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I believe that the Ichor exploration device contains a needle so, if that is true, it is ruled out.

I wonder if micro needle patches come under the heading of needle free

https://www.cdc.gov/globalhealth/immunization/stories/microneedle-patch.htm

"The microneedle prototype is a collection of dozens of tiny needles that are lined up on a small patch. The needles are so tiny that each one is measured in micrometers and is as thin as a human hair. "

"The polymer microneedles then dissolve between layers of the skin, effectively delivering the vaccine."

Hi Ivy
We aren't we talking about 2 different subjects.
The application will be needle free but the actual delivery of the vaccine to both the APCs and the soft muscle cells requires the GET peptide and the nanoparticle. As I understand it, no matter how the vaccine is applied, it still has to gain entry into both types of cell.
With the Ichor device, this had a dual purpose, getting the vaccine into the body and with the mild electric shock disrupting nearby cell membranes.
Or am I missing something?

Thanks WTP
What's really heartening is that Lindy is obviously really going for this in a big way.

What with

1) The GET peptide delivery system
2) Needle free application
3) The incorporation of Avidimab (who would have though that was possible?)
4) Possibly a separate booster jab trial on top of the SA trial

Amazing what a bit of money can do :-)
You can see exactly why Lindy was so keen on securing the extra Redmile money that Vulpes was trying to block. At the time it may well not have been linked specifically to the Covidity project but Lindy just wanted to give her entire pipeline the boost it needed.

But you can't help feeling that she really likes the Covidity pre-clinical results.

https://www.nottingham.ac.uk/pharmacy/research/molecular-therapeutics-and-formulation/research/pharmacokinetics-and-targeted-drug-disposition.aspx

"Research in this theme includes Biopharmaceutics/Pharmacokinetics, Targeted Drug Delivery and Disposition, Drug Design and Development, and includes the following specific areas:

Improvement of the efficiency, selectivity and safety profile of pharmacological therapy based on knowledge of pathophysiology of disease states and using advanced drug design, development and delivery methods.

Targeted disposition achieved by specific formulation or route of administration approaches to increase the therapeutic benefits of potent drugs while minimizing the systemic toxicity.

Intestinal lymphatic transport and targeting of drugs to lymph nodes to improve treatment outcomes of autoimmune diseases, cancer and HIV.

Effects of disease states on pharmacokinetics and pharmacodynamics of drugs.

Oral drug delivery, including the mechanisms of intestinal absorption and novel methods to overcome barriers to systemic bioavailability of orally administered drugs.

Targeted delivery to lungs to improve treatment outcomes of a variety of disease of respiratory system

Projects in the theme have very direct translational significance and are accomplished by active links with clinical researchers at the hospital interface."

Now how much research had already been carried out when Covidity came along, who knows?

Hi Ivy.
I agree, the timelines just don't fit but I do recall that Prof Dixon's group are working on their own needle free application methods with Scancell sponsorship.

Hi Autonomy
The connection is that the Covidity trial in SA will use 2 needle free application methods.
We have no further details about these methods but it is possible that these have been developed by the Nottingham Uni School of Pharmacy.
ATB

Hi Ivy
It is worth pointing out on your point 2) that the 2 trials (SCIB1 combo and Covidity) are very different trials.

The SCIB1 trial is for stage 3/4 melanoma patients and there is a long list of selection criteria and exclusions. Plus the trial is taking place during a pandemic where cancer trials have been on hold or severely disrupted.

For the Covidity trial it should be much easier to recruit (Healthy adults with no Covid19 symptoms and unvaccinated are the main criteria) plus hopefully there are no pandemic-related restrictions.

Remember that this is a phase 1 trial and the main objectives are to prove safety and find the most appropriate dose. Of course, antibody and T Cell levels will be measured but accurate efficacy will only be determined by a large phase 3 trial.

It will all be in Lindy's memoirs :-)

2 obvious candidates spring to mind

Biontech and Genentech/Roche

Simply because both Ugur Sahin and Ira Mellman were on Lindy's GC team.
I think Lindy would be looking to carry on her work in the way she wants to and not be dictated to by big pharma. With either of these 2 guys involved, I would think there is a good chance of that.

But there could easily be different partners for different parts of Scancell's pipeline.

