BOSTON, MA, USA I April 17, 2023 I Pieris Pharmaceuticals, Inc. (Nasdaq:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer, and other indications, announced the presentation of cinrebafusp alfa (PRS-343) clinical results from the Company’s study in 2L+ HER2-positive gastric cancer at the American Association for Cancer Research annual meeting being held in Orlando, Florida on April 14-19, 2023. The study’s principal investigator, Dr. Geoffrey Ku, will present these encouraging results at 1:30 PM EDT on April 17, 2023, which include an unconfirmed 100% objective response rate and promising emerging durability profile in the five patients enrolled into the study before discontinuation of enrollment for strategic reasons. A copy of the poster can be viewed here from 1:30 PM EDT today.

“The power and potential of both cinrebafusp alfa and the 4-1BB franchise can be seen in this exciting signal,” stated Shane Olwill, Chief Development Officer of Pieris. “The ability to drive response in patients who progressed on the most potent currently available therapies provides further evidence of the differentiation of cinrebafusp alfa in the HER2 landscape as well as the overall 4-1BB franchise. Beyond cinrebafusp alfa, we look forward to the progression of-and future data read-outs for-the broader 4-1BB franchise, including our PD-L1/4-1BB bispecific in collaboration with Servier in Phase 1 studies, our CD228/4-1BB bispecific with Seagen in Phase 1 studies, and our GPC-3/4-1BB bispecific with Boston Pharmaceuticals entering the clinic shortly.”

The presented data from the multi-center, open-label Phase 2 clinical study evaluating a combination of cinrebafusp alfa, ramucirumab and paclitaxel in HER2-positive gastric cancer patients provide further encouraging evidence of clinical activity for this program. The combination regimen was well tolerated, and all patients experienced a partial clinical response, with three patients remaining on study as of the abstract submission cut-off date of December 19, 2022. Each patient received trastuzumab and a checkpoint blockade in prior lines of therapy, and three patients previously received-and progressed on-trastuzumab deruxtecan. Pieris is considering a range of transactions to facilitate the continuation of cinrebafusp alfa, from an immuno-oncology focused spinout to traditional partnering transactions, given the emerging transformative activity seen in gastric cancer and exciting potential in other HER2 settings.

About Cinrebafusp Alfa:

Cinrebafusp alfa, is a HER2/4-1BB bispecific designed for the treatment of HER2-expressing cancers. Previously reported Phase 1 study results provided initial evidence showing that cinrebafusp alfa was generally well-tolerated and resulted in durable responses-including complete response-in patients with HER2-positive malignancies.

About Pieris Pharmaceuticals:

Pieris is a clinical-stage biotechnology company that combines leading protein engineering capabilities and deep understanding into molecular drivers of disease to develop medicines that drive local biology to produce superior clinical outcomes for patients. Our pipeline is focused on inhalable Anticalin proteins to treat respiratory diseases and locally-activated bispecifics for immuno-oncology. Proprietary to Pieris, Anticalin proteins are a novel class of therapeutics validated in the clinic and by strong partnerships with leading pharmaceutical companies. For more information, visit www.pieris.com.

SOURCE: Pieris Pharmaceuticals