Member Info for KonarA

some news.. although mostly already known.

Trial reg in South africa has been updated. Recruitment status now set to "Closed to recruitment,follow-up continuing" with last follow scheduled by 31st Dec.

What was interesting is that trial has also had outcome measures changed - "Updated according to protocol amendment V3". The main difference I can see being, they were previously looking for number of patients with a 4 fold increase in antibodies, whereas now they are just measuring increase. I expect this relates to giving the vaccine in patients who have had covid, and will therefore have higher existing levels already.

https://sanctr.samrc.ac.za/TrialDisplay.aspx?TrialID=5625

It branches. Monotherapy expands to full recruitment. The CPI branch effectively starts from cohort 1 again - low dose Modi1 with CPI

@violindog - that says it all.

I imagine it will come down to the strength of your negotiating position. The stage payments are obviously a way for the pharma to de-risk their investment, and are beneficial to the research company as they encourage pharma to invest. But the pharma will want to push as much of the payments out to as late as possible, and the bio will want to bring them forward as much as possible. How much each side is prepared to shift will depend on the perceived risk of the investment (is it in an area of unmet need? what are the pre-clinical results showing? what is the projected market? is there competition for the product from other pharma?).

My gut feel on this deal is that it has novelty on its side, but early stage against it. I suspect it will therefore be a standard type payment structure. all imho

@RR only Redmile know how they would play it. We could guess all day.

@c7 I honestly don't know and it would be pure speculation on my part.

@RR its a non-sensical argument. If i bought a china plate at a jumble sale for 50p, and it was then found to be Ming Dynasty plate worth a £1,000,000, I'm not going to sell it for £100 just because it is more than what I paid for it. Redmile are experienced biotech investors. They will know exactly how much they can squeeze big pharma for, and will go for every £.

Just my 2c worth. Although it is "impossible for us to calculate" because we don't have full visibility of all the factors that would go into the calculation of a value, the money men/women in pharma know how to calculate these values - certainly to within a ball park. All of the factors mentioned by Burble above will be accounted for, and as described, are all in Scancell's favour. They will then adjust according to factors such as competition - novel successful platforms could drive a bidding war. All in all, if Immunobody and Moditope prove successful in the current trials, then estimates of £2 would be on the very very conservative side - imho. I strongly believe that in the event of a total buy out none of us have yet estimated correctly.

If they can do a few more MaB deals and financially secure up the future of the company to take moditope into later stage trials, then our bargaining hand is strengthened even further.

my comment was really a response to the OP of that thread. Agree it is still ridiculously quiet. Hoping its a slow burner.

I think the shouting will come with time. The old saying "One Swallow does not make a summer" could apply here. The news of the first patient showing a partial response is amazing, and suggestive that Moditope does exactly as we hope, but the company have said previously they will not prejudice the trial or give false hope to patients by making unsubstantiated claims of success.

Given that it is only a matter of months since this patient begun treatment, and they have been able to see these clinical improvements, it bodes well for how soon we may get meaningful updates. The monotherapy trial arms are monotherapy because they are not currently approved for treatment with Checkpoint Inhibitors. I would expect that to mean that recruitment in these indications should be less of a challenge. Couple that with clinician enthusiasm from the partial responder, and we may fill up these monotherapy trial arms fairly quickly. It could be as soon as Q1 next year that we get early clinical data in these cohorts. That's when I hope the media pick up on success. IMHO

perfect - thanks Bermuda. So the patient that has already had 30-50* ish reduction in tumour can still probably expect to receive another 3 doses over the coming months. I can't even begin to imagine the amount of hope this trial has given that patient.

the chart showing each patient previous treatments, modi1 treatments and progression/recurrence. Seen in the SCIB1 results.

Should tell a lot for Modi1 when we get it.

partial exit described as "we were" able to. Sounds very past tense to me. Guessing they must have finished the exit when they issued the RNS.

https://calculuscapital.com/exit/scancell/

its at the bottom of the page

you are probably right in terms of still trying to find optimum schedule and so on... but i doubt the MHRA would give them carte blanche for dosing. They must surely have an agreed dosing schedule/plan.

Ultimately what I was trying to understand is how many more doses might the "partial response" patient expect to receive and from that maybe do some back of a fag packet extrapolation. the result we are all obviously hoping for would be complete tumour removal!

On another note though, I would imagine in certain indications, a "partial response" alone may be sufficient to make an inoperable tumour, operable. A "partial" response could add years onto a patient prognosis.

hi wild - thanks, but this is the trinity delta slide I mentioned. This shows the cohorts, but not the dosing schedule. Do the patients receive 2, 4, 10...100 doses? or am I missing something?

"All three patients in Cohort 2 successfully received two doses and the injections were well tolerated with no safety concerns, Scancell said, while all three showed a delayed-type hypersensitivity response to the vaccine, which is indicative of a T cell response,"

wonder if they will ever finish this sentence.

I have tried to look up the information from the trials website, but can't seem to see it there or in the presentation pdf from trinity delta - what is the dosing schedule for the trial? How many doses of the medication would each patient expect to receive over what time period? It would be useful to put today's very early results into context if we knew how early in the treatment regimen that patient is.

thanks - definitely should be the near term target