I'm sure this has been posted here before and this PhD is being sponsored by Scancell. Maybe they already have needle-free delivery systems and this PhD is to improve on them.

https://www.findaphd.com/phds/project/development-of-an-intradermal-or-inhaled-dna-vaccine-for-covid-19-and-beyond/?p127093

"Intradermal and inhaled delivery of nucleic acid vaccines could be clinically effective, safe and globally-deployable against multiple complex diseases. This project will aim to combine physical and peptide-based delivery systems to enhance the efficacy and application of such technologies to the COVID-19 vaccine (‘Covidity’) presently under-development by our consortium (funded by Innovate-UK). This PhD will formulate and test combined systems for skin and lung-focused vaccine delivery in ex vivo tissue models, then move to rodent models, examining virus neutralisation, T cell responses and protection in virally challenged animals. The platform technology optimised and demonstrated will have wide ranging impact on future applications of nucleic acid vaccine approaches (including DNA, mRNA and oligo-based methods). The PhD will also directly aid attempts to translate antibody and peptide-engineering knowhow to generate a rapidly deployable and safe immunisation system for multiple complex diseases."

This article has been posted before here.

https://www.nature.com/articles/s41586-020-2550-z

It is worth reading the whole of the abstract:

"Memory T cells induced by previous pathogens can shape susceptibility to, and the clinical severity of, subsequent infections1. Little is known about the presence in humans of pre-existing memory T cells that have the potential to recognize severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Here we studied T cell responses against the structural (nucleocapsid (N) protein) and non-structural (NSP7 and NSP13 of ORF1) regions of SARS-CoV-2 in individuals convalescing from coronavirus disease 2019 (COVID-19) (n = 36). In all of these individuals, we found CD4 and CD8 T cells that recognized multiple regions of the N protein. Next, we showed that patients (n = 23) who recovered from SARS (the disease associated with SARS-CoV infection) possess long-lasting memory T cells that are reactive to the N protein of SARS-CoV 17 years after the outbreak of SARS in 2003; these T cells displayed robust cross-reactivity to the N protein of SARS-CoV-2. We also detected SARS-CoV-2-specific T cells in individuals with no history of SARS, COVID-19 or contact with individuals who had SARS and/or COVID-19 (n = 37). SARS-CoV-2-specific T cells in uninfected donors exhibited a different pattern of immunodominance, and frequently targeted NSP7 and NSP13 as well as the N protein. Epitope characterization of NSP7-specific T cells showed the recognition of protein fragments that are conserved among animal betacoronaviruses but have low homology to ‘common cold’ human-associated coronaviruses. Thus, infection with betacoronaviruses induces multi-specific and long-lasting T cell immunity against the structural N protein. Understanding how pre-existing N- and ORF1-specific T cells that are present in the general population affect the susceptibility to and pathogenesis of SARS-CoV-2 infection is important for the management of the current COVID-19 pandemic."

Yes, and in addition to targeting epitopes (plural) of the highly conserved N protein, it does suggest that Covid19 could be a goner with this vaccine.
It also has a head start on other Coronaviruses past and present, since up till now the N protein is also conserved across all Coronaviruses.

crumbs, if I recall correctly, SCIB2 targets 16 epitopes!
We don't actually know if there is a limit.

https://www.scancell.co.uk/immunobody
https://www.scancell.co.uk/covidity

Very bullish article, thanks bill.

It is possible that the 2 protagonists are 2 little old ladies who live in the same street and are having a joke.

Yes crumbs, I think Cliff got a stay of execution until the Covidity trial green light was given.

To me, it is largely irrelevant how it was handled.
The person most invested in the science is now in charge.

Already we see the difference in style of communication and a more confident attitude.

"I believe Scancell has an unrivalled pipeline of products and I, along with the rest of the team at Scancell, intend to continue to drive our pipeline through the clinic as we focus on accelerating the development of what we believe to be our most commercially promising assets."

"We are very pleased that this CTA was approved so rapidly, reflecting the importance of the study in South Africa, and it is a testament to the dedication and professionalism of the Scancell team and our colleagues in Cape Town. Our approach of targeting the conserved N protein in addition to generating potent, cross-reactive VNAbs has the potential to provide a significant clinical advantage by eliciting potent T cells that can destroy cells infected with any SARS-CoV-2 variants and other SARS-CoV viruses that may emerge in the future."

Scancell are so aware that success with Covidity would be a mind boggling game changer for the company.

It's not just all the revenue that will result, its

a) a further validation of Immunobody, this time for an infectious disease and with the distinct possibility that Immunobody
could be used for a variety of infectious diseases
b) a validation of Avidimab and we have seen some huge deals recently on ADCs and mABs. Also what price the glycans mABs?
c) a validation of a novel delivery method, let's hope this comes in house
d) a possible Universal vaccine for future coronaviruses

There is so much at stake and that is why they have designed 4 trials in 1 for the SA trial - 2 vaccines and 2 needle-free application methods. Then there is the possibility of another trial aimed at proving the efficacy as a booster jab.
It's so good to see Lindy at the helm in such an important 6 months. After that, who knows whether Lindy stays as CEO or a Steven Gerrard of the world of pharma takes over

Lindy would say that it doesn't follow that it works in humans.
But it does look like humanised mice are now safe.