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Fevertree,

FWIW I completely agree about the need to strengthen the board. I also agree that deals take far longer than most appreciate, not just the time required for due diligence, but also the decision making process can be painstakingly slow in some of these large organisations. A perfect example is the sale of Redx Pharma's BTK inhibitor when they were in administration. It was a fire sale at a knock-down bargain basement price of a hugely promising small molecule and the cash was needed to pay off Redx's creditors and take the company out of administration. There were 3 interested parties - all 3 wanted to buy but the successful company was the only one who could complete due diligence and the sale within 3 months. The other 2 pharmas simply couldn't meet that timescale and so lost out.

So here we are, just 8 weeks after a small British company becomes the first ever to secure FDA approval and to create a new FDA class of CTC liquid biopsy and yet we have people calling for AN to resign as they believe he has failed or will fail to commercialise Parsortix. It is absolutely impossible to make that judgement call at this stage as anyone with even the most basic understanding of this sector and the corporate world would appreciate.

AN has very clearly laid out the commercial strategy and began months and months ago putting in place the infrastructure to support it - time will tell whether or not it's successful. In the meantime, he didn't say that they wouldn't raise funds - he simply stated the cash runway and various options were discussed. In the current environment and given the pressure on m&a valuations, it makes sense to raise early rather than find themselves forced to accept a lowball offer.

Of course it's relevant for pharma services clinical trials contracts.

JustThinkItThu

I assume before posting you've done some basic research - where did you get the figure of $20 per test?

Johnny,

Yes an extra study centre will help.

The most significant protocol change for the SCIB1 trial is opening the it up to patients being treated with Opdivo and Yervoy. Apologies if I'm teaching anyone to suck eggs here, but for the sake of any newcomers, originally the study was designed to test SCIB1 in combination with Keytruda where Keytruda was being prescribed as the standard of care treatment. However, for reasons that are irrelevant to this post, the trial has taken so long to get going that things have moved on and the doublet therapy of Opdivo plus Yervoy is now the standard of care for many patients. With the best will in the world, if a doctor believes that Yervoy+Opdivo is a better treatment option than Keytruda for a patient, they're not going to recruit that patient to a trial testing SCIB1 with Keytruda.

Recruitment was never going to be quick to this trial, but the changing treatment landscape had shrunk the suitable patient pool and meant that it would have been incredibly slow and difficult to fully recruit. Opening the trial up to patients being treated with Yervoy+Opdivo should help.

bazooka -

Seneca was previously the Hygea Fund, there was a name change 2 or 3 years ago. You'll find Hygea listed as a major shareholder in old annual reports but their holding is now below the notifiable threshold

The SCIB1 trial record on clinicaltrials.gov has now been updated with the protocol changes announced on 15th June. Have to say the updated record makes for much easier reading - 66 different primary and secondary outcome measures now condensed down to just 12.

https://clinicaltrials.gov/ct2/show/NCT04079166?term=scancell&draw=2&rank=3

There is no such thing as 'keeping up with' in phase 1 oncology clinical trials. Happy to elaborate if required but if anyone is concerned that another drug being tested in phase 1 poses any sort of a threat to Scancell, or indeed any other drug in development, then they may not have appreciated the scale of the industry or the way clinical trials work and will have a very stressful time holding any clinical stage bio.

The investment case here is most definitely not that any of Scancell's products will complete trials before anybody else's or that they'll be rolled out before anyone else's.

bazooka

Thanks for the reply.

bazooka -

How so? Can you explain what you mean when you say 'keeping up with' - in what sense?

Konar,

In answer to your 14.30:-

1) I believe that originally the first 2 cohorts were to receive a low and then high dose of vimentin peptides only. That has now changed. Cohort 1 = low dose vimentin peptides, Cohort 2 = high dose of the full Modi-1 vaccine ie. vimentin and enolase peptides. Each of these cohorts will consist of 3 to 6 patients. So in effect the high dose vimentin only cohort has been removed which will speed up the trial.

2) I don't believe a safety run-in is required for each cancer type, however there will also be a 3rd and 4th safety cohort for the combination of Modi-1 and the PD-1. So Cohort 3 = Modi1 plus standard of care PD-1 low dose, Cohort 4 = Modi1 plus SOC PD-1 high dose, again each cohort will be between 3 and 6 patients.

3) Cohorts 3 and 4 can only commence when cohort 2 has been completed and shows that Modi-1 is safe enough to continue. As I understand it this won't hold the trial up as they can simultaneously move to the expansion phase in ovarian and breast cancer where Modi-1 is being used as a monotherapy.

