Forum Topics ATX ATX ATX is 30% Today - This are my thoughts
ciocan76
Added 3 months ago

From today announcement:

  1. On September 20, 2024, Amplia Therapeutics Limited (ASX: ATX) announced that the US FDA granted Fast Track Designation to their lead drug narmafotinib for the treatment of advanced pancreatic cancer.
  2. Narmafotinib is a Focal Adhesion Kinase (FAK) inhibitor, which is showing promise in treating pancreatic and other cancers.
  3. The Fast Track Designation will allow Amplia to have more frequent communication with the FDA and potentially expedite the drug's development and review process.
  4. Amplia is currently conducting the ACCENT trial for narmafotinib in Australia and South Korea, and is planning a trial in the US following FDA clearance of their IND application.
  5. The company is also exploring narmafotinib's potential in other fibrotic cancers and chronic diseases like idiopathic pulmonary fibrosis (IPF).


Here are my personal thoughts and why I have a small position in RL in ATX:

  1. Promising technology: FAK inhibitors are gaining attention in cancer research, which could position Amplia well if narmafotinib proves effective.
  2. Regulatory support: The Fast Track Designation and previous Orphan Drug Designation for narmafotinib in pancreatic cancer suggest that the FDA sees potential in this treatment, which could expedite its path to market.
  3. Unmet medical need: Advanced pancreatic cancer has a poor prognosis and limited treatment options, so a successful drug in this area could have significant market potential.
  4. Early stage: The company is still in clinical trials, which means there's still risk involved. Success in early stages doesn't guarantee approval or commercial success.
  5. Pipeline potential: If narmafotinib shows promise, it could potentially be applied to other cancers or fibrotic diseases, expanding the company's prospects.
  6. Competitive landscape: The success of Amplia will also depend on how narmafotinib performs compared to other treatments in development for pancreatic cancer.

Overall, while Amplia Therapeutics shows promise with its lead drug candidate, it's important to note and probably is well known that the biotechnology sector is highly volatile and risky. The company's prospects will largely depend on the outcomes of their clinical trials and their ability to bring narmafotinib to market successfully.

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mikebrisy
Added 3 months ago

@ciocan76 thanks for putting this on the radar screen. While Phase 2a is too early for me, I will keep an eye on this one over the coming months and years, and might only initiate a position after you've done 10-20x!

Pancreatic cancer, while relatively uncommon comprising only 2-3% of all cancer diagnoses annually, has as you say a significant unmet clinical need. So if the product proves safe and even partially effective, it would be an easy blockbuster. But there is a long way to go.

Regarding the trial, 5/5 PR's is a good strike rate (you don't need advanced statistics to do that calculation!), and a positive announcement for a 6th will unlock the enrolment of the next 24 for the rest of Phase 2a. The good interim news will likely accelerate availability of trial candidates.

For the more speculatively-minded (i.e. not me), newsflow through Phase 2a might involve multiple and frequent SP catalysts like today. Importantly, if a high positive strike rate continues, as well as positive longer-term progression, I imagine there is also the propsect that the study could morph in due course into an adaptive combined Phase 2/3 - such is the need in this case. Hence the open communication channels with the FDA from Fast-Track status facilitates that kind of decision. That would be a gamechanger for the company. Now, in writing this, I have to highlight I am speaking only in generic terms, and I have not studied all the material that has been published to date on this drug. So definitely, DYOR!

And of course, further positive newsflow makes this a strong M&A candidate. The big pharma cancer specialists wouldn't bat an eyelid at acquiring a promising molecule for $<50m. That's a damn sight better than waiting 2 years and paying $1bn+. Several of the leading companies are pursuing pancreatic cancer drugs through clinical development, and adding a promising molecule at Phase 2 at such a cheap price would strengthen their development portfolio. However, the decision on whether to acquire or not, is a complex one that depends on the details of the progress of each of the competing candidates, and their assessed chances of success. So, I don't think the likelihood of that can be assessed further beyond noting that probably more than 20% and fewer than 40% of molecules that show success at Phase 2 end up being acquired or licenced. That range of stats is a global range, an I imagine the % chance of acquistion is higher if the owner is a micro-cap. On acquistions, because there can be a big SP spike on successful completion of Phase 2, there is a real premium on making the call early.

One issue with pancreatic cancer is that it is often found at a late stage, with 50-80% of diagnoses being made after the disease has already metasticised, and therefore current survival rates are very low. So it is often referred to as the "silent killer". Only a few months ago, a parent of a close friend of mine died of pancreatic cancer. One week, they are travelling the world with their partner, the next week they are diagnosed, the next in a hospice, and the next deceased.

This sad reality means that the addressible market is only a fraction of total diagnoses. But the clinical need is great, so it makes sense that the FDA would fast track anything that looks to hold some chance of success, and by the same token, would support an adaptive trial approach if the results continue to look good.

For me, $ATX is one to watch, for sure.

Disc: Not held

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