Polyphor announces second positive Data Safety Monitoring Board recommendation to continue Phase III FORTRESS study without modifications

Polyphor AG / Key word(s): Study

03-Aug-2020 / 07:00 CET/CEST
Release of an ad hoc announcement pursuant to Art. 53 KR
The issuer is solely responsible for the content of this announcement.

Allschwil, Switzerland, August 3, 2020

Polyphor announces second positive Data Safety Monitoring Board recommendation to continue Phase III FORTRESS study without modifications

Polyphor AG (SIX: POLN) announced today that the Phase III clinical trial independent Data Safety Monitoring Board (DSMB) has completed the second, pre-specified interim analysis on July 31 of safety outcomes for 284 randomized patients (data lock June 1st) in the Phase III pivotal study with balixafortide in HER2 negative, locally recurrent or metastatic breast cancer patients. The DSMB indicated that the Phase III clinical study should continue without modifications.

"While we approach the completion of the enrollment of the FORTRESS study in the near future and many patients continue on their treatment, we are very pleased with the DSMB recommendation that the Phase III clinical trial with balixafortide continues without any protocol modification", said Frank Weber, MD, CMDO of Polyphor. "Despite the unprecedented challenges posed by the COVID-19 pandemic, and thanks to the tremendous efforts of our teams and investigators around the world, we have been able to randomize 339 patients to date."

FORTRESS (POL6326-009) is an international, multicenter, randomized active-controlled, open-label Phase III trial which will investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, locally recurrent or metastatic breast cancer. The study will comprise a total of 384 patients with HER2 negative MBC, with at least 320 patients receiving third or subsequent line and 64 patients receiving second line chemotherapy. Subject to the data Polyphor may be able to submit a filing for accelerated approval approximately six months after the recruitment is completed on the basis of the analysis of the overall response rate (ORR), confirmed by an independent blinded review, and of the associated durability of response. The full approval would be based on the magnitude of Progression Free Survival (PFS) on blinded independent review, supported by an overall survival trend favoring balixafortide arm and a favorable risk-benefit profile.

For more information about the POL6326-009 clinical trial of balixafortide, please visit www.clinicaltrials.gov (Identifier: NCT03786094).
 

For further information please contact:

For Investors:
Hernan Levett
Chief Financial Officer
Polyphor Ltd.
Tel: +41 61 567 16 00
Email: IR@polyphor.com

For Media:
Stephan Feldhaus
Feldhaus & Partner GmbH
Tel: +41 79 865 92 56
Email: feldhaus@feldhaus-partner.ch

About Polyphor
Polyphor is a research-driven clinical-stage, Swiss biopharmaceutical company committed to discovering and developing first-in-class molecules in oncology and antimicrobial resistance leveraging the company's leading macrocyclic peptide technology platform. Polyphor is advancing balixafortide (POL6326) in a Phase III trial in combination with eribulin in patients with advanced breast cancer and exploring its potential in other cancer indications. In addition, it has discovered and is developing the Outer Membrane Protein Targeting Antibiotics (OMPTA). OMPTA are potentially the first new class of antibiotics in clinical development in the last 50 years against Gram-negative bacteria. The company's lead OMPTA program is an inhaled formulation of murepavadin for the treatment of Pseudomonas aeruginosa infections in patients with cystic fibrosis. Polyphor is based in Allschwil near Basel and is listed on the SIX Swiss Exchange (SIX: POLN). For more information, please visit www.polyphor.com.

Disclaimer
This press release contains forward-looking statements which are based on current assumptions and forecasts of the Polyphor management. Known and unknown risks, uncertainties, and other factors could lead to material differences between the forward-looking statements made here and the actual development, in particular Polyphor's results, financial situation, and performance. Readers are cautioned not to put undue reliance on forward-looking statements, which speak only of the date of this communication. Polyphor disclaims any intention or obligation to update and revise any forward-looking statements, whether as a result of new information, future events or otherwise.