- Pieris Pharmaceuticals Inc 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 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 -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.
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