Member Info for Burble

So now we know ModiFY trial is open for recruitment what are peoples bets on FPD announcement?

20/04 - Burble

After yesterday's stellar rise, I wonder whether we will see more of the media picking up on the modi-1 trial starting up or whether we will have to wait for first patient dosed before we see any real noise made. It would be good for the SCLP team to have things lined up with press releases in advance, a bit like the Transgene announcement back on the 4th February.

This is what also stood out for me ‘ Leading oncology clinical research sites and investigators across the UK have agreed to contribute patients to the ModiFY study.’

Suggesting patients have possibly been identified already and recruitment won’t be slow once sites open.

Agree! What a great start to the week. So early data by H2! I wonder how long it’ll be before we get a FPD RNS.

https://www.independent.co.uk/news/health/omicron-xe-new-covid-variant-symptoms-b2053321.html?amp

New variant detected! Covid isn’t going away any time soon. As the days pass, we’re one day closer to Covidity results.

A really good find Bermuda, it’s nice that the article contextualises both the immune system and how it works, as well as how existing vaccines work and their drawbacks. This context really sets the scene for Covidity and demonstrates why if successful this has the potential to be superior to existing spike vaccines. Also loved the fact they’ve included a section on the needle free vaccination.

Here’s hoping results come soon!

Moonparty - excellent summary. Also add the following items which may influence the share price further.

- More glycan mAb discoveries including new antibodies, or development of existing ones as ADCs, antibody guided surgery imaging, radio-isotope imaging (PET scans etc).
- More moditope discoveries - Modi-3? Moditope collaborations coming to fruition - think BioNTech.
- Modi-2 development update?
- iSCIB-1 and i-SCIB2 development
- Avidimab licencing deal(s)
- Preliminary read outs from Modi-1
- Preliminary read outs for needle-free delivery of immunobody vaccines - could this replace the Ichor electroporation delivery system used in SCIB1.
- Further publications/presentations/conferences

So plenty of news which could arrive when least expected.

Clarification - 'So I don't think we'd ever know 100% in patients whether it has benefit.'

I don't think we'd ever know what the efficacy of Covidity would be without the enhancement from Avidimab. Though as per the SCLP website 'In every instance, the modifications have enhanced the preclinical efficacy of these products.' so it obviously does enhance the parent.

Definitely! I don't believe there has been any head to head trials where an Fc engineered antibody is tested against it's parent molecule. Though happy to be corrected on that one. So I don't think we'd ever know 100% in patients whether it has benefit. Pre-clinically, I would assume there would have been comparisons done.

The main thing is no negative side effects or off target effects.

Yeah feeling a lot better, still testing positive on LFT but apart from a slight lingering cough I'm feeling a lot more human.

To add to Ray's post, something many have maybe not considered is that avidimab is included in the Covidity trial. The fact that there are no safety issues from those dosed is excellent news. This clinical trial is a two for the price of one trial because not only does it validate the anti-covid vaccine but it also adds clinical evidence of avidimab doing what it is expected to do, in patients and in a safe and efficacious manner.

Suddenly avidimab becomes v.valuable indeed, especially as it is something which can be licensed - hopefully non-exclusively!

TF

Good taste in music!

AB

SCLP will obviously know more about the trial than has been released to market. Hence, it wouldn’t surprise me if they’re already in conversation with the necessary organisations to get the UK trial designed, protocols written, sites identified. They’ll also have data on the initial participants which would be ready for submission to the authorities as soon as the final trial design was confirmed.

It wouldn’t surprise me if this new expansion of recruitment goes on at the same time as trial design and submission occurs. My hunch would probably be aiming for a Q4 2022 UK trial.

Berm

'Wouldn't the original protocol of dosing with SCOV1 and then boosting the same patients with SCOV2 have given all the data they needed to secure MHRA approval for the UK trial?' - yes most likely, especially as this is a Ph1 trial.

