ILA strengthens US biodefence positioning ahead of clinical trials
Our Biotech Pick of the Year Island Pharmaceuticals (ASX: ILA) just added Mark Herzog to its team as “Senior Global Health Security Advisor”.
So ILA now has Mark on board - someone with 25+ years of experience and a track record of securing US$100M+ US government stockpiling contracts.
(The exact skillset ILA needs in its corner ahead of clinical trials for its Marburg disease drug).
ILA also confirmed that it has been appointed to two Medical Countermeasures Coalition (MC2) working groups - on R&D and Procurement & Stockpiling.
This puts ILA inside the policy discussions on Strategic National Stockpile (SNS) funding and "virtual stockpile" frameworks being considered by US health security agencies.
In short - ILA is strengthening its position in the US biodefence ecosystem right before it kicks off the FDA Animal Rule studies for its Galidesivir drug to treat against the Marburg Virus Disease.
ILA expects dose escalation studies for its Marburg drug to start next quarter (advanced negotiations underway with biocontainment facilities). (source)
For context - Marburg is classified as a Category A bioterrorism threat (the highest level threat) by the US government (source).
And Marburg is the only Category A biothreat with NO current vaccine or FDA approved treatment...
ILA’s drug already has human safety trials completed.
It is the type of drug that can find itself getting a government stockpiling deals, which can generate lifetime sales into the billions:
(source)
ILA has flagged that this drug could be used to treat Ebola also which is topical given the current outbreak in Africa, Marburg is also from the same virus family:
(source)
Why we like today’s news
Mark Herzog brings exactly the kind of CV ILA can benefit from as it moves from clinical development toward potential US government procurement/stockpiling.
Here is that CV:
- 25+ years executive leadership across biopharmaceutical, biodefence and clinical laboratory sectors
- Most recently 12 years in senior roles at a US pharmaceutical company supporting multiple US Department of Defense (DoD) biodefence initiatives
- Track record of developing and obtaining US$100m+ in US and international government contracts
- Led FDA-approved product launches
- Deep working relationships across:
- DoD (Department of Defense)
- HHS (Department of Health and Human Services)
- BARDA (Biomedical Advanced Research and Development Authority)
- NATO and allied procurement ecosystems
- Currently serves on the executive committee of the Medical CBRN Defense Consortium (MCD) - a leading US biodefence consortium supporting the development and procurement of medical countermeasures targeting chemical, biological, radiological and nuclear threats
Herzog has been hired to assist with:
(source)
That last point is the key one for us as SNS contracts for Category A bioterror threats have historically been worth between US$100M and US$1.2BN in lifetime sales.
We covered this prior here and ILA have included a slide in their presentation about it, for reference a couple of companies with stockpiling sales are SIGA Technologies capped at ~$420M and Bavarian Nordic at $3.2BN:
(source)
ILA’s drug also gives us a free-kick at an Ebola vaccine/treatment
We think today's news also relates to the note we put out yesterday on ILA.
Check out that note here: ILA: World Health Organisation declares “Health Emergency of International Concern” as harder to detect strain of Ebola with no approved vaccine kills 80, spreads to major city.
The World Health Organisation declared the current Ebola outbreak a "Public Health Emergency of International Concern"
(source)(source)(source)(source)(source)(source)
And here is a quick overview of where ILA sits with respect to applying its drug on Ebola:
- ILA owns Galidesivir - the antiviral drug originally developed by $3.2BN Biocryst with over US$70M in US government funding before being sold to ILA
- Galidesivir has shown 100% 48-hour survival rates in Ebola-infected primates and up to 94% survival in Marburg studies
- ILA has a CRADA (Cooperative Research and Development Agreement) with USAMRIID (US Army’s top biowarfare lab)
- The current WHO Ebola PHEIC declaration mobilises international funding, coordination and emergency response efforts - the same kind of declaration that triggered US government funding into Galidesivir back in 2016
We think entrenching itself inside the US biodefence ecosystem could mean the chances of getting funding for ILA’s drug for Ebola also increases.
Here is what we said in our note yesterday:
(source - our ILA article yesterday)
What's next for ILA?
🔄 Galidesivir Animal Rule approval pathway
Here are the two next major milestones for ILA’s Galidesivir drug:
- Stage 1 - Optimisation study - Working out the optimal dose and the best time to administer it
- Stage 2 - Pivotal confirmatory study - The big one - this will determine how effective Galidesivir really is. Fingers crossed it improves on that 94% survival rate.
Here are the milestones we are tracking for the trials:
Stage 1 - Optimisation study:
- ✅FDA confirmed Animal Rule eligibility
- ✅FDA confirmed staged approach for approvals
- ✅CRADA (Cooperative Research and Development Agreement) signed with USAMRIID (US Army’s premier infectious disease research institute) and Geneva Foundation (highly influential non-profit that manages nearly US$383M in military medical research funding)
- 🔄Optimisation study (to start next quarter, advanced negotiations underway with biocontainment facilities) (source)
Stage 2 - Pivotal study:
- 🔲 Pivotal study design completed
- 🔲 Pivotal study commences
- 🔲 Pivotal study results
- 🔲 FDA submission (NDA)
IF the pivotal study results are positive, ILA could then pursue:
🔲 FDA approval of Galidesivir for Marburg
🔲 Priority Review Voucher (~US$200M based on recent sales)
🔲 US Government Strategic National Stockpile contract (potentially worth hundreds of millions in revenue)
Here is an indicative timeline on when to expect all of the above from ILA’s recent presentation:
(source)
