Weekly Quick Hits (Research Triangle Park) – Week of September 18, 2023

Two biopharma companies with deep ties to North Carolina saw setbacks this week. Nighthawk Biosciences announced plans to scale back operations and lay off 14% of its employees and a Novo Nordisk manufacturing facility in the state was flagged by the FDA for quality control issues. On the research front, researchers at N.C. State and UNC made strides on environmental and neurological fronts.

By Alex Keown | September 22, 2023

Quick Hits is BioBuzz’s weekly round up of all the life science news you don’t want to miss, in your region of interest. Don’t miss a beat; SUBSCRIBE to our weekly Quick Hits newsletter via LinkedIn (BioHealth Capital Region, Greater Philadelphia, Research Triangle Park) or get it delivered to your inbox every week.

Funding, Awards and Collaborations 

Nighthawk Biosciences Scales Back Operations, Lays Off Some Workers

Facing dwindling cash, Nighthawk Biosciences, formerly known as Heat Biologics, announced a restructuring plan that includes the potential sale of non-core assets, as well as a 14% reduction in staff. According to a filing with the U.S. Securities and Exchange Commission, the company will focus its resources on its subsidiary, Scorpius BioManufacturing, which operates as a contract development and manufacturing organization. The restructuring announcement comes about a month after NightHawk CEO Jeffrey Wolf made an offer to acquire Elyusys Therapeutics, a Nighthawk subsidiary. 

Mercalis Launches with an End-to-End Vision for Life Sciences Companies

TrialCard Incorporated, a fully integrated life sciences commercialization partner based in Morrisville, announced it is rebranding as Mercalis. Simple shorthand for ‘commercializing life sciences’, the new name reflects the company’s vision to help life sciences companies enhance patient lives. Years of organic growth and purposeful inorganic expansion, including seven acquisitions over the past five years, have further diversified the company beyond patient support into broader life sciences commercialization services. This transformation prompted the development and launch of the new brand—Mercalis—to encompass it all.

Raleigh Biotech Hoofprint Biome Raises $2.5 million to Reduce Methane Emissions

Hoofprint Biome, a spinout from N.C. State University, received $2.5 million from New Zealand-based AgriZeroNZ to support its research into the development of cattle probiotics and natural enzymes that improve health and digestive efficiency through the elimination of methane. 

Novo Nordisk Plant in N.C. Caught in Regulator Crosshairs

A report from the FDA flagged quality control concerns at Novo Nordisk’s manufacturing facility in Clayton, N.C. The plant produces semaglutide, which is used in diabetes and weight loss drugs Ozempic and Wegovy, respectively. The FDA report raised concerns regarding unexplained batch discrepancies and issues with microbial controls. 

Levee Medical Nets $4.3 Million to Accelerate Development of the Voro Urologic Scaffold

Durham-based Levee Medical, raised a total of $4.3 million in oversubscribed funds. Additionally, Levee Medical successfully treated the first study participants in its first-in-human (FIH) study, demonstrating initial safety data for the Voro Urologic Scaffold. The trial will evaluate the safety and performance of the Voro Urologic Scaffold as a prophylactic treatment for post-prostatectomy stress urinary incontinence.

New Products

RedHill Announces FDA sNDA Approval for Talicia

The FDA approved RedHill Biopharma’s supplemental new drug application for Talicia, allowing a change to a more flexible three times daily, taken at least 4 hours apart with food, dosing regimen for H. pylori eradication. The FDA previously approved a dosing regimen (Q8H) that required dosing every eight hours with food. The new regimen enables patients to follow a convenient “breakfast, lunch and dinner” dosing routine, which may support increased patient adherence and optimize the potential for successful H. pylori eradication. Talicia is a first-line therapy for eradication of H. pylori, a bacterial infection that affects approximately 35% of the U.S. adult population.

Marius Pharmaceuticals Expands Kyzatrex Access to Department of Veterans Affairs

Marius Pharmaceuticals, which is focused on developing therapies for testosterone deficiency, announced expanded access of its FDA-approved oral testosterone therapy, Kyzatrex to the Department of Veteran Affairs. Studies have shown that the stress associated with intense military field training can result in up to a 47% decrease in testosterone levels. This initiative is a significant milestone in Marius Pharmaceutical’s ongoing mission to provide accessible and life-enhancing therapies to focused communities.

Research Roundup

Researchers Identify Neurons that Guide Flies Upwind

Research conducted by Janelia scientists and collaborators at the University of North Carolina at Chapel Hill shows that a cluster of neurons in the fruit fly brain is able to transform memories about past rewards into actions. This helps the fly find food. The study identifies a cluster of neurons, dubbed Upwind Neurons or UpWiNs, that integrate inhibitory and excitatory inputs from these compartments, causing the fly to turn and move into the wind, according to the report. 

Genetically Modified Bacteria Break Down Plastics in Saltwater

Researchers from N.C. State University genetically engineered a marine microorganism to break down plastic in salt water. Specifically, the modified organism can break down polyethylene terephthalate (PET), a plastic used in everything from water bottles to clothing that is a significant contributor to microplastic pollution in oceans. The paper, “Breakdown of PET microplastics under saltwater conditions using engineered Vibrio natriegens,” is published open access in the AIChE Journal. The paper was co-authored by Stefano Menegatti, an associate professor of chemical and biomolecular engineering at NC State.

