Member Info for JohnnyB1

Talking about Covidity trial data at the AGM Lindy said “We were hoping to do this by the end of the year but we will probably just get into January before we report there”.

I see CureVac went up 29.47% yesterday (an increase of circa $358 million in their market cap). This rise is way in excess of Scancell’s total market cap of circa £201 million.

This rise seems to be on the back of positive preliminary results on its Covid 19 and Flu Vaccines:-

https://investorplace.com/2023/01/curevac-cvac-stock-rises-25-on-positive-data-for-covid-19-and-flu-vaccines/

I realise things aren’t that straight forward but nonetheless a positive update on Covidity (and therefore the Avidimab platform) has got to have a good effect on the share price.

Thank you for your comments WeTookPelham and Wildforce, I appreciate it.

Wildforce. I take your point but I just felt that it was worth mentioning on here. I personally think that we may get Scancell’s update on the Modi 1 trial in mid January’23 because:-

1. The first patient in the expansion phase of Monotherapy arms should have had 3 doses and their first scan on or around 15 January’23. (i.e. This is the patient that received their first dose 31 October’22 as detailed in the RNS).

2. The other 2 patients in Cohort 2 should both have received their 4th vaccines and second scans by this time.

There was a new post on the MacM site 9 days ago under the heading “What’s next on the cancer treatments”.

It appears that there are now 2 people in the MacM community on the Modi 1 trial.

https://community.macmillan.org.uk/cancer_types/head-neck-cancer-forum/f/diagnosis-and-treatment/251474/what-s-next-on-the-cancer-treatments/1819177

There are 2 separate responses under the new post:-

“That's not the news you need....so sorry. Yes there are other treatments ..more chemo (but maybe they won't offer you that?), immunotherapy and there are two people in this Community on the Modi trial. Both Immunotherapy therapy and the vaccine trial are producing remarkable results......so hold onto that”.

“Hi Min not what you want to hear but as Dani says there’s options out there. I know a few on immunotherapy plus like Dani says the modi trial is having great results. Keep in touch sending hugs”.

We know about patient 1 but, despite searching, I cannot find any further information about patient 2 on the MacM site. I wonder if patient 2 is also achieving “remarkable results” (The above responses seem to imply they are but on their own are not 100% conclusive).

I have listened again to what Lindy said at the AGM and I now feel positive about both Avidimab and Covidity.

Talking about Avidimab Lindy says “Potentialy next year we are hoping to go out and try to sell that to other companies as a revenue generating deal because it could enhance a number of the antibodies on the market”. “Again the Covidity vaccine has actually used that Avidimab and validated it in the clinic and indeed we are using that now in the new SCIB1 product”.

This is something for the more scientifically minded, so please correct me if what I am saying is incorrect. I interpret “….used that Avidimab and validated it in the clinic” as Lindy effectively telling us that Avidimab has proven to have worked in the Covidity trial.

Turning to Covidity itself Lindy said “As soon as we got into South Africa there was a big omicron infection. So alot of the patients had received a single immunization and then got omicron. Indeed I think we’d recruited 18 patients and only 3 of them did not get omicron ………… Because they were safe and we had no problems we got permission to go as a post vaccine in patients who had already been infected or had another vaccine and that’s really the commercial place for this as a booster vaccine and not as an initiating vaccine. We’ve fully recruited to that study, how many patients? (Colleagues reply “Forty”) forty patients”.

(It is significant that the patients who caught omicron will have had a single immunization of SCOV1).

I suspect that the forty patients Lindy refers to were patients who received SCOV 2 only. As detailed in the trial protocol 40 patients out of a possible 80 is sufficient (i.e. 10 in each of the 4 SCOV2 only populations):-

2 populations (One intradermal and one intramuscular) of “Vaccine Naive and Previously Vaccinated participants: Two doses of SCOV2 (administered on Day 1 and Day 29) with a final end of study assessment performed 6 weeks after last dose of study vaccine (Day 71)”.

