Imugene ASX:IMU Friday 26th April 2024
Analysis of where we are currently:
- PD1 Vaxx: Initial trial saw 1 CR in Phase 1 Clincial Trial for NSCLC (Non-Small Cell Lung Cancer).
- Recent announcement of PD1-Vaxx acquiring patents in Europe and Japan.
- New Phase II study in Colorectal Cancer (CRC) in the UK and AUS to begin in 2024 being partly funded by the investigators and Imugene funds which have been allocated accordingly. Little information so far has been provided in the way of updates with respect to this trial in the UK.
- The promising aspect of this is that the vaccine PD1-Vaxx was noticed and approached by the clinicians in the UK for a trial in Pre-Operative?? Or Post-Operative?? surgery patients in CRC patients.
CF33: Vaxinia: MAST (Metastatic Advanced SolidTumours)
- Trial is in Phase 1 currently. Initial interim results were relatively positive for Phase 1. The results presented showed viral replication is occurring in the solid tumours that have been injected so far. Results were 1CR in Bile Duct Cancer patient, 1PR in Melanoma and 16 SD in a myriad of cancer indications?
- The trial will be pivoting into a Phase 1B expansion trial which will look at dosing patients at 1x10^8? In Biliary Tract Cancer. This will be a true test to see if the CR was an outlier or if there is good efficacy when treating Cholangiocarcinoma patients with Vaxinia. If successful this will then allow for discussions through the FDA Fast Track Approval pathway that was granted to Vaxinia late 2023. These discussions could relate to a Phase 2 Registrational trial with the hopes of getting the product expedited through to an approved marketed treatment option. There is also an outlook that has been mentioned by the company in various presentations of possibly other expansion trials in other unmet needs. One that has been presented as a possibility but not confirmed is into the indication of Head and Neck Squamos Cell Carcinoma and (Melanoma??)
- The trial seems to be tracking well so far and the wait for new data and results is what really this company lives by and only those results will add or subtract value based on their outlook.
- They have mentioned that patient T-Cell diversity now will be screened to assess patients. This could be due to the mechanism of action requiring a more robust patient immune system rather than one that has been ravaged by previous cytotoxic therapies. This could mean that the results may be mixed in the next update as this seems to have been noticed late. The mentioning of this can either mean that the virus is able to replicate and destroy the cancer cells which then alert the patients immune system to a recognisable target for killing and thus the immune system is the main driver of change in tumor size reduction, or it means that the virus does replicate and destroy come tumor cells but with out enough CD4+ and CD8+ T-Cells then maybe the cancer is able to outgrow the virus' cancer killing capabilities.
- The trial is still dose escalating and its hard to see what this will entail as an increase in viral load may no exclusively mean more cancer killing properties, based off pre-clinical trials the virus worked at low doses and so has been seen here in humans too but the question is whether viral load will correlate with improved patient outcomes, hopefully this is the case and we see improving results going up the orders of magnitude.
- A positive from this trial which extends into the Oncarlytics trial is the observation of viral infection and replication in tumours and the lack of severe toxicity. Another bonus is that this could be seen as a precursor to Oncarlytics ability to then infect, replicate and in the same process shuttle up the CD-19 flag for which will be the target for the Blinatumomab (Blincyto) Bi-specific T Cell therapy.
OnCARlytics:
- This trial sees patients with varying cancers being screened and admitted with the first patient dosed in the Monotherapy being a patient with Ovarian Cancer.
- The Monotherapy has started and is looking at safety of the same virus as Vaxinia but without the hNIS and the inclusion of the CD-19 gene edited addition.
- This Monotherapy dosing seems to have so far being going well and we await a FPI in the Combination therapy arm which is with Blinatumomab (Blincyto) by Amgen.
- This trial is supposedly according to Leslie Chong the one that US investors are so eager to see and hopefully the trial provides and these investors jump on board once results get released.
- I find that with this product in particular that it has potentially just that extra kick if the Vaxinia results aren't good enough. What I mean is that if OnCARlytics works as in the virus infects the cancer cells and allows for tumour bursting and also the shuttling up of the CD-19 flag, then this approach could be a three pronged attack. This would be the CF-33 virus destroying some cells, the immune system coming in and cleaning up or attacking the cancel cells that have had their tumor antigens released through lysis and coming over the top the Blincyto Bi-Specific T-Cell which hopefully if the CD-19 process works could allow for effective killing in solid tumours.
Now this is all just musings of mine and there is no scientific explanation by my as if this would, could or will work and so we have to wait and see what occurs in the trials and their resulting reports. The trial should, by the dates given, finish before the Vaxinia trial and will hopefully provide meaningful data that can be used for expansion trials and so forth.
Some points here may not be exactly accurate and I've tried to put question marks where I wasn't 100% on the details, I have written the majority of this on the plane and off the top of my head so just bear this in mind.
As always do your own research.
(20min delay)