There's bad news out of Celldex Therapeutics (CLDX) Monday morning. The pivotal brain tumor clinical trial involving the company's experimental cancer vaccine Rintega was stopped for futility.
Celldex was informed of the failure of the Rintega phase III study known as ACT IV on Friday evening following an interim analysis conducted by independent data monitors. The study enrolled patients with a certain type of glioblastoma multiforme (GBM), an aggressive brain tumor.
At the interim analysis, Rintega was found to reduce the risk of death by just 1% compared to the control arm. However, at the median, Rintega-treated patients fared worse, surviving 20.4 months compared to 21.1 months for the control arm, the company said.
As a result, Celldex is discontinuing clinical development of Rintega. Obviously, the company's plans to seek approval for the product in the U.S. or Europe are also being shelved.
Celldex shares are getting crushed, down 59% to $3.37 in premarket trading. The stock closed Friday at $8.19, down 48% for the year already because of the biotech bear market and investor skittishness about owning the stock ahead of the Rintega study interim analysis.
How much Celldex's stock price declines now that Rintega has blown up will depend on the value investors place on the rest of the company's cancer drug pipeline. The most advanced drug in Celldex's pipeline is glembatumumab vedotin, an antibody drug conjugate being studied in a randomized clinical trial enrolling triple-negative breast cancer patients. Patient enrollment into this study is expected to be completed in the second half of the year.