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]

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:


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.




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.





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.




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.





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.





female doctor putting new papr shield on male

3D-Printing Gives Medical Teams COVID Protection

A protective respirator created by the Duke COVID-19 Engineering Response Team to combat the critical shortage of medical equipment was used successfully by health care workers in two Duke Health surgical cases last week.

With the high need for more personal protective equipment, Duke engineering professors Ken Gall, Paul Fearis and Eric Richardson recognized the need to turn a surgical helmet, which uses room air, into a powered air-purifying respirator (PAPR), which uses filtered air.

The Duke Engineering team worked closely with Chip Bobbert, Sr. Engineer and Fabrication Architect in Duke’s Innovation Co-Lab to print and test numerous designs using their Formlabs printers.

Eric Richardson testing a powered, air-purifying respirator device
Eric Richardson testing a powered, air-purifying respirator device
Sample PAPR

“We were able to use the wonders of 3D printing here at Duke to start to print those, see what works, see what didn’t. We worked through about four or five iterations, and so we ended up with the final version that you see on the suit now,” said Fearis, Lecturing Fellow, Senior in the Department of Biomedical Engineering.

The modified protective equipment will keep doctors safe while caring for a patient.

“Basically, it is the highest level of protection we can offer our providers, particularly those that are intubating patients,” said Eric Richardson, associate professor of the practice of Biomedical Engineering.

Surgical N95 respirator face masks are personal protective equipment (PPE) that health care workers use to protect themselves from airborne and fluid dangers. When they are not used, there’s a risk the worker could be exposed to bodily fluids and blood, according the Centers for Disease Control.

As many hospitals experience PPE shortages, PAPRs are an approved alternative that provides equivalent or greater protection for health care workers. The reusable respirators completely cover health care workers’ faces and a battery-powered blower pulls air through filters or cartridges.

The task force developed the 3D printed part for the adapted helmet under the guidance of Duke orthopedic spine surgeon Melissa Erickson. Her idea of modifying a surgical helmet to incorporate a filter combined with her knowledge of medical equipment led the team to deliver a protective device that could be used to safeguard health care workers during the COVID-19 pandemic. Erickson is a Weekend Executive MBA student at the Fuqua School and credits her work in operations management as inspiring her interest.

“Uniquely we have these helmets that we wear during arthroplasty surgery and we started to wonder, ‘Can these be repurposed?’ So if there’s national shortages on PPE and PAPRs, maybe we can use things that we have plenty of in the hospital and do modifications to be able to increase the number of protective personal equipment that we have to provide for health care workers.”

The device sits on top of an existing piece of medical equipment and turns a surgical helmet system into a PAPR, which basically is the highest level of protection we can offer our providers, particularly those who are intubating patients, described Richardson.

Eric Richardson and Dr. Melissa Erickson testing the PAPR hood

Eric Richardson and Dr. Melissa Erickson testing the PAPR hood

The task force’s PAPR was rigorously tested by a HEPA certification company, Precision Air Technology, before care providers began using it. They have already made more than a dozen additional units to deliver to Duke Health.  The final devices for clinical use are being printed using a Formlabs printer and resin, a Boston based company with a local office in Durham.  Richardson and the task force plan to continue printing the device in order to deliver more hoods to Duke Health in the coming days.

“It’s fun working with extremely talented people, and having an urgent and meaningful goal. I think we’re all exhausted, but feeling like we’re making impact,” said Richardson.”

In addition to the PAPRs, the COVID-19 Engineering Team also 3D printed a part to create medical shields, which has been approved for use by health care workers. The task force has been working to engineer and produce a wide range of much-needed equipment including bed tents to isolate infectious patients and 3D-printed “splitters” that make a single ventilator work for more than one patient.

Expedition 27 flight engineer Cady Coleman, wearing Extravehicular Mobility Unit (EMU) gloves, poses for a photo in the Destiny U.S. Laboratory.

NASA Climbs Aboard with Support for Robot Project



The robot can autonomously place an IV in an astronaut’s arm for crewed space missions and to improve access to healthcare on Earth.

