Weekly Quick Hits (Research Triangle Park) – Week of September 25, 2023

RTP will see a first-of-its-kind life sciences campus with HUB RTP. The new site will include offices, lab space, retail sites and even residential units. Pfizer will re-open its manufacturing facility in Rock Mount that was damaged by a tornado earlier this year. This will restore the flow of essential medicines used by hospitals across the country. 

By Alex Keown | September 29, 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 

New Innovation Center Coming to RTP

Developers are constructing a mini-city in the middle of Research Triangle Park. Called Hub RTP, the complex is expected to include office buildings, shops, a hotel, and 406 multifamily residential units. The new complex marks a departure from historical developments, which typically emphasized secluded corporate campuses that gave employees little reason to remain after the work day. A groundbreaking is expected in 2024 and developers are in advanced talks with potential tenants. 

NCBiotech Secures Share of $150,000 Federal Grant for Agtech

The North Carolina Biotechnology Center will receive $10,000 over two years from the Small Business Administration to support and promote innovation in crop science, animal health, food tech and precision agriculture. There are approximately 200 agtech companies in North Carolina. To date, NCBiotech has awarded almost 450 ag tech grants worth a total of $21.4 million, as well as 40 ag tech loans totaling $3.2 million.

Tornado-damaged Pfizer Plant in North Carolina Restarts Production

A major Pfizer pharmaceutical plant in North Carolina that makes critical supplies for U.S. hospitals restarted production about 10 weeks after it was heavily damaged by a tornado, the Associated Press reported. The plant produces anesthesia and other drugs as well as nearly one-fourth of the sterile injectable medications Pfizer supplies to U.S. hospitals. Thirteen medicines were prioritized based on patient need and inventory levels, and are now back in production on the lines that have restarted, Pfizer said. The medicines are expected to ship to distribution centers in the fourth quarter of this year, according to reports. 

Kriya Forges License, Collaboration Agreement with Everads to Advance Gene Therapies

Kriya Therapeutics entered into an exclusive license, collaboration and supply agreement with privately-held Everads Therapy, Ltd to advance Kriya’s portfolio of gene therapies for retinal diseases using Everads’ suprachoroidal delivery device. Everads developed a novel technology enabling targeted delivery of therapies to the retina via the suprachoroidal space, an anatomical compartment located between the sclera and choroid that traverses the circumference of the posterior segment of the eye. Suprachoroidal delivery is an emerging, non-surgical route of administration in ophthalmology. This route of administration offers the potential to enhance the efficiency of gene therapy delivery to the retina while minimizing intraocular inflammation.

Nasdaq Hits RedHill Biopharma with Notice Regarding Minimum Bid Price Deficiency

RedHill Biopharma revealed that on Sept. 19, 2023, it received a letter from the Listings Qualifications Department of The Nasdaq Stock Market LLC indicating that, for the thirty consecutive business days from Aug. 7, 2023, to Sep. 18, 2023, the bid price for the Company’s American Depositary Shares had closed below the minimum $1 per share requirement for continued listing. The Nasdaq letter is only a notification of deficiency and has no immediate effect on the listing or trading of the company’s ADSs. The company has been provided an initial period of 180 calendar days to regain compliance. 

UNC Trial Receives Financial Support from DoD for Tonix Pharmaceuticals Trial

The University of North Carolina Institute for Trauma Recovery was awarded a $3 million grant from the Department of Defense (DoD) to investigate the potential of Tonix Pharmaceutical’s TNX-102 SL (cyclobenzaprine HCl sublingual tablets) to reduce the frequency and severity of adverse effects of acute trauma. Such adverse effects include acute stress reaction (ASR), acute stress disorder (ASD), and posttraumatic stress disorder (PTSD). The trial will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients following a motor vehicle collision. The trial will enroll approximately 180 trauma survivors at study sites around the U.S. Participants will be randomized in the emergency department to receive a two-week course of either TNX-102 SL or a placebo.

In the Clinic

United Therapeutics Announces Milestones for Xenotransplantation Programs

United Therapeutics, which has a significant presence in RTP, announced the second transplant of a UHeart xenoheart into a living person. The pig heart was transplanted into a man with end-stage heart disease. He was deemed ineligible for a traditional transplant with a human heart due to his pre-existing peripheral vascular disease and complications with internal bleeding. 