2 populations (One intradermal and one intramuscular) of “Previously Infected participants: A single dose of SCOV2 (administered on Day 1) with a final end of study assessment performed 6 weeks after last dose of study vaccine (Day 43)”.

This is an interesting article on covid vaccines, it shows how far ahead Lindy is with Covidity:-

https://www.raps.org/news-and-articles/news-articles/2022/12/marks-says-evaluating-t-cell-immunity-for-future-c

“The US Food and Drug Administration’s (FDA) top vaccines regulator, Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) told vaccine experts that it “makes sense” to consider T cell responses in evaluating the next generation of COVID-19 vaccines in light of waning immunity with existing vaccines and the emergence of new variants”.

“Marks said the consortium could also suggest that the agency update its guidance on COVID-19 vaccine development to include looking at T cell response in addition to the current testing approach of antibody assessment”.

I wish you all a very happy Christmas.

That's coffee served with a smile and a large slice of cake:-)

Hopefully the other 2 patients in cohort 2 of the Modi-1 trial will show a similar response to that of the first patient. I think (AIMHO) that some scientists may be about to wake up and smell Lindy’s coffee:-

https://www.nationalgeographic.co.uk/science-and-technology/2022/12/cancer-vaccines-are-showing-promise-heres-how-they-work

“But “vaccines haven’t been very good at generating the quality and quantity of T cells necessary to eliminate large tumours,” Bhardwaj says. It’s ideal to vaccinate when the tumour is small, she says”.

“Despite the renewed excitement in developing and testing cancer vaccines, given technological advances, some scientists like Klebanoff remain skeptical. He wonders if the vaccines will ever be potent enough to cause tumour shrinkage in a way that is clinically meaningful and whether alternatives like engineering a patient’s T cells—so called CAR-T cell therapy—so they can better recognise tumour cells will be a more effective strategy. His research group uses the latter approach. But he remains eager to see what the data from ongoing vaccine clinical trials reveals”.

Talking about this at the AGM Lindy said “We were hoping to do this by the end of the year but we will probably just get into January before we report there”.

The following article points to the Covidity update being very interesting:-

https://www.insideprecisionmedicine.com/drug-discovery/the-dawn-of-next-generation-covid-19-vaccines/

“The nucleocapsid protein is a structural protein with an integral role in viral assembly and the packaging of genetic material (Figure 1). It is 90% conserved between SARS-CoV-1 and SARS-CoV-2, compared to 76% for the spike protein. These two features combined make it a very promising target for vaccine design”.

“Added to this is the fact the nucleocapsid protein has been shown to elicit a powerful T cell response. Where B cells produce antibodies that can bind to viral particles before they enter cells, T cells are in charge of destroying host cells already infected with the virus; the stronger the T cell response, the better the body can contain the spread of the virus and clear the infection. Analyses of people infected with SARS-CoV-1 have indicated that N-specific T cell immunity can be very long lasting, with some individuals retaining memory T cells up to 17 years after initial infection. These same T cells managed to recognize the SARS-CoV-2 nucleocapsid protein, mounting a quick and specific immune response”.

“Indeed, research published in Science Translational Medicine corroborates this, suggesting an mRNA vaccine that targets both the SARS-CoV-2 spike protein (S) as well as the nucleocapsid protein (N) may offer stronger and broader protection than current, spike-only vaccines”.

Hamster models: “To further test the breadth of the immune response elicited by the mRNA-N+S vaccine, Hajnik et al. exposed hamsters to the Omicron variant (BA.1). At two micrograms, the spike-only vaccine induced modest viral clearance from the lungs; a 12-fold reduction in viral RNA copies two days after infection. The mRNA-N+S vaccine, in contrast, managed to completely clear viral RNA copies from the lungs by day two of the infection”.

“Intradermal delivery holds a few distinct advantages”.

“A recent study comparing intradermal and intramuscular administration of the SARS-CoV-2 receptor binding domain (RBD) confirmed as much, describing improved T cell responses after injection into the dermis”.

