Not many unfortunately. There are hundreds and hundreds of...

Not many unfortunately. There are hundreds and hundreds of companies targeting cancer, yet only a handful of fast track and breakthrough therapy designations are metered out by the FDA each year. To be groundbreaking the therapy must represent a paradigm shift or game change when it comes to cancer treatment. T cell therapy was perhaps an example in recent years for those suffering from blood cancers, or even Enhertu when it comes to the treatment of breast cancer patients. But as you would be aware only a handful of Car T therapies have achieved ultimate FDA approval.

As noted on many occasions Imugene's mark and kill approach utilising their Vaxinia and Oncarlytics platforms represents potentially groundbreaking therapy, as solid tumours have historically been unable to be treated utilising Car T therapy. However the proofs in the pudding and until Imugene's clinical trial results categorically exemplify those delivered pre clinically, despite their existing fast track designation for Vaxinia in the bile duct indication, the tagline groundbreaking is purely a synonym at this stage of the equation.

A point to note is that of all the companies seeking to develop ground breaking or breakthrough therapy often it is the big pharmaceuticals who achieve the mantra. A quick glance of breakthrough therapies in recent years highlights the fact most breakthrough cancer drugs have sponsors with deep pockets, i.e., Merck, Astra Zeneca or Novartis. If Vaxinia and/or Oncarlytics are successful in progressing through to Phase 2 Trials and beyond is it going to be Imugene flying their flag? Let's wait and see...

DYOR