It’s been a bittersweet start to 2014 for Caldera Health, the Auckland company bidding to develop a new diagnostic tool for prostate cancer.
Early signs that the first round of clinical trials are likely to produce a positive result have been overshadowed by the death in January of co-founder Dr Richard Forster, one of our most brilliant and entrepreneurial scientists and arguably best known publicly for his founding role with biofuel venture LanzaTech.
Forster’s death leaves his Caldera co-founder Dr James Watson to carry on the quest to produce a more reliable test for the second biggest cancer killer of Kiwi men.
It was anger at the misdiagnosis of their prostate cancer that inspired the two scientists to launch Caldera in 2009.
“It was a major driver for Richard – it still is for me,” Watson says.While he says he is “blessed” that his own health is very good, the death of his colleague and great mate has reinforced the pressing nature of Caldera’s task.
“The one good thing about having the disease you’re working on and being our age – I’m 70 – is that you become very focussed in your work.”
Single-mindedness explains Caldera’s rapid progress. Since the moment four years ago when Watson, a renowned immunologist, and Forster, a biotech and genetics expert, pooled their complementary talents, the company has passed several milestones.
Partnering with investment firm Pacific Channel Ltd, it raised $1.5 million in the first two years to advance its efforts sourcing the capital from angel investors and the Crown-owned New Zealand Venture Investment Fund.
“It’s been a series of steps,” Watson says. “We had to find biomarkers to put into our diagnostics. That took 18 months.
The second step is to put those diagnostics onto a platform that allows you to do assays (analytical procedures) quickly, economically and to look at genetic heterogeneity.
The next step is clinical studies where you put your test to the sword and ask ‘has this set of diagnostics got the ability to distinguish between some of the different forms of prostate cancer?’.We’re in the early days of analysing our data but the signs look extremely positive.
“The commercialisation process began in earnest last year with the appointment of Graham Watt as managing director. Formerly of Roche Diagnostics, Watt has extensive experience in diagnostic business development and a potent network at his fingertips.
“When you look at the hurdles you face in developing diagnostics you begin to realise that to get global reach you have to bring in powerful partners as collaborators,” Watson says.
“We now have Graham helping to map that pathway to commercialisation.”Getting a better prostate cancer diagnostic into the market is more than a commercial enterprise for Watson and his colleagues.
Caldera Health’s position is that the current PSA test overestimates prostate cancer by more than 40 per cent and doesn’t detect early-stage cancer.
In Watson’s case, the founder of Genesis Research and Development was diagnosed by a PSA test very late in the piece – the first GP he’d visited hadn’t believed in prostate screening. Richard Forster, by contrast, had a more timely PSA test.
His cancer was allowed to advance because the test showed nothing sinister, putting him among the 15 per cent of men who return low PSA readings despite suffering severe prostate cancer.
“For men over the age of 40, finding a good diagnostic for prostate cancer is one of the major unmet clinical needs,” Watson says.
“This is about finding a way through for other males, and in a very personal way, for our sons and grandsons.”Caldera Health chairman Dr Alistair MacCormick got involved for just that reason.
“One can’t mistake the fact that there are people all over the world going after this,” says the former Dean of the Business School at the University of Auckland and a member of the Government’s Innovation Board.
“Caldera is but one of many, but it is very exciting that this is going on in New Zealand… And if I rely on the scientists that the firm is working with, the current feeling is that the company does have an edge.”
A second clinical trial is in the pipeline. Distinguishing between different forms of prostate cancer – aggressive versus indolent – is one goal.
Caldera wants to develop a diagnostic that doesn’t rely on tissue samples from the prostate but simpler and less invasive use of blood or urine.
Ultimately, the hope is that an effective diagnostic could also be tailored to optimise treatment approaches for individuals. Everyone is genetically distinct, and one person’s cancer may not resemble someone else’s, Watson notes.
“You have to solve the problem of analysing the cancer in this heterogeneous background, and as soon as you do that you begin to realise that some treatments work for some people and not for others.
“The next logical step is to extend the diagnostic tools to really understand what are the attributes that enable one patient to respond to one drug and not another.”
For now, however, the team is entirely focused on the diagnostic component.
“In two years I’d expected we’d have our next big clinical study completed and I’d like to think that we will have cemented some kind of commercial relationship with some group to get into the market. It’s not fast progress, and there lots of regulatory hurdles, but you move it along.
“Success would certainly be a fitting legacy for the late Forster. Says MacCormick: “Richard was incredibly energetic, his mind worked at a rapid rate and his enthusiasm infected everyone in the team to go hard at it.”