Juho stated in a webcast that the PD-1+Bex combination study (at Royal Marsden in London) for melanoma and NSCLC has been delayed due to agreements with Gilead. It should, however, start by the end of the year. This is a small trial, primarily investigating how adding Bex activates the patient’s immune system so that PD-1 works again. Proof of concept. Investigator-initiated, meaning no major costs. Based on the findings, larger basket studies in various solid tumors would follow. Significant costs.
Let’s recap that Gilead is the company that acquired the previous macrophage-targeting drug, magrolimab, which had significant expectations, for USD 4.9 billion. It turned out to be a disappointment.
Let’s recap again what this Gilead anti-PD-1 asset is. Zimberelimab Faron Pharmaceuticals - Innovatiivisia lääketieteen ratkaisuja (Osa 1) - #6761 käyttäjältä Vino_Pino
Gilead’s strategy is not to bring the tenth ‘me-too’ drug to market, e.g., because patents for blockbusters are expiring and prices are falling. Instead, in solid tumors, it combines its own PD-1 with various other drugs. One of them is Bex. This way, it can gain a significant share of the PD-1 market if efficacy can be demonstrated beyond PD-1 drugs. Either by aiming for better efficacy directly in the first line, or at least initially when PD-1 is not effective or stops being effective, as is usually the case.
For the aforementioned reasons, Faron has the opportunity to become Gilead’s combination partner, but agreements will likely involve negotiations, e.g., precisely on these exclusivity clauses. Other PD-1 manufacturers ‘may’ also be interested in a deal if efficacy is shown in preliminary results. Especially those who already have market share and have demonstrated efficacy in various indications.
The biggest market for Bex could be as its own drug product on the market, allowing everyone to combine it with their own drugs. The problem is that as a monotherapy, i.e., as a standalone drug, no demonstration of efficacy as a first-line drug is expected for some time. Another contractual point is how Faron can proceed if Zimbe proves to be poor; can it get out of the agreements? It’s understandable that Juho’s mind is racing to the point of sleep difficulties.
Ralph Hughes is building the business case with his market analyses, and an investment bank will organize an auction/discussions with pharma without Faron being undervalued in negotiations.