Regulatory officials in Europe are waving off Advaxis’ attempt $ADXS to land on the continent with a conditional approval of axalimogene filolisbac for metastatic cervical cancer — probably not too unexpected as their Phase I/II study of the drug combined with Imfinzi was halted by the FDA recently.
According to a company statement, the EMA took a preliminary look and determined that they’d need more data before they could green-light the drug on an accelerated basis.
The FDA hold in March — a month after they filed in Europe — was followed by a company restructuring, looking to carve $30 million out of their annual budget after the setback. That revamp included braking work on axalimogene filolisbac and scrapping studies if they can’t find a partner to pick up the burn — particularly for the late-stage cervical cancer study in the plans.
In the meantime, they’re focusing more of their efforts on a preclinical program called ADXS-HOT, looking to “target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or ‘public’ mutations in tumor driver genes along with other cancer-testes and oncofetal tumor-associated antigens that also commonly occur in specific cancer types.”
There’s a new executive team at Advaxis, meanwhile, which is trying to open a new chapter at the company. That includes new CEO Kenneth Berlin as well as new CMO Andres Gutierrez.
Advaxis shares are down 8% so far today, falling by more than half since the beginning of this year.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 30,400+ biopharma pros who read Endpoints News by email every day.Free Subscription