Galena Biopharma fell more than 80% in premarket trading on news that an Independent Data Monitoring Committee (IDMC) stopped a Phase III trial of its NeuVax in early stage breast cancer for futility.
The company is waiting to evaluate the data from the study, known as PRESENT, to determine its next steps. It will hold a conference call next week to review the data and to update its immunotherapy and hematology pipeline plans.
“We are extremely disappointed with the outcome of the PRESENT futility analysis,” said Galena President and CEO Mark Schwartz in a statement. “To date, the trial has not been un-blinded other than by the IDMC, and we need to evaluate the data.”
NeuVax is the company’s lead candidate; it has it in an additional 4 clinical trials in various indications. It also has a pair of Phase II candidates: immunotherapy GALE-301 in ovarian and endometrial cancer and GALE-401 (Anagrelide CR) in MPN-related thrombocytosis.
The trial halt came at a planned safety and futility interim analysis that was triggered after 70 qualifying disease free survival (DFS) events.
“At this time the DMC recommends that the study be stopped for futility unless it is determined that there has been a systematic reversal in the study drug treatments in the two arms, in which case the IDMC should reevaluate the clinical evidence,” the committee said in a letter disclosed by Galena.
NeuVax (nelipepimut-S) is a cancer immunotherapy targeting human epidermal growth factor receptor (HER2) expressing cancers. It’s an immunodominant nonapeptide derived from the extracellular domain of the HER2 protein. It is combined with GM-CSF for injection under the skin.
The PRESENT trial enrolled 758 patients with a primary endpoint of disease free survival (DFS) upon reaching 141 events with three years minimum of follow-up. The trial is in breast cancer patients who are node positive, HER2 IHC 1+/2+, and HLA A2+ and/or A3+. The study is double blind, randomized 1:1, and is stratified by stage, type of surgery, hormone receptor status, and menopausal status.
Galena had $34.7 million in cash at the end of the first quarter, with an operating loss for that period of $13.1 million. So, at that point it already had less than roughly three quarters of runway.
In premarket trading on June 29, Galena fell 83% to hit a market cap of $60 million.
- here is the release
- here is the IDMC letter
- and here is the Clinicaltrials.gov trial record
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