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We have been told that SCIB1 + CPI's will read out in Q4 / 24 and iSCIB+ in Q1 / 25.

For Scancell to be confident at the time of that announcement that SCIB1 would be ready to report in Q4/24 they must have known it was not going to fall short of that all important 27 responders.

It does mean that the 86% figure is probably correct at the time this interview was recorded and that would also confirm to me that they are very confident of having 27 responders in the Q4/24 report .

The list is meant to remind everyone just how many questions there are to be answered in the ModiFY trial.

It’s a complicated mix and when the data is presented it will offer answers and probably a lot more questions.

The ModiFY Basket trial must be bursting with presentable early data.

What news would a Q3/24 Update consist of :

1 ) Mono-therapy - Stable disease RNS’ed in the past.

2 ) Modi1 + Single CPi - this cohort should have many scan results and hopefully showing an advance over Mono only.

3 ) Modi1 - Harvested Moditope T Cells as requested by BionTech. Is this still a thing or have BionTech moved on ?

4 ) Modi1 + CPi in Renal Cancer - Request to Upgraded from a 3rd Line Treatment to a 1st Line Treatment :

Are we still Awaiting Approval or was the approval just not received ?

5 ) Modi1 + Double CPi’s ( BMS Checkpoints ) : Still Awaiting the start of this cohort. Approval granted 30th May 2024 ?

6 ) Neo-Adjuvant Arm where the resected tumour is analysed for the Ingress and Impact of the ModiTope generated ‘T’Cells.

15 patients given Modi1 plus CPI and 15 patients just the CPI, resected after 6 weeks. There should be a good many of the Modi1 dosed and then resected patient results already to hand.

The ModiFY Trial will have produced many results in Mono-therapy and also with a the Single Checkpoint.

What positives have been achieved in Patient Outcomes ?

Continued :

As you say there could be many more than my guess at 10 patients that have already been scanned by today.

Good point KonarA.

My assumption was drawn from two sources, firstly Sath said after a live presentation that there were 10 enrolments in one month.

Also the 22 patients enrolled on the 24th July. From this I guessed that 50% actually made it through selection and to dosing. However you are correct that there will have been a pool of patients that missed out on the SCIB1 cohort that would pass straight on to the iSCIB+ cohort. A ready made source of patients that have already made the grade.

So should Scancell let us know how well the first 13 scans have done or should they hold back the data as long as possible.

We all expect the ORR to be over 70% so is delaying this early data release a good or a bad thing.

Lastly, what if there is an NDA in place that is tied to the Registration Trial.

As you say there

Based on the first patient dosed on the 26th March and their 13 week scan was approx 25th June, we can guess that by now ( end Aug ) the scan results could be confirmed for between 7 and 10 patients. Obviously we don’t know exactly how smoothly the process is running in the various clinics but the enrolment has been approximately 8/10 per month, which should mean at least 5 patients per month have reach the dosing criteria.

24th July confirmed 22 patients enrolled.

If Scancell want to share the early scan data, as they did with SCIB1, 9 out of 11 showing 82% ORR, that number of scans for iSCIB+ could be easily achieved by 13th September.

If iSCIB+ is showing the same potency at this stage would it be proper for that information to be RNS’ed or better to keep the data private ?

Anyone any thoughts about this ?

I don’t have any first hand experience of the Pharma or Bio industries. What I presume is that they are very selective in what they deem to be a good fit with their own infrastructure and integration would have to be smooth or if not the new asset extremely valuable.

I would also imagine that if an opportunity presented itself where a multi £million deal had one very significant asset but it came with several other assets they did not want they could create a team to dispose of those other parts. I would think that the original prize would have to be huge to cover all that extra time and cost of that disposal exercise.

So at present I don’t see a scenario where Scancell would be bought wholesale.

Development, Partnership, Deal and move on.

Immunobody looks likely to be extremely valuable and easily packaged as a Platform for Sale, then we have GlyMab deals, hopefully AvidiMab deals and Development of ModiTope Modi1-Modi2-Modi3 and our own Antibodies in through clinical trials.

This could be exactly what Redmile want, a company that keeps on giving.

When the Registration Trial is approved Scancell need to partner up or find the funding to go it alone.

The only possible partner is surely the company that owns the two checkpoints, BMS.

No other pharma is going to pay to prove up that combination. If they changed checkpoints it’s back to the start with a whole new cohort, which will take at least 12 months if not longer.

Taking these thoughts into account and realising that the CAB is in place and we have Redmile recently taking a seat on the board plus the appointment of Chief Medical Officer, you could surmise from these factors that BMS are already keen to proceed.

Makes complete sense to me given that the alternative is BMS have said they are not interested and told Scancell to “go it alone”.

So I reckon it’s now just a matter of how much more effective is iSCIB+ over SCIB1.

Welcome recce

As we approach a very pivotal moment in the development of Scancell it’s good to have you onboard.

Bojo that’s a very good point.

I think Lindy Durrant is savvy enough to see through any bull. At the moment it’s odds on to be BMS solely because it’s their checkpoints that are working so well with SCIB1.

Hi violindog

That’s the great thing about these discussions, we all have slightly different ideas of what may or may not happen.

