Opinions only, by WMHB
Bile Duct cancer, the existing standard of care and Vaxinia
Each year, an estimated 8,000 people in the United States are diagnosed with bile duct cancer. If the cancer has spread to the regional lymph nodes, the 5-year relative survival rate is 9%. If the cancer has spread to a distant part of the body, the 5-year relative survival rate is 2%.
Without doubt this illness is crippling, debilitating and ultimately life threatening for all those concerned. Current medication is more often than not a collective of surgery, radiotherapy and MAB’s, i.e., Keytruda. In short Imugene is proposing a viable alternative to the existing standard of care with their oncolytic virus Vaxinia involving less hospital time, reduced amounts of pain and suffering, less expense, fewer side effects and potentially more time on earth, for advanced cancer patients.
So why is yesterdays Imugene announcement so important?
The ability of Vaxinia to exhibit signs of efficacy in late stage bile duct patients whose tumours have metastasised is extraordinary, when one takes into consideration their immune response rates, despite having previously failed on all lines of treatment. We are already aware of a complete response rate among the early cohort of participants in the Vaxinia (MAST) Trial.Given their poor prognosis coming into the trial and limited treatment options available, the aforementioned survival rates are testament to the fact Vaxinia does not indeed have to produce multiple complete response rates to in fact be better than the existing standard of care. If Vaxinia continues to stabilise disease and display positive signs of immune responsea case could be mounted the drug is a superior alternative for late stage bile duct patients than the existing standard of care (SOC). Therefore it goes without saying any hint of Vaxinia producing immune responses in late stage bile duct patients could be a significant step toward filling the huge unmet need in this indication.
Vaxinia treating Cholangiocarcinoma and the road ahead
Some people have suggested next week may be yet another week of anticipation, expectation and ultimately let down, when it comes to Imugene (IMU -ASX) Announcements. To the contrary I am of the opinion next week Imugene crosses the line toward revenue, with ongoing results in the Vaxinia (MAST) Trial possibly warranting not only the push toward a registrational trial in the indication of bile duct cancer, but evidence of Vaxinia’s continued replication from tumour to tumour. Such results would undoubtedly signify the virus is working toward not only stabilising patient disease, but reducing their overall tumour burden. I am now confident the company’s selection for a short oral presentation during the Basic Science Research Seminar at the 2024 Cholangiocarcinoma Foundation Annual Conference on Thursday, April 18 concludes that CF33-hNIS monotherapy may be an effective and safe treatment option for GI malignancies. These conclusions have not been reached through animal or human xenograft models. No, these results have been derived through monotherapy within humans. Patients with a rare disease for which there is a huge unmet need.
8,000 patients are diagnosed with Bile Duct cancer in the US each year. If Vaxinia is producing immune responses in late stage bile duct patients with suppressed immunity clearly the drugs impact on earlier stage recipients with stronger immunity should be significant. Therefore it would not be too presumptuous to assume that if found to be superior to the existing SOC Vaxinia would attain deep penetration when it comes to market share in the bile duct cancer indication. Given the reduction in hospital hours, reduced cost of treatment and less invasive nature of the drug, when compared to alternate treatment regimes, Vaxinia has much to offer patients and regulators alike. With this in mind we don’t have to look too far for comparable valuations when it comes to rare disease drugs. Our friends over at Arcadia Pharmaceuticals on 10 March 2023 received marketing approval from the US Food and Drug Administration (FDA) for Daybue™ (trofinetide) to treat Rett syndrome in adults and paediatric patients 2 years of age and older in the United States. Approximately 10,000 girls are born in the US each year with Retts. Neuren Therapeutics, who developed Dayblue before out licensing it to Arcadia is currently trading on the ASX under the ticker NEU, and assumes a value of 260 billion AUD, close to 4 times that of Imugene (IMU).
