2020

14.05.2020 – Polyphor AG

Polyphor announces acceptance of balixafortide abstract at the American Society of Clinical Oncology (ASCO) 2020 virtual scientific program

Polyphor AG / Key word(s): Conference
Polyphor announces acceptance of balixafortide abstract at the American
Society of Clinical Oncology (ASCO) 2020 virtual scientific program

14.05.2020 / 07:00

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Allschwil, Switzerland, May 14, 2020

Polyphor announces acceptance of balixafortide abstract at the American
Society of Clinical Oncology (ASCO) 2020 virtual scientific program

Polyphor AG (SIX: POLN) a research-driven clinical-stage, Swiss
biopharmaceutical company committed to discovering and developing
first-in-class molecules in oncology and antimicrobial resistance announced
today that the abstract "Balixafortide (a CXCR4 antagonist) plus eribulin in
HER2 negative metastatic breast cancer: dose-response analysis of efficacy
from Phase I single arm trial" has been accepted for the ASCO 2020 Virtual
Conference, which is being held from May 29-31. The data, published online
on the ASCO Meeting Library, show a consistent dose response of increasing
doses of balixafortide in combination with the approved dose of eribulin.

"This analysis published and supported by the steering committee of the
study demonstrates an impressive overall efficacy of balixafortide at the
dose of 5.5mg/kg in comparison to lower doses of balixafortide and to
historical results of eribulin monotherapy in comparable populations. This
benefit is observed consistently throughout all efficacy endpoints," said
Peter Kaufman, Professor of Medicine, and Hematology/Oncology, at the
University of Vermont Cancer Center and lead author of the abstract. Frank
Weber, MD, CMDO of Polyphor adds: "Polyphor is looking forward to the
results of the ongoing Phase III study FORTRESS which investigates the
efficacy and safety of balixafortide at the 5.5mg/kg dose in combination
with eribulin. We have randomized a total of 273 patients by today and plan
to complete the enrollment of 384 patients into FORTRESS by September 2020."

The 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, of which 320 patients receiving third
or subsequent line and 64 patients receiving second line chemotherapy.
Subject to the data Polyphor will have the possibility to submit a filing
for accelerated approval approximately six months after the recruitment is
completed on the basis of the analysis of the objective 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.


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