My comment was really with regards to running a trial in the UK and recruitment to that. As we have seen with a number of other covid vaccine trials the MHRA and UK Government are twitchy about what will and won't be approved end game. See the trouble that Valneva etc are going through for their whole virus vaccine trial. They've recently expanded their P3 trial to include VLA2001 vaccine trial to include the same jab but as a booster. Yet have run into hurdles because it's not an approved vaccine and so many countries around the world were refusing to acknowledge that patients on this trial had been vaccinated meaning travel etc was becoming problematic. A significant proportion of patients have ended up leaving the trial, going and getting themselves immunised using AZ, Pfizer/BioNTech etc just so they could travel.

When it comes to running trials, you not only have the patient recruitment demographic to balance, but also the cost of running the trial and the cost to the NHS of hosting that trial. If you're not going to get enough patients to complete the trial, or if it's going to cost the NHS a lot of time, money and man power then you unfortunately will struggle to get things off the ground without a lot of hard work and shoe leather. The last thing any trial manager wants is to go through setting up the trial, getting teams on the ground trained and then the patient demographic changes or dwindles. Hence, this RNS today means that we come into that with data generated from patients who have either already been infected and/or have already been immunised with an already approved vaccine. This opens up many more options for running a successful Ph2 and Ph3 trial to completion in the UK or elsewhere in the world.

So yes, whilst I do believe the original data generated from this trial SCOV1 and SCOV2 could be used in this way, I suspect that by expanding it to cover patients who have already had infections or immunisations using other things, will smooth the passage for getting trials started in the UK once data from this cohort has been collected and interpreted.

A question I have - are they still aiming for the 40, or does this protocol change also include increasing the target number recruited? I would assume the latter. If so, I wonder what to?

More data = better leverage when negotiating either for further phases of clinical trials or partnering.

By expanding the criteria for patient selection this allows also the benefit of data generated in real world applications - which will provide SCLP with data that can be used by the MHRA in any application for using Covidity as a booster jab here in the UK.

Torquay

You must have been psychic! RNS just released detailing amendments to the trial and expansion of candidate selection criteria

RuckRover

In response to your question, LFT and PCR tests seem to be holding up just fine against these variants. There is a slight difference in limits of detection based on which test you are using - different variants have slightly altered viral loads dependent on location and time-course through the infection. Meaning if you have one of the LFT tests which is a nasal swab only and are infected with a variant which presents earlier in the throat, then you may not pick it up as quickly. Hence a negative on LFT is not always a 100% negative in real life. You're definitely more likely to pick something up using the nasopharyngeal swab LFTs rather than just the nasal swab tests but anything is better than nothing.

Sadly a lot of the reason people are coming down with colds and other respiratory infections which have similar symptoms to covid is the fact that for the past two years we haven't been mingling as much as would be considered normal. Meaning that our basal level of immunity against respiratory infections (and tbh all of the routine illnesses) will have dropped considerably. So as people move back to the 'new normal' and are mingling more, we'll see more of these cropping up, with differing levels of severity than would normally be seen in the general population pre-covid. All that we can do is continue to test, take appropriate precautions and follow any guidance which is given to us.

Who knows, if Covidity reads out with good topline results, maybe someone will try and do something similar for seasonal infections.

Scouse

Yeah it's crazy how different people are. I know people completely thrown for six, a friend of ours was running ultramarathons and ironman competitions who now can hardly walk up a flight of stairs without being out of breath. That was despite 2 doses of the vaccine at the time when he caught Delta. Another friend, not in the best of shape, brushed it off like it was a simple cold.

Yeah feeling a lot better thank you. It’s such a weird illness. Cough feels like I was coughing up a lung lobe, but that most likely was a combination of chest infection and covid. Antibiotics for the CI seem to be working which is good, so now it’s more a low level cough rather than the proper hacking cough I’ve had. I can go hours without coughing, then be sat basically coughing for two to three hours constantly. Headache and fever have thankfully gone.

The weird one for me has been intense fatigue. Completely unlike anything I have ever experienced. I’ll be functioning one minute, then suddenly it’s as if my battery has gone from 100% to zero. I’ll just sleep for hours. There’s no warning when it comes, it just does. I’m hoping that goes soon and doesn’t linger because it’ll be a PITA with driving (I suspect DVLA would say no driving for a period of time!)

Thank you!

Had a rough night last night, probably managed a few hours sleep max.

But got to stay strong. It’s the weekend and the sun is shining.