At this very moment in time Scancell don’t have anywhere near enough positive data to attract a bid. The numbers of patients is to low, LD said as much. We need that statistically important 27 out of 43 patients in the SCIB1 cohort showing a 30% regression to meet the minimum hurdle of proof.

I have every confidence that we are going to achieve that 27 and from a much lower number than 43.

Then we need to wait for the iSCIB+ results because that is what we will progress with. Until those results land there will not be a deal on the table.

Scancell may actually be negotiating the terms and structure of a deal with a sliding scale to fit with how well those results turn out. They know a lot more than us lowly speculators.

“Oh to be a fly on the wall”

Ok I think it will play out as follows :

Partnership with BMS to complete the Registration Trial early 2027. They would pay for the trial and make an upfront payment so Scancell can continue with Modi1, Modi2 and SC134 all in the clinic.

A successful Reg Trial they would buy the Immunobody platform for £2.6B in 2027.

Modi1 then goes for a registration trial but we have the cash to go it alone. SP over £10.

Depends on who’s doing the calculations.

Given that these are Platforms and very likely to expand into multiple cancer indications and that these results are with stage 3 & 4 cancer patients so there are also many much earlier stages where these treatments will be even more impressive.

Try adding up all the market potential and then multiply that by 10, 15 or 20 years of possible profits.

That would be my starting point.

Hi Dalester

I would be amazed if a large number bid was presented to Scancell before there is a cast iron decision that the Registration Trial can go ahead. If MHRA didn’t approve where would that leave the bidding company?

Also I would be shocked if we don’t see a deal once that approval is given.

Scancell will now have in their possession the 13 week scan results from the first 5 or 6 patients on the iSCIB+ cohort. So they will have a good idea if it’s working well or very well and I would expect they will now be working on all the documentation and trial protocols for the earliest possible start date.

Thinking in terms of what the minimum requirements are for such a deal to be sanctioned by any Pharma or Bio, Board of Directors.

I’m of the mind that they will need the reassurance of the Registration Trial, Approval, before any deal would be signed up.

Hi BuddhaBob

Yes, end of November is the norm.

I went in 2022 but unfortunately I was unable to go last year. Definitely worth the effort because you can meet the Scancell team. If you have invested for some time and expect to stay with them as the company develops then it makes it much more enjoyable.

I would expect plenty of news before the AGM so that’s another great reason for being there in person.

Chester 👍

EE

That would be Christmas and the next ten Birthdays all rolled up into one big prezzie.

We can dream……

In reality we need good solid results for SCIB1 plus 2 CPI’s where the ORR is still around 80% as a starting point. Then we want iSCIB+ to match those results only now across 100% of patients.

When both of those SCOPE trial results are in we need approval to setup the Registration Trial. Only then will we know if there is someone lurking with a pocket full of cash.

The ModiFY results should be solid but not amazing, that will come when we know how the double checkpoint cohort has progressed.

This years AGM will probably be the most important ever and is already on my ‘must be there’ list.

You can imagine that the executives at Bristol Myers Squibb would move to buy Scancell if and when ‘Modi1 plus Opdivo and Yervoy’ confirms Regression/ Clearance of RCC tumours similar to what has been achieved with SCIB1 in Unresectable Melanoma. Even though they would both be Phase2 results, the opportunity to own and develop Immunobody and ModiTope into multiple cancer indications would be too tempting.

Those two platforms in combination with their checkpoints would set BMS up for the next 10 to 20 years. I’m sure our CEO would ( at the right price ) welcome and trust a company the size and scope of BMS.

I would hope in that scenario, other large Bios / Pharma companies also seeing the huge potential of Scancell’s technologies.

A bidding war would be very acceptable to us ‘little old PI’s’.

Hi Bojo

I think you could be right that it’s the ASCO conference that generated enough of a buzz that it brought Scancell into the spotlight. Whoever it is that has spent a £1m or two in the last 6 weeks must be very convinced.

Learning from the journey of SCIB1 Lindy knows that Modi1 needs that combination of double checkpoints to overcome these multi-complex late stage tumours.

Modi1 is probably already a fantastic treatment for some early stage cancers but new technology is not going to be given to those patients until it has proven itself. So we have to find a path that works in the most advanced and difficult stage lll and lV cases.

Modi1 plus the single checkpoint ( Keytruda ) is creating stable disease which in that scenario is still fantastic but the WoW factor won’t happen until we start to see 30% reductions and hopefully, clearances.

Success in the yet to be started Renal Cell Carcinoma with double checkpoint will open the way for Modi1 to begin testing that combination in more and more cancer indications.

The SCOPE trial first and then the jewel that is ModiTope will have the chance to shine.

The late 2023 and early 2024 trial report guidelines were Q3 for the Modify Trial and I’m sure across the various cohorts there will be elements that could be reported by the end of September.

However the very last ModiFy update when announcing the new Renal Cell Carcinoma cohort with a double CPI the RNS ends with “data expected by the end this year”.

What I’m hoping is that those parts of the ModiFY trial that have achieved positive results are reported as early as possible and arrive before Q4 starts.

Or alternatively another fund / investment company decides to also build an early stake. The current positive sentiment needs positive news or action to keep it sustained until a major announcement arrrives.