Member Info for Burble

Taverham,

No you shouldn’t be worried. Clinical trials take time, they take effort and sadly most trials have some form of delay to the proposed timeline. This is nothing new and as the RNS states, no safety issues which is what this phase 1 trial is really getting at. So that is a positive.

Due to the inclusion criteria, Covidity was needing covid naive patients (so in vaccinated and non-infected (both current and historic). Which due to Omicron wave most likely was putting the brake on recruitment. On top of that as we have seen, trial staff will have been off themselves with covid and that adds additional pressures. Factoring in also many in SA won’t have been vaccinated. Meaning Omicron may have resulted in additional pressures to ICU units etc and so staff may have been redeployed.

The delay therefore doesn’t surprise me. It also doesn’t worry me in the slightest, especially given the safety profile being stated as good. So it’s just a sit on hands moment and wait for good news in the near future. Not long to go!

You and me both Ivy.

I definitely read this as ‘only 16 recruited so far’ which is frustrating, but understandable given the criteria for inclusion and the omicron wave going on in SA.

Hopefully that has now passed and recruitment picks up.

Same I guess goes for the SCIB1 and Modi-1 trials. Hopefully recruitment will pick up to these.

Free webinar discussing why we need a pan-serbecovirus vaccine!

https://www.who.int/news-room/events/detail/2022/01/28/default-calendar/who-consultation-on-covid-vaccines-research-why-do-we-need-a-pan-sarbecovirus-vaccine

Violindog

I would say SCIB1 trial validated Immunobody for cancer. It demonstrated that T cells were activated and did what they were told to do.

Covidity will validate if successful the Immunobody platform but this time against infectious disease, it will also validate Avidimab which now has been integrated into it (and therefore validate it for use in potentially any existing or in development antibody therapeutic) AND it will validate the needle free method for administration which then in turn will demonstrate that all three could/should be used against cancer targets.

Pivotal results. But built on many years of knowledge, experience and skilled work by LD et al.

Now this is where it gets interesting. Due to the nature of mRNA vaccines they will struggle to make polyvalent vaccines in single molecules. I believe they could go down the route of mixing different mRNA strands into a single lipid nanoparticle, but from a regulatory perspective this may pose problems.

DNA vaccines (like Covidity) lend themselves to delivery of multiple targets in a single molecule. They’re also cheaper to make as the mRNA based vaccines would basically need to double their manufacturing capacity and therefore throughout would be reduced.

I sense LD is right place, right time. Let’s hope next weeks update is solid

Off the top of my head, Destiny Pharma (Aim: DEST) is developing novel anti-infectives for Staphylococcus and C. diff infections. That’s the only one I can think of at the moment though there may be others.

Full disclosure, not invested there and this was a quick Google search.

Aldebaren,

‘Now those feedstocks simply won't exist’ - fantastic! Congratulations on solving the plastic waste crisis in a single sentence.

Jokes aside, even if there is continuing legislation banning single use plastics, we still have billions of tons of plastic waste sat destroying our planet from all the production before the ban. So PHE and other technologies used to remove this from the environment won’t be going anywhere soon. Just think of the mountains of plastic waste in places like Indonesia and Asia. Even if the source dries up, there will be many years worth of feed stock waiting to be recycled into high value goods.

Before we all panic, this most likely is caused by PCR contamination. Whereby equipment used to process samples from a delta patient are then used to process samples from an omicron patient (or vice versa).

The 'Deltacron' sequences reported in Cyprus by several media outlets clearly look to be experimental contamination as they do not cluster on a phylogenetic tree. They also display a whole Arctic primer primer sequencing amplicon of Omicron in an otherwise Delta backbone suggesting experimental artefact rather than true variant.

Ray,

I just admit I had never thought of that. That would be a good way of keeping the cancer vaccines side of the business in house whilst allowing the world to access the power of the Immunobody platform for ID use.

IMHO I don’t see an all out sale of Immunobody till we have got Modi-1 patients dosed. No point selling a platform you know works if you find your second platform doesn’t do what you expect it to do.

I could see it licensed initially before an outright sale.

iPad

Following on from Bojo's post earlier. There are key differences between Gritstone Bio's self-amplifying RNA and our DNA vaccine.

