EMA, Regulatory

Caught in a regulatory limbo following FDA hold, EMA spurns Advaxis’ effort to seek conditional OK

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.

Kenneth Berlin

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.

Andres Gutierrez

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.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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