Gordon Stein, CFO of CleanTech Lithium, explains why CTL acquired the 23 Laguna Verde licenses. Watch the video here.
@Rambo23 - just catching up and spotted your queries - I will attempt to give some answers / context. Also want to comment on the 9:38 post so lets; deal with that one first. No they don't. There is no need to go back to MHRA for permission to dose the second cohort unless that has been specifically asked for (and I've never come across that before) they will just follow the protocol submitted and approved in the CTA. - There is one exception to that that I mentioned to someone else today coincidentally and that is if they wanted to modify the dosing strategy because for example the result form the first cohort were so good that they thought they could do the dose escalation in less steps - then they could go back to the regulator with a CTA amendment to change the protocol. I don't think it is likely and in my view it would only be a positive if they did so please no one start trying to spin a negative.
OK on to the 3996 selection. Briefly - yes they will start generating more costs. If not done yet there will need to be excipient / drug mix tox studies and more critically they need to both formulate and then manufacture to CT standards samples initially to generate stability data then subsequently for dosing patients. As Avacta don't to the best of my knowledge have their own manufacturing facilities nor the formulation teams both these activities are likely to be contracted out and they are a substantial cost. They will then need to prepare the CTA/IND docs.
My understanding is that they have the funding to do this already from the last raise and when AVA6000 data can be shared a great way forward for 3996 would be to farm it out and get all the costs carried as well as an upfront payment I think this is a realistic strategy for them.
Hope this helps
Ophidian
Sorry, I should have added in my last post. I see nothing to suggest anything is problematic in fact quite the reverse. Selection of 3996 wouldn't have happened without some positive data out of the first cohort from the AVA6000 trial basically demonstrating that the PreCISION linker works in man.
Ophidian
@comeonyou- it would not be unusual for a phase 1a FTIM study like this to be conducted all in one Hospital - in fact it is the norm. Because this study will expand in the later phase there needs to be recruitment across a number of specialist cancer centres. Having checked my spreadsheet if the RNSed dosing regimen has been followed and (I suspect it has), then a cautious approach will have had the third patient in the first cohort completing their second complete round on or around Jan 26th 2022. Therefore - allowing for some time to review and assess all of the collected data across the first three patients it is possible that the second cohort of three begin dosing at the higher level anytime from say the second or third week of Feb.
Now - I have to admit, I think waiting for the third patient to complete two rounds is/was unnecessary however given that we have just been through another COVID wave and I know from friends and contacts in hospitals that a number of clinical trial starts were suspended / delayed by up to 6 weeks maybe the decision was taken to just run out to the end of the second round. I know from conversations with others that oncology trials were the least impacted by COVID so who knows. However - nothing untoward in the progress of this one as far as we know and potentially a nice surprise RNS soon if Dr Smith does in fact get permission to RNS the dose escalation.
I'll admit - I expected it to have already happened but having realised the possible dates recently I think there might be an explanation in that coupled with COVID anchors dragging on trials generally.
Ophidian
go back to your boss wyndrum and tell him you are Green again so don't waste your time and everyone elses - you really have absolutely nothing to say to anyone based on your recent record you are a one man posting danger to wealth - maybe you should consider a tattoo to that effect.
Well done for remembering which account to use to post this time too - no doubt your alter ego will be along soon in one guise or another - who is on shift tonight ?
if you say it enough it happens ? This place is a complete zoo at the moment and I notice the appearance in harmony of the two main protagonists of all attempted manipulations for the last two years plus.
01 Feb 2021
AffyXell $7.3 Million Series A Financing
Avacta’s next generation cell and gene therapy joint venture with Daewoong Pharmaceutical secures Series A venture funding
Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, is pleased to announce that AffyXell Therapeutics (“AffyXell”), the joint venture with Daewoong Pharmaceutical (“Daewoong”), has closed a Series A venture capital investment of $7.3 million to further develop its pipeline of next generation cell and gene therapies.
AffyXell was established in January 2020 by Avacta and Daewoong as a Joint Venture to develop novel mesenchymal stem cell (MSC) therapies. AffyXell is combining Avacta’s Affimer platform with Daewoong’s MSC platform such that the stem cells are genetically modified to produce and secrete therapeutic Affimer proteins in situ in the patient. The Affimer proteins are designed to enhance the therapeutic effects of the MSC creating a novel, next generation cell therapy platform.
