This week's roundup on the region's life sciences industry includes one company securing two FDA approvals, a South Jersey institution receiving a $12 million research grant, and more. Here's the rundown:
Incyte Corp.
The Wilmington biotechnology company started the week receiving marketing clearance from the Food and Drug Administration for Opzelura, the company's topical cream for mild-to-moderate atopic dermatitis — a chronic skin disease that affects more than 21 million people in the United States — in non-immunocompromised patients 12 years of age and older. Opzelura, according to Incyte, is the first and only topical formulation of a Janus kinase (JAK) inhibitor approved in the United States. JAK inhibitors are synthetic small molecule drugs that inhibit the activity and response of enzymes, known as Janus kinases, to interfere with signal pathways linked to disease.
Also this week, Incyte (NASDAQ: INCY) received a new FDA approval for its flagship product, Jakafi, allowing the drug to be used to treat chronic graft-versus-host disease after the failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. The immune condition occurs in patients after transplantation of bone marrow or stem cells, when immune cells present in donor tissue attack the host's own tissues.
Jakafi was previously approved by the FDA as a treatment for polycythemia vera, a rare blood disorder that causes an increase in blood cells, and for steroid-refractory acute graft-versus-host disease, in adult and pediatric patients 12 years and older.
Coriell Institute for Medical Research
The Camden research institution and the Van Andel Institute in Grand Rapids, Michigan, were awarded a five-year Specialized Programs of Research Excellence (SPORE) grant, valued at $12.4 million, from the National Cancer Institute. The grant will support the efforts of nearly 20 scientists working to improve epigenetic therapies for cancer. Epigenetic therapies aim to treat cancer by correcting abnormal gene expression caused by nongenetic influences.
The project is co-led by Coriell’s CEO Dr. Jean-Pierre Issa; Peters A. Jones, the Van Andel Institute’s chief scientific officer; and Dr. Stephen Baylin of Johns Hopkins University and Van Andel Institute.
“SPORE grants hold a special place in translational cancer research," Dr. Issa said. "Through them, the NCI enables groundbreaking work and the trust it puts in the awarded scientists allows for unparalleled freedom and collaboration. … It's a sign of more exciting things to come for the Coriell Institute.”
Carisma Therapeutics
The Philadelphia immunotherapy company received a fast track designation from the FDA for its new drug candidate CT-0508, which Carisma is developing as a treatment for cancer patients with solid tumors.
The designation is designed to facilitate the development and expedite the review of investigational treatments that demonstrate a potential to address unmet medical needs in serious conditions. Companies getting the designation benefit from early and frequent communication with the FDA and the ability to submit a rolling submission for their new drug candidate application.
“The FDA’s decision to grant fast track designation to CT-0508 is another important milestone in gene-based cell therapy development,” said Steven Kelly, CEO of Carisma.
CT-0508 was originally developed by the company's scientific co-founders, Dr. Saar Gill, an associate professor of hematology-oncology at the University of Pennsylvania's Perelman School of Medicine, and Michael Klichinsky, senior vice president of discovery at Carisma.
Virpax Pharmaceuticals
The Berwyn drug developer specializing in pain management products acquired the exclusive worldwide rights to use Nanomerics' molecular envelope platform technology for the nasal delivery of a cannabidiol to manage epilepsy in adults and children.
Financial terms of the deal were not disclosed.
Under the license agreement with London-based Nanomerics, Virpax (NASDAQ:VRPX) has the right to develop, manufacture, market and sell VRP324 — the first investigational formulation delivered via the nasal route — to enhance the delivery of cannabidiol, a chemical found in cannabis plants, to the brain.
“We believe VRP324 is the first step toward building our neurological disorder therapy pipeline, expanding the use of our novel delivery platform technologies to multiple categories of neurology,” said Anthony P. Mack, CEO of Virpax.
