saxena presenting BioLabs Golden Ticket to Tellus Therapeutics founder, Eric Brenner

Adding to Duke innovation successes, Duke start-up Tellus Therapeutics was awarded a Golden Ticket from Duke’s CTSI and the NC BioLabs granting their company a free bench for a year in the BioLabs located in the Chesterfield Building. Tellus Therapeuticsfounded by Eric Brenner, is developing novel small molecules derived from human maternal breast milk for the treatment of newborns with perinatal brain injury.

“Last night’s event demonstrated the excitement around innovation and entrepreneurship on campus and in our local community. Duke is a vital center of innovation right now, transforming today’s ideas into tomorrow’s new products,” said Rasor.  “Our goal in highlighting Duke’s success in technology commercialization is to not only display the inventiveness and ingenuity of our faculty, students, and staff but also to encourage them to bring their new innovations forward.”

 

Here Was This Year’s Lineup Of Featured Innovators:

Upstream

UpstreamInventor: Xinnian Dong

A novel method that allows for increased disease resistance in crops without decreasing yield.

 

Gavilán Biodesign

Gavilan BiodesignInventors: Bruce Donald, Marcel Frenkel, Mark Hallen, Jonathan Jou
Gavilán is a software platform that predicts and out-maneuvers possible drug resistance mutations using AI technology to design drugs with a property called resistance-resilience.

 

CasTag Biosciences

CasTagInventor: Scott Soderling
CasTag Biosciences has developed innovative CRISPR-based reagent kits for labeling and manipulating endogenous proteins in cells and tissues with unprecedented precision and ease of use for academic and industry laboratories.

 

 

ImageOn

ImageOnInventors: Allen Song, Dean Darnell, Trong-Kha Truong
ImageOn is developing a new technology, iPRES, for MRI scanners.  This technology can improve the image quality while reducing manufacturing costs, saving space in the scanner bore, and improving patient comfort.

 

 

Lacuna Medical

Lacuna MedicalInventor: Muath Bishawi
Lacuna Medical has developed a 3D-shaped memory catheter technology aimed at decreasing catheter failure and dislodgement.

 

 

 

Phitonex

PhitonixInventors: Alvin Lebeck, Craig LaBoda, Chris Dwyer
Phitonex is painting a newer, more colorful future in life science research with its advanced fluorescent technologies.  This technology allows researchers to investigate diseases at the single-cell level and advance their discoveries with more insight and higher resolution.

 

 

U-Core

UCoreInventors: Kamran Mahmood, Paolo Maccarini, Donald Pearce
U- Core is a novel cutting biopsy device that can be inserted through an endoscope and obtain high quality, reliable distant core biopsies from deep organs like lungs, minimizing biopsy attempts, procedure time, complications and non-diagnostic procedures.

 

 

STINGAR (Shared Threat Intelligence for Network Gate-keeping with Automated Response)

STINGARInventors: Tracy Futhey, Richard Biever
STINGAR is a security threat intelligence solution developed by Duke OIT to identify and defend against attacks targeting your network.

 

 

 

restor3d

restor3DInventor: Ken Gall
restor3d produces orthopedic implants with enhanced anatomical fit and superior integrative properties using cutting-edge additive manufacturing (AM) technologies.

 

 

The Hydrean

The HydreanInventor: Michael Klien
The Hydrean is a mindfulness tool and method designed for use by anyone, anywhere, and anytime. Its tactile features link to simple prompts that guide your awareness towards intentional living.

 

Protect3d (Student)

Protect3DInventors: Kevin Gehsmann, Clark Bulleit, Tim Skapek
What began as a novel engineering project helping former Duke QB and #6 overall draft pick Daniel Jones return to the field has become a startup revolutionizing protective equipment used in all levels of athletics and beyond.

 

Caia Curve (Student)

Caia CurveInventor: Beryl Baldwin
The Curve is a realistic model women can use to train themselves in performing breast self-exams.

 

 

 

MesnAR (Student)

MesnARInventor: Erikson Nichols
MesnAR is a medical venture whose mission is to provide efficient and effective customization and creation of anatomical models in a mixed media platform.