UNC: Scientists Take Next Big Step in Understanding Genetics of Schizophrenia

Led by Hyejung Won, of the UNC School of Medicine, researchers developed a new research model to glean a deeper understanding of the genetic variants implicated in schizophrenia, including how genes are turned on or off to affect health and disease. The team’s findings provide insights into the intricate regulatory landscape of genes but also propose a groundbreaking approach to decoding the cumulative effect of genetic variants on gene regulation in individuals with schizophrenia. The research was published in the journal Cell Genomics. The research marks a significant step forward in our understanding of the genetic basis of schizophrenia. Read more here.

On the Hill – Regulatory and Advocacy

INESSS Recommends Public Reimbursement for BioCryst’s Orladeyo

BioCryst Pharmaceuticals announced that the Institut national d’excellence en santé et services sociaux (INESSS) issued a positive recommendation for Orladeyo (berotralstat) to be reimbursed for the prevention of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years of age and older in Quebec. Health Canada authorized Orladeyo in June 2022 for the routine prevention of recurrent HAE attacks in patients 12 years and older.

People on the Move

UNCW Chancellor Volety Joins NCBiotech Board of Directors

Chancellor Aswani K. Volety, an advocate for strong collaborations among higher education, government, industry and community leaders, has joined the North Carolina Biotechnology Center Board of Directors. Volety, a well-respected administrator and a marine scientist with expertise in toxicology, immunology and biochemistry, brings a wealth of knowledge, experience and commitment to NCBiotech.

Parexel Appoints Gwyn Bebb to Lead Oncology Clinical Development

Parexel, one of the world’s largest clinical research organizations (CROs), announced the appointment of Gwyn Bebb as Senior Vice President and Global Therapeutic Area Head – Oncology. In this role, Bebb will lead the research and development of new cancer treatments for biopharmaceutical customers worldwide. Bebb is a licensed medical oncologist with more than 20 years of experience in academia and the clinical research and biotechnology industries. Most recently he was a Clinical Research Medical Director at Amgen in both early- and late-stage oncology drug development.

Duke Celebrates Nobel Prize Winner Robert Lefkowitz’s 50 Years of Scientific Discovery

Duke University will honor Nobel Prize winner Robert J. Lefkowitz’s 50 years at Duke with a two-day symposium, “Celebrating Scientific Discoveries that Advance Human Health,” to be held Oct. 2-3 at Page Auditorium. Lefkowitz’s trailblazing research on how cells communicate reshaped modern medicine. He revealed the workings of G-protein-coupled receptors that are relied on by almost half of the medications available today. 

Science 37 Chief Delivery Officer Darcy Forman Named to PharmaVoice 100 List

Science 37 Holdings Chief Delivery Officer Darcy Forman was honored with a coveted spot on the prestigious PharmaVoice 100 list. This recognition not only underscores Darcy’s leadership, it highlights the industry-wide impact of Science 37 and its positive contributions to patients, community providers, CROs, and clinical trial sponsors. In just over three years at Science 37, Darcy Forman has played a pivotal role in propelling the organization to new heights. Darcy’s leadership extends across various domains, from patient recruitment and engagement to clinical operations, global provider networks, and oversight of mobile nursing.

Triangle Insights Promotes Sarah Jims to Partner

Triangle Insights, a Durham, NC-based life sciences consulting firm, promoted Sarah Jims to partner. Jims has more than a decade of experience in the life sciences industry. Since joining the firm in 2014 as an associate strategy consultant, Jims has advised numerous biotech and pharma clients on commercial assessment, portfolio strategy, commercialization strategy, and launch readiness. She has particular expertise advising on cell and gene therapy. Jims was named a manager in 2018 and a principal in 2021.

UNC Professor Receives Diversity in Science and Excellence Award

Nancie M. Archin, assistant professor of medicine in the division of infectious diseases at the UNC School of Medicine, was awarded the International Society for Antiviral Research Diversity in Science and Excellence award. The award goes towards a scientist of any group historically underrepresented in the Society who has made outstanding contributions to the field of antiviral research. Archin’s area of interest includes HIV Latency and Cure HIV infection and latency in women.

Clinical ink Announces Senior Hires in Data Management and Data Integrity

Life sciences technology company Clinical ink announced the appointment of Jeff Bock, Vice President of Data Management and Tom Haag, Vice President of Data Quality Control. Bock will lead the development of the company’s data management strategy and expanding technology portfolio to support clinical trials. Haag will oversee the strategy and execution for ensuring the integrity of customer data sets. Bock is an experienced data management executive with 20 years specializing in building and leading data management teams in the delivery of clinical trials. Prior to Clinical ink, Bock served as Executive Director, Data Operations Technical Services at Syneos – a leading CRO biopharmaceutical solutions organization. Haag has a deep expertise in digital health and data integrity in clinical trials. He joins the company following senior roles at CRF and Novartis in digital development and quality assurance.

Parexel’s Amy McKee Named to 2023 PharmaVoice 100

Chief Medical Officer and Global Head, Oncology Center of Excellence, Amy McKee has been named to the PharmaVoice 100 list of influential people in the life sciences industry. McKee was recognized for her inspirational leadership qualities and commitment to guiding the next generation of industry leaders along with her leadership in creating breakthrough strategies for sponsors. At Parexel, McKee has been instrumental in providing patient-led medical and scientific expertise in support of the company’s therapeutic and regulatory strategies.