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Wild,

I think all we can take from this trial is that Avidimab and PharmaJet are validated for ongoing development of the oncology pipeline.

krafty-

As you know, this was a phase 1 trial assessing safety and immunogenicity. The trial wasn't designed or powered to look at efficacy in terms of preventing infection/reducing severity - to make any definitive claims on that front would require a massive trial involving thousands of patients.

Scancell would have been looking to see that both vaccines generated antibody and T cell responses to both targets and that they were safe.

The most important sentence from the whole RNS:-

'The success of a human trial demonstrating that an AvidiMab ® modified DNA vaccine, delivered via a needle free injection, can induce both T cell and antibody responses, with no safety concerns, is a pivotal proof point for Scancell's clinical strategy.'

Lochinvarlass,

What company are you referring to?

Chelsea

I thought long and hard about replying to your post last night as I'm sure you're absolutely right in saying that all were delighted to learn that Trish's tumour had shrunk. However, Trish herself has confirmed that she was horrified to learn that her comments had been taken and quoted on other platforms - we were responsible for causing her distress and anxiety and that can't be OK under any circumstances, no matter how good the intentions.

Ciaskin,

Yes possibly, although usually it would be a seamless transaction taking place as the deal is executed - ie. any outstanding options would automatically be exercised and the holders would receive a cash sum based on the takeover price per share less the exercise price - depending on the terms of the deal of course.

Riley,

Obviously when the share price is higher than the strike price common sense dictates that you wouldn't, unless you didn't have the cash to exercise the options or were concerned that you would be unable to sell them. Clearly neither of those scenarios apply in this case.

I was making the point that the news today is routine, there's no hidden meaning. and partners/collaborators exercising options before they expire is more or less neutral news (IMO)but then I think you probably understood that.

violindog -

True, but then that situation already existed with the tranche 2 options.

These options were granted to Ichor Medical systems over a decade ago in return for the use of their electroporation device. It's very common for tiny bios who don't have the funds to in-license vital technology to grant share options in lieu of hard cash payments. The Ichor device was an integral part of the development of the ImmunoBody platform and Scancell could not have taken SCIB1 into the clinic without it, but they didn't have the cash for a standard licensing agreement.

Worth noting the contribution the ImmunoBody platform has made to the growth of the Company and that the market cap at the time they granted the options was around £6m - I'd say a win/win situation and a pretty good deal for Scancell shareholders.

Chester,

Why now? I expect because it's got to the top of Ichor's finance officer's to do list.

As for the drop in SP today - I hope it's not down to retail investors panic selling on the back of the RNS. If so, then they really don't understand share options and the role they play in early biotech. If Ichor had let the options expire it would have been understandable, but this is just routine stufff.

Chester,

Yes you're right, but it was the original phase I/II trial which was completed in Q4 2015.

TF - lol

Krafty - who knows whether they intend to hold, sell or have already sold? Tranche 2 were exercised back in 2018 but were subject to a 2 year lock-in period. I'd need to check, but am pretty sure Ichor continued to hold beyond the end of the expiry of the lock-in. I don't know whether they're still holding them or whether tranche 3 are also subject to a lock-in. In the grand scheme of things, it's not a vast number of shares.

chester - there's no connection to the current SCIB1 trial or iSCIB. Ichor could have exercised these options at any point from their vesting date (2016)

Just to comfirm my earlier post, this is from the last Annual Report:-

'The options have been granted at 4.5p per share and the outstanding 3,184,630 share options vested on 23 April 2016 and have an expiry date of 30 April 2023'

So it seems that Ichor are exercising before the expiry date. I have no idea why the expiry date was extended - assume it was part of the negotiations for the extended use of the device for the SCIB1 trial.

That's the third and final tranche of Ichor share options - all now exercised. For any who weren't aware, these options were granted to Ichor Medical Systems as part and parcel of the licensing agreement allowing Scancell to use Ichor's electroporation device to administer the SCIB1 vaccine. In total Ichor were granted options over 7.9 m shares in 3 tranches:-

Tranche 1 - 1.59m vesting on regulatory approval for SCIB1 clinical trial
Tranche 2 - 3.18m vesting on commencement of the trial
Tranche 3 - 3.18 vesting on completion of the trial

Ichor had already exercised their options over tranches 1 and 2 and a good while back were still holding tranche 2 - I don't know, but assume they'd sold tranche 1.

It's easy to read all sorts of things into the timing of these events, but these options had to be exercised within 5 years of vesting and that may have been the driving force here - Ichor either had to exercise the options or lose them. Of course there may be another reason, but it could be related to Ichor rather than Scancell.

Ruck,

Covidity is based on IP from both the Avidimab and ImmunoBody platforms and it would be an odd strategic move (IMO) to move it into a new company leaving the IP it relies upon behind in another - messy.

FWIW, I think that Zakari was Cliff Holloway's initiative to facilitate either a deal or funding for the glycan mAbs. I'm not sure it went down well with some larger shareholders and once CH had departed, it was unlikely ever to be used. Makes sense therefore to simply close it down.

corr

'he obviously will go ahead and prescribe'

should read

'he or she obviously will go ahead and prescribe'

Konar,

I'm not sure, it's probably too early to tell and don't forget the interims mentioned another 16 patients who had been recruited and I assume were undergoing screening - some of those may well be for cohorts 3 and 4.

I haven't checked the figures, but I think recruitment is probably more straightforward for the monotherapy arms of the trial - the patients have failed other treatments and no other therapies are currently indicated.

It's more complicated when it comes to the combination arms. As you know, in order to be eligible patients must be receiving a checkpoint inhibitor alone as their standard of care (SOC). However, where checkpoint inhibitors (CPIs) are approved as SOC, it's often in combination with other drugs. For example, with triple negative breast cancer, Keytruda is approved in combination with chemotherapy, with renal cancer NICE have recently approved Keytruda as a first line treatment - but in combination with the tyrosine kinase inhibitor, lenvatinib etc. etc.. Where a consultant feels an approved combination of CPI and another drug is the best option for the patient, he obviously will go ahead and prescribe that treatment which would exclude the patient from the Modi1 trial. So lots of factors to be taken into account.

Pure speculation on my part, but given their limited treatment options, I also wonder whether patients might be more willing to consent to join the monotherapy arms of the trial .

DeAar,

Regarding your earlier post on the neoadjuvant arm of the Modi1 trial.

As you say, Scancell will only begin recruiting patients to the neoadjuvant study when they are given the green light to enter the expansion phase of the combination trial. However, it's worth noting that the dosing period for the neoadjuvant patients is only 6 weeks at which point they'll have their tumours surgically removed. A tissue biopsy will be taken from the resected tumour and will be analysed and compared to the baseline tissue biopsy.

Also worth noting that the neoadjuvant study is randomised - patients will either be given Modi1 as a monotherapy or Modi1 + Keytruda. So the tumour tissue analysis will not only look at changes from baseline, but also any differences between the monotherapy and combination arms.

So whilst recruitment won't start immediately, the dosing period is much shorter for the neoadjuvant patients and results should be available shortly after surgery.

Matt - I think it would and at some stage Scancell really must start hitting its own published timescales.

hyms - spot on.

No, I didn't realise either.

I know we've discussed it here before and that it's the logical next step for those cohort 1 patients, but I must have missed the confirmation from Scancell that they'd already applied for approval.

Johnny, thanks for the summary.