4) I'm not sure how long before the green light is given to escalate the dose and move onto the next cohort. If it's any help, with SCIB1, dose escalation was approved when the first 3 patients had received their 3rd dose which was at 6 weeks but the situation with Modi1 may be completely different and obviously this question would be one for SA or LD.

5) I'd hope that Scancell would issue an RNS as and when they are authorised to move through the dose escalation cohorts.

6) I may have been particularly slow but it wasn't immediately obvious on clinicaltrials.gov and in case anyone else was wondering, Modi-1 = all 3 peptides including enolase and Modi-1v = vimentin only peptides.

Hope this helps.

Kashdog,

Blimey, if Scancell have given away 50% of Modi1 to Isa then the whole Board need replacing now. Of course we don't know the exact terms for licensing Amplivant, but we do have a good idea or industry norms for each stage of development and for each therapeutic field. For a preclinical deal you'd be looking at very low single digit royalties, phase 1 medium to high single digit etc. etc. So even if Scancell have cut a poor deal and are paying double the going rate, it still should be nowhere near 15% let alone 50%.

Looks like the prostate cancer collaboration with Solaris and MidLantic Urology is moving quickly - clinical trial now showing as recruiting on clinicaltrials.gov

Https://clinicaltrials.gov/ct2/show/NCT05437679?term=NCT05437679&draw=2&rank=1

In terms of the future of Angle and commercialisation of Parsortix, it's other scientists including those working in pharma R&D, at CROs, medtech companies and in academia who need to know and of course they would all have had access to the original research paper which clearly described Parsortix's involvement.

Cleanerworld, the interims for the 6 months ending 31st October 2021 were published on 26th January. The Annual report for the year ending 30th April must be issued within 6 months and is likely to be published some time in September or October.

Thanks to all for replies to my post yesterday.

Agreed, this research received quite a bit of interest last week from both the scientific community and the national press. Good to see Parsortix being used to enable such groundbreaking discoveries and to further our understanding of this dreadful disease.

https://www.telegraph.co.uk/news/2022/06/22/breast-cancer-spreads-sleep/
https://www.independent.co.uk/news/health/breast-cancer-world-health-organisation-switzerland-b2106961.html
https://www.express.co.uk/life-style/health/1629591/breast-cancer-spreads-at-night-new-research
https://www.dailymail.co.uk/health/article-10942441/Cancer-grows-best-youre-sleeping-Scientists-warn-tumours-awaken-night.html
https://www.standard.co.uk/news/uk/breast-cancer-world-health-organisation-switzerland-b1007764.html

Chester,

If Scancell want to scale up to over 100 staff with 4 ongoing trials then they're going to have to put in some addional infrastructure and also support for LD. I don't believe that it's possible to run a company of that size with a part time CEO, especially one with a scientific rather than business background and of course, there would also be an impact on cash burn.

I wish LD had done some media following the glycan mAb RNS last week. There has been a clear change in strategy and it would be good to have a more detailed explanation covering the commercial and financial implications.

bobbust,

Can I just clarify your earlier post - as I understand it, at the last AGM LD confirmed that they'd had offers for glycan mAbs from 2 of Redmile's investee companies. Have I got that right?

Balerno,

In the past on this bb there have been some really poor and uninformed posts regarding Redmile and Redx. I'm not sure whether this was down to ignorance or deliberate mischief making - take your pick.

Without going through the whole story again, when Redmile first invested Redx were in a dire position re. funding and they were forced to make a mandatory offer. Redmile have shown themselves to be a supportive, long term investor and this is where Redx are today:-

1) They have nearly £60m sitting in their bank account having just executed an oversubscribed funding round at no discount to which Redmile contributed - a significant achievement given current market conditions
2) They have completed 3 commercial deals, all of which have generated both up front payments and additional milestone payments with more milestones and royalties to come
3) Their CEO has just been voted Chief Executive of the Year at the European Mediscience Awards
4) Major shareholders now include 5 high quality specialist healthcare funds
5) They have been storming ahead with both preclinical AND clinical development of their pipeline

All the while, far from forcing the company to delist as claimed by some, Redmile have gradually reduced their overall percentage holding and allowed Redx to flourish. Hopefully this answers your question regarding what happened to shareholders in Redx - I hope Scancell shareholders will have a similar experience.

Excellent progress in both clinical and preclinical development of the pipeline, just under £60m in the bank and 5 specialist healthcare funds on board. Good stuff.

wdik12 - the whole purpose of early stage trials is to establish safety and inform the design for the next stage of development. They can design the phase 1b however they like. If any of the biomarkers in the phase 1 were of no use then they wouldn't take them forward into the phase 1b.

Anyone who believes this is a small contract does not understand the pharma services business. For a phase 1b trial this is a high margin, high value contract and Andrew Newland was quite right to be delighted.