This week's Lab Notes has items on a Montgomery County CDMO's expansion project, a Main Line pharmaceutical firm's licensing deal, positive study results from a Philadelphia gene therapy company and more.
Here's the roundup:
Almac Group
The Irish global contract development and manufacturing organization has started construction for its previously announced $65 million expansion project on the company’s North American headquarters campus in Souderton.
The 115,000-square-foot addition, expected to be completed in 2025, will increase Alma Group's current building footprint by 50%.
"We are committed to reinvesting our profits back into the business, and this expansion in Pennsylvania will play a vital part in our continued growth," said Alan Armstrong, Almac's CEO.
The project is expected to create 355 new jobs at the site by 2026. Almac currently has almost 1,600 workers in Montgomery County, most of whom work in Souderton. The company, based in Northern Ireland, has 7,000 employees overall at 18 sites in the U.S., Europe and Asia.
The company received a $1.775 million grant through the Department of Community and Economic Development's Pennsylvania First program and a $250,000 workforce development grant.
The expansion, according to company officials, will yield a 60% increase in capacity for Almac’s clients and create more space for cold chain operations, just-in-time processing, and analytical testing capabilities to support the development of advanced therapeutic medicinal products.
The project will include the installation of a 140-foot pedestrian bridge to minimize impact to the environment on the expanded campus, while also upgrading walkability for employees and visitors. Almac said it is committed to reaching net-zero emissions by 2045.
NRx Pharmaceuticals
The Radnor biopharmaceutical company signed a license agreement for covering the use of its new drug candidate NRX-101 to treat chronic pain.
The experimental medicine contains the active ingredients D-cycloserine — an antibiotic approved by the Food and Drug Administration to treat tuberculosis, and lurasidone, an anti-psychotic medication. NRX-101 is in late-stage testing as a potential treatment for bipolar depression.
Under the terms of the license agreement with patent holder Dr. Vania Apkarian, a professor of physiology, anesthesia, surgery, and neuroscience at Northwestern University's Feinberg School of Medicine, NRx (NASDAQ: NRXP) will make undisclosed milestone payments and royalties based on the progress of the treatment.
Apkarian's patent covers the use of D-cycloserine to treat chronic neuropathic pain.
The company has also signed an agreement with Apkarian to join the NRx's scientific advisory board. Apkarian, according to NRx, has been devoted to "unravelling brain mechanisms that underlie acute and chronic pain."
"Adding a scientist of Vania's caliber will be invaluable to advancing our clinical program in chronic pain," said Dr. Jonathan C. Javitt, chief scientists and founder of NRx.
Chronic pain is estimated to be a $60 billion industry with the potential to grow to a $120 billion industry by 2033, according to NRx,
Passage Bio
The Philadelphia gene therapy company announced additional positive clinical study results from a phase 1/2 clinical study of its experimental treatment for early and late infantile GM1 gangliosidosis, also known as GM1.
GM1 is a rare, fatal lysosomal storage disease in which mutations in the GLB1 gene result in low activity of the enzyme beta-galactosidase. The inherited central nervous system disorder progressively destroys nerve cells in the brain and spinal cord.
"We are highly encouraged by the compelling data emerging from our Imagine-1 study, with results underscoring the potential of PBGM01 to be a transformative therapy for GM1 patients,” said Dr. William Chou, CEO of Passage Bio (NASDAQ: PASG).
Chou said the updated data from the first eight treated patients show that PGBM01 continues to have a favorable safety profile, is well tolerated and demonstrates initial evidence of improved survival relative to what is predicted by the natural history of the disease.
Passage Bio has already treated the first patient in the study to evaluate the gene therapy's at its highest dose level. Chou said the company expects to share initial data by mid-2024.
Quick hits
The FDA granted Orchestra BioMed Holdings Inc. (NASDAQ: OBIO) of New Hope an investigational device exemption to initiate its pivotal study evaluating the efficacy and safety of Virtue SAB for the treatment of patients with coronary ISR, a re-narrowing of a stented coronary artery segment. Virtue SAB is Orchestra's drug/device combination product that features an angioInfusion balloon for the treatment of artery disease that is designed to enable the protected delivery of SirolimusEFR — a proprietary, investigational, extended-release formulation of the immunosuppressive drug sirolimus — to the artery during balloon angioplasty without the need for balloon coating or a permanent implant.… Berwyn-based Virpax Pharmaceuticals (NASDAQ: VRPX) said it has filed a new provisional patent application with the U.S. Patent and Trademark Office, titled "NSAID Formulation and Method," related to the company's Epolader product candidate. Epoladerm is an over-the-counter topical spray film that Virpax is developing for pain associated with osteoarthritis. The product candidate will be delivered via a pre-filled device which will administer an environmentally friendly metered therapeutic dose of diclofenac in a concentrated spray film that will dry rapidly on contact with the skin.
