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Amgen Stops Phase 1 For One BiTE Molecule While Resuming Dosing For Another, Plans Second Drug Substance Plant

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Amgen Stops Phase 1 For One BiTE Molecule While Resuming Dosing For Another, Plans Second Drug Substance Plant
  • During the latest quarterly updateAmgen Inc (NASDAQ: AMGN) disclosed that it is resuming dosing for pavurutamab (AMG 710) but halted enrollment to a trial for AMG 427. Both were BiTE molecules with extended half-lives.
  • It said in February that it’d paused enrollment in the Phase I study for pavurutamab to discuss with the FDA “protocol modifications to optimize safety monitoring and mitigation with the FDA.” 
  • Pavurutamab is under development for relapsed or refractory multiple myeloma.
  • Acute myeloid leukemia candidate, AMG 427, was moved into a phase 1 study in 2018. Last week, Amgen updated the ClinicalTrials.gov listing for the therapy to “active, not recruiting” without explaining the decision to stop enrolling new patients.
  • The Company also said it would invest close to $550 million in a drug substance plant in Holly Springs, North Carolina, marking its second drug manufacturing announcement in a little more than a month.
  • The North Carolina facility will create more than 350 jobs. Construction will start in 2021 and be completed by 2029.
  • Amgen posted a fall in Q2 profit to $464 million from $1.80 billion a year earlier.
  • Price Action: AMGN shares are down 6.4% at $228.44 during the market session on the last check Wednesday.
 

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