Australian biotech Invion Limited has had a busy 2018, and it expects to keep that momentum going in 2019.
Working with its research partner, the Monash University-based Hudson Institute of Medical Research, Invion announced last month that its photo-dynamic therapy (PDT) candidate compound, IVX-P02, showed significant ability, in laboratory tests, to kill ovarian cancer cells in vitro.
IVX-P02 is Invion’s own re-formulation of its proprietary Photosoft technology, over which Invion has exclusive commercialisation rights in Australia and New Zealand, granted to it in 2017 by the Cho Group, a Hong Kong-based group that has successfully commercialised a number of advanced technologies.
Last year, the Cho Group underwrote a $2.5 million rights issue, and emerged as 70.6% shareholder in Invion. Under the exclusive distribution and licence agreement, and the separate R&D services agreement, Invion has exclusive Australian and New Zealand rights to commercialise and distribute Photosoft for the treatment of cancers; Invion is responsible for global clinical development strategy for Photosoft; and the Cho Group provides non-dilutive funding for R&D and clinical trials.
Derived from chlorophyll, Photosoft is a ‘photo-sensitiser’ compound that can be introduced to a cancer cell and taken up by the cell, and then be activated using a particular wavelength of light to form oxygen free radicals, which kill the cell; and also, set up an immune response in the body.
The Hudson Institute found in laboratory tests that both Photosoft and IVX-P02 were substantially more effective at killing cancer cells than several other photo-sensitisers it tested – and that the IVX-P02 compound was about 15 times more efficient in killing cancer cells than Photosoft. Being more potent means that lower doses can be used to get the same effect, or an increased dose can get more effective cancer-cell mortality.
“The Hudson tests were testing a new formulation of Photosoft, that we’ve manufactured here in Australia,” says Invion chief executive officer, Dr. Greg Collier. “We changed the formulation slightly, and created a far more potent ingredient.”
IVX-P02 will now go into a topical formulation, aimed at skin cancer – indeed, any cancer that can be seen and touched – and an intravenous formulation, to be used against various solid tumours, including ovarian cancer, prostate cancer, lung cancer and brain cancer.
“We believe we’ll be in the clinic for skin cancer treatment as soon as the first quarter of 2019, with the intravenous formulation coming along about a quarter behind,” says Collier.
At its current share price of 2.8 cents, Invion is capitalised on the Australian Securities Exchange (ASX) at $154 million. At the end of the June 2018 quarter, it had cash on hand of $2.89 million: importantly, the agreement by which Cho Group will fund all clinical trials and global development of Photosoft means that Invion does not need to raise capital for this purpose.
The move to focus on Photosoft/IVX-P02 has seen Invion propose to spin off its respiratory drug candidates, INV102 (nadolol) and INV104 (zafirlukast), into an unlisted company called Chronic Airway Therapeutics (CAT), which is being offered to Invion shareholders on a one-for-one basis: anyone who holds Invion shares as of 16 November 2018 will be entitled to a one-for-one shareholding in CAT.
The company says the demerger provides a separate structure for each entity to focus on the development of their respective assets: in the case of CAT, this is a range of treatments for chronic diseases such as chronic obstructive pulmonary disease (COPD), which will be advanced into Phase 3 trials, and developed specifically for the Chinese market, where there is a very high rate of chronic lung disease.
This means that Invion is now solely focused on its cancer portfolio. The next stage in the PDT work is to move to a pre-clinical mouse model of ovarian cancer, hoping to demonstrate both direct tumour destruction and also induction of anti-tumour immunity. Invion has received ethics approval to start animal studies, with the first results expected by the end of the year. Collier says that data would then justify first clinical trials.
Invion hopes to create a new cancer treatment that can affect cancer types which have already become resistant to current treatments, such as chemotherapy, and as an alternative to surgery – and a treatment that is free of side-effects.
“When the compound is taken up by the body, it has no toxicity, no effect on the cells – there are zero side-effects, unlike chemo-therapy or immune-suppressant therapy. The therapeutic effect is switched on when light at specific wavelengths is shone directly on the compound: only then does it become toxic specifically to the cancer cells. Neither the compound nor the light has any effect on the body on its own: the effect on the cancer cells comes from the light generating oxygen free radicals from the photo-sensitiser. It’s the combination of the two that is required. Thus, it is a non-toxic approach to cancer treatment, and in that, it is a potential replacement to the current standard of care.”
Photosoft/ IVX-P02 also stimulates the body’s immune system to generate a positive immune response to the cancer. “That will set up a lot more beneficial immune response for the future in hopefully controlling any recurrence of the disease. This is quite a nice effect and down the track it could be a useful combination therapy with some of the new immune- drugs being developed,” says Collier. “The combination with the immune-treatment sets up hopefully a potential of protecting from spread, in the future.”
Invion hopes that the favourable side-effect profile will position Photosoft/ IVX-P02 as an early-stage treatment. “We would hope that eventually patients would have the opportunity to use this in all cancers, before any other more invasive therapy – before chemotherapy, and before surgery, and really help the patient earlier,” says Collier.