Pieris Pharmaceuticals Announces Results from 2017 Annual Meeting of Stockholders and Provides Update on Therapeutic Programs
BOSTON, MA - 07/05/17 - Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for cancer, respiratory and other diseases, announced today the results from the Company's 2017 annual meeting of stockholders, and provided more details on the status and anticipated progression of its three most advanced programs.
In Friday's shareholder meeting, all proposed resolutions passed, including the re-election of Michael Richman and Stephen Yoder to three-year terms expiring in 2020. In addition, shareholders ratified the appointment of Ernst & Young LLP as the Company's independent registered public accounting firm for the fiscal year ending December 31, 2017.
The Company also provides an update on its most advanced programs: PRS-343, a 4-1BB/HER2 Anticalin-antibody bispecific fusion protein for HER2-positive solid tumors, fully proprietary to Pieris; PRS-080, an anti-hepcidin Anticalin to address functional iron deficient (FID) anemia, partnered in Japan with ASKA Pharmaceutical; and PRS-060, inhaled anti-IL4Ra Anticalin to address asthma, partnered with AstraZeneca:
The Company filed an IND for PRS-343 and has been engaged in discussions with FDA to finalize the clinical trial protocol for this first-in-patient study. Following FDA's request to modify the dose-escalation portion of the protocol, the Company has filed a response it believes addresses FDA's request. As start-up activities with initial clinical trial sites have been underway since IND filing, the Company anticipates dosing the first patient in due course following final FDA approval of the IND.
The Company filed separate clinical trial applications (CTAs) with the German and Czech Republic regulatory authorities to conduct a multi-dose trial for PRS-080 in FID anemia patients in a randomized placebo-controlled trial and, pending timely regulatory approvals, expects to enroll patients in the third quarter across several sites. The trial expects to enroll approximately twelve patients, six of whom will receive placebo and six of whom will receive PRS-080, who will be scheduled to receive five weekly doses at 8 mg/kg. Primary endpoints for this study include safety and tolerability of PRS-080, while hemoglobin represents a key secondary endpoint. ASKA has the option, following completion of this trial, to obtain an exclusive license to develop and commercialize PRS-080 in Japan, South Korea and certain other Asian markets (excluding China).
In collaboration with AstraZeneca, Pieris plans, as trial sponsor, to initiate and dose healthy subjects in the fourth quarter of 2017 in a single ascending dose trial followed by a multi-ascending dose trial under a clinical trial notification (CTN) to the Therapeutic Goods Administration (TGA) in Australia. The dosing of the first subject would trigger a milestone payment of $12.5 million by AstraZeneca to Pieris.
"We're pleased to have received strong shareholder support at the annual meeting to pass all presented resolutions," commented President and CEO Stephen Yoder. "The first half of 2017 has been an extraordinary growth period for the Company, with the signing of three major collaboration agreements. The second half of the year will be a period focused on deploying three programs through key clinical trials, with the anticipation of a number of readouts in 2018."