“Needle-free delivery also nullifies the possibility of needle reuse and subsequent cross contamination, which continues to be a commonplace issue in many parts of the globe, with up to 1.3 million deaths a year attributed to such practices”.

I agree Wildforce, we should hear something before the year end. It could potentially be a great christmas present to shareholders.

In the RNS 31 October’22, referring to Modi-1, Lindy said “………….. and look forward to announcing further safety and immunogenicity data in H2 2022”.

At the AGM (When asked about Moditope in the Q&A) Lindy said “We will give you regular updates”.

I see that Scancell have posted a new vaccine publication today in the “Moditope” categorie:-

https://www.scancell.co.uk/Blog/ViewCategory.aspx?cat=44&mid=166&pageid=72

The link leads on to a full 14 page article (I have not read this as it is over my head).

Something that I can say with confidence is that patient X will not be posting an update between 1pm and 7pm on Monday. This is because Macmillan will be updating their community website:-

https://community.macmillan.org.uk/cancer-blogs/b/community_news/posts/online-community-downtime---wednesday-30th-november

One for the conspiracy theorists I guess :-)

Thank you Chester, Violin, Max & Ray for your positive comments.

Sorry, I made a mistake in the last paragraph of my post, where I referred to “Cohort 3” I meant to say:-

“The first patient in the expansion phase of monotherapy arms should have had 3 doses and their scan on or around 15 January’23 (This is their “Day 76”).” (i.e. This is the patient that received their first dose 31 October’22 as detailed in the RNS).

As far as cohort 3 goes, Lindy stated at the AGM (at the beginning of the Q&A) “We have recruited but not immunised cohort 3”.

I have looked at what we know about the Modi 1 timeline (From RNS and Macmillan):-

DAY 1: 16 August’22 RNS First patient dosed in cohort 2

DAY 76: 31 October’22 RNS first patient in the expansion phase of the monotherapy arms in the multicentre Phase 1 Modi-1 clinical trial (ModiFY) has been enrolled and dosed. All 3 patients in cohort 2 have successfully received 2 doses. The first patient to be assessed has shown a partial tumour response at first radiological reassessment

DAY 78: 2 November’22 Patient X (First patient cohort 2) had received 3 doses to date. Reported a 30-40% reduction in Tumour size.

DAY 92: 16 November’22 Patient X had their 4th dose. Reported hearing completely restored.

DAY 106: 30 November’22 (Today) Patient X to have their next scan.

My conclusions based on the above (AIMHO):-

Cohort 2: We know dose 1 and dose 4 appear to be 91 days apart. This points to each dose being 30 days apart. We know that the 2nd and 3rd patients dosed had had 2 doses as at 31 October’22. So by today at the latest they will have both had 3 doses. The scan appears to be 2 weeks after the 3rd dose. They may have already had their scans or be due them very soon.

Cohort 3: First patient should have had 3 doses and their scan on or around 15 January’23 (This is their “Day 76”).

At the AGM Lindy said that because Modi 1 was safe they have now moved on to cohort 3. At the same time they have also moved into the monotherapy cohorts and have almost completely recruited the ovarian cohort (This will be without a check point because ovarian cancer does not have a check point that is approved).

By way of a comparison, I see that Immunogen, Inc. has recently announced that its platinum-resistant ovarian cancer drug ELAHERE (mirvetuximab soravtansine-gynx) has been granted FDA accelerated approval:-

https://www.fiercepharma.com/pharma/four-decades-immunogen-gets-landmark-green-light-advanced-ovarian-cancer

The following points about Immunogen’s drug stand out to me:-

1. It is the first approval in eight years for advanced ovarian cancer.

2. Side effects (I found this information in a separate article): Packaged with a black box warning of the potential damage ELAHERE can do to patients’ eyes, including vision impairment and pain.
(Modi 1 has so far been safe, though this is at very early stages in the trial)

3. The FDA approved the drug based on data from a trial of 106 patients which showed Elahere’s ability to shrink tumors. The drug achieved a 32% objective response rate (ORR), with five patients completely cleared of tumors. The ORR was a decided improvement on the 12% figure seen in an earlier trial of single-agent chemotherapy.
(Modi 1 has seen a partial response in the first patient; albeit this is a head and neck cancer patient. It will be interesting when we start getting data from the ovarian cohort)

4. Costs: ImmunoGen has priced a 100 mg dose of Elahere at $6,220, CEO Mark Enyedy said on the call. Patients typically receive three to four vials in a cycle of treatment, leaving the cost between approximately $18,500 and $25,000.
(I have no knowledge in this field but this strikes me as being expensive. That said, I don’t know what Modi 1 might cost; though Scancell will clearly need to recover all their development costs).

