Weekly Quick Hits (Research Triangle Park) – Week of August 14, 2023

Chimerix makes significant clinical headway on its small molecule developed for brain cancer. A paper published in a peer-reviewed journal highlights the efficacy of ONC201. Humacyte’s investigational Human Acellular Vessel is also demonstrating promise to save lives on the frontlines of the war in Ukraine. Research from UNC shows a link between the virus that causes the common cold to a blood clotting disorder.

By Alex Keown | August 18, 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 

Parexel and Partex Announce Innovative Drug Discovery and Development Alliance

Durham-based CRO Parexel and Germany’s Partex announced a preferred strategic alliance designed to leverage artificial intelligence-powered solutions to accelerate drug discovery and development for biopharmaceutical customers worldwide and de-risk the assets in their portfolios. Parexel and Partex have a shared mission to improve outcomes for patients and create an environment of continuous innovation leveraging advanced technologies, data-driven insights and collaborative ecosystems. 

Precision BioSciences Completes Strategic Transaction with Imugene for Azer-Cel

Gene editing company Precision BioSciences, based in Durham, completed a strategic transaction with Imugene Limited for global rights to Azercabtagene Zapreleucel (azer-cel), Precision’s lead allogeneic CAR T candidate, for cancer. Imugene will assume ongoing clinical execution for azer-cel in the large B-cell lymphoma population who have relapsed following autologous CAR T treatment. The license also includes an option to develop up to three other cancer research programs in the future. Precision will receive $21 upfront, consisting of cash and equity. The company is eligible for $198 million in milestone payments and up to $145 million in milestone payments and tiered royalties on net sales.

Fluree Partners with Vitality TechNet to Accelerate Drug Discovery

Fluree, which developed a knowledge graph database and semantic data pipeline toolset for secure and trusted data sharing, announced a partnership with Vitality TechNet to build a semantic data infrastructure for pharmaceutical organizations looking to enable digital Regulatory Information Management and accelerate drug discovery. Fluree provides first-class data security, audit and sharing capabilities needed by pharma organizations as they look to implement IDMP standards and build data collaboration platforms.

NightHawk Biosciences Continues to Invest in Operations: Q2 Report 

In a Q2 report, Jeff Wolf, chief executive officer of NightHawk Biosciences, said the company continues to develop its biomanufacturing operations, in the company’s San Antonio facilities and continues to evaluate a “variety of strategic options to advance these operations.” Additionally, the company continues its R&D activities. Wolf said they are “highly encouraged” by the latest preclinical data. Nighthawk will continue to develop these potential therapies through key milestones, with a focus on licensing or partnering these assets to maximize value for shareholders, Wolf said.

Fortrea Reports $793M in Revenue – First Quarter as Public Company

Durham-based Fortrea, the new life science contract research organization spun out from Labcorp’s CRO business, reported revenues of $793 million and a gross profit of $28.3 million in its first full quarter as a public company. Looking ahead, Fortrea, which has some 19,000 employees worldwide, now expects revenues of between $3.034 billion and $3.096 billion for the year with earnings of between $255 million and $285 million. Revenues were flat compared to Labcorp’s CRO business in the second quarter of 2022.

In the Clinic

Humacyte Presents Clinical Data of HAV From Ukrainian Humanitarian Program

Durham-based Humacyte’s investigational Human Acellular Vessel (HAV) was provided to five hospitals treating traumatic vascular injuries sustained in that country’s war with Russia. Clinicians reported that the rate of success in treating patients with HAV was high, with an observed 30-day HAV patency (presence of blood flow) of 95%. At 30 days after treatment with the HAV, the limb salvage rate was 100%, meaning no amputations occurred in patients treated with the bioengineered vessel. In addition, there was 100% patient survival and no cases of infection of the HAV. There was one patient whose HAV had to be removed due to shrapnel-related bleeding. This data will be included in Humacyte’s BLA to the FDA, planned for the fourth quarter of 2023.

Chimerix Data Highlights Efficacy and Molecular Mechanisms of Response to ONC201

Chimerix announced the publication of data in support of the company’s first-in-class small molecule imipridone, ONC201, as a treatment for H3 K27M-mutant diffuse midline gliomas in the peer-reviewed journal, Cancer Discovery, a journal of the American Association for Cancer Research. The manuscript titled, “Clinical efficacy of ONC201 in H3K27M-mutant diffuse midline gliomas is driven by disruption of integrated metabolic and epigenetic pathways,” reports survival analyses of 71 patients with H3 K27M-DMG treated with ONC201 which demonstrated promising results in a patient population with a poor prognosis and few treatment options. In addition to assessing clinical outcomes, the study corroborated mechanistic findings from laboratory models in samples from treated patients that demonstrated the ability of ONC201 to disrupt metabolic pathways and reverse the epigenetic consequence of the H3 K27M mutation.

RedHill Biopharma Shares Half Year Highlights

RedHill Biopharma saw positive momentum in the first half of 2023. The company reported its investigational asset RHB-107 was included in the U.S. Department of Defense-supported ACESO PROTECT multinational platform trial for early COVID-19 outpatient treatment; The 300-patient Phase II study is estimated to be completed by the end of 2024. The company also noted that its asset  Opaganib was awarded $1.7 million in U.S. government medical countermeasure development funding, which is in addition to the multimillion dollar-valued National Institutes of Health’s Radiation and Nuclear Countermeasures Program product development contract for gastrointestinal acute radiation syndrome. Following the divestiture of Movantik and the ongoing commercial and financial streamlining, the company is debt-free.