Designing a robot to autonomously place an IV in an astronaut’s arm while in zero gravity requires smart, passionate, persistent engineers. What better team for the project than Duke physician-engineer Dan Buckland, who is both assistant professor of mechanical engineering and materials science and an emergency department physician, and mechanical engineering doctoral student Siobhan Oca?

Expedition 32 Flight Engineer Akihiko Hoshide after undergoing a generic blood draw in the European Laboratory/Columbus Orbital Facility. Duke engineers are building a robot that would replace the need for specialized astronaut training to access a vein for a blood draw or to administer fluids or medication. Photo: Courtesy of NASA
Expedition 32 Flight Engineer Akihiko Hoshide after undergoing a generic blood draw in the European Laboratory/Columbus Orbital Facility. Duke engineers are building a robot that would replace the need for specialized astronaut training to access a vein for a blood draw or to administer fluids or medication. Photo: Courtesy of NASA

“NASA needs to both expand the medical capabilities available on a Moon or Mars mission and reduce the number of trained medical personnel required to achieve mission objectives.”

NASA is on board with the idea, recently funding their project, “Automated Vascular Access for Spaceflight,” through its Human Research Program with a one-year, $150,000 grant.

Buckland said autonomous medical procedures can further those goals, and that placing an IV autonomously would be particularly helpful as that’s the first step of almost any medical procedure or diagnosis.

This first step of the long journey toward sending the robot aboard crewed Artemis missions to the Moon, and later Mars, will take place on the ground, however. By the end of this grant, Buckland and Oca hope to have Institutional Review Board approval to test the robot on human arms. Hopefully, that will lead to funding to test the prototype during spaceflight.

Siobhan Oca helps boy direct robot
Easy as child’s play? While not an official test of its ease of use, Siobhan Oca allows one of Dan Buckland’s children to maneuver the robot’s arm from a touchscreen in the lab. Buckland and Oca are designing this complex medical robot for NASA specifically for astronauts without advanced medical training to use in-flight on missions to the Moon or Mars.

Robots that insert IVs into patients’ arms already exist, said Oca, but they all require clinician oversight. The one Buckland and Oca are designing is for use by someone without clinical training or even a clinician nearby. It uses a noninvasive ultrasound probe to locate the correct vein—importantly distinguishing it from an artery. Unlike other robots, though, for human safety, it must also have parts that remove easily for sterilization in an onboard autoclave or are disposable. The motor, which cannot be superheated in an autoclave, also needs protection from contamination along with calibration to operate in zero gravity.

“The system must be easy to clean and easy enough to use that you don’t poke yourself with the needle. Add to that, it must be lightweight, reliable, and inexpensive,” said Oca. “We’re actually using a fairly low-end, inexpensive ultrasound—that’s the point.”

This project fits into an all-encompassing dream they both have, which is to make medicine more accessible, especially in low-resource settings. Space, with its many constraints and limited onboard supplies, is a low-resource setting. Others here on Earth include the U.S. Indian Health Service with its remote locations and shortage of clinicians.

Oca is no stranger to persistent pursuit of her passion amid constraints, including those that occur without warning. When she was 11, her family fled the devastation of Hurricane Katrina from their native New Orleans and resettled in Richmond, Va. During her freshman year at a public high school for academically gifted students, while on a path to become a doctor in the footsteps of both her parents, she inexplicably lost a significant portion of her vision.

With a still unwavering passion to help people through medicine, she pivoted to undergraduate study of mechanical engineering at MIT and then earned a master’s degree in translational medicine from a joint program at the University of California–Berkeley and the University of California–San Francisco. From there she joined a startup company using her newly acquired know-how in regulation and marketing to help them commercialize a medical device.

“I realized though that I want to be the person who helps to decide the design, and so I decided to go back for my Ph.D.,” she said. That decision brought her to Duke’s Ph.D. program in mechanical engineering and materials science in 2018.

Siobhan Oca
Siobhan Oca

“It was such luck that I get to work with Dan because he wasn’t on the faculty when I applied to Duke. I kind of fell specifically into medical robotics because of Dan, and I am very excited that I did,” she said.

This is where her persistence comes in—like a well-developed muscle strengthened from daily use. She uses her cell phone to magnify documents for reading and her spatial memory to memorize the layout of icons and commands in software. She also uses many other effective workarounds that have enabled her to mentor undergraduate students in making designs for the ultrasound holder and angling mechanism of the robot using computer-aided design (CAD) software.

