Black Diamond goes all in on EGFR
Black Diamond had already pivoted to its fourth-generation EGFR inhibitor BDTX-1535, and now the group is doubling down on this asset: on Monday, it deprioritised its RAF inhibitor BDTX-4933 in a bid to save costs. The company should now have cash until the second quarter of 2026; the previous estimate had it running out of money in late 2025. Black Diamond recently reported phase 2 data on BDTX-1535 in relapsed EGFR-mutated NSCLC, with a focus on C797S and PACC (P-loop alpha-c helix compressing) mutations. While a 36% ORR looked promising, investors seemed unimpressed. The company said it would home in on post-Tagrisso patients with these mutations in a pivotal trial, although firm details aren’t expected until the first quarter of 2025. Next year will also see phase 2 data from a cohort of same trial in first-line EGFR-mutant NSCLC. Meanwhile, Black Diamond is looking for a partner for BDTX-4933, which is in a phase 1 solid tumour trial; initial data had been due by the end of this year. The group’s previous lead project was the EGFR/HER2 inhibitor BDTX-189, which the group had been trialling in NSCLC with EGFR exon 20 insertions; that asset was discontinued in 2022.
Black Diamond’s pipeline
Project | Description | Indication(s) | Status |
---|---|---|---|
BDTX-1535 | 4th-gen EGFR inhibitor | NSCLC; glioblastoma | Ph2 data Sep 2024: ORR 36% (8/22) in relapsed EGFRm NSCLC; data in 1st-line EGFRm NSCLC due Q1 2025 |
BDTX-4933 | RAF inhibitor | KRASm NSCLC; RAF/RAS mutant solid tumours | Oct 2024: deprioritised, seeking potential partners |
BDTX-4876 | FGFR2/3 inhibitor | Achondroplasia or solid tumours | May 2023: seeking potential partner |
Source: OncologyPipeline.
659