When US Supreme Court judge Louis Brandeis in 1914 opined that sunlight was the best disinfectant, he was referring to the desirability of transparent legal and government processes.

But he could well have been talking about the role of light in shrinking tumours, a treatment that has been known about for a similar amount of time.

Formerly focused on a smoking cessation drug, Invion (ASX:IVX) is emerging as a key local exponent of so-called photodynamic therapy.

Invion’s solid tumour targets include ovarian cancer, skin cancer and ano-genital cancer, which is as gruesome as it sounds.

Invion created a squeak of excitement in late November when it reported that its Photosoft treatment halved the size of tumours of mice induced with ovarian cancer over three weeks.

The “immediate and specific” death of the tumour tissues was also accompanied by an influx of immune cells, indicating an immune response.

The stock more than doubled on the results of the 48-mouse study, carried out by the Hudson Institute.

After prodding from the ASX, the company admitted the study “was not powered for statistical significance and no statistical analysis was undertaken”.

The study of course was early stage and rodent studies are notorious for producing encouraging results.

The Hudson Institute is now working over the data ahead of a phase 1b trial to treat non-melanoma skin cancers.

In a separate arrangement, Melbourne’s Peter MacCallum Cancer Centre will tackle ano-genital cancer. This effort will be overseen by leading cancer research scientist Professor Robert Ramsay, the joint head of Peter Mac’s gastrointestinal cancer program.

“We will choose to collaborate with various institutions and hospitals where the expertise fits,” Invion’s new CEO Craig Newton says.

He notes that 1500 new cases of ovarian cancer are detected in Australia each year, with 4000-5000 women already suffering the disease. There are 240,000 patients globally.

“The grim reality is that nearly half of those diagnosed with the cancer will succumb to the disease within five years,” Newton said.

 

Cho is the go for funding

For a biotech minnow, Invion is in the unusual position of not having to worry too much about fundraising. That’s because it’s 51 per cent owned by the Cho Group, which stumps up the dough for all trial work under a research and development agreement.

“This gives us a measure of certainty that doesn’t exist with other biotechs,” Newton says.

Cho is the corporate vehicle of Melbourne-based entrepreneur Michael Cho, who was aware of the common use of photodynamic therapy in China.

Formerly known as Cbio, the company focused on inflammatory conditions such as rheumatoid arthritis, but with limited success.

The company changed its name to Invion in August 2012. Invion had sought to commercialise its anti-inflammatory lead program INV102 (nadolol) as a smoking cessation aid, but could not interest any partners despite looking for two years.

In a back door listing deal in late 2017, the company entered an exclusive distribution and licence agreement to commercialise and develop Cho’s Photosoft. The deal involved Cho Group subscribing for $5.5m worth of shares at 0.2c and Cho underwriting a $2.5m rights issue at the same price.

In a 2019 deal, Hudson Institute said it would partner with Invion to research and develop the next-generation photodynamic therapy.

Hudson will provide research and clinical expertise, while Cho Group will continue to stump up the spendoolies.

In October last year, the company and Peter Mac announced a collaboration to research ano-genital cancers.

The trouble with penile and anal cancers is that sufferers are too embarrassed to see their doctor until it’s too late.

The company’s CEO for six and a half years, Greg Collier retired on October 31 last year and was replaced by Newton, the company’s chief operating officer since April 2018.

(Dr Collier founded Chemgenex, which won regulatory approval for its chronic myeloid leukaemia drug before being taken over by Cephalon for $230m in 2011).

In September 2018, Invion said it would package up its respiratory assets – nadolol and a respiratory treatment called zafirlukast – and spin them off as a separate unlisted entity focused on the China market.

In February last year Chronic Airways Therapies was born, with Invion holders receiving shares on a one-for-one basis as part of the in specie distribution. Invion also undertook a 0.3c-a-share capital return.

“Fundamentally the trajectory remains the same,” Newton says. “The company’s efforts are built around building Photosoft technology as a basis for … getting through relevant regulatory scrutiny.”

 

Seeing the light

Light therapy dates back to 1903, when Icelandic physiologist Niels Finsen snagged a Nobel Prize for his work in the area.

At least 500 trials have been carried out since.

“Light therapy has been around for a long time but for various reasons it hasn’t taken off,” Newton says.

He notes the so-called first generation light treatments were problematic in a few ways: they were derived from toxic materials and it took two to three months for the body to clear them. They also had limited membrane penetration and thus efficacy.

Photosoft uses non-toxic photosensitisers that react with visible light and oxygen to kill malignant cells in a chain reaction.

Photodynamic therapies are thought to kill malignant cells, shut down tumours and stimulate the immune system.

Photosoft uses a laser light activation method based on short, pulsating ‘near infrared’ wavelengths.

Photosoft is chlorophyll (plant) based and only accumulates in the actual cancer cells.

It produces singlet oxygen, a cytotoxic reactive agent that allows more effective zapping of the bad cells.

In the late 1970s, New Jersey-based Roswell Park Cancer Institute developed photodynamic therapies. In the 1990s they were used for prostate cancer. In 1995 the US Food & Drug Administration agreed the truth indeed was out there and approved the use of the therapy for oesophogeal cancer.

In 2017, Israeli biotech Steba Biotech won European approval for its light therapy prostate cancer treatment, Tookad.

With skin cancer, the company is targeting basal cell carcinomas and squamous cell carcinomas, the non-melanoma ones that are not generally life threatening.

The current standard of care involves cutting or freezing them off.

“Cosmetically, the results are poor,” Newton says. “This market represents low hanging fruit for a topical formulation.”

Newton says the therapy potentially could also be used as an adjunct to surgery or chemotherapy.

Other tumours of interest are lung cancers, including mesothelioma.

 

Financials and performance

As we noted previously, Invion is pre-revenue and externally funded so the company’s financials are more of a case of ‘nothing to see here, move on’.

For the record, Invion burnt $447,000 of cash in the December quarter and ended 2019 with cash of $119,000. The burn rate was affected by the timing of invoices, as pre-agreed between the parties.

In the last year, shares have traded between 0.8c (ahead of the November 26 trial results) and 2.6c (April 11). Historically the stock has traded as high as 4.8c (April 4 2018).

 

 

Dr Boreham’s diagnosis

As the only ASX-listed biotech in the photodynamic therapy game, Invion at least has a rarity value. Management has done well to snare the Cho and Hudson deals – the former involving the actual folding stuff – but it is very much a work in progress.

The unanswered question is whether Photosoft has clear clinical advantages and much more work needs to be done. In the short term, investors can expect some skin cancer results this year.

“Things are moving quite quickly,” Newton says. “We are pretty confident when we look at the penetration of the drug we have something broadly applicable.”

Overall, he says, the key to development is to bring years of experience in photodynamic therapy development into a modern regulatory framework.

“It is essentially an established concept but the key has been to make it clinically relevant,” he says. “We are putting the support we have to good use.”

Disclosure: Dr Boreham is not a qualified medical practitioner and does not possess a doctorate of any sort.  He was sceptical about photodynamic therapy but has now seen the light.

This column first appeared in Biotech Daily.

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