The Series A funding has been raised from a group of venture funds including Samsung Venture Investment Corporation, Shinhan Venture Investment, Smilegate Investment, Shinhan Investment Corporation, Kolon Investment, Stonebridge Ventures, and Gyeongnam Venture Investment.
The capital raised will be used by AffyXell to further the development of MSCs engineered to produce Affimer molecules generated by Avacta that suppress immune response and restore immune balance. While initially focusing on inflammatory and autoimmune diseases and prevention of organ transplant rejection, longer term goals could also include applications in regenerative medicine, infectious diseases and oncology.
Under the terms of the collaboration and licence agreement, Avacta’s research and development costs associated with the generation of the Affimer proteins are funded by AffyXell whilst Avacta retains the rights to commercialise the Affimer proteins outside the field of cell therapies.
@Richob - just to expand your thread a little if I may. I think AVA is misunderstood too but from a regulatory perspective. Just by way of example - let's consider Ibuprofen by way of example. The original NCE and dosage form will have had to go through the full process of clinical phases and regulatory hurdles - but as everyone knows as well as just tablets - you can get Ibuprofen as capsules, gels, chewable tablets, oral suspensions, syrups and probably a few others too - each of these is a line extension and they do not require the full 3 phases of clinical trials. Let's specifically now look at a dosage form called an enteric coat tablet. This is a tablet with a coating that ensures that the tablet does not dissolve in the stomach but travels through to the intestines where the pH is higher and the coat then breaks down. This protects the gut from being damaged by the Ibuprofen but is also a way of delaying the release of the drug so you could maybe take it at bedtime and then benefit from the effect of the drug later just before waking up.
The very first enteric coat would have had to have some additional clinical testing to prove it was safe - thereafter, it becomes just another "functional" excipient and can be used for other drugs - Asprin, paracetemol maybe - anything really.
The point is - PreCISION is just like an enteric coat in many respects - it is not itself pharmacologically active in the body - it's not a drug. But it does have a functional purpose in modifying the action of the drug associated with it (doxorubicin in the case of AVA6000).
The first time it goes into a person there needs to be a study to check it is safe thereafter it can just be used as part of the toolbox. This is why the AVA6000 trial is so important - not just for the pro-dox drug but for the proof of the concept.
It is also why it doesn't need all the phases of clinical trials because doxorubicin (like Ibuprofen in my example) has already been through them and now has 40 years of data to rely on.
Food for thought I hope
Ophidian
I don't see PK data being released until the end of 1a (and I think that is COVID delayed by up to 6 weeks), I do expect the investor roadshow to hear about "promising" or "positive" results to date which can be used to illuminate potential for investors.
Ophidian
Irrespective of what the Bishop and his cronies try to say - as effectively a modified release line extension (albeit a really clever chemical one) - AVA6000 will be pivotal at phase 2. The phase 2 trial will be quite sizeable and on of the challenges therein will be to actually supply the clinic. My view is that there will be long term partner identified who will pay a sizeable upfront fee but then wear the bulk of the costs for running and supplying phase 2 With an on success agreement to a royalty around 7-10% and a long term deal. If it is one of the big boys - then that agreement could well extend past just AVA6000.
Ophidian
Bought in again today at 40p I think there is plenty of upside potential from here with now much reduced downside room. GL all
Ophidian
@TonyFawcett - I think there is room for enthusiasm with todays RNS. As most of us hoped and expected, the PreCISION platform will in the fullness of time provide significant additional weapons in the fight against Cancer.
Worth reminding ourselves also that the Phase 1 trial for AVA6000 and in all likelihood the phase 1 trials for the follow on prodrugs - including AVA3996, will be conducted because of the good graces of patients with a terminal diagnosis choosing to contribute something for future generations of Cancer sufferers with little or no expectation of benefitting substantially themselves. These are remarkable people who demonstrate the very best of humanity, the antithesis of so many who plague this and other fora.
My best wishes for your future Tony.
Ophidian
@DDRRon - likely that phase 1a will complete at the original 3 sites and expansion to the others (and potentially US at the same time) will be in 1b.
Right now many Clinical trials have suspended recruitment due to COVID pressures on nhs staff at the participating hospitals. I wouldn't expect the AVA6000 trial to be any different. Probably looking at a 3,4,5,6 week hiatus would be my guess.
Ophidian