Proposed Directors of Tirupati Graphite explain why they have requisitioned an GM. Watch the video here.
Morning sometimes in times like this it may be worthwhile stepping back and note comments of very respected posters like Bermuda.
For all we know they have still been actively trying to recruit but have been unable to get any patients through screening - worth noting the inclusion criteria for the trial. It's not just that patients can not have been infected themselves, but also they must have had no known exposure to SARS-CoV-2 virus in the last 14 days. So if they have had any contact with anyone who tested positive for Covid in the last 2 weeks, they have to be excluded.
So it may be that with the Omicron wave past it’s peak if it is the contact rather than past infection point that is issue to recruitment then this position can be quickly reversed.Ifvthe results had been accompanied by an interview to clarify things then maybe some of this speculation can be avoided.
Some of us have been criticised for wanting a more open and transparent communication on trial progress over the years and in fairness I don’t think it is any kind of wish to conceal matters just a common trait amongst many small bios whose scientific imbalance and inward looking nature tend to reinforce these actions.
Am sure in time as SCLP grows it will realise than the non scientific part is as valuable as the science although we all recognise it is the science that provides the ultimate value here.
ATB
Extrader agree with Elrics view re Covid data but do appreciate the progress of Covid CHIMs has been much slower than anticipated so has been largely excluded as guided by CF.
Think that is split into 2 bits the U.K. Govt slots and the wider commercial application.The wider one I am very happy with and do feel those contracts will come in due course.
Think the 3 Govt ones are harder to predict coming to fruition as yes an important need but not sure about Govt commitment moving forward in terms of current Covid challenges and preparedness for future Pandemics but that is due to issues outside of ORPH control
Thanks Burble,
We know the environment for recruiting trial patients is very difficult and we look forward to these interim results statements for guidance on all platforms but I really don’t see anything new and no imminent indication of any trial results.
Morning
Dies not the 16 patients represent the current total.
Highlights (including post period):
Vaccines:
· First subject dosed in the Company's COVID-19 vaccine Phase 1 clinical trial (COVIDITY) in South Africa, with 16 patients having been recruited to date.
I am actually disappointed with this progress as yes the 16 patients have experienced no safety issues which is good but did expect much quicker progress than this.Plus slow progress in getting Modi 1 underway.
Just my thoughts but happy to be proved wrong.
Evening extrader,
The fact the ORPH CHIMs are not based on the most up to date variant is not a concern as until Covid becomes an endemic disease threat then the CHIMs will always be behind the latest variant.
It is what you can learn on the HC trials that is important plus they are there to compare against each other not necessarily vs Omicron as it is yes more transmissible but less severe than say Delta.
The Pfizer-Bion Tech based on the mRNA is simply designed to change the antigenic focus like a plug and play when a new variant becomes dominant.
This does not mean other Covid 2.0 approaches or in particular the 3rd generation Covid Vax which seek a more universal approach will likely follow a similar pathway or more likely consider HC trials esiecuslky in a phase 2 taking into account the current difficulties of doing larger p3 trials except as straight boosters.
Omicron is much more closely related to Beta than say Delta so testing of Vax vs Delta is harder to evaluate than you may think.
So plenty of future for Covid HC work and CHIMs imo
Excellent summary Bermuda and does indeed highlight much of the logic of SCLP approach.
It would be fascinating to talk to LD about at what point did she decide to try and develop a Covid Vax based on Immunobody.
I suspect it was a mixture of wanting to do something/ other plans being held up but more crucially a discussion amongst her fellow scientists that led her her to concluding this approach could be be a real winner.
This creative spark off between leading scientists and colleagues is so important in these matters and then to have someone of Linda’s brilliance to progress the matter forward is critical.
As you say the trial data will prove the ultimate proof but so far this approach has certainly highlighted the weaknesses of other current approaches which yes have produced outstanding success gave also highlighted areas where improvements can be made
This bit highlights it
"Our study provides the clearest evidence to date that T cells induced by common cold coronaviruses play a protective role against SARS-CoV-2 infection."
Professor Ajit Lalvani
Director of the NIHR Respiratory Infections Health Protection Research Unit
Current vaccines do not induce an immune response to these internal proteins. The researchers say that – alongside our existing effective spike protein-targeting vaccines – these internal proteins offer a new vaccine target that could provide long-lasting protection because T cell responses persist longer than antibody responses which wane within a few months of vaccination.
Professor Ajit Lalvani, senior author of the study and Director of the NIHR Respiratory Infections Health Protection Research Unit at Imperial, says: “Our study provides the clearest evidence to date that T cells induced by common cold coronaviruses play a protective role against SARS-CoV-2 infection. These T cells provide protection by attacking proteins within the virus, rather than the spike protein on its surface.
"The spike protein is under intense immune pressure from vaccine-induced antibody which drives evolution of vaccine escape mutants. In contrast, the internal proteins targeted by the protective T cells we identified mutate much less. Consequently, they are highly conserved between the various SARS-CoV-2 variants, including omicron.
"New vaccines that include these conserved, internal proteins would therefore induce broadly protective T cell responses that should protect against current and future SARS-CoV-2 variants.”
Hi Bermuda,
Chris’s comment is based on following data at Imperial which has been highlighted but not sure everyone got significance re SCLP.
https://www.google.co.uk/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwjBmfi8vLP1AhWMIMAKHXRNAG0QFnoECAgQAQ&url=https%3A%2F%2Fwww.imperial.ac.uk%2Fnews%2F233018%2Fcells-from-common-colds-cross-protect-against%2F&usg=AOvVaw3r3meVCRlh6KvWOR1nJDM2
Chris Smith on Breakfast specifically talking about Vaccine 2.0 which is additional modifications to existing Vax like adding valencies and separately new Vax targeting the conserved part of the virus for eg the Nucleocapsid part to be a Universal Covid Vax
Morning.Don’t think this has been posted.
