Weekly Quick Hits (Research Triangle Park) – Week of April 3, 2023

By Alex Keown, Mark Terry, and Sarah Ellinwood
April 7, 2023

Funding, Awards and Collaborations

Sciencix Named SBA Exporter of the Year

Based in Cary, Sciencix was named the Small Business Administration’s 2023 Exporter of the Year. Sciencix manufactures high-performance liquid chromatography and mass spectrometry parts. Those products are used in drug testing, contamination analysis, pesticide detection and more. Exports account for about one-third of Sciencix’s total sales, representing a 10% increase from 2020. 

Bioventus Enters into an Amendment with its Credit Agreement Lenders

Bioventus, a global leader in innovations for active healing, announced it entered into an amendment with Wells Fargo Bank, National Association as Administrative Agent and Collateral Agent. The amendment provides for financial covenant relief through the first quarter of 2024. The amended covenant levels will provide the company with greater financial and operational flexibility relative to its operating plan in order to execute on key growth initiatives and enhance profitability.

RedHill Biopharma Secures $6 Million Registered Direct Offering

RedHill Biopharma Ltd. raised $6 million through the sale of 1,500,000 of the company’s American Depositary Shares. The Raleigh-based company intends to use the net proceeds from this offering for general working capital, acquisitions, research and development, and general corporate purposes.

Calyx Partners with Ceretype to Neuropsychiatric Imaging Biomarkers

Regulatory services provider Calyx entered into a strategic partnership with Ceretype Neuromedicine, Inc., whose novel functional MRI (fMRI) platform incorporates optimal image acquisition and advanced analytics to de-risk and accelerate the development of psychiatric and neurological therapies. The current lack of objective biomarkers presents a real challenge for researchers developing treatments for depression/anxiety, schizophrenia, and other neurological/psychiatric conditions such as Parkinson’s Disease.

AQuity Solutions Acquires Axea Solutions

Cary-based AQuity Solutions, a provider of virtual solutions for clinical documentation capture, medical coding, and mid-revenue cycle offerings, acquired Cumming, GA-based Axea Solutions. The purchase strengthens AQuity’s revenue cycle management portfolio, gaining Axea’s expertise in its revenue cycle solutions, consulting, and education strategies for revenue cycle professionals.

Autism Research Center Awards $25,000 in PIlot Grants to UNC Research Projects

The Autism Research Center awarded three $25,000 pilot grants to UNC School of Medicine faculty members working on three interdisciplinary research projects. These research projects were selected as finalists for the Kelley Altman Greer Pilot Awards, which are aimed at funding grants for autism research conducted at UNC. The three projects backed are: “A comparative study of abnormal movements in Angelman Syndrome across mice and humans”; “With our powers combined: uniting UNC’s gender and autism expertise to meet the needs of adolescents at the intersection of autism and gender diversity”; and, “Developing brain-wide CSF flow imaging for infants at likelihood for autism.”

CREO CEO Receives 2023 Life Sciences Award

CREO CEO and co-founder Susan Acker-Walsh is a recipient of a Triangle Life Sciences Award for her contributions to advancing growth and innovation in life sciences in the Research Triangle region. The annual Triangle Life Sciences Awards recognize both individuals and research organizations that are breaking ground in this field. 

New Products

restor3d Snags Clearance of Patient-Specific Guides for use with Total Ankle System

Durham-based medical device company restor3d announced the FDA granted 510(k) clearance to the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. The Axiom PSR (patient-specific resection) System is additively manufactured from titanium alloy, making it the first all-metal, patient-specific instrument system cleared for use with an ankle arthroplasty system.

Metabolon Launches Bile Acids and Short Chain Fatty Acids Targeted Panels

Metabolon, a leader in providing metabolomics solutions, launched its Bile Acids and Short Chain Fatty Acids Targeted Panels. The panels measure microbially-derived metabolites of biological significance to identify biomarkers for the prediction and early detection of disease areas, including oncology, neurology, liver, diabetes, and gastrointestinal, and gut health. This new suite of panels targets dozens of microbially-derived metabolites across multiple pathways, including bile acid metabolism, sulfur metabolism, nitrogen metabolism, and vitamin B metabolism to advance pre-clinical and clinical research efforts.

