RE: Modi1 Questions19 Apr 2022 16:15
Hi Ruck,
Great questions. I believe that there is only one Modi-1 formulation. Originally the trial was running initially with the two citrullinated vimentin peptides and then would have the citrullinated enolase peptide added in later. But I believe the design for that trial was due to the difficulties in manufacturing the enolase peptide. Now that this manufacturing hurdle has been overcome, if I understand it correctly the trial will be looking at all 3 combined in a single ****tail which in the clinic would be an 'off the shelf' i.e. would not need to be made bespoke per patient.
1) Whilst the different cancers have molecular differences, the similarities between them are that they are very aggressive, are hard to treat and have limited treatment options available. As such, moditope would be relatively easy to demonstrate superioritiy in comparison to standard of care. From the patient perspective, it also gives them a glimmer of hope if it were to work as well as it did in pre-clinical.
The fact these are aggressive tumours also plays into the hands of moditope. Moditope as a therapy exploits the bodies immune response at removing stressed cells. Cancer cells are in a state of cellular stress due to having low oxygen levels (hypoxia), nutrient deficient (metabolic stress) and which are rapidly dividing cause the protein to undergo autophagy (self-eating) which causes the generation of stress-induced post-translational modifications. These are what moditope is training the bodies immune defences on.
By targetting aggressive hard to treat cancers, clinically you have a lower threshold to prove that the product works vs standard of care. Ethically, you're offering a chance for patients who have no treatment available to them to have a chance at survival and from a mechanistic standpoint, you're targetting a cell which will exhibit the stress induced post-translational modifications that act as flags to the immune system.
2) possibly - I believe that we will see differences between them based on the expression profile of the citrullinated vimentin and enolase. By combining the three peptides into a single treatment, offers the best chance of it working. If a tumour expresses only 1 of these the effect will be lower, than if it expresses a combination of two of these or all three. This I suspect will be down to individual cells, the drivers behind tumours and how aggressive they are. I think by combining the three, Modi-1 has the best chance of success.
By targetting four cancer types, with a reasonable number of patients in each cohort, we can understand whether some tumours or some disease types are better than others at Modi-1 working against. Especially as this is a phase 1, First in human.
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