Imugene does not yet have final unconditional approval for Vaxinia to treat bile duct patients in the US. Whilst being granted a fast track designation pathway by the US Food and Drug Authority there, they are not in a position to start manufacturing and selling their drug, as Arcadia is entitled to do when it comes to Dayblue. Hence the potential reason behind a lower valuation being afforded for Imugene (IMU - ASX) by analysts, in comparison to Neuren (NEU - ASX). Though it must be remembered Imugene has many strings to her bow, including as an example the 2020 Innovator of the year Finalist Professor Pravin Kaumaya’s PD1 Vaxx, a B cell vaccine exemplifying outstanding results in the lung cancer indication, that being the worlds biggest cancer killer.
Imugene (IMU - ASX), Vaxinia and the market size in play
If next week brings with it further proof of concept in the indication of bile duct cancer IMU must be due for a massive rerate based on the aforementioned analysis, in my opinion. Realistically the stock should be gapping at 25 to 30 cents, based on the potential market size in play. But what if Vaxinia is shown to produce positive signals in other cancer indications, aside from bile duct? Now that’s a whole other question isn’t it. What is the market size of those indications? Are they as rare as bile duct cancer? Keep in mind these results are in a trial treating late stage patients whose cancer has metastasised, in other words spread throughout their bodies. As you are aware solid tumour patients in such a state are facing a huge unmet need, that being the primary criteria for fast track designation when it comes to FDA fast track pathways. As an example Imugene CEO and Managing Director Leslie Chong has discussed Vaxinia’s treatment of those suffering from head and neck cancer. In the United States, head and neck cancer accounts for approximately 71,100 cases annually and 16,100 deaths. What if Vaxinia is found to be efficacious in the treatment of this condition? I’ll leave it for you to perform the prospective valuation for Imugene (IMU - ASX) based on that market size.
Irrespective of the hype surrounding Imugene, IMU holders are well within their rights to feel extremely excited about the forthcoming AACR Presentation next week, together with the pending release of clinical trials results for their pre-eminent drug candidate. The ongoing Vaxinia (MAST) Trial has amassed a large amount of data since the last data cut on October 31, 2023, with up to 40 patients being scanned, and perhaps scanned again in many instances, between now and then. Despite being a dose escalation trial, Vaxinia had already displayed signs of efficacy back in October last year, at the relatively low doses administered to participants in the initial phases of the trial. Data from later cohorts, administered with higher dosage levels may in fact come close to realising the optimal biological dose rate for the drug. However as Dr Bradley Glover of Imugene recently suggested, trial supervisors shall let the data drive Vaxinia’s trial direction, with scope to dial up dosage rates further notch should the need arise.
PD1 Vaxx and IMPRINTER
Speaking of Optimal Biological Dose Rates I for one am keen to see how PD1 Vaxx is performing at its optimal dosage rate in its ongoing combination trial with the Roche Therapeutics owned Tercentriq, in the treatment of late stage lung cancer patients. Professor Kaumaya has long suggested PD1 Vaxx is suited to combinations with other efficacious immunotherapies. Given the vaccines success in treating lung cancer patients at lower doses than those currently being administered in Imugene’s Imprinter Study, I am of the opinion the drug may well be far from dead in the water, as some posters on these threads have insinuated.
DYOR Seek investment advice as and when required opinions only
P.s Don’t forget to message me at the COB on Friday April 12 to let me know how my opinions stack up.
Disclaimer : Please do not take this analysis or any of my posts as a recommendation to buy IMU - ASX. These are opinions only. Investment decisions must be made based on ones personal circumstances, risk profile, available funds and investment time frame. Investors who diversify and dollar cost average have traditionally performed well when investing in equities over a 5 to 7 year period. But keep in mind equities are but one investment instrument, and the biotech sector is but one of many, with Imugene (IMU-ASX) being but one of many stocks comprising that market segment. Imugene like other medium sized pre revenue biotech stocks is fundamentally driven by clinical trial results, which may of may not deliver the desired outcome.
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