Wilson’s reportWhat does independent HNSCC reg development look...

Wilson’s report
What does independent HNSCC reg development look like?
It's important to say at this point that independent commercialisation should be and is the base case on which HNSCC contributes to our Immutep forecasts and valuation. This includes a $35M R&D/opex envelope, ear marked for a pivotal Phase Ill trial limited to the CPS<1 subgroup. MSD's potential involvement could be upside (if limited to CPS<1) or even neutral/downside if their involvement went broader because that would likely take Immutep's share of program expenses beyond what we've budgeted for (notwithstanding the indication upside on offer). In any case, FDA will probably want to see the Phased Ill trial enrolling patients before considering an accelerated approval. If TACTI-003-B is considered sufficient to bring the accelerated approval into frame, the logistics from there are straightforward. Efti has already been granted Fast Track designation. The three components of a BLA seem near at hand: a) an efficacy package, the guts of which is summarised in this note; b) a safety package comprising hundreds of patients from this and other clinical trials; c) a commercial scale manufacturing scheme in the process of being characterised and validated, obviously leveraging the preparatory work Immutep and its partner WuXi Biologics has done in initiating TACTI-004.What if Efti is approved?