Can’t claim any credit for finding this as posted on another platform but taken from Pharmafile Winter 21 as part of a bigger article.
“The pandemic has highlighted the growing need for DNA vaccines, in multiple areas including infectious diseases and cancer. Looking ahead to the future of healthcare during the precariousness of a pandemic, we spoke to Professor Lindy Durrant, CEO of Scancell, which develops immunotherapies simulating the body’s own immune system response. Scancell believe that DNA vaccines are one component of tackling diseases, believing the vaccines “give more sustained production of antigen which should lead to longer term protection than RNA vaccines.” This vaccination form is significant for the increasing demands and needs of global healthcare: “Dendritic cell-targeting DNA vaccines are cheap and easy to manufacture, and have long term stability at -20°C. They can be rapidly adapted to give protection against both infectious disease and cancer. They can be used for repeated injections or for injections for other viruses, whereas viral vector-based vaccines can only be used twice before the immunity to the vector overwhelms the response to the inserted virus.” For the many and varied needs presented by patients of infectious disease, this is significant.
Scancell uses a human monoclonal antibody to target cells that stimulate immune system response. This vaccine can be customised against a specific disease – a promising feature considering the changing nature of
disease we have witnessed over the past year, and even the past month. This has
the potential to change the current impact
of vaccination. “A vaccine encoding both nucleocapsid protein linked to a modified Fc and receptor-binding domain should stimulate long-term memory B and T cells, and should give sustained protection over several years. This will give less opportunities for variants to arise and prevent people from having to be vaccinated every six months.
Scancell shared that its vaccine “targets antigens to dendritic cells to give more
potent T cell responses that lead to long-term memory, and still give high titre neutralising antibody responses. The nucleocapsid protein is more highly conserved, giving better protection against variants.”
As for the future, Professor Durrant looks forward to “simpler delivery systems for DNA vaccines. Currently we use a mechanical needle free device which is acceptable, but a simple injection would be more reasonable”. Durrant also hopes for “better investment
in vaccines that give broad protection (i.e. all coronaviruses – not just COVID-19), and sustained protection for 5-10 years should be developed now so they can be rapidly adapted when the next pandemic hit“
Just thought a very good article.
https://www.immuno-oncologyeurope.com/
Lindy one of speakers
Krafty,We are not far apart in that we both recognise the short term priority.
The Pfizer boss is simply talking about using the current Vax every 3-4 months based on hindsight of current knowledge based on Omicron- it is the suggestion that this was somehow planned in advance to simply maximise profit that is my main objection.You simply can’t predict with certainty about whether a Vax will work how much / long it will work for.
It is probably others who will likely be more interested in developing newer Vax Approaches as Pfizer already have their successful offering and can tweak the Technology fairly quickly if required.
As I have said I believe the SCLP approach has proved very relevant in potentially predicting the type of immune responses needed to create an effective universal Covid Vax but it is one of several novel approaches.
If it is proven to work then it will be fantastic and very good for SH but just as Pfizer and Moderna have done well don’t forget that other huge players like Merck faiked
Morning Krafty,
They targeted the Spike protein and pushed ahead as those platform technologies were already advanced in other spaces both infectious diseases and cancer and the critical need was to develop potential solutions as quickly as possible.
If they had targeted the Nucleocapsid protein to start with it would have taken much longer to develop the Vax with all those consequences as no one knew at the time what the relative influence of nABs vs T Cells would be.
Linda’s approach looks very promising from a science point of view but there are no guarantees any approach will work just because it looks good in theory.So SCLP approach was always going to be 2nd generation as they were simply not far enough down the track at the start of the Pandemic as compared to others.
I can guarantee if it it was a slam dunk approach it would have produced a deal by now.
No one is doubting LD brilliance but there are others equally as knowledgable and gifted at the science.
It is more those that think it is all about Pharma conspiring to simply screw the world to earn profit
Good p1 results here and that is huge for SCLP
Evening some interesting mentions of SCLP in recent days and their approach which hopefully should prove very successful.
However some of the comments about the motivation of big pharma in developing Covid Vax are ludicrous like they planned a 1 short interval between boosters to maximise profit or they only targeted Spike protein as a short term solution,do not understand mutation or looked to develop a longer term solution.
Developing a Vax is a very risky business with no guarantee of success however promising the science is so you cannot predict how long it will last or how effective they are in advance.
Just be pleased they have proved largely effective and saved many lives
Hi Burble,
I did not realise that the immune response was against the Vector as well and that it had a longer effect.
I have been selling Vector Viral Vaccines for a long time and the platform used is identical to the ChAd one in terms of technology.
The Vector is not affected by either the CMR or Humoral response as essentially it is simply to deliver the DNA gag and envelope part into the target and then just naturally disappears as I would expect a Chimpanzee Adenovirus to do so within a human.
Just very interested in your thoughts as you know a lot more about this space than me
In case it was not posted here
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1037560/100_Days_Mission_-_First_Implementation_Report.pdf
Morning Rab,
I think the Boris Meeting mentioned in your link referred to the launch of the 100 day rollout which was last Thursday rather than next week.
Hope I am wrong as there are so many Meetings and developments but the 100 day publication was pretty significant in determine the global way forward.
Did not contain much mention about DNA platforms specifically but did have a nice mention of need to develop needle free injections for future Pandemic control