NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

As always, an interesting article by DD. Two topics, I believe DD might need to research more on are data exclusivity and biologic exclusivity.

While Flaskworks protects the manufacturing process, biologic exclusivity protects the end product.

Let’s pretend some hacks, let’s say their initials are LC and EX, want to make a biosimilar of an ATMP cell therapy like DCVax-l.

1. Could they just try to copy it and get a marketing license?
Answer: Not for about a decade after approval due to biosimilar restrictions

2. Could they just use a similar manufacturing process?
Answer: Not for about 20 years after the original patent filing date.

3. Could they make some other product and take it through i, ii and phase iii trials?

Answer: Sure, be my guest. However, if it’s a dendritic therapy, they can’t use DCVax trial data to shortcut their safety claims or efficacy claims for several years.

4. Do most biologic and drug companies want to endlessly select their own target antigens or utilize their own small molecules instead of using autologous therapy, and do they all want a little lucrative niche with their own prized molecule, antigen target or other silver bullet that maintains the funds rolling in but keeps real cures forever at bay because they are each only dealing with part of the problem?

Answer: Yes, many companies want to keep that cynical economic paradigm alive by building single antibody drug conjugates with chemo or mRNA peptide therapy that tries to select their own antigen bundle then adds an unnecessary step of trying to get the dendritic cells in the body to manufacture and express these antigens. Many would like to put a cure out of reach by dividing up the antibodies and t-cell types amongst various companies, effectively guaranteeing tumor escape.

5. Does DCVax target all tumor antigens of each particular patient with Dendritic cells that directly express to a very broad spectrum of cytotoxic and helper t-cells whilst indirectly thus also creating an army of similarly varied antibodies, that, working together, minimize tumor escape?

Yes.