Two significant announcements for oncology-focused biotechnology company, Novogen (ASX:NRT).
The company announced its has fully-acquired Glioblast, a privately-held, neuro-oncology-focused Australian biotechnology company. It also announced it has entered into a worldwide licensing agreement with Genentech, a member of the Roche Group, to develop and commercialise GDC-0084, a small molecule inhibitor of the phosphoinositide-3-kinase (PI3K) pathway.
Under the terms of the agreement to acquire Glioblast, Novogen will make an upfront payment of $2.1 million, comprising $600,000 in cash and ordinary fully-paid shares valued at AU$ 1.5 million.
The shareholders of Glioblast will be eligible for further payments in cash or equity on the achievement of performance-related milestones.
"The first two of these milestones provide for the issue of ordinary fully-paid shares valued at AU$ 1.25 million respectively on commencement and successful completion of a phase II clinical trial of GDC-0084, with the actual number of shares determined on the basis of the volume-weighted average price of Novogen shares on the ASX in the seven days prior to satisfaction of the relevant milestone being announced," said the company.
"A further two milestones may trigger payments in cash or equity at Novogen's sole discretion. Any issue of equity in Novogen will be subject to a minimum six-month escrow period."
Under the terms of the agreement with Genentech, Novogen will pay the company an upfront payment of US$5 million and performance-related consideration linked to regulatory and commercial outcomes. In addition, Genentech will receive royalty payments in-line with industry benchmarks.
Genentech will immediately initiate transfer of the IND for GDC-0084 to Novogen, as well as key manufacturing and analytical processes.
The lead indication for GDC-0084 is glioblastoma multiforme (GBM), which is the most aggressive form of brain cancer, accounting for approximately 15 per cent of primary brain tumours. Median overall survival is considered to be approximately 12 – 15 months from the time of diagnosis.
Genentech has completed a phase I study of GDC-0084 in patients with recurrent GBM, and data was presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, IL in June 20162.
According to Novogen CEO, Dr James Garner, “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.”
He added, “The PI3K inhibitor class is well-validated and is of considerable interest to larger pharmaceutical companies. While a number of development candidates are in clinical trials across a range of cancer types, we believe GDC-0084 is well differentiated and represents an important opportunity to contribute to the treatment of patients with glioblastoma.”