2020

30.03.2020 – Polyphor AG

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

Polyphor AG / Key word(s): Study
Polyphor announces positive Data Safety Monitoring Board (DSMB)
recommendation to continue Phase III FORTRESS study without modifications

30-March-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.

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Allschwil, Switzerland, March 30, 2020


Polyphor announces positive Data Safety Monitoring Board (DSMB)
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 first,
pre-specified interim analysis, of safety outcomes for the first 193
randomized patients 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.

"As we continue to randomize new patients into the FORTRESS study and many
patients continue on treatment, we are very pleased with the DSMB
recommendation that the Phase III clinical trial continues without any
protocol modification," said Frank Weber, MD, CMDO of Polyphor. "We reaffirm
the timeline to recruit 384 patients into FORTRESS by September 2020 and
have randomized a total of 245 patients by today which is ahead of our plan.
In the current situation with Covid 19 we are taking all possible measures
to safeguard patients, investigators and the study conduct in general."

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 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 24
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 based clinical stage, Swiss biopharmaceutical company
focused on the discovery and development of immuno-oncology compounds and a
new class of antibiotics. 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 po-tentially 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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