Pieris Pharmaceutical Inc. (NASDAQ: PIRS) jumped 23.45% has announced that the FDA has granted its cinrebafusp alfa (PRS-343) orphan drug designation for HER2-low and HER2-high expressing gastric cancers treatment.
Cinrebafusp receives orphan drug designation for HER-2 gastric cancer treatment
The FDA gives the orphan drug approval to encourage the development of a treatment for ailments that affect fewer than 200,000 people in the US each year. In addition to other regulatory exclusivities, orphan drug designation offers qualifying therapies with development and commercialization incentives, such as FDA assistance during clinical trial design, application fee waivers, tax credits for qualifying clinical trials, and market exclusivity for up to seven years following FDA approval.
Pieris CEO and President Stephen S. Yoder said, “The granting of orphan drug designation to cinrebafusp alfa underscores the high unmet medical need that persists in the treatment of gastric cancer and reinforces our conviction in the importance of developing this program while setting a high bar for success to help patients with limited therapeutic options. We look forward to beginning the phase 2 trial of cinrebafusp alfa later this summer.”
Pieris to advance Cinrebafusp to Phase 2 study.
Cinrebafusp alfa is a 4-1BB/HER2 fusion protein made up of an Anticalin protein that targets 4-1BB and a HER2-targeting antibody. The company is actively working to initiate a phase 2 study of cinrebafusp alfa in combination with ramucirumab and paclitaxel to treat HER2-high expressing gastric cancer and in combination with tucatinib for the treatment of HER2-high expressing gastric cancer. The move to Phase 2 studies is based on encouraging phase 1 study results that showed clinical benefit as a single agent and biomarker data indicative of a 4-1BB-driven mechanism of action.
The company is developing novel biotherapeutics using its novel Anticalin tech platform for cancer, respiratory disease, and other indications. Anticalin inhalable proteins treat respiratory diseases and locally activated immune-oncology biospecifics.