Weekly Quick Hits (Research Triangle Park) – Week of February 20, 2023
By Alex Keown, Mark Terry, and Sarah Ellinwood
February 23, 2023
Funding and Collaborations
Emmes Opens New Office North Carolina
Maryland-based Emmes, a full-service clinical research organization, opened a new office in Wilmongton, N.C. The company called the coastal community a “center for clinical research innovation” and noted the area is views as an incubator for the CRO industry. Emmes currently has about a dozen employees in the greater Wilmington area and expects the number to grow as recruiting efforts continue.
Dentsply Sirona Initiates Organizational Changes
Dentsply Sirona, Inc. initiated an organizational restructuring plan intended to improve operational performance. The plan is anticipated to achieve at least $200 million in annual cost savings over the next 18 months through a new operating model that will streamline the organization, enhance operational efficiency, and position Dentsply Sirona to drive future sustainable growth, the company said.
Thermo Fisher Scientific Selected to Support NIH’s Blueprint MedTech program
The Wilmington-based PPD research business of Thermo Fisher Scientific was awarded a five-year contract to provide regulatory affairs support and related services for the Blueprint MedTech (BPMT) program, a new multi-institute/center initiative at the National Institutes of Health. The BPMT program is a new NIH incubator with a collaborative reach across 11 NIH institutes, whose goal is to accelerate patient access to safe, effective, cutting-edge medical devices to diagnose and/or treat disorders of the nervous system.
Life Edit, Moderna Forge Strategic Collaboration
Durham-based Life Edit Therapeutics and Moderna announced a strategic research and development collaboration to discover and develop in vivo mRNA gene editing therapies. The partnership will combine Life Edit’s suite of proprietary gene editing technologies, including base editing, with Moderna’s mRNA platform to advance in vivo gene editing therapies against a select set of therapeutic targets. Life Edit’s gene editing platform offers a large and diverse library of base editors and RNA-guided nucleases.
In the Clinic
Grid Therapeutics Initiates Phase II Trial of GT103 in Non-Small Cell Lung Cancer
Durham’s Grid Therapeutics LLC will pair its investigational lead asset, GT103 with Merck’s powerhouse checkpoint inhibitor, Keytruda as a potential treatment for advanced non-small cell lung cancer. GT103 is a novel, first-in-class antibody targeting complement factor H. The trial will enroll patients with refractory non-small cell lung cancer who have progressed on no more than two lines of systemic therapy, including prior PD-1 treatment.
BioCryst Presents New Orladeyo Data in Hereditary Angioedema Attack Rates
New data from BioCryst Pharmaceuticals’ APeX-S and APeX-2 studies evaluating once-daily Orladeyo (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) demonstrated sustained reductions in attack rates and improvement in quality of life among patients living with HAE. The company also announced additional analyses from new real-world data that further demonstrate a meaningful reduction in attack rates experienced by patients taking the medication. The new data are being presented next week at the 2023 American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting.
Aerami Therapeutics Expands AER-901 Development Program
Aerami Therapeutics expanded its AER-901 development program to include pulmonary hypertension associated with interstitial lung disease. The expansion builds on the company’s existing program in pulmonary arterial hypertension. PH-ILD is a devastating form of pulmonary hypertension affecting approximately 80,000 to 100,000 people in the United States and Europe.
Accord Healthcare Offers Generic Treatment of Schizophrenia, Bipolar Depression
Accord Healthcare, based in Durham, added Lurasidone HCL tablets to its line of generic drugs. Accord’s product is AB-rated to Sunovion Pharma’s Latuda. Lurasidone is an oral, atypical antipsychotic, which is a first-line treatment option for the management of schizophrenia in adults and adolescents.
UNC Researchers Find New Protein Activity in Telomeres
Researchers from the UNC School of Medicine discovered telomeres contain genetic information to produce two small proteins, one of which they found is elevated in some human cancer cells, as well as cells from patients suffering from telomere-related defects.