We have seen across the pandemic the use of mRNA vaccines. These consist of modified messenger RNA molecules which code for the C-19 spike protein, encapsulated with lipid nanoparticles and delivered to the patient. To achieve clinical benefit, doses of these mRNA vaccines are 30 ug for Pfizer/BioNTech and 100 ug for the Moderna vaccine. These are relatively high because the body relatively rapidly breaks the mRNA molecule down inside the cell.

Gritstone are using what is termed a self-amplifying RNA. This contains the target protein sequence region (in this case coding for the spike protein and other protein elements from the C-19 virus) and also the structural protein elements which code for a separate protein called a replicase. Once inside the cell, the patient's cell machinery translates this mRNA into both the target proteins (Spike and others) and the replicase. In turn the replicase is able to copy the mRNA molecule. Amplifying this and in turn amplifying the amount of target protein produced. As such, a far lower dose is required (0.1-10 ug) to achieve clinical benefit.

Obviously the benefit for saRNA vaccines, is the dose lowering - meaning less mRNA associated side effects for patients and also more patients dosed per ug of product - hence reducing costs and increasing availability. However, there still remains some of the drawbacks that mRNA has - mainly lower stability (so the need for cold chaining) and also the need for a robust delivery vehicle that is able to deliver this saRNA to the patients cells. Furthermore, the actual size of the individual transcript is longer - meaning problems may be met with formulation.

SCLP has taken a different approach and instead is using a DNA based vaccine - this is easier to produce in large volumes at low cost with relatively simple materials, the platform itself is able to encode far greater amounts of genetic information (allowing multiple targets to be constructed into a single vaccine molecule). DNA is also far more stable than mRNA (it can be stored at room temperature) and so is less susceptible to problems with cold chain and delivery networks. Due to the nature of DNA vaccines, they are generally lower dose in ug than RNA - as they too are transcribed inside the cell into their mRNA molecule - so a single DNA molecule can produce numerous copies of mRNA.

So some similarities, a number of differences. I believe the lower dose AND stability that a DNA vaccine offers is a strength in a pandemic setting.

For more information:
This is a relatively easy to understand publication on saRNA.
https://portlandpress.com/biochemist/article/43/4/14/229206/The-next-generation-of-RNA-vaccines-self

Slightly more in depth on the technical front.
https://www.nature.com/articles/s41434-020-00204-y

Still no word about the mysterious 40m trade either....

Even more evidence that a robust T-cell response helps prevent variant escape. https://www.theguardian.com/australia-news/2022/jan/04/t-cells-can-fight-omicron-when-antibodies-fail-to-australian-researchers-say

Not long to wait until we find out whether Covidity does what it says on the tin.

Bermuda,

I share that sentiment. I hope 2022 is pivotal to us this year.

Nice that Julia has decided of all the companies her previous article covered, that Scancell is the one to watch for 2022.

Also nice that she included ‘specialising in cancer vaccines’. That may whet some investors appetites when they realise we’re not just a covid one trick pony!

Having been to PEGS four times, it’s HUGE! Plus it’s attended by many many different players, a nice mix of academic, biotech, large pharma etc.

Happy Christmas one and all!

Here’s to an exciting and hopefully pivotal year ahead!

https://twitter.com/balazslab/status/1470726999538745355?s=21

An interesting pre-preprint, what is concerning is the clustering of mutations on the RBD. This is where VNAbs generated by covidity are focussed to. Would be interested to see what the overlap between Covidity and the location of these mutations is. I’m sure LD will be on the case but Omicron looks a step change from delta.

https://www.theguardian.com/environment/2021/dec/14/mps-call-for-halt-to-britains-incinerator-expansion-plans?CMP=Share_iOSApp_Other

As we see articles like this calling for a ban on incineration. It’d be good to see Eqtec not be lumped into the same category and MPs start looking at the alternatives there are available like our advanced gasification technology! It seems so much of the time that this country is stuck in the past using and applying old technologies when we have workable systems with proven track record which could be deployed but seem to be glossed over in all but a few rare cases.

I wonder when the tide will change.

Maybe Julia’s article, coupled to Omicron have all coincided at the right time. Here’s hoping that this upward momentum is maintained and we hear Modi-1 news in the not so distant future.