Reality Bites for Amgen’s bispecifics

Snippets

Developing bispecific antibodies is not easy. Just ask Amgen, which last night disclosed the halting of three such projects: pavurutamab because of apparent toxicity, AMG 673 because of a target overlap with another asset, and AMG 596 owing to “portfolio prioritisation”. All three are bispecific T-cell engagers (Bites), which are relatively small constructs that retain only some antibody features, as opposed to many other companies’ bispecifics that use a full antibody format. Those competitors have also had their problems, with Regeneron recently revealing US clinical hold on odronextamab after an Ash presentation that revealed much toxicity. True, Amgen is pressing on with the rest of its Bite portfolio, and has not written pavurutamab off. But it has made clear that cytokine release syndrome, a side effect typically associated with Car-T therapy, is also a big problem for bispecifics, on yesterday’s analyst call saying this toxicity was “the single challenge that sits before the entire [bispecifics] field”.

Amgen's Bite portfolio 
Project Target Partner Status
Active…
AMG 160 PSMA Beigene Ph1 prostate cancer trial recruiting
AMG 757 DLL3 Beigene Ph1 SCLC trial recruiting
AMG 330 CD33 Beigene Ph1 AML trial recruiting
AMG 562 CD19 Beigene Small ph1 haem cancer trial ongoing
AMG 420 BCMA Boehringer/ Beigene Ph1 multiple myeloma trial ongoing
AMG 199 Muc17 - Ph1 gastric cancer trial recruiting
AMG 427 Flt3 Beigene Ph1 AML trial recruiting
AMG 910 CLDN18.2 - Ph1 gastric cancer trial recruiting
…not so much
Pavurutamab / AMG 701 BCMA Beigene Ph1 multiple myeloma trial paused pending FDA discussions over protocol modification to "optimise safety monitoring and mitigation"
AMG 673 CD33 Beigene Ph1 AML trial on hold while AMG 330 generates more info
AMG 596 EGFRvIII Beigene Discontinued ("portfolio prioritisation")
Pasotuxizumab / AMG 212 PSMA Bayer No trials since ph1 completed 2018
AMG 211 / MEDI-565 CEA Dropped by Astrazeneca in 2018 No trials since ph1 completed 2018
Source: Amgen & EvaluatePharma.

Related Topics

Share This Article