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

During the latest quarterly update, Amgen Inc 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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