Pieris Stops Work On Cancer Med, Tested In Combo With Eli Lilly Drugs

Pieris Pharmaceuticals Inc PIRS decided to end work on Cinrebafusp alfa (PRS-343), a 4-1BB/HER2 anticalin-based bispecific, as part of a strategic pipeline prioritization to focus its resources.
The drug was slapped with an FDA clinical hold in July 2020.
In August, Eli Lilly And Co LLY announced a trial collaboration to contribute its ramucirumab (Cyramza) and paclitaxel for the Phase 2 study in HER2-positive gastric cancer.
For the AstraZeneca plc AZN-partnered program, Pieris says its Big Pharma did a “reforecast” of the study to account for “global challenges” in recruiting patients because of COVID-19’s impact.
The companies are loosening the enrollment criteria and focusing on the 3 mg cohort for the efficacy readout. Topline results are slated for Q3 of 2023 after initially expecting the data this year.
After the results come in, Pieris can exercise a co-development option and could co-commercialize the drug in the U.S.
Pieris held a cash balance of $117.8 million. With the wind-down of the cinrebafusp alfa phase 2 trials and the expectation of modest near-term development milestones, the company believes operations are sufficiently funded into Q2 of 2024.
Price Action: PIRS shares are down 7.69% at $1.68 during the market session on the last check Thursday.