Milestone Pharmaceuticals AFib-RVR Study Selected for AHA Scientific Sessions

Milestone Pharmaceuticals announced that results from a double-blind, randomized, placebo-controlled Phase II etripamil study will be presented at the American Heart Association (AHA) Scientific Sessions 2023. Selected for a Featured Science Presentation, the ReVeRA study evaluated etripamil in emergency department patients with atrial fibrillation with the rapid ventricular rate (AFib-RVR). The presentation will take place at the AHA Scientific Sessions in Philadelphia, PA and virtually from November 11-13, 2023.

New Patents

Precision BioSciences Receives U.S. Patent Allowance Covering PBGENE-PMM 

Precision BioSciences received a Notice of Allowance from the U.S. Patent and Trademark Office for U.S. Patent Application No. 18/161,560, titled “Engineered Meganucleases That Target Human Mitochondrial Genomes.” The composition of matter claims in this application encompasses a mitochondria-targeted ARCUS nuclease designed to specifically target, cleave, and eliminate mutant mitochondrial DNA comprising an m.3243A>G mutation. Once issued, the patent arising from this application will have a standard expiration date in April 2042.

Research Roundup

UNC Researchers Connect Alzheimer’s-Associated Variants with Brain Cell Function

Scientists from the University of North Carolina and UCSF identified thousands of genetic variants in the genome in the development of Alzheimer’s disease. The variants are located in genomic regions that do not code for proteins. Researchers identified the connections of risk variants with functions in microglia and how they may contribute to AD. Findings from this study are expected to serve as a foundation for other researchers to discover more causal variants of AD, predict disease risks, and develop more effective therapies, the university said. 

UNC Research Leads to Insights into the Molecular Mechanism of Protein Degradation

A new study led by UNC researchers published in the journal Nature Structural and Molecular Biology, explores the movements of the Anaphase-Promoting Complex/Cyclosome (APC/C), a ubiquitin ligase, which drives the cell cycle. The mechanics behind APC/C’s attaching of a ubiquitin signal remained an unsolved puzzle.

New EGIDs Real World Registry Surpasses 1,000 Patient Milestone

Launched as a response to market interest and high unmet need, today real-world evidence (RWE) leader Target RWE, based in Durham, announced a milestone achievement of surpassing 1,000 patients enrolled in the company’s eosinophilic gastrointestinal disorders (EGIDs) disease state registry. EGIDs are a group of chronic, immune-mediated gastrointestinal diseases. They affect different parts of the digestive system, from the esophagus to the large intestine, and may be linked to food allergen exposure.

New AI Model Improves Accuracy of Tumor Removal in Breast Cancer Surgery

A clinical and research partnership between the UNC Department of Surgery, the Joint UNC-NCSU Department of Biomedical Engineering, and the UNC Lineberger Comprehensive Cancer Center created an AI model that can predict whether or not cancerous tissue has been fully removed from the body during breast cancer surgery. Their findings were published in Annals of Surgical Oncology.

People on the Move

IQVIA Appoints Richard Staub III President of Research & Development Solutions

IQVIA appointed Richard Staub III as president of its Research & Development Solutions (R&DS) business unit. He is currently senior advisor to the Chairman and CEO. Staub is an experienced executive with 34 years in the life science sector and has held numerous senior executive roles across multiple contract research organizations. He previously served as the president of the R&DS business unit at IQVIA from 2016 to 2022. During his tenure Richard oversaw the rapid expansion of IQVIA’s clinical research capabilities and, critically, he successfully led this business unit through the unprecedented challenges of the COVID-19 global pandemic.

Syneos Health Names Terttu Haring President, Clinical Sites & Patients

Syneos Health appointed Dr. Terttu Haring as President of Clinical Sites & Patients. Haring will lead the global clinical operations organization to drive exceptional delivery, quality and data integrity for customers while ensuring a positive experience for sponsors, sites and patients. Haring most recently held multiple leadership roles at Sanofi, with escalating responsibility across Clinical Research, Trial Operations and Data Management, and Clinical Innovation. 

EmVenio Research Adds Two New Principal Investigators

Clinical research organization EmVenio Research announced the addition of Dr. Michelle Mallitz and Dr. Thomas Wade to its team to serve as principal investigators. In their roles, they will oversee and conduct objective clinical research. Mallitz was most recently a clinical investigator at Care Access. She has worked on 130 clinical trials in various areas of study focusing mainly on cardiovascular effects. As a principal investigator, Wade has participated in more than 75 clinical trials, including studies for treatments for chronic illnesses and rare genetic conditions.