Weekly Quick Hits (Research Triangle Park) – Week of May 15, 2023

By Alex Keown
May 19, 2023

Funding, Awards and Collaborations

Science 37 Wins MedTech Breakthrough Award for “Best Overall Clinical Trial Platform”

Science 37 has been named the winner of the prestigious “Best Overall Clinical Trial Platform” award in the 7th annual MedTech Breakthrough Awards program. Built on a proprietary unified platform, the Science 37 Metasite, transforms clinical research by enabling patients to participate in trials from the comfort of their homes. The Science 37 unified platform delivers trial orchestration and data capture in a single, end-to-end platform that guides the workflow for patients and study staff, and electronically captures study data. The platform enables eConsent, ePRO, telemedicine, scheduling, and wearable/ device integration to deliver clinical trials directly to patients, wherever they are. 

Syneos Health Leaders Recognized as PM360 2023 ELITE Award Recipients

Syneos Health announced PM360 named Maria Fotiu, President, Sites and Patients, Syneos Health; Sayee Natarajan, CEO & Co-founder, RxDataScience (a Syneos Health company); and Greg Christie, Chief Product Officer, StudyKIK (a Syneos Health company), as recipients of its 9th Annual ELITE Awards. The PM360 ELITE Awards recognize individuals in 19 categories in the life sciences industry who exemplify the following traits: Exceptional Leaders, Innovators, Transformers, and Entrepreneurs (ELITE).

RedHill Biopharma Receives NASDAQ Notification

RedHill Biopharma announced it received a written notification from the Nasdaq Stock Market indicating that the company is not in compliance with the minimum Market Value of Publicly Held Shares set forth in the Nasdaq Rules for continued Nasdaq listing. Pursuant to Nasdaq Listing Rule 5810(c)(3)(D), the company has a compliance period of 180 calendar days to regain compliance. 

Labcorp and Providence Expand Strategic Laboratory Relationship

Labcorp and Providence expanded a longstanding strategic relationship between the two organizations. Through the agreement, Labcorp will acquire Providence Oregon’s outreach laboratory business and select assets in Oregon. Providence Oregon will maintain operation and ownership of certain anatomic pathology and genomics outreach testing and its hospital laboratories in the region. Labcorp currently provides laboratory services to several Providence affiliate medical facilities and reference testing for facilities across multiple states served by Providence in the western United States.

In the Clinic

9 Meters Biopharma Eyes Monoclonal Antibody IND

Raleigh-based 9 Meters announced it held a successful pre-IND meeting with the FDA to obtain guidance on the preclinical development plan to support NM-136 in obesity disorders. Based on feedback from the FDA, the company believes it has the proper plan in place to progress NM-136 toward the submission of an Investigational New Drug (IND) for this indication. The company presented an abstract entitled The prevention and treatment of obesity in wild-type (WT) and hyperphagic leptin-deficient (OB/OB) mice using monoclonal antibodies (mAbs) to glucose-dependent insulinotropic polypeptide (GIP) occurs independently of appetite suppression at the Digestive Disease Week conference in Chicago,May 6 – 9.

G1 Confirms Risk of Myelosuppression for Patients Receiving Chemo for Lung Cancer

G1 Therapeutics described real-world data that confirm a consistent risk of myelosuppressive events (neutropenia, anemia, thrombocytopenia) across patients with small cell lung cancer (SCLC) being treated with chemotherapy. These findings were presented in a poster session at the 2023 meeting of the International Society for Pharmacoeconomics and Outcomes Research. Results showed that, among adult patients in this data set diagnosed with SCLC who received chemotherapy, grade ≥3 myelosuppression occurred in 60.9% of patients in the overall population. Further, more than half of the patients experienced grade ≥3 myelosuppression in all subgroups among the overall population, except one subgroup of patients for whom their SCLC stage was not documented at diagnosis. Multivariate regression analyses identified no significant associations between patient characteristics and myelosuppression; similar findings were observed in age-specific and lineage-specific regression models.

