Dive Brief:
- Shares in Celldex Therapeutics Inc. fell almost 65% on Monday after the company announced the failure of its Phase 2b METRIC study in patients with metastatic triple-negative breast cancers which over-express the gene gpNMB.
- The New Jersey-based biotech's drug — called glembatumumab vedotin — did not improve progression-free survival (PFS) compared with Roche's Xeloda, notching a median PFS of 2.9 months versus 2.8 months in patients treated with Xeloda.
- Celldex will discontinue development of the compound across all indications, and focus on the five other candidates in its clinical pipeline. The company is also planning "organizational restructuring efforts" to extend its financial resources, which may mean job cuts.
Dive Insight:
The loss of one of Celldex's lead candidates is a major blow to the biotech, reflected in the tumbling value of company shares.
"Triple-negative breast cancer is a very difficult disease to treat, and we are extremely disappointed for patients that the METRIC Study was not successful," said company CEO Anthony Marucci in an April 16 statement.
The company said it will provide an update when first-quarter earnings results are presented in May.
"We are evaluating our operational and workforce needs to extend our financial resources and direct them to continued pipeline advancement," said Marucci.
The setback compounds the effect felt by a March 2016 failure of Celldex's glioblastoma vaccine Rintega in Phase 3, which led to a then 50% drop in the company's stock.
The company now places it hopes on varlilumab, a CD27 agonist currently in a Phase 2 study together with Bristol-Myers Squibb Co.'s PD-1 inhibitor Opdivo (nivolumab) across five cancer types. Data is expected sometime in 2018.
A readout from a Phase 2 trial of the ErbB3 inhibitor CDX-3379, combined with Eli Lilly & Co.'s Erbitux (cetuximab) in head and neck cancer, is also expected this year.