AstraZeneca success torpedoes PCI’s pivotal plan, crushing stock

The shock waves caused by the success of AstraZeneca’s TOPAZ-1 clinical trial have reached Norway. After reviewing the results, PCI Biotech has decided to scrap its own pivotal advanced biliary tract cancer trial in the belief it may struggle to complete the study and win approval. 

Outcomes in advanced biliary tract cancer have largely stood still in recent years, causing Norway’s PCI to start the pivotal trial of its light-activated compound fimaporfin with high hopes of improving on the old chemotherapy combination that is the standard of care for patients with inoperable tumors. However, the landscape changed overnight last week when AstraZeneca showed improved survival in the disease. 

AstraZeneca’s success prompted PCI to reevaluate its pursuit of the advanced biliary tract cancer market, which was beset by recruitment and retention challenges even before the TOPAZ-1 results. Less than one week after AstraZeneca dropped its data, PCI revealed the outcome of its soul searching. 

PCI expects the success of AstraZeneca’s checkpoint inhibitor Imfinzi to rapidly change the treatment of the patients it is targeting in RELEASE, its pivotal trial of fimaporfin. “Such a change in the standard of care treatment will render the RELEASE trial challenging to complete and potentially inadequate for approval and will significantly diminish the opportunity for PCI,” the company wrote in a statement.

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AstraZeneca’s interim analysis meant PCI was braced for the positive results presented last week and has acted swiftly to change its own plans. PCI CEO Per Walday said “stopping RELEASE was a hard decision to make, but it is necessary to act decisively when the competitive landscape shifts.” 

The RELEASE trial has enrolled 41 patients so far, around 30% of whom will continue to receive the study treatment for up to six months. PCI plans to swiftly wind the study down to free up resources for other programs. The biotech is shifting its attention to its fimaVACC immunotherapy technology and fimaNAc nucleic acid delivery platform.

PCI posted phase 1 data on fimaVACC in 2019 and is yet to take a fimaNAc program into the clinic. The rapid reversion of PCI into an early-phase biotech sparked a 45% drop in its stock price, which fell to around 5 Norwegian krone ($0.55). PCI ended 2021 with around $13 million in cash and plans to start a phase 2 clinical trial of a peptide-based vaccine based on the fimaVACC technology.

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