Duke Health Leads Its First Clinical Trial Testing a New Universal Flu Vaccine

Duke Health is leading its first clinical trial under a large federal initiative to develop a new-generation flu vaccine. The Phase I clinical trial, which launched last month, is testing the safety of a vaccine candidate devised under the Collaborative Influenza Vaccine Innovation Centers (CIVICs) program. CIVICs is a multi-million-dollar investment by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to develop a modern vaccine that provides longer and broader protection against both seasonal and pandemic influenza viruses.

GeneCentric Therapeutics Initiates the Alamance Study

GeneCentric Therapeutics initiated the Alamance study, a multi-center bladder cancer study conducted in collaboration with investigators at Memorial Sloan Kettering Cancer Center and the University of Wisconsin – Madison Carbone Cancer Center. Results from the study will be used to provide further clinical and analytical validation of GeneCentric’s fibroblast growth factor receptor predictive response signature (FGFR-PRS), which is a multi-gene RNA expression test that may help identify a larger population of patients who may achieve greater clinical benefit from FGFR-targeted therapy than from currently available fusion- and/or DNA mutation-based tests. The FGFR-PRS test is being developed in collaboration with Labcorp.

UNC Researcher Coauthors New Guideline

UNC Hematology faculty and Blood Research Center member Dr. Stephan Moll is coauthor on the new American Society of Hematology guideline on thrombophilia testing in patients with venous thromboembolism. These evidence-based guidelines support clinical decision-making regarding which patients and family members should be tested for inherited thrombophilias and which individuals should not be tested. The guidelines are available here.

Research Roundup

Nature Publishes Work Showing Clinical ink Technology Sensitivity to Parkinson’s 

Clinical ink, a global life science technology company, announced the publication of “Using a smartwatch and smartphone to assess early Parkinson’s disease in the WATCH-PD study” in npj Parkinson’s Disease. Baseline data from the WATCH-PD study—a longitudinal, multicenter study that deployed consumer-grade wearable and sensor devices loaded with a movement disorders application developed by Clinical ink—underwent feature engineering and statistical modeling to evaluate the technology’s sensitivity to symptoms of Parkinson’s disease. The application consisted of digital assessments of cognition, speech, and motor performance. Results demonstrated significant associations between the digital biomarkers developed from the wearable device and sensor data streams, and conventional clinical scoring methods used in Parkinson’s disease.

Precision BioSciences Presents Preclinical Data Demonstrating ARCUS Potential

Precision BioSciences will present preclinical data demonstrating the potential of ARCUS in vivo gene editing for large gene excisions toward the goal of treating Duchenne muscular dystrophy at the American Society of Gene & Cell Therapy meeting. The oral presentation is dubbed “ARCUS-Mediated Excision of the “Hot Spot” Region of the Human Dystrophin Gene for the Treatment of Duchenne Muscular Dystrophy (DMD).” Precision’s PBGENE-DMD program strategy is to restore expression of a functional form of dystrophin by utilizing a pair of ARCUS nucleases that are delivered by a single adeno-associated virus (AAV) to excise an approximately 500,000 base pair mutation “hot spot” region of the dystrophin gene.

People on the Move

Alcami Taps Laurent Boer as GM of Biostorage and Pharmaceutical Support Services.

Alcami Corporation, a leading contract development and manufacturing organization (CDMO), announced the appointment of Laurent Boer to the newly created position of General Manager, Biostorage and Pharma Services. Before joining Alcami, Laurent was Vice President & General Manager at Resilience’s biomanufacturing site in Allston, Massachusetts. Before that, he held several leadership roles at Sanofi Genzyme over a ten-year period. Laurent’s prior executive leadership experience includes supply chain roles at UCB Pharma and Biogen. Laurent received his Master of Science in Business Econometrics from Erasmus Universiteit Rotterdam in the Netherlands.

Syneos Health Leaders Recognized by HBA

Syneos Health announced that Jennifer Sozio, SVP Clinical Operations, FSP360, and Caitlin Purinai, Senior Director, Human Resources Business Partner, have been recognized by the Healthcare Businesswomen’s Association (HBA) as admirable female leaders in the healthcare industry. HBA is a global nonprofit organization comprised of individuals and organizations spanning the healthcare industry, committed to furthering the advancement and impact of women.