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| Statement |
|---|
| We are confident in these ambitious goals |
| We had notable success on both fronts |
| The UK is an ideal jurisdiction to expand our Alzheimer's disease trial given it possesses one of the highest rates of Alzheimer's disease in the western world coupled with robust for profit medical research infrastructure |
| We've been successful in upscaling the manufacturing process and have completed the validation of that new process to CGMP |
| We remain very excited about the potential of the immune platform as it begins its transition into the treatment of solid tumors |
| So, it's be really nice to think that we could provide long-term benefit by combining these |
| As I spoke about earlier we believe that XPro going down a completely different pathway than where steroids, than what steroids pathway provides significant benefit over a lot of the problems that we are that are associated with steroids |
| It’s a really, really excellent question |
| In my opinion and many of those at the meeting the most promising Duo is GFAP was Glial Fibrillary Acidic Protein at biomarker of Astra site activation and phospho-tau T217 a biomarker of neurodegeneration are promising |
| All these other countries, their patients are getting access to what we think is a pretty good drug XPro for Alzheimer's disease |
| And I think the UK is a good example we have |
| Recent data from the DMD program confirms the potency of the 10 keloid on pSar DN-TNF in mouse models of the disease |
| And so it just makes me more enthusiastic about the prospects where it need |
| So one of the great things that might come out of the XPro trial is that there are three, you could actually combine those two drugs in a very, very nice way to break down the trap to enhance the T cell entry into the tumor |
| In summary XPpro improves the function of innate immune cells needed to defeat the ravages of neurodegenerative diseases of the brain and cancer and the macrophage is the common denominator to these effects |
| In summary, management feels that the company has two great platforms and as a small organization with limited resources we will tried to expand the applications of these platforms in order to benefit shareholders |
| This investment paves the way for our ambitious plans for trials in other solid tumors, including ovarian, renal and nasopharyngeal cancer as we acquire more and more and more of the relevant supporting data |
| So that's a really exciting combination drug I'd love to that could also be combined with a checkpoint activation T-cell checkpoint inhibitor because once the T-cells are there we want to make certain that are not inhibited further by the inhibitory checkpoints in the tumor |
| But we've solved that problem with a robust and scalable process for INKmune |
| INmune Bio has making progress on two-fronts |
| We're ahead of where we expected to be in the UK |
| In other words we want to be able to back it up and things are just changing so quickly and quite frankly to our advantage |
| And there was evidence of benefit as demonstrated by cute and chronic changes in the P300 amplitude on EEG after treatment with XPro |
| Because corticosteroids are the most common drug used to treat DMD, a strategy that provides the benefit of corticosteroids without the side effects will benefit all patients with DMD regardless of age, stage of disease, or concomitant therapy |
| Each of our platforms have had a significant increase in shall we say profile and then last quarter |
| We believe this work is further evidence of improved and synaptic function after extra treatment, and future work will correlate this activity with cognitive function and pharmacodynamic responses to the NTNS |
| But our confidence in the use of INKmune solid tumors is based on good biology |
| Joel Beatty Great |
| We thank you for your attention today and to those of you that are shareholders, we thank you for your continuing support |
| We are persistent in our belief that cognitive decline is the sum of synaptic dysfunction and nerve cell death, phospho-tau as an excellent measure of neurodegeneration or nerve cell death in patients with Alzheimer's disease |
| Statement |
|---|
| The DMD market with inconsistent results in gene therapy and confirmatory trials for access skipping drug still long underway is confusing |
| I'm sure you would be you've shared us with us this extreme frustration in the lack of recruitment in the UK to that trial |
| Once again the desire for combination therapy reflects the frustration with the current results |
| And I know this has been a very frustrate us |
| In my opinion the desire for earlier treatments is driven by the frustrating results from anti-amyloid monotherapy |
| The US patients are sitting on the sidelines because of regulatory challenges both with the FDA |
| And then a question about them rep missed their top line yesterday as well |
| When these are therapies attempted to enter the commercial world, many failed due to manufacturing issues |
| And in other words the immune response to amyloid appears to drive nerve cell death and synaptic dysfunction that results in cognitive decline |
| As I'm sure you know from the CAR-T story, manufacturing of cell therapies is difficult to do at scale |
| So that overcomes part of that problem |
| So all I can say Joel hang tough and I think right now we have not changed our guidance |
| This leaves the US and the FDA; the FDA is the outlier here |
| And I just saw that Amgen pulled a drug from clinical trials yesterday in prostate and wrote down about $600 million |
| One of the things that frustrates us is that clearly what the FDA is doing is different from what are the other regulatory agencies are doing |
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