Beam Therapeutics
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Gene editing technologies are advancing rapidly in the clinic, with the potential first approval later this year, but challenges remain.
Orbital will use Series A funds to advance RNA-based vaccines, immunomodulators and protein replacement therapies.
Currently, there are no gene editing–based treatments on the market, but the technology continues its march toward potential FDA approval, with several products in mid- and late-stage trials.
The FDA has lifted its clinical hold on Beam Therapeutics’ BEAM-201 and cleared the way for an Investigational New Drug Application, the company announced Friday.
Beam Therapeutics has enrolled the first patient in a Phase I/II trial studying a gene therapy leveraging base editing in adults with severe sickle cell disease.
Verve Therapeutics’ base editing program has been forced into a detour after the FDA placed a hold on its investigational new drug application. Beam has also posted its own regulatory update.
Orbital Therapeutics, co-founded by John Maraganore, launched with the goal of harnessing the full potential of RNA-based therapeutics to tackle diseases in a new and more effective manner.
The FDA has had a busy week, accepting drug applications, approving clinical trials and granting various special designations for Gamida Cell, Cellectis, Scynexis & more.
The FDA has placed a clinical hold on Beam Therapeutics’ leukemia/lymphoma therapy and has lifted the hold on Celyad’s CAR-T candidate for colorectal cancer.
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