Cancer Logic

Both RNA vaccines and co-bodies offer the possibility of being made quickly into individual treatments, but for that reason alone they cannot conform to present-day regulatory processes for medicines. An entirely new approach to regulation is required, to allow the necessary degree of individuality of treatment; but also required is the concentration of massive resources.

It has been well understood for more than sixty years that cancer is a disease of multiple mutations: the search for how those mutations produce their effects has given us our detailed knowledge of cellular controls. For some ten years we have known that in a typical cancer there are thousands of mutations scattered over the genome rather than just a handful, creating new difficulty and complexity but also simplifying concepts enormously because we now have in principle a means of exactly identifying the cells of each individual cancer - suddenly, driver mutations, oncogenes and stem cells seem less important.

Cancers are clonal. The existence of stem cells or ‘selfies’ complicates the issue but there must be a mutation set defining an original malignant clone and all sub-clones, the McDMS.

If means exist to attack all cells bearing that set then there is a real prospect of eliminating the entire family of malignant clones rather than merely modifying the behaviour of cancer cells.

Though most mutations are in non-coding regions, some neo-antigens are produced. This offers the prospect of specific agents and vaccines specific against the individual cancer rather than cancers generally. Such agents and vaccines should be directed against targets of the malignant-clone-defining mutation set. Sufficient selectivity, binding strength and effectiveness may require the presence of two or more binding entities in a single molecule (co-body, heteropolyvalent antibody, etc.) or T-cell.

Clearly such vaccines or binding agents of this new class have to be made extremely quickly, for the individual patient. Both RNA vaccines and co-bodies offer this possibility, but for that reason alone they cannot conform to present-day regulatory processes for medicines. So an entirely new approach to regulation is required, to allow the necessary degree of individuality of treatment; but also required is concentration of massive resources.