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under the expanded access section of this trial register:
https://beta.clinicaltrials.gov/study/NCT05329532?patient=Scancell&locStr=&distance=0
it says "Scancell Ltd has indicated that access to an investigational treatment associated with this study is available outside the clinical trial."
Could this mean that IF modi 1 demonstrates clinical benefit in areas of unmet need then people can apply to take Modi 1 outside of the trial? Given that there are no checkpoint inhibitors approved in some of the indications, this could be a big number. Thoughts?
There is a strong argument for wanting to use Modi without CI if a combination is no better or limited benefit. CIs are expensive and toxic. I can absolutely see why Scancell would love to build up the trial data to compare monotherapy with combination.
My question is more around the ethics of trialling a drug without the CI when it is standard of care, and under what circumstances would someone be rejected for CI but accepted for a IND immunotherapy.
In her AGM speech Lindy stressed this part of the trial is "LOVED" by clinicians. I'm just trying to understand why?
My guess is that it gives a treatment option to people not responding to CI whilst still waiting for the CI combination trials to get underway.
These new monotherapy arms have got me wondering.
In the original trial design, the monotherapy cohorts were those that didn't have approved checkpoint inhibitors. In those cases, giving Modi 1 as a monotherapy was better than giving the patient nothing. In cancers that do have approved Checkpoint Inhibitors, then the patient is foregoing the Checkpoint Inhibitor combination.
I wonder what the driver for this design is? Are they patients that have failed to respond to CIs? In which case, wouldn't adding Modi in, in combination be a better option? Are they patients that have had a bad reaction to CIs, or are contra-indicated? In which case would they be allowed or willing to take a different immunotherapy? Are they patients that have refused the CIs? How likely would they be to refuse one immunotherapy but accept another? The only conclusion I can come to is that they are fairly confident they can deliver equivalent or better results with a lower side effect profile, and they are asking patients to try the monotherapy. What's the ethics of this? I'd be interested to hear the thoughts of others on this.
I was just relooking at the AGM slides, and something that I hadn't noticed before, is that the monotherapy arms have been expanded to include all 4 tumour types. The previous trial design slide only had 2 tumour types (Ovarian and Triple Negative Breast). Also the Combination arms have an additional indication (Triple Negative Breast)
2021 AGM Slides (expansion cohorts)
Monotherapy - 2 x 16 = 32
Combination - 2 x 21 = 42
Pre-surgery - 2 x 15 = 30
N = 104
2022 AGM Slides
Monotherapy - 4 x 15 = 60
Combination - 3 x 21 = 63
Pre-Surgery - 2 x 15 = 30
N = 153
Don't know if this has been discussed before, but that looks positive and confident to me. Also suggests to me that Scancell are confident they can beat standard of care.
I reported the original post at the time. The reason I did was because I believe an RNS should be discussed on the message board of that company, and posting immediately on another Bio is a naked attempt to drive interest in the other company at the possible expense of the second company. AIM is an illiquid and volatile market and even small divestment can result in bigger wobbles. Had the OP waited till layer in the day, I probably wouldn't have reported it. I didn't report any subsequent posts.
You asked the question.. thats the honest answer.
I am also of that mind... and expect it will be in a few weeks.
Although I am also of the mind that it would be typical of Intersystems to release an RNS saying full remission of all three patients on the 29th December.
It's why I have always been so excited by the potential of Moditope. It's mechanism of action and target patient cohort mean that *if* it is successful, that success can be seen fairly quickly. If results are dramatic in an area of unmet clinical need, then the demand for acceleration of trials will only grow. Breakthrough designation would be a real possibility.
As well as all three patients in cohort 2 having scans, it's worth remembering that it's been 4 weeks since first patient dosed in expansion cohort, so some of those patients will have had 2 doses and be approaching their 3rd. Scancell might be starting to see responses in these patients as well now, and if recruitment and dosing is going as well as we are told that data could be coming thick and fast.
I'm not sure why you would think I'm "falling out" with anyone. Just a difference of opinion.
The fact remains that account was brand new, had no other post history, is not a member of any groups on that site.. and only questioned the scancell patient. So I stand behind my assessment.