Pieris trims fat with phase 2 cancer drug culls to focus on AstraZeneca asthma collab

Pieris Pharmaceuticals is trimming the fat, putting its lead immuno-oncology asset on the chopping block to make more room for its AstraZeneca partnership.

With the readout for the AstraZeneca-partnered phase 2 asthma drug now delayed to next year, Pieris has decided to cut its only clinical-stage independent asset.

"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,” said Stephen Yoder, Pieris president and CEO, in a press release. The move will better position Pieris to deliver on its overall pipeline objectives in 2023 and will extend its cash runway into the second quarter of 2024, he added.

The news has taken a toll on Pieris’ stock. Opening at $1.79 per share Thursday morning, its stock had tumbled about 10% by midday and currently rests at $1.63.

The culled drug, cinrebafusp alfa, was being investigated in certain HER-2 gastric cancers. Launched in November of last year, the phase 2 trial was evaluating the bispecific fusion drug’s effect in combination with Eli Lilly’s Cyramza plus paclitaxel, as well as with Array BioPharma’s and Cascadian Therapeutics’ Tukysa.

The cut comes despite phase 1 results that “demonstrated clinical benefit” and an FDA orphan tag.

The AstraZeneca-partnered asthma candidate, PRS-060/AZD1402, on the other hand, was already in phase 2, but that's been delayed.

Last year, Pieris said it anticipated the phase 2a readout for the inhaled IL-4 receptor alpha inhibitor in 2022. However, the trial is still enrolling, and the biotech now anticipates a top-line readout by the third quarter of next year.

In cutting cinrebafusp alfa, Pieris has lost its only clinical-stage independent asset, but it does have one other unpartnered drug, which is in preclinical studies. Instead, the biotech will lean on its host of pharma-partnered drugs, which run the gamut of discovery stage to phase 2.

In addition to its partnership with AstraZeneca, Pieris is working with Servier, a French pharmaceutical company with U.S. headquarters in Boston. The 4-1BB/PD-L1 bispecific, which is meant to treat solid tumors, is in the dose-escalation portion of a phase 1/2 study.

Pieris also signed a research collaboration and licensing agreement with Roche’s Genentech last year. The biotech received $20 million upfront, and the partnership will focus on locally delivered respiratory and ophthalmology therapies using Pieris' Anticalin technology. The deal could give Pieris up to $1.4 billion in biobucks across multiple programs in the future.   

And Pieris also holds an exclusive product license agreement with Boston Pharmaceuticals to develop an immuno-oncology antibody bispecific fusion protein. That deal included $10 million cash and could make Pieris up to $353 million in additional biobucks.