UNC Researchers: Mechanisms of Brexanolone and the Role of Inflammation in PPD
Research conducted by the Department of Psychiatry at the UNC School of Medicine, found that a drug for post-partum depression works by inhibiting systemic inflammatory pathways.
Brexanolone, approved in 2019, inhibits key systemic inflammatory pathways that are associated with depression. The new finding suggests that PPD is likely caused, at least in part, by inflammation.
New Focused Ultrasound Effective for treating Parkinson’s, Movement Disorders
Research conducted at UNC show a new focused ultrasound treatment improved dyskinesia and motor impairment in patients with Parkinson’s disease. Dyskinesia is an involuntary movement of any region of the body that can occur with long-term use of levodopa, a common drug used to treat Parkinson’s. Data from the study showed almost twice as many patients achieved improved motor function or reduced dyskinesia in the focused ultrasound group than placebo. The data was published in the New England Journal of Medicine.
Duke: New Avenue for Prostate Cancer Treatment
A Duke University School of Medicine research team found what could be a new avenue for drug developers to take in creating a therapeutic for prostate cancer. A protein called glypican-3, is expressed on the surface of neuroendocrine cells and is critical to their function. The protein is “turned off” in most normal cells, so this becomes a potential target, suggests the research, which was published online in the Journal of Pathology. This is the first to identify this protein in prostate cancer, althoughit has been seen before in liver cancer.
Study Suggests Alcohol Consumption Linked to Acceleration of Alzheimer’s Disease
A new preclinical study conducted by scientists at Wake Forest University School of Medicine showed even modest amounts of alcohol can accelerate brain atrophy and increase the number of amyloid plaques, the accumulation of toxic proteins in Alzheimer’s disease. The researchers said the findings suggest alcohol mayaccelerate the pathological cascade of Alzheimer’s disease in its early stages. The study appears in the February issue of Neurobiology of Disease.
PFAS Can Suppress White Blood Cells’ Ability to Destroy Invaders, Study Shows
Research conducted at N.C. State University found the PFAS chemical GenX suppresses the neutrophil respiratory burst, which is the method white blood cells use to kill invading pathogens. PFAS are a class of per- and polyfluoroalkyl chemicals used to make consumer and industrial products more resistant to water, stains and grease.
Regulatory and Advocacy
Areteia Therapeutics Granted ILAP Designation from UK MHRA
Chapel Hill’s Aretia Therapeutics received an Innovation Passport for dexpramipexole, an eosinophil lowering small molecule by the UK’s Medicines and Healthcare products Regulatory Agency.Dexpramipexole recently entered Phase III. The Innovation Passport is the first step in the the Innovative Licensing and Access Pathway process.
People on the Move
Kite Pharma CEO Christi Shaw to Depart at End of Q1
Gilead on Friday said Shaw will be leaving as Kite Pharma’s CEO at the end of March. The company didn’t give a reason for her departure, but the drugmaker said she’ll work closely with Gilead CEO Daniel O’Day on the transition in the coming weeks. Gilead is also kicking off a Kite CEO search.
Alcami Appoints President of Laboratory Operations
Alcami Corporation promoted Katie Schlipp to president of laboratory operations. Schlipp began her career with as an assistant scientist with AAIPharma, now known as Alcami. As President of Laboratory Operations, Schlipp will be responsible for Alcami’s laboratory network acrossfour campus locations that offers comprehensive analytical development and method establishment, QC release and stability testing, microbiology, and identification/characterization to support both small molecules and biologics.
Precision BioSciences Announces Senior Leadership Promotions
Durham-based Precision BioSciences announced multiple leadership changes. Neil Leatherbury was promoted to Senior Vice President, Head of Chemistry, Manufacturing and Controls. Leatherbury leads Precision’s teams responsible for gene delivery, analytical development, process development, manufacturing, supply chain and manufacturing science and technology. Additionally, Derek Jantz, the co-founder and chief scientific officer of the company announced his intentions to gradually step away from his current day-to-day duties. He will assume an advisory role within the company.
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