This company just made an IND submission to the US FDA, here’s why its a big step!

Imagion Biosystems (ASX:IBX) just made a IND submission. This is a big deal for the company, and we thought it would be the perfect time to explain to investors just what this means.

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Here’s what you need to know about an Investigational New Drug or IND submission

An Investigational New Drug (IND) application is the formal process of asking the FDA for permission to begin testing a new drug in humans. Before any clinical trial can legally start in the U.S., the sponsor has to convince the FDA that the drug is reasonably safe to give to people and that the proposed study is ethically and scientifically sound.

An IND involves submitting a package of information rather than a single form. The FDA expects to see preclinical laboratory and animal data showing how the drug works and what kinds of toxic effects it might have, with enough detail to justify the starting dose in humans.

They also require information on how the drug is manufactured, what it contains, how consistent and pure it is, and how it will be stored and handled, so there is confidence that trial participants will receive a controlled and predictable product. Finally, the IND includes the clinical trial protocol itself, laying out who will be enrolled, how the drug will be administered, how safety will be monitored, and what safeguards are in place for participants.

Once the IND is submitted, the FDA has thirty days to review it. If the agency does not raise objections during that window, the IND automatically goes into effect and the clinical trial may begin. If the FDA has concerns, it can place the study on a clinical hold, which pauses the trial until the issues are addressed. Holds are not unusual and are often resolved with additional data or protocol changes.

Imagion Biosystems has made an IND for its MagSense imaging agent

Imagion Biosystems (ASX:IBX) has been aspiring to take its MagSense imaging agent into Phase 2. Accordingly, it made an IND submission and hopes this will be the pathway to it. Investors familiar with Telix would know that there is opportunity in imaging agents.

Imaging agents are substances that are ‘administered’ to patients (usually via injection) and tumour cells show up in medical scans because the nanoparticles find and bind the tumour cells and make them more ‘detectable’. Where MagSense is special is that it can detect disease earlier, since it can identify tumours as small as one millimietre. In detecting cancers when they are smaller (i.e. at earlier stages), better treatment options may be possible.

The only alternatives are biopsies, which are surgical procedures where tissues or cell samples are removed from the body to be examined under a microscope. The ultimate outcome can take several days. Now there is a reputation for radioactivity among imaging agents, but this is not so with MagSense. And there is a low dose of it to see the ‘contrast’ needed.

Next Step Phase 2

Imagion plans to commercialise MagSense, initially for HER2+ breast cancer. Down the track, it is targeting prostate cancer and ovarian cancer. Between these, they cumulatively represent a TAM of US$2bn. But HER2+ breast cancer will be first and the subject of Imagion’s planned Phase 2 trial. HER2+ Breast Cancer is so-called because it is a phenotype of breast cancer where the HER2 protein (Human epidermal growth factor receptor 2) overexpresses in the surface of cancer cells, leading to uncontrolled cell proliferation and thus faster tumour growth and progression. IBX has chosen this indication because this is where the most promising Phase 1 data was generated and also because of the market opportunity, which we will come to shortly.

HER2+ accounts for almost 15–20% of the ~2.3 million breast cancer patients globally per annum which translates to 345,000–460,000 patients with HER2+ breast cancer every year. The high patient population represents a significant addressable market for diagnostics companies such as Imagion.

There are no current imaging agents approved by the FDA, except those only approved for use in niche circumstances – one being Lumisight that is approved for use during lumpectomies where it can help surgeons detect any remaining tumour mass remains but doesn’t tell you if the primary tumour has spread to the lymph nodes as MagSense does.

The trial will take up to 2 years, implying completion in early 2028. It has been designed in 3 parts:

• • In Part A, the trial will commence with an initial cohort of subjects to collect additional safety data
  • Part B, which will follow Part A, will evaluate the reduced dosing regimen and optimised imaging protocol established in its research collaboration with WSU.
  • Part C will establish diagnostic performance and take place in a larger cohort of clients.

IBX anticipates that the study will take 18-24 months from commencement and the study will not only show diagnostic performance but provide insights into the impact of MagSense on cost of care, patient outcomes, and overall clinical value. Moreover, by integrating quantitative imaging techniques into the study protocol, the Phase 2 trial will yield critical data for the development and training of AI diagnostic tools.

Readers interested in more on Imagion, MagSense and IBX’s commercialisation plans should check out Pitt Street Research’s reports on Imagion, the most recent of which was published earlier this week.

Investors should consider that MagSense is not a ‘never been tried before’ drug or unproven medical device. Rather, MagSense is an imaging agent (a contrast media product), a category where the chances of regulatory approval are much higher. There is no longer fundamental technical risk and likely only needs to show non-inferiority to ultrasounds to gain approval as opposed to having to demonstrate superior efficacy.

Conclusion

The filing of an IND is a big step for a company – it is an application to conduct a clinical trial. Imagion is one company that just did this and anticipates an answer in the coming weeks, potentially enabling it to start a Phase 2 trial against HER2+ Breast Cancer in the first half of 2026.

Imagion is a research client of Pitt Street Research.