I am assuming that everyone has seen the accelerated approval of Zanidatamab for HER2 expressing Biliary Tract cancers. I think this provides an excellent example of what IMU could be expecting if the decision is made to follow through with P2 cholangiocarcinoma.
1) Jazz Pharmaceuticals announced the exclusive licensing agreement with Zymeworks, owners of Zanidatamab
- USD $50M upfront
- USD $325M second payment
$375M purchase for Zanidatamab, which had unique MoA for cancer type, 52% ORR, and breakthrough therapy designation.
- USD $525M regulatory milestone payments
- USD $862.5M commercial milestone payments
USD $1.76B total potential payments plus royalties on net sales.
2) Zanidatamab achieved breakthrough therapy designation from the FDA in November 2020, and at the time of the licensing agreement in October of 2022, Zanidatamab had been involved in 8 clinical trials both completed and ongoing. Breakthrough therapy designation was given due to 38% ORR and extended survival for biliary tract patients in the P1 trial.
3) Accelerated approval was based on a 52% ORR in HER2 expressing biliary tract cancer patients.
4) Zanidatamab patent coverage extends to 2034. With accelerated approval now in place, that provides 9-10 years of revenue protected by patents.
Due to the similarities between Zanidatamab and CF33, I think that this information highlights what IMU shareholders should be expecting from the P1 biliary tract expansion trial. A durable (>6 months) response rate of ~40% from these patients and there is a chance for CF33 to provide some value for shareholders. Estimations are 7.6c for upfront, and 27.9c for additional regulatory and commercial value. This is if you assume IMU will initiate another 15+ clinical trials including CF33, they have identified the specific patient population and they respond well to the drug, it achieves both BTD and accelerated approval, the correct regimen (either single agent or combination) is determined, and there are responses in cancer types outside of biliary tract.
Personally, I think the efficacy demonstrated in CHECKvacc and MAST will be maintained in the biliary tract expansion group, and, thus, the risk is too high for the reward. There are numerous examples of more efficacious OV therapies failing to be commercial, the greatest of these being CG0070.
https://pmc.ncbi.nlm.nih.gov/articles/PMC7589713/
(20min delay)