Sapan Gai, CCO at Sovereign Metals, discusses their superior graphite test results. Watch the video here.
Coupled with dose dependent effect, AVA6k will target cancer associated fibroblasts (part of the stroma) due to their high expression of FAP. CAF density has a direct relationship to poorer outcomes. CAFs encourage tumour cells growth, metastasis, blood vessel growth to the tumour, inhibits immune response against the tumour and can cause drug resistance. Destroy the stroma and you have a much better chance of positive outcomes for patients. The state of the stroma has a major effect on how well immunotherapies like keytruda work. You'd assume combination therapy (chemo then immunotherapy) would work very well.
Response rate of STS is fairly low around 20%. Doxorubicin and STS demonstrates a dose–response relationship. Literature and Dr Tapp both say it. The more Dox you can get into STS patients the more effective the drug will be. Higher doses and shorter time spans between doses will all improve outcomes.
So Viking you believe the pharmaceutical industry is not interested in the exquisite specificity of the pre|CISION? A molecule that is so targeted it can drop activate a warhead directly on top of a tumour, a warhead that is inactive until it reaches that tumour's microenvironment? Can you tell me why there is a gold rush towards antibody–drug conjugates within almost the pharma whole industry? Drugs which basically do exactly the same thing but have much higher manufacturing complexities and cost?
The question is what are they seeing in the PK data that means the 65% reduction patient can probably have 7 more cycles. Obviously its a huge amount of cycles and vastly improves on dox (new standard of care anyone?), it does suggest Avacta have likely seen something in the PK data to think there is a celling to the amount of cycles a patient can have.
Hi RAH, that's an interesting point. As you say if would only affect C7. If it happened that way Avacta would also be missing out on secondary outcome measures which says data like max drug concentration and elimination half life are measured for 72 hours after the second dose.
To follow what RAH has said about cardiac toxicity, a review of the detailed side effects from the presentation main deck (slide 83) shows Troponin T levels only increased in one patient and that event was below grade 3. This one event was thought to be due to patient's pre existing comorbidities. Troponin levels in the blood are an indicator of cardiac muscle cell death. The literature suggests detection of increased Troponin levels during doxorubicin regimen are strongly related to adverse cardiac events. Around 11% of dox patients suffer from acute cardiac events, while 2% suffer chronic cardiac toxicity. The AVA6000 P1a side effect chart (on the face of it) suggests there was no increase in Troponin T levels. So not only are patients not showing cardio symptoms they are also not showing increases in Troponin T, which is an indicator of cardiac cell death and adverse cardiac events. It's a shame Dr Tap's soft cell sarcoma trial did not measure Troponin T for direct comparison but the fact Troponin T increases have not been seen is incredibly encouraging for AVA6000 safety. This is especially so as there is no evidence of increase even at 200mg. Hopefully we'll get further evidence of this when the direct comparison between Dox and AVA6000 is completed in P1b.
On the subject of director buys, I bet they would love to but they can't. It would be classed as insider trading, as it would be hard to argue to wasn't based on clinical trial knowledge not yet released to the market.
AS won't release the date before the end of 1a as the number of patients being reviewed is so low. Although they seem like they are seeing wonderful safety data, the next batch of patients dosed might not react in the same way. They've only had the results of at most 4 terminally ill patients (one of whom has sadly probably died), they are also suffering from different types of tumours. The statistical significance/confidence intervals of the results will be very low. Results could change. AS does not want to get burnt again the way he did with the LFT.
Having said that I'm really excited, DE at 50% is going ahead, so that means patients have had mild or asymptomatic symptoms (from 90% of a theraputic cycle of doxorubicin!) and the data AS and FM have seen across tumours is very consistent. What more do you want at this stage? Wish I had some money under the mattress to grab some more, come June/July holders will have the last laugh. Drug pipeline worth billions annually. Put in £10k now and avacta gets sold for £10B (could easily happen) you have £636k. That's a very lumpy mattress. Risk vs reward.
Hectordog. so you want the CEO to RNS the idea that he is unsure how the regulators will review the changing of the LFT antibody? He's going to be releasing a lot of RNS' if he has to cover all known unknowns. Regarding the share price, if people are too impatient to wait until the end of phase 1a in June/July which will indicate if we have a platform worth billions then more fool them. Risk vs reward.
I'm unsure when this updates but it says its based on data sourced from the FCA's daily short positions report.
https://shorttracker.co.uk/company/GB00BYYW9G87/
Hey Hurst, you might know what information the MHRA allow investigators to provide to the sponsor (in this case Avacta) of a clinical trial? Can any information be released until the end of a phase? I doubted sponsors could release selective information on the findings of the trials as it would be misleading to investors, but your post about the IND has me wondering. Can you point me in the direction on what the FDA allow to be released? If you have the same info for the MHRA that'd be great.
As Glengarth has very helpfully pointed out the twitter handle BBN @BigBiteNow keep a eye on graphite prices so we don't have to. https://twitter.com/BigBiteNow/status/1458695034598006785/photo/1
All looking rosy so far.
I'm waiting to see how these fall, any sort of upward momentum I'll add a few more. There are so many upsides to this share. There is limited graphite production outside of Chinese hands and natural graphite is a critical resource as per EU (https://ec.europa.eu/growth/sectors/raw-materials/areas-specific-interest/critical-raw-materials_en) and USA. The price of graphite will only go up with the global push to decarbonise and there is every indication they can sell whatever they produce (graphite prices are already going up). If Tripuati manage to get production up to 30k tonnes in the first quarter year and get the margin up a few points again, it'll all be sunshine and lollipops. Never mind if they manage to produce a workable alloy for graphene and Al.
https://www.pharmaceutical-technology.com/features/4d-pharma-potential-gut-bacteria-cancer-beyond/
https://www.***************************/tirupati-graphite-building-a-fully-integrated-graphite-and-graphene-company-lontgr/4121022506
Mradventurous you've said you worked in pharmacological research and you have misgiving about Avacta's therapeutics. Do you know what the success rate of successful animal trails going on to mirror their results in human trials? I read it was about 35%ish. I know it's success will be based on loads of biological unknowns but I want to get my head around the level of risk of it failing. If it succeeds it will be revolutionary. Thanks