Alongside their phase 2b pancreatic cancer trial, Amplia have also decided to run a phase 1 ovarian trial, to be called PPROSE. Theoretically, their FAK inhibitor makes sense here too due to the nature of ovarian tumours.

I'm trying to understand where Amplia's drug candidate sits in the pack of current solid tumour treatment candidates. I'll spare you the details of my research, however, it's apparently in a good position.

In short, it's interesting because it's potentially a simple 'amplifying' addition to existing and any future treatments, rather than a complex new drug combination. It acts to break down the protective shell of some solid tumours (it's an FAK inhibitor) and shows signs of improved survival and response rate for one of the main chemo protocols. Thankfully, that's pretty easy to understand.

For all parties involved, if it continues in larger trials to add a few extra months to life on average compared to the existing treatment, while also giving some lucky patients a complete response at a remarkable rate, then who wouldn't want it assuming the same safety and tolerability seen so far?

There are plenty of other candidates out there, but they are apparently mostly more complex, so have to 'replace' existing treatment which is a higher bar.

As with all trial drugs, a lot can go wrong between now and approval, however, a lot can go right too. With more frequent dosing in the next pancreatic trial (now that they are confident about tolerability), and an ovarian trial to start soon too, there's room for positive surprises.

I have no idea when exactly a big pharma buyer swoops in to pick it up, and couldn't say when the best time to invest is, but it's an interesting candidate to track. I got in when it was neglected and cheap, then a happy surprise came and now I'm just along for the ride.

Disclaimer: Not a doctor.

The best way to judge management is to watch them over time. Helpfully, Amplia have a YouTube channel where they release neat 3 minute updates at regular intervals, along with longer form presentations. I get understated and reliable vibes.

Because of the downsizing of the Amplicity trial, the company has pivoted resources to launch a Phase 2b trial with the more gentle chemo option, the same as was used in the promising Accent 1b/2a trial.

Dosing adjustment: The new study will evaluate daily dosing to see if more continuous FAK inhibition can further enhance the clinical benefit. The Accent trial only used an intermittent dosing, but with that it demonstrated a 36% confirmed objective response rate, including 6 complete responses out of 55, and a median overall survival of 11.1 months.

Key dates:

• Patient enrolment for the 2b is planned for Q4 2026
• Safety/tolerability/PK assessment for 12 patients expected by Q2 2027.

Any further complete responses from this drug combination would reignite the buzz you can observe in the chart in 2025.

This 2nd 'AMPLICITY' trial had a setback of sorts in April, shortly after excellent updated results from the 1st 'ACCENT' trial.

It's a setback, but for reasons which aren't entirely bad. The company has cash and has already made logical pivots.

The 2nd trial was designed to test narmafotinib combined with FOLFIRINOX chemo in advanced pancreatic cancer patients. FOLFIRINOX is the more aggressive of the 2 standard chemo options and has documented toxicity issues. The previous ACCENT trial was completed with the more gentle and tolerable chemo option. The company wanted evidence for both options.

The setback for the AMPLICITY trial is that recruitment was halted after only 8 patients were dosed because 3 experienced dose-limiting toxicities attributed to the chemo itself, not narmafotinib.

Despite this, the trial continues—5 of the 8 enrolled patients are continuing with ongoing safety monitoring. The patients presumably know about the handful of complete responses from the ACCENT trial.

Early efficacy data shows 4 of the 8 patients had stable disease at 2 months, with one achieving a partial response by 4 months. So there's still the possibility for more good fortune to emerge.

This is getting interesting. Out of 55 advanced pancreatic cancer patients enrolled in their phase 2a drug trial, Amplia have seen 15 partial responses and a week ago they reported 2 complete responses. The company says achieving 15 partial responses already indicated an improvement on standard-of-care (chemo) and they are only part way through the trial.

Actually, 10 of the initial 26 in the first cohort had already shown a partial response by January. If the second cohort responds similarly then the numbers will be unambiguous. Top line read out is due in Q3 2025.

What is a complete response? When no cancer can be detected in scans for 2 months. Extremely rare in advanced pancreatic cancer.

What is a partial response? When tumours appear to have shrunk.

What is the drug? An FAK inhibitor that breaks down the fibrous shield of cancers, being combined with standard-of-care chemo to make that more effective.

2 trials: There are two main types of chemo drug cocktails that Amplia's drug will be combined with in trial. The first is more common in Australia and is currently being trialled in Aust and Korea. The second is a more aggressive chemo favoured in the USA (soon to be trialled).