At 12 minutes 40 seconds into the AGM questions and answers recording Lindy gets asked a question:-

Questioner: ……………. and that will be after you have had some more positive results from Modi 1?

Lindy: “Potentially yes, I mean………..I should stay there (laughter in the room) I will get shouted at (more laughter).”

I get the impression that Lindy had to stop herself from saying something very positive.

I feel confident that Scancell will still look to partner SCOV2 as a booster (If it did as well in the clinical trial as it did in preclinical models).

As Lindy said at the AGM “As soon as we got into South Africa there was a big omicron infection. So alot of the patients had received a single immunization and then got omicron. Indeed I think we’d recruited 18 patients and only 3 of them did not get omicron ………… Because they were safe and we had no problems we got permission to go as a post vaccine in patients who had already been infected or had another vaccine and that’s really the commercial place for this as a booster vaccine and not as an initiating vaccine.”

(It is significant that the patients who caught omicron had single immunization of SCOV1).

The AGM (and Botski’s kind recording) was the first that we heard about this. However Lindy already knew this when the RNS dated 31 January’22 was issued. Scancell chose to put the following wording in the RNS:-

“Scancell has previously shown in preclinical models that both SCOV1 and SCOV2 induce high titre antibodies and potent T cells against both the S and N antigens, and that these responses cross-reacted with the Delta variant. The Company has now confirmed in preclinical studies that although both vaccines induced responses against the Omicron variant, THE STRONGEST RESPONSES WERE SEEN WITH SCOV2.” (I put this in capital letters to emphasise).

We're certainly getting closer to shouting from the roof tops than jumping from them.

I see that Richard Goodfellow has also been removed from Scancell Holdings plc, Scaqncell Ltd and Zakari Therapeutics Ltd at Companies House:-

https://find-and-update.company-information.service.gov.uk/company/06564638/filing-history

Hi Moonparty, I must admit that confused me initially, what is the definition of not in public hands?

If you go back and look at the share info page the percentage not in public hands appears to be the total holdings of Redmile, Vulpes and the Directors and related holdings.

I interpret that the reason for this is despite the fact that Calculus are/were a significant holder, they are not on the BOD or tied into Scancell in any way. So they are just shareholders like you and I in that respect.

If you click on the back arrow in the following link and pick any previous version, you will see that Calculus are never included in the percentage not in public hands.

https://web.archive.org/web/20221122161116/https://www.scancell.co.uk/share-info

I suspect that Scancell amended the page because Richard Goodfellow has left (he is no longer on the Directors page) but omitted Calculus in error. They realised their mistake and put Calculus on again but put still got the number of shares wrong.

I am beginning to question my sanity.

The “Share Info” page of Scancell’s website has now been updated again and reverted to include Calculus Capital as a significant shareholder with 40,560,345 shares. This is the number of shares they held following the RNS dated 28 September 2022:-

https://www.scancell.co.uk/share-info

However, this is clearly incorrect because page 20 of the year end accounts show that Calculus Capital held 37,546,331 shares as at 26 October 2022.

https://www.scancell.co.uk/Data/Sites/1/media/fininfo/scancell-holdings-financial-statements-to-30-april-2022.pdf

For information purposes this is the earlier 22 November’22 version of the “Share Info” page of Scancell’s website (You will see that Calculus Capital were NOT showing as a significant share holder) :-

https://web.archive.org/web/20221122161116/https://www.scancell.co.uk/share-info