ValanBio Developing New Synthetic Antibiotic to Treat Urinary Tract Infections

RTP startup ValanBio is developing synthetic antibiotic technology LPC-233 as a potential treatment targeting gram-negative bacteria like Salmonella, Pseudomonas, and E. coli, all of which can cause many urinary tract infections (UTIs). Animal tests have shown that small molecule therapy works by interfering with the bacterium’s ability to form its outer lipid layer. The drug’s target is an enzyme called LpxC which is essential to making this outer membrane in gram-negative bacteria.

New Patents

Patent for Primary Template-Directed Amplification Bolsters BioSkryb’s Technologies

Durham-based BioSkryb Genomics announced a composition of matter patent, US Patent 11,643,682 related to its novel Primary Template-Directed Amplification (PTA) method and applications for research, diagnostics, and treatment. The patent is exclusively licensed to BioSkryb by St. Jude Children’s Research Hospital. 

Research Roundup

UNC Researchers Link Common Cold Virus to Potentially Fatal Blood Clotting Disorder

UNC School of Medicine researchers have linked adenovirus infection with a rare blood clotting disorder. This is the first time that the common respiratory virus, which causes mild cold-and flu-like symptoms, has been reported to be associated with blood clots and severe thrombocytopenia, according to reports. The data was published in the New England Journal of Medicine and sheds new light on the virus and its role in causing an anti-platelet factor 4 disorder.

Duke University Health System Launches OneDukeGen, a New Precision Medicine Study

Duke University is launching OneDukeGen, a precision medicine study to advance healthcare through cutting-edge research and collaboration. In a partnership with nference, OneDukeGen will embark on a journey to unravel the intricate connections between genetics, health, and disease. OneDukeGen will integrate comprehensive genomic data and health information to foster a deep understanding of hereditary disease susceptibilities.

Scientists Unlock Secrets of Gut Bacteria Linked to Heart Health

Researchers from Duke University decoded the genetic makeup of Akkermansia, a gut bacterium that could help manage cholesterol levels and be used as a next-generation probiotic. Akkermansia thrives in the mucus layer of the intestine and has a knack for breaking down a type of sugary protein called mucin. When Akkermansia is present in the right amounts, it’s associated with better metabolic and immune health. That’s why some scientists are exploring it as a probiotic. Data was published in Nature Microbiology.

WFU School of Medicine Awarded $1.9 Million to Study Biomarkers for Chronic Pain

The National Institute on Drug Abuse (NIDA) awarded researchers at Wake Forest University School of Medicine $1.9 million in funding to continue their research with the Acute to Chronic Pain Signatures (A2CPS) Consortium. The project was established in 2019 by the National Institutes of Health in support of research to identify novel biomarkers that can better identify individuals who are at risk of developing chronic pain. The research team will profile small molecules (metabolites and lipids) in blood samples of patients before and after surgery to identify specific changes that predict the development of chronic pain.

NC State Licenses Supplement Reducing GI Inflammation

NC State researchers created a new probiotic supplement that reduces gastrointestinal inflammation. A strain of L. acidophilus NCFM was discovered at NC State in the 1970s and has been studied extensively since. NCFM stands for North Carolina Food Microbiology, the lab where this strain was discovered. The supplement was licensed to the biotechnology company Provaxus and is now sold under its CodonRx brand.

People on the Move

Wound Healing Technology Company Merakris Adds Two Executives to Leadership Team

Merakris Therapeutics added two new executives to its leadership team as it prepares to expand its product line and increase its investigational new drug programs aimed at treating patients with chronic skin and tissue wounds that fail to heal properly. Roger Ilagan joined Merakris as Vice President, Research and Development and Mark Rogers has been named Vice President, Quality and Regulatory Affairs. Prior to joining Merakris, Ilagan was Vice President for Research and Chief Scientist at Pennsylvania-based Tavanta Therapeutics. Ilagan also spent nearly 10 years at United Therapeutics in North Carolina. Before joining Merakris, Rogers was Chief Quality and Regulatory Officer at Arizona-headquartered human cellular and tissue-based products company, Surgenex. He also worked at Georgia-based biomedical company MiMedx for eight years, where he contributed directly to that company’s dramatic sales growth.

Science 37 Recognized as Best Digital Health Solution Nominee 

Science 37 Holdings, Inc. announced its nomination for the prestigious 2023 Prix Galien USA Awards in the category of “Best Digital Health Solution.” The Prix Galien Awards, organized by The Galien Foundation, recognize and celebrate groundbreaking innovations in the life sciences industry that significantly advance human health and well-being.

Recruiting Begins for US Radiology Connexia

Raleigh-based US Radiology Specialists is recruiting for US Radiology Connexia, its new teleradiology organization designed to provide high-quality remote work options that meet the evolving needs of radiologists across various career stages. Connexia is tailored to address the rapidly growing demand for outpatient imaging services across US Radiology and the desire for a flexibility-first lifestyle among radiologists. At Connexia, radiologists can experience a more flexible work/life balance while maintaining career advancement, competitive compensation, and peer connectivity.