“Every new software I have to use, I memorize where everything is. I know where everything is in Microsoft Word,” said Oca. She also plays to one of her strengths, which is coding and programming the human-robot interaction, because she can more easily enlarge it on a screen.

“I’m passionate about building things to help people,” she said.

Deep Blue's new hernia mesh being held by a pair of gloved hands

FDA clearance for hernia mesh product approved for Deep Blue

Duke start-up, Deep Blue Medical Devices, has been approved to start selling their hernia mech technology after receiving FDA approval in August.  This novel product, developed by Duke plastic surgeon Howard Levinston, has enhanced anchoring strength that will resist wounds from gaping and bursting open.

Deep Blue developed the mesh to address the unacceptably high rate of hernia occurrence and recurrence. Millions of hernia surgeries are done globally with billions of dollars in clinical cost.  Their T-Line® Hernia Mesh with integral suture-like extensions is designed to eliminate a key point of failure for conventional mesh fixation – the mesh, suture, tissue interface – and to provide superior anchor strength.

Dr. Howie Levinson shows off his hernia mesh design to President Price. Deep Blue is addressing the unacceptably high rate of hernia occurrence and recurrence. Photo by Jared Lazarus/Duke Photography

Deep Blue has raised more than $800,000 in funding, with $295,000 raised August 2018.

In separate efforts, Levinson is working on additional projects including an anti-biofouling Foley catheter, a non-invasive light imaging technology to diagnose skin disorders, and tissue-engineered skin that resists contraction.

“Sewing a bit of each extension into the abdominal wall, in lieu of traditional sutures, significantly increases mesh anchoring strength and thus the durability of the repair,” Levinson says of the T-Line in an interview with WRAL Techwire. “We believe this approach will greatly improve patient outcomes without necessitating significant changes to current surgical practice.”

The firm says it plans to launch the T-Line at “selected sites” in the near future.

Precision BioSciences Announces Dosing of First Patient in Phase 1/2a Clinical Trial

-PBCAR269A Targets BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma and is the Company’s Third Investigational Allogeneic CAR T Candidate Advanced to the Clinic –

-PBCAR269A is the First Off-the-Shelf Candidate Produced at In-House Manufacturing Center-

DURHAM, N.C., June 08, 2020 (GLOBE NEWSWIRE) — Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company dedicated to improving life with its novel and proprietary ARCUS® genome editing platform, today announced that the first patient has been dosed in a Phase 1/2a clinical trial of PBCAR269A, its third allogeneic chimeric antigen receptor (CAR) T cell therapy candidate. Wholly-owned by Precision, PBCAR269A targets the B-cell maturation antigen (BCMA) and is being evaluated for the treatment of relapsed/refractory multiple myeloma.


“PBCAR269A is our third off-the-shelf CAR T candidate to advance into the clinic; the second within the last two months. Despite the uncertain impact of COVID-19 on patients and the healthcare community at large, we maintained our focus and dedication that have enabled continued execution during the pandemic,” commented Matt Kane, CEO and co-founder of Precision Biosciences. “Notably, this will be our first study for which all clinical trial material will be produced at our in-house manufacturing facility.”

“There remains significant unmet need for a broadly available and well-tolerated treatment for patients with relapsed or refractory Multiple Myeloma,” said Chris Heery, MD, Chief Medical Officer of Precision BioSciences. “We are committed to improving the access of CAR T therapies for more patients. We appreciate the commitment of our clinical sites to start enrollment ahead of schedule, even during these difficult times, and the willingness of patients to take part in this trial.”

In preclinical disease models, PBCAR269A demonstrated potent in vivo clearance of BCMA+ tumor cells and overall tumor volume reduction, with no evidence of graft-versus-host disease (GVHD). Clinical trial material for this study is generated at the Company’s in-house Manufacturing Center for Advanced Therapeutics (MCAT) in Durham, North Carolina. PBCAR269A has received Orphan Drug Designation from the FDA for the treatment of multiple myeloma.

