Novogen has acquired Glioblast, saying its capabilities will help it develop a Phase II-ready glioblastoma multiforme (GBM) candidate it is licensing from Genentech, a member of the Roche Group.

Novogen said overnight it has fully acquired Glioblast for A$2.1 million (about $1.6 million) upfront and three potential milestone payments. One of the milestone payments was disclosed—A$1.25 million in shares tied to starting and successfully completing the planned Phase II trial of GDC-0084. The other two milestones were undisclosed but will entail Novogen paying cash or equity at its sole discretion.

GDC-0084 is a small-molecule inhibitor of the phosphatidylinositol 3-kinase/serine-threonine kinase/mechanistic target of rapamycin (PI3K/AKT/mTOR) pathway that according to Novogen can penetrate the blood–brain barrier, unlike other molecules in the class—potentially making the candidate suitable for cancers of the central nervous system.

Novogen acquired rights to GDC-0084 from Genentech for $5 million upfront and undisclosed payments tied to achieving regulatory and commercial milestones. Novogen also agreed to pay royalties on a percentage of net sales.

“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,” Novogen CEO James Garner, MBBS, MBA, said in a statement.

GDC-0084 is set to enter a Phase II trial in 2017. Early in the new year, Novogen said, it anticipated providing updates on the design, project cost, and timelines of the planned study.

In June at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, data was presented from a Genentech-conducted Phase I study of GDC-0084 in recurrent glioblastoma patients.

The study—which enrolled 47 patients at five centers—showed GDC-0084 reduced tumor size in some patients and showed a reduction in the activity of some tumors using fluorodeoxyglucose positron emission tomography (FDG-PET).

The study also showed GDC-0084 to have acceptable tolerability in a group of patients with advanced brain tumors, including a majority of patients with GBM, the most common form of primary brain cancer.

Current standard of care for brain cancer offers an expected survival ranging from 12 to 15 months. The market potential for a brain cancer treatment could exceed $1 billion, Novogen said in the presentation.

Privately held Glioblast is based in Sydney, as is publicly traded Novogen.

Two Glioblast shareholders—life sciences executive Paul Hopper and Leslie Chong, the former clinical program lead for GDC-0084 at Genentech—will become consultants to Novogen and will advise it on clinical development, the company said.

Novogen’s upfront payment for Glioblast consisited of A$600,000 ($456,000) in cash and A$1.5 million ($1.1 million) in shares. The actual number of shares will be based on the volume-weighted average price of Novogen shares on the Australian Stock Exchange in the 7 days before the announcement.








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