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Black Diamond Therapeutics to Discontinue ErbB Inhibitor Program, Lay Off 30 Percent of Workforce

NEW YORK – Black Diamond Therapeutics on Monday said that as part of efforts to extend its cash runway, it is discontinuing development of the ErbB inhibitor BDTX-189 and laying off 30 percent of its workforce.

The Cambridge, Massachusetts-based company is instead focusing on drugs developed using its Mutation-Allostery-Pharmacology (MAP) discovery engine, including the EGFR inhibitor BDTX-1535 and the BRAF inhibitor BDTX-4933, along with two undisclosed candidates, one of which targets FGFR. In order to extend its cash runway into Q3 2024, the company said it decided to stop developing BDTX-189, which was designed to treat tumors with EGFR and HER2 biomarkers.

The layoffs will allow the firm to refocus organizational priorities, reduce operating expenses, and "continue to invest in value-generating clinical development activities," Black Diamond CEO David Epstein said in a statement.

Black Diamond was studying BDTX-189 in a Phase I trial involving patients with advanced solid tumors harboring EGFR or HER2 biomarkers. In data presented last year, the drug showed initial efficacy across several tumor types, including partial responses or stable disease in patients with EGFR exon 20- and HER2 exon 20-mutated non-small cell lung cancer, and in HER2-amplified ovarian, pancreatic, and cancer of unknown primary.

According to the company, it decided to stop developing the drug "due to the rapid evolution of the treatment landscape in NSCLC harboring either EGFR or HER2 exon 20 insertion mutations." Last year, the US Food and Drug Administration approved Janssen Biotech's Rybrevant (amivantamab) and Takeda's Exkivity (mobocertinib) for advanced NSCLC patients with EGFR exon 20 insertion mutations.

Meanwhile, Black Diamond's other programs are progressing. This week, the company dosed the first patient in a Phase I study of BDTX-1535 in recurrent EGFR-mutant NSCLC and glioblastoma. It expects to provide a clinical update from this trial in the second half of 2023.

Its BRAF inhibitor, BDTX-4933, is currently in preclinical studies, which will support an investigational new drug application. The drug is designed to target class I, class II, and class III BRAF variants, where current BRAF-targeted therapies only target mutations in class I variants, such as BRAF V600E. Black Diamond expects to submit an IND for this drug in the first half of 2023.

Black Diamond will also announce a development candidate for its FGFR-targeted program later this year and disclose a small molecule development program in 2023.