Amgen has stopped development of a Phase 1 bispecific T cell engager, a type of medicine that is core to its oncology portfolio and for which it has trademarked the BiTE acronym.
The California drugmaker terminated a clinical investigation of its experimental treatment AMG 794 in patients with certain forms of Claudin 6-positive cancers, including non-small cell lung, epithelial ovarian and malignant solid tumors, according to a July 8 update to the federal trials database. The study, with sites in the US, Australia and Switzerland, ended up enrolling three patients out of a planned 98.
In the update to clinicaltrials.gov, Amgen wrote that it “made the business decision to discontinue development of AMG 794. The safety profile of AMG 794 remains unchanged.” In the Claudin 6 landscape, BioNTech has an mRNA-based candidate and a cell therapy targeting CLDN6. Context Therapeutics is developing a CLDN6 and CD3 bispecific antibody. Meanwhile, Mark Alles’ TORL BioTherapeutics expects to start a pivotal trial of its antibody-drug conjugate for CLDN6+ tumors before the end of this year.
Amgen’s candidate is still listed on its oncology pipeline, which includes a handful of assets in the class of bispecific T cell engagers. The class of medicines comes with two arms that bind a T cell and a tumor cell to bring them closer, with the ultimate goal of destroying a tumor.
The company does not “have additional information to share” beyond the trial entry update, an Amgen spokesperson said in an emailed statement to Endpoints News on Tuesday afternoon. Amgen plans to release its second-quarter update on Aug. 6.
Amgen “first pioneered the concept of BiTE with Blincyto,” chief scientific officer Jay Bradner said on an investor call in May, according to an AlphaSense transcript. Blincyto came by way of Amgen’s $1.16 billion acquisition of Micromet in 2012. It also received approval for Imdelltra in a particularly aggressive lung cancer in May.