This week's life sciences news includes items on a new headquarters and research space for a growing Philadelphia biotechnology company, a cell therapy tech transfer deal involving Penn and a local CDMO, a key designation for a Conshohocken company's experimental NASH treatment, and more.
Here's the roundup:
Integral Molecular
The Philadelphia biotechnology firm unveiled its new $10 million, 32,000-square-foot headquarters and research center that will allow the company to double its workforce over the next few years.
Integral Molecular, which has 100 employees and specializes in developing and applying proprietary technologies to advance the discovery of therapeutics against difficult protein targets, is the first tenant to move into One uCity Square, a 13-story, 400,000-square-foot commercial research building at 25 N. 38th St. in West Philadelphia.
When fully occupied over the next few years, Integral Molecular's offices and research center, which includes pandemic preparedness laboratories, will accommodate up to 200 employees and add 100 new technology-based jobs to the region. The company will expand to the ninth floor next year.
Integral Molecular's last expansion occurred in 2019 when it opened a 26,000-square-foot research site at 3624 Market St.
“Our expansion in uCity Square marks a new and exciting time for Integral Molecular,” said Ben Doranz, the company's co-founder and CEO. "With our expanded infrastructure, we have more capacity for R&D and manufacturing and can quickly mobilize our technologies to combat future viral threats.”
Doranz noted that throughout the pandemic, the company has provided safe "pseudovirus" particles as a critical reagent to vaccine developers seeking alternatives to "live" viruses.
The $280 million One uCity Square building is being developed by Wexford Science & Technology, Ventas, Inc. (NYSE: VTR), and the University City Science Center.
Center for Breakthrough Medicines
The King of Prussia contract development and manufacturing organization (CDMO) has completed a technology transfer covering the University of Pennsylvania Gene Therapy Program’s cell manufacturing platform for producing adeno-associated virus gene therapies.
Financial terms of the deal are being kept confidential.
As the Penn gene therapy program's exclusive CDMO partner, the center said its clients will have immediate access to the platform for manufacturing AAV vectors, which are used to deliver cell therapies. The manufacturing platform has already been used to manufacture 100 successful production scale batches and production runs for four clinical phase programs testing cell therapy candidates.
Jennifer Manning, the center's senior vice president of global strategic partnerships, noted as the exclusive provider of the technology, the center will be able to provide its customers the option of a "well-characterized adherent AAV platform to advance their programs from discovery to first-in-human studies safely and rapidly — with less risk and expense."
Madrigal Pharmaceuticals
The Conshohocken-based biopharmaceutical company received breakthrough designation from the FDA for its lead new drug candidate resmetirom.
Resmetirom is being developed as a treatment for nonalcoholic steatohepatitis, or NASH, a liver disease characterized by the accumulation of liver fat in people who drink little or no alcohol.
The breakthrough designation, which expedites the review process for drugs targeting serious or life-threatening conditions, covers the uses of the therapy for treating NASH patients with liver fibrosis.
Madrigal (NASDAQ: MDGL) also said it has completed enrollment for the outcomes portion of its Phase 3 biopsy trial for resmetirom.
Dr. Paul Friedman, the company's CEO, said Madrigal remains "on track" to file a new drug application for the treatment during the second quarter of 2023.
Quick Hits
Incyte (NASDAQ: INCY) has received marketing authorization from the European Commission for Opzelura, the Wilmington company's treatment of non-segmental vitiligo, a chronic autoimmune disease characterized by depigmentation of skin and reduced quality of life. Opzelura, which was approved by the FDA last year, is the first and only approved treatment in the European Union to offer support for repigmentation in eligible patients ages 12 and older. … Reliefband of Horsham has launched a next-generation, water-resistant wearable product, called the Reliefband Flex, that provides the user with two weeks of uninterrupted nausea relief. The device can be worn like a watch or be attached to a smart watch. It features FDA-cleared neuromodulation technology that alters nerve activity through targeted delivery of gentle pulses to the underside of the wrist to “turn off” feelings of nausea and vomiting. The Reliefband Flex is priced at $179.99. … The FDA granted marketing approval for 50-milliliter, prefilled syringes of Hizentra, King of Prussia-based CSL Behring's treatment for primary immunodeficiency or chronic inflammatory demyelinating polyneuropathy. Demyelinating polyneuropathy is a neurological disorder that involves progressive weakness and reduced senses in the arms and legs. The 50-milliliter prefilled syringe will be available in early 2024, which the company said will give it the time to manufacture supply to meet anticipated demand. Hizentra will continue to be available in smaller quantity prefilled syringes and vials.
