Cell therapy weekly: Catalent acquires commercial-scale cell therapy facility from Erytech
This week: Catalent acquires commercial-scale cell therapy facility from Erytech, Gilead’s HIV treatment studies are full steam ahead as US FDA lifts clinical hold and SwanBio secures US$56 million in Series B funding for AAV-based gene therapy.
The news highlights:
Catalent acquires commercial-scale cell therapy facility from Erytech
Catalent (NJ, USA), a leading partner for the pharmaceutical industry in development and manufacturing, has recently announced its acquisition of the Princeton (NJ, USA) commercial-scale cell therapy facility from Erytech (MA, USA), a clinical-stage biopharmaceutical company. The 30,900-square-foot facility will become a strategic hub for clinical and commercial-scale development and manufacturing of cell therapies, with the intention to support Erytech’s development of a red blood cell-derived product to treat acute lymphoblastic leukemia, eryaspase (GRASPA®). The acquisition is a testament to the rapid expansion of the cell and gene therapy industry, as well as Catalent’s commitment to supporting the development and clinical and commercial supply of cell therapies.
“The talented and experienced staff already employed at the facility, the capabilities it has in place, and the opportunity to quickly add further capacity on the same site, allow Catalent to expand rapidly to create a US campus and center of excellence for cell therapy development and manufacturing that will serve customers around the world,” commented Manja Boerman, President of Catalent Cell & Gene Therapy.
Gilead’s HIV treatment studies are full steam ahead as FDA lifts clinical hold
Gilead Sciences (CA, USA), a research-based biopharmaceutical company, has recently announced that the FDA has lifted the clinical hold imposed on its lenacapavir treatment. The hold was placed late last year due to concerns of the possible formation of sub-visible glass particles in borosilicate vials. With the clinical hold lifted, the investigational new drug application aims to test lenacapavir for HIV treatment and pre-exposure prophylaxis, allowing Gilead to continue clinical studies to evaluate the efficacy of the treatment. The hold was said to be removed as the FDA reviewed Gilead’s plan and corresponding data regarding the storage and compatibility of lenacapavir with an alternative vial made from aluminosilicate glass.
“We are pleased to have identified an alternative vial for lenacapavir, and to now advance the clinical program for this potential first-in-class long-acting option for HIV treatment and prevention,” remarked Merdad Parsey, Chief Medical Officer of Gilead Sciences. “Today’s news brings us one step closer to our goal of offering therapeutic options for the diverse communities affected by HIV as we work to end the epidemic for everyone, everywhere.”
SwanBio secures US$56 million in Series B funding for AAV-based gene therapy
SwanBio Therapeutics (PA, USA), a gene therapy company for neurological conditions, has recently announced their US$56 million success in Series B financing to support their clinical development of SBT101, an AAV-based gene therapy to treat adrenomyeloneuropathy. The funding round was led by Syncona Limited (Guernsey) and Mass General Brigham Ventures (MA, USA), after SwanBio’s FDA clearance of its investigational new drug application, orphan drug and fast track designations to SBT101. Resultantly, SwanBio’s total funding has reached US$133 million – the success will see Phase I/II studies begin later this year.
“Since our initial investment, SwanBio has made excellent progress, including rapidly advancing its lead program for adrenomyeloneuropathy toward the clinic. In parallel, the company has built the platform capabilities that will allow it to advance its broader pipeline of AAV gene therapies for spinal cord-related disorders toward clinical development,” commented Chris Hollowood, Chief Investment Officer of Syncona and Chair of SwanBio. “We are excited by the potential we see in this business to become a leading gene therapy company, delivering life-changing treatments to patients with debilitating neurological disorders.”
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