This week's Lab Notes has items on a biotech company's partnership with a celebrity singer-songwriter, a Philadelphia medical diagnostic company's FDA recognition, a joint venture designed to help the care of premature infants and more.
Here's the roundup:
Incyte
The Wilmington biotech company has entered into a partnership with actress, singer and songwriter Mandy Moore on an educational initiative called "Moments of Clarity."
The campaign features the stories of people living with mild-to-moderate atopic dermatitis and their journey to finding relief from their symptoms.
Atopic dermatitis is the most common form of eczema, a chronic condition characterized by inflammation of the skin which can manifest as persistent itch, dry and scaly patches or red lesions on the body. The chronic skin disease affecting more than 21 million people aged 12 years and older in the U.S.
Incyte (NASDAQ: INCY) markets the drug Opzelura to treat the condition. The prescription cream launched in September 2021 and generated sales of $129 million last year.
The campaign includes the disclaimer that Moore has never been prescribed or taken Opzelura.
“A few years ago, I noticed that the skin around my eyes was itchy, inflamed and peeling," Moore states in the campaign. "After seeing a dermatologist, I was diagnosed with eczema.”
Moore, 39, goes on to encourage others with eczema to take charge of their health and talk to their dermatologists about finding an appropriate treatment.
Terms of the deal with Moore were not disclosed.
FloBio
The Philadelphia medical diagnostics company's rapid bleeding risk diagnostic test was granted breakthrough device designation by the Food and Drug Administration.
FloBio’s test determines blood clotting status and whether a patient is on popular blood thinners know as direct oral anticoagulants. The point-of-care test, if approved, would help emergency and critical care clinicians make informed treatment decisions about drug reversal to reduce serious bleeding — a major cause of preventable complications and death at hospitals.
The device combines hemodynamic flow and discrete clot activation to mimic physiological blood clotting and, in turn, rapidly produce a comprehensive direct oral anticoagulants drug assessment at the patient’s bedside.
Breakthrough device designation provides a company with an expedited regulatory review process.
"We are encouraged that the FDA has recognized that our device has the potential to provide more effective diagnosis and treatment of life-threatening diseases and conditions," said Jerri Ann Thatcher, FloBio's founding CEO.
Thatcher said the company's next step will be working with the FDA to accelerate the development, assessment, and commercialization of FloBio's technology.
FloBio, founded in 2017, was spun out of the University of Pennsylvania.
Astarte Medical
The Yardley pediatric clinical intelligence company has formed a joint venture with Tiny Health, the Texas maker of gut microbiome tests for babies and expecting parents.
The purpose of the joint venture, according to the companies, is to optimize gut health for vulnerable preterm infants.
The partnership combines Astarte Medical’s proprietary NICUbiome dataset and NICUtrition electronic medical record platform with Austin-based Tiny Health's metagenomics sequencing and functional profiling expertise to help providers will be able to identify and stratify risks and monitor the gut health of preterm babies.
NICUbiome is Astarte's digital platform that leverages machine learning to provide quantification of, and insights to, preterm infant gut health. NICUtrition is the company's real-time tool that enables NICU clinical care teams to standardize and streamline the practice of feeding.
“Nutrition for preterm infants is guided by two main factors: a baby’s age and weight," said Astarte Medical CEO Tracy Warren. "Today, technology allows us to measure and compare thousands of gut profiles, which can directly inform how we treat babies during the extremely formative first 1,000 days."
Warren said the partnership will form the basis for evidence-based precision nutrition care models for clinicians, with the goal to deliver more effective feeding to preterm babies to improve their growth, neurodevelopment and long-term immune health.
Financial terms of the joint venture are being kept confidential.
Quick Hits
Philadelphia-based Spark Therapeutics has signed an exclusive collaboration and licensing agreement with SpliceBio of Barcelona under which Spark will use SpliceBio's proprietary protein splicing platform to develop a gene therapy for an undisclosed inherited retinal disease. Financial terms of the deal were not disclosed.… SwanBio, a Philadelphia gene therapy company added two industry veterans to the company’s leadership team: Dr. John Tsai as executive chairman and Christopher “Topher” Brooke as chief operating officer. Tsai is an executive partner at Syncona and CEO at Forcefield Therapeutics. Brooke was the founder of Rumpus Therapeutics, which was acquired by Aytu BioPharma in 2021.… Centinel Spine of West Chester completed its previously announced deal to sell its global spine fusion product portfolio and related assets to Silony Spine of Switzerland. Financial terms of the sale were not disclosed.