About the PBCAR269A Clinical Trial
PBCAR269A is being evaluated in a Phase 1/2a multicenter, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR269A in adults with relapsed/refractory multiple myeloma. The starting dose of PBCAR269A will be 6 x 105 CAR T cells/kg body weight. Subsequent cohorts will be treated with escalating doses to a maximum dose of 6 x 106 CAR T cells/kg body weight. The trial will be conducted at multiple U.S. sites. For more information, visit, study identifier number NCT04171843.

About Precision’s Allogeneic CAR T Platform
Precision is advancing a pipeline of cell-phenotype optimized allogeneic CAR T therapies, leveraging fully-scaled, proprietary manufacturing processes. The platform is designed to maximize the number of patients who can potentially benefit from CAR T therapy. Precision carefully selects high-quality T cells derived from healthy donors as starting material, then utilizes its unique ARCUS genome editing technology to modify the cells via a single-step engineering process. By inserting the CAR gene at the T cell receptor (TCR) locus, this process knocks in the CAR while knocking out the TCR, creating a consistent product that can be reliably and rapidly manufactured and is designed to prevent graft-versus-host disease. Precision optimizes its CAR T therapy candidates for immune cell expansion in the body by maintaining a high proportion of naïve and central memory CAR T cells throughout the manufacturing process and in the final product.

About Precision BioSciences, Inc.
Precision BioSciences, Inc. is a clinical-stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. ARCUS is a highly specific and versatile genome editing platform that was designed with therapeutic safety, delivery, and control in mind. Using ARCUS, the Company’s pipeline consists of multiple “off-the-shelf” CAR T immunotherapy clinical candidates and several in vivo gene correction therapy candidates to cure genetic and infectious diseases where no adequate treatments exist. Elo Life Systems is a wholly-owned subsidiary of Precision BioSciences also using ARCUS to benefit human health and wellness with novel food products that enhance the nutrition and diversity of global food supply. For more information about Precision BioSciences please visit

About IonQ

We’re building the world’s best quantum computers to solve the world’s hardest problems.

We believe useful quantum computers will look as different from the laptops and smartphones we use every day as classical computers appear next to an abacus. And we believe the best way to build a quantum computer is by starting with nature’s qubit: the atom. Accurate, powerful, and flexible, ionized atoms are the heart of our quantum systems.

After decades of research, IonQ was founded in 2015 by Chris Monroe and Jungsang Kim with $2 million in seed funding from New Enterprise Associates, a license to core technology from the University of Maryland and Duke University, and the goal of taking trapped ion quantum computing out of the lab and into the market. The next year, we raised an additional $20 million from GV, Amazon Web Services, and NEA, and built two of the world’s most accurate quantum computers.

Phitonex Launches NovaFluor Dyes Enabling High-Res Analysis

Phitonex, Inc. launched their new suite of NovaFluor dyes today at CYTO2019, the 34th Congress of the International Society for Advancement of Cytometry, the largest industry conference in single cell biology.

Phitonex logo

New dyes developed on the NovaFluor platform were shown, which enable researchers to radically increase in the number of scientific questions they can answer, accelerating discoveries in biomarkers and treatments for life-threatening diseases.

“Our NovaFluor dyes address key unmet needs across the spectrum of cell analysis and help researchers answer substantially more questions per cell on extant flow cytometry instrumentation. We are incredibly excited to get our NovaFluor dyes into the hands of researchers and move forward with our game-changing InfiniFluor dyes,” said Michael Stadnisky, Ph.D, CEO of Phitonex.

Presentations describing the new dyes and the Phitonex platform technology were presented at CYTO Innovation and the Futures panel discussion by CEO Michael Stadnisky. Additionally, Phitonex won the CYTO Innovation Technology showcase based on its transformative technology, team, market opportunity, and business approach.

The Phitonex platform enables the deterministic engineering of optical properties to provide high-resolution analysis of single cells by flow cytometry, and in the future, other applications. Lower noise, less spectral overlap, and fluorescence-by-design means that Phitonex dyes immediately unlock a higher number of parameters across current instrumentation and provide unmatched cell population resolution to drive enhanced biological insight.

“By leveraging DNA as a structural tool, our platform technology allows us to customize fluorescent labels with a remarkable degree of flexibility,”  Craig LaBoda, Co-Founder and CTO said.



[Originally posted by Yahoo Finance — June 24, 2019]