Below is from a publication I subscribe to.
Imagion Biosystems drops a bombshell in quarterly
Here’s the key bit from the quarterly that sent the share price in a spiral:
‘As signaled (sic) in our shareholder newsletter in March 2021, the COVID-19 pandemic has reduced the volume of potential eligible patients presenting to the clinic. As a result, we have gotten off to a somewhat slower start than we, and our investigators, had anticipated. During the quarter we added a second site which is now actively screening for patients and we expect a third site to be screening before the end of May. To-date none of the eligible patients screened have elected to enrol in the study.’
That bold bit (last line) was a real killer.
No one elected to enrol in the study. It’s a big nasty, ‘hairs on it’ problem.
The general commentary we have on it is that these things happen in the world of breakthrough biotech. Getting Phase 1 studies up and going is not always easy, even though it’s the first hurdle.The specific commentary we have is that this is not actually a truly huge bombshell.As per their March investor newsletter:
‘One of the impacts of COVID-19 reported in Australia has been a decline in the number of patients undertaking initial screening (e.g. routine mammogram), with the Cancer Council Victoria reporting a 30% drop in diagnostic procedures in the first six months of the pandemic. Our sites have confirmed that the trend of fewer patients coming in for assessment has since remained below normal levels. We are expanding our efforts to bring on additional sites and are productively working with our sites and clinicians to help educate and reach eligible patients to mitigate risks to enrolment. We have always expected that it would take about nine months to conduct the study given the relatively small population in Australia and the requirement of only enroling (sic) newly diagnosed HER2 breast cancer subjects that have not yet undergone any treatment. We remain committed to completing the study in a timely manner and, as noted above, are working with our advisors and investigators to ensure the study is a success.’
So IBX had already flagged difficulties but based on the market reaction at the time, this wasn’t particularly surprising.The surprise was the zero enrolled patients.
The thing here is that HER2 breast cancer subjects are just a niche of the overall breast cancer problem that IBX is trying to help fix.
This makes sense, as we said in our monthly recommendation:
‘HER2-positive breast cancer affects about 25% of the 12% of women who develop breast cancer. Now the survival rate for this type of breast cancer is between 75–84%, but it's still important to detect it early.’According to Cancer Australia, in 2020 there were 19,807 new female breast cancer cases. 25% of that would be less than 5,000 patients available (potentially) and in a pandemic year, that would be tricky getting the right diagnostics done.Chuck in the 30% drop in diagnostic procedures in the first six months of the pandemic, and the pool shrinks further to around 3,500.Then it gets even further shrunk by the fact that there are only two recruiting hospitals: Monash Medical Centre in Moorabbin and East Bentleigh and Austin Health at Austin Hospital, Heidelberg.Taking Melbourne’s population of five million divided by Australia’s population of 25 million, reduces the total number of HER2 cancer patients available to IBX to 700.Some 30% of breast cancer patients have a recurrence of the cancer — and the trial specifically excludes these potential enrolees.Then you have the 5km lockdown radius of the two hospitals that was in place for months...Well, you can see where we are going with this.
But let’s really dig into this.
Turns out, there’s a human factor as well, beyond the numbers. Study dynamics might throw off prospective patients.
Let’s check out what the Australia New Zealand Clinical Trial Registry (ANZCTR) is saying about this study.
Here’s the description:
‘MagSense (Trademark) Human Epidermal Growth Factor Receptor 2 (HER2) Test Reagent (MSH2TR) will be administered once only as a subareolar injection (the pigmented area around the nipple) near or around the tumour; at dose of 30mg as either a single 3mL injection or divided into 3 x 1mL injections next to each other if the volume of injection causes discomfort, after the baseline MRI and approximately 72 hours prior to the scheduled biopsy. If 30mg is not tolerated by more than 2 subjects in the first cohort of 6 subjects, MSH2TR will be administered at 20mg either a single injection or divided into 2 x 1ml injections next to each other if the volume of injection causes discomfort.’
In a nutshell, a needle to the breast that may cause discomfort followed by a biopsy, where they take a bit of you out. Doesn’t sound like the most thrilling clinical trial. But there’s more in the summary:
‘As this study is investigating the safety of the investigational agent, participants will be asked to attend a series of seven (7) clinic visits where they will provide up to three (3) blood and urine samples.’
Seven visits and three blood and urine samples — that's a heap of effort. As far as we can tell too — this is not a paid trial. We’d also add that prospective clinical trial candidates would be likely more interested in trying therapies than diagnostic services.
‘Fix it, don’t try and figure out how to find it,’ is probably the mentality.
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