
AstraZeneca partner Pieris ends work on HER2 drug tested in combo with Eli Lilly, Seagen cancer meds
As Pieris Pharmaceuticals favors an AstraZeneca-partnered program in asthma, and because the mid-stage study is taking longer than expected, the biotech is deciding to end work on a HER2 drug.
The Boston biotech put out word Thursday that it’s ending the development of cinrebafusp alfa (PRS-343), which was in a Phase II study for certain HER2 gastric cancers. Earlier in its development, the 4-1BB/HER2 fusion protein drug ran into a partial clinical hold in its Phase I in the summer of 2020. Despite that, Eli Lilly came to the table a month later to contribute its ramucirumab (Cyramza) and paclitaxel for the Phase II study.
Shares $PIRS dipped almost 11% before Thursday’s opening bell.
Pieris was testing cinrebafusp alfa in combo with Cyramza and the chemo drug paclitaxel in patients with HER2 high gastric or gastroesophageal junction (GEJ) adenocarcinoma. The biotech was also testing the drug in combination with Seagen’s Tukysa in patients with a HER2 low version of the gastric cancer.
Back in May, Jefferies analysts noted the drug met enrollment challenges in the HER2 low cohort, citing “more education and sites,” and changed the expected data readout from this year to 2023. HER2 high data were also expected next year.
“Since the PRS-060/AZD1402 phase 2 study will take more time to enroll than originally planned, we have made the difficult but necessary decision to discontinue cinrebafusp alfa (PRS-343), despite showing clear single-agent activity in phase 1 and meaningful clinical benefit in the ongoing phase 2 study in HER2-expressing gastric cancer patients,” CEO and president Stephen Yoder said in a statement. The duo recently expanded their research terms around two discovery stage programs.
On that AstraZeneca-partnered program, Pieris says its Big Pharma peer did a “reforecast” of the study to account for “global challenges” in recruiting patients because of Covid-19’s impact on clinical trials of respiratory drugs. The companies are loosening the enrollment criteria and focusing on the 3 mg cohort for the efficacy readout, Pieris said in its quarterly earnings Thursday. Topline results are slated for the third quarter of next year after originally expecting the data this year.
After those results come in, Pieris can exercise a co-development option and could co-commercialize the drug in the US.
Pieris will continue testing a 4-1BB drug, its Servier-partnered PD-L1 bispecific. Known as PRS-344 and S095012, the drug is being studied in patients with solid tumors in a Phase I/II trial that is expected to collect final primary outcome data in November 2024.
The company had $80.9 million at the end of June, which it anticipates will keep operations going into the second quarter of 2024, taking into account the culling of cinrebafusp alfa Phase II trials and the “expectation of modest near-term development milestones.”