Lel Smits from The Stock Network sat down with Imagion Biosystems’ Bob Proulx to discuss how MagSense® looks to improve upon today’s imaging, what the Phase 2 trial needs to show, and what the wider pipeline holds for the future

Video Transcript:

Imagion Biosystems is testing MagSense®, a non-radioactive imaging agent designed to help MRI scans detect cancer earlier and more precisely, starting with HER2+ positive breast cancer. Since last speaking with The Stock Network in September, the company has secured central ethics approval for its US clinical trials, selected five clinical sites, and restarted nanoparticle manufacturing. I’m joined today by Imagion Biosystems Chair Bob Proulx to discuss how MagSense® compares with today’s imaging, what the trial needs to show, and the wider pipeline. Bob, welcome back to the stock network.

Great to be here. Thanks for the invite.

Now, Imagion positions MagSense® as an alternative to radioactive PET imaging that works on existing MRI scanners. Where does it sit against PET and also standard contrast MRI for a breast cancer patient?

Yeah. So I think first to understand is PET imaging is not typically the first line of image based assessment, and that’s primarily for a couple of reasons. One is although PET is extremely sensitive the resolution of a PET image isn’t very good, and so if you really want good soft tissue imaging, you typically would pair PET with some other form like a CT or a spec. So now you’re really exposing patients to a lot of radiation unnecessarily as a screening or initial imaging tool. So, PET really hasn’t been picked up as a primary tool for image base and in particular in breast cancer since we have so many other good imaging modalities. PET really doesn’t play a significant role in primary diagnosis for breast imaging. Where it does play a role though is for example looking for potential of distant metastases. One thing I’ll give a lot of credit to PET for is because of its sensitivity and because you can do a whole body scan by PET in a relatively short period of time, that sensitivity shows up very easily all over the body. So if in fact there are distant metastases, PET is a really good way to identify that kind of thing. So I think in reality in breast imaging and in particular nodal metastasis PET is not likely to gain a foothold there because simply it’s just not the best way to image lymph nodes and axillary lymph nodes and that kind of thing. Standard contrast media for MRI similarly can be used to help improve the image for a primary tumor. But a contrast media like gadolinium is not going to disseminate into the lymph nodes and help you identify whether there’s nodal metastasis in lymph nodes. And so that’s ultimately why we identified this as an unmet medical need still. There isn’t a good solution by imaging to do this. We often use axillary ultrasound, but as you probably know from standard ultrasound images, they’re not very clear. And so being able to differentiate a node that is involved with cancer versus not, today is simply reliant on anatomical size and shape.Does it look irregular and is it big? Right? That’s not a really great way to assess whether or not there’s cancer in there because a lymph node could be enlarged in someone who’s undergoing an immune response. You know during COVID we saw a lot of people with inflamed lymph nodes because their immune system is responding to the infection. So, today the unmet medical need still is that we don’t have a really good way by other imaging tools to know whether or not what we see in a lymph node is in fact cancer.

Okay. And Bob, early clinical data suggested that MagSense® could help tell cancerous lymph nodes from healthy ones. Bob, can you tell us what will the US trial need to show for surgeons to rely on it over a biopsy?

Yeah. So, we were really excited that our phase one data, the study we did in Australia, in fact demonstrated that our methodology actually could start to solve that problem that I just described. So if ultrasound only shows you something that’s enlarged by size and shape, our
phase one data said no actually the MagSense® imaging agent can be detected in the lymph nodes and we can differentiate a node that is normal from a node that actually has cancer in it.
So now if the phase two study is designed to extend that can, we only did 13 patients in phase one, so now the primary purpose of the phase two is to establish a larger cohort of patients where we can go and see whether or not the end point of being better than ultrasound for the detection of lymph nodes is still concordant with pathology. So if we say the node is involved, did the tissue sample by pathology show there were cancer cells in it yes or no. So yes and yes and no and no kind of thing. It’s still not enough to go ahead and get regulatory approval. We will need to do a larger cohort of patients. But you start with this intermediate phase two because you don’t want to spend a lot of money until you’re pretty sure that your end points are going to be reached in the final pivotal study.

Yes. And in terms of really extending MagSense® to prostate and ovarian cancer, changing the targeting molecule lets MagSense® look for other cancers. How are you though prioritizing prostate and ovarian cancer and also what milestones are ahead for those programs?

Yeah, so one of the really nice things that we found is irrespective of what the targeting ligand is. So whether it’s for targeting HER2+ breast cancer or whether it’s targeting prostate cancer, the image that we get is virtually identical. So if you look at our pre-clinical animal studies, the spotty pattern you get associated with the presence of our particles, you couldn’t tell the difference between an ovarian cancer tumor and a prostate tumor and a breast lymph node involved because they all work exactly the same. So that’s really great. That means we in fact we have a platform to build on here. And so now really it’s a function of having the resources necessary to continue to advance those. You know, these are two slightly different cases in terms of the market potential. The prostate cancer market is a very large market. The number of men that are screened for prostate cancer and ultimately need some form of treatment is larger than the market for ovarian cancer. But the downside for ovarian cancer is today the imaging that we have doesn’t detect cancer until it’s very late. So the unmet medical need is very high in ovarian cancer. But the market size is larger for prostate. So the question you asked is how do we balance that? I think if you gave me my drothers, I’d say I want to have the capital to advance both of those as fast as I can because they both have significant unmet medical need and address really important markets. And so the next milestone for us would be that we are able to fund the pre-clinical toxicology programs necessary to get into a phase one study and get those in the clinic as quickly as we can.

Well, Bob, I appreciate the update from Imagion Biosystems today.

Thanks very much. Glad to be here.