Roche licenses out PI3K pathway brain cancer med to Oz biotech

Just a few months after posting early-stage data for its experimental brain cancer med GDC-0084, Roche ($RHHBY) has handed over development rights for the drug to Australian upstart biotech Novogen ($NVGN).

Under the deal Novogen, which says this marks a new chapter in its development as an oncology biotech, will pay up $5 million to Roche for GDC-0084, a small molecule inhibitor of the phosphoinositide-3-kinase (PI3K) pathway. More biobucks are marked in the future.

The drug has finished a small Phase I in glioblastoma multiforme, a deadly form of brain cancer that can hit younger patients, and Novogen said now it has the rights to the med it will seek to push on to midstage testing in 2017--with timelines and costs to be made public early next year.

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It becomes its most advanced candidate, and comes just after the FDA gave it approval for the first phase of in-human studies of its ovarian cancer drug Cantrixil.

A number of biopharmas are working on the PI3K pathway across several cancers, though Novogen believes GDC-0084 is distinguished from most molecules in the class “by its ability to cross the blood-brain barrier,” which could help it target CNS-based cancers.

Novogen CEO Dr James Garner said: “We are excited that Genentech has entrusted us to take forward this promising investigational medicine in one of the most challenging areas of cancer treatment.

“This is a transformative step for Novogen, and the addition of GDC-0084 to our portfolio strengthens our position as an emerging oncology biotech company. Our pipeline is now diversified across three distinct technology platforms, and we anticipate it will provide a rich flow of value-driving milestones as the company progresses.”

Roche already has an approval in some countries for its multitargeting anti-VEGF blockbuster Avastin (bevacizumab) in patients with certain forms of glioblastoma.

It has however remained a difficult-to-treat cancer and is seen as the most aggressive form of brain tumor, with median survival being only around 12 to 15 months.

Novogen has also announced that it has bought up small Sydney-based biotech Glioblast Pty, a privately held neuro-oncology outfit, for just AU$2.1 million, in what it says will be directly complementary to its acquisition of GDC-0084.

Novogen, which trades at just $1.52 a share, was down 5% on Friday before the news was released, but up by the same amount first thing this morning.