Research Roundup

UNC Researchers Share Findings from Landmark Trial for Pediatric Crohn’s Disease

A clinical trial under the direction of Michael Kappelman, professor of pediatrics at UNC School of Medicine, found that patients receiving the tumor necrosis factor inhibitor adalimumab combined with a low dose of methotrexate, a second immunosuppressant, fared better than patients who were treated with adalimumab alone. However, patients initiating infliximab, another tumor necrosis factor inhibitor, had similar outcomes with or without methotrexate, the data showed. The findings were published in Gastroenterology, the leading journal in the field of gastrointestinal disease.

NC State Researchers Assemble Pathogen ‘Tree of Life’ for Agricultural Science

A research team from N.C. State University developed an online tool that assists in the identification, detection and monitoring of species of Phytophthora, which have been responsible for plant diseases ranging from the devastating 1840s Irish potato famine to sudden oak death. The online tool provides information about more than 192 species. The new tool will allow researchers to update plant disease information in real time.

Activation of adult-born neurons restores cognition in Alzheimer’s mouse models

UNC researchers used mice to study a process through which new neurons are generated in adulthood, called adult hippocampus neurogenesis (AHN). The research showed that deep brain stimulation of new neurons helped restore both cognitive and noncognitive functions in mouse models of Alzheimer’s disease. Data was published in the journal Cell Stem Cell.

Regulatory and Advocacy

Fennec Pharmaceuticals Receives Positive CHMP Opinion for Pedmarqsi

Fennec Pharmaceuticals Inc., a commercial stage specialty pharmaceutical company, announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended granting a Marketing Authorization for Pedmarqsi for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients 1 month to <18 years of age with localized, non-metastatic, solid tumors. When formally approved by the European Commission, Pedmarqsi will be the first and only treatment approved in the European Union (EU) to address this area of significant unmet medical need.

CMP Pharma’s Potassium Phosphates Injection Receives FDA Shelf Life Extension

CMP Pharma announced that in order to mitigate drug shortage concerns, the FDA’s CDER Office of Compliance granted a shelf life extension for CMP Development LLC Potassium Phosphates Injection. CMP Pharma’s Potassium Phosphates Injection is appropriate for pediatric patients 12 years of age and older who weigh at least 40 kg and adults weighing at least 45 kg. Other formulations are in shortage again which is a recurring problem. CMP consistently has supply of potassium phosphates available for you and your patient’s needs.

9 Meters Biopharma Reports Successful Pre-IND Meeting with FDA 

Durham-based 9 Meters Biopharma is closer to initiating a Phase I trial for its obesity treatment, NM-136, a novel humanized monoclonal antibody antagonist targeting glucose-dependent insulinotropic polypeptide (GIP). The company received a written response from the FDA for a Type B pre-IND (Investigational New Drug) meeting on the planned pre-clinical development of NM-136 for the treatment of obesity. Based on the response, 9 Meters currently plans to submit an IND to the FDA for this indication in the second half of 2023 based on the completion of the preclinical program.

People on the Move

BioCryst Appoints Nancy Hutson, PhD as Chair of the Board

BioCryst Pharmaceuticals appointed Nancy Hutson, PhD as chair of its board of directors, effective immediately. She succeeds Bob Ingram. A longtime Pfizer executive, Hutson was appointed to the board in January 2012. She retired from the pharma giant in 2006 after spending 25 years in several research and leadership positions. Hutson currently serves on the board of directors for Clearside Biomedical, Inc., Endo International and PhaseBio Pharmaceuticals.

Syneos Health Names Jeanine O’Kane as Communications President

Morrisville-based Syneos Health named Jeanine O’Kane as president of Syneos Health Communications, a portfolio of agencies spanning advertising, public relations, patient advocacy, medical communications, managed markets, and naming and branding. She previously served as president of the U.S. Public Relations Group at Syneos Health Communications.