Polyphor announces positive results from the FDA Type B Guidance meeting on the planned Phase III study for balixafortide Montag, 03. Dezember 2018 - 07:01

Polyphor AG / Key word(s): Study
Polyphor announces positive results from the FDA Type B Guidance meeting on
the planned Phase III study for balixafortide

03-Dec-2018 / 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, December 3, 2018


Polyphor announces positive results from the FDA Type B Guidance meeting on
the planned Phase III study for balixafortide


The proposed study is intended to support the global registration of
balixafortide. Polyphor expects to enroll the first patient in the second
quarter of 2019.

Polyphor announced today that it has received the meeting minutes from a
Type B Guidance meeting with the US FDA on the study design and statistical
analysis plan of the planned Phase III study POL6326-009, that will evaluate
the efficacy and safety of balixafortide and eribulin versus eribulin
monotherapy in patients with locally recurrent and/or metastatic breast
cancer (MBC).

The FDA reviewed the design, inclusion and exclusion criteria of the
international, multicenter, randomized, open-label Phase III trial which
will comprise a total of 384 patients with HER2 negative MBC, of which 320
patients receiving third line and 64 patients receiving second line
chemotherapy. The FDA agreed with the proposed indication for the treatment
of MBC in patients who have previously received at least two
chemotherapeutic regimens and confirmed the possibility to submit a filing
for accelerated approval at the end of the recruitment 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 will 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.

"This FDA meeting was an important milestone to advance the development of
balixafortide and potentially bringing it to the patients suffering from
metastatic breast cancer, who have only limited treatment alternatives. We
are excited by the opportunity to start the trial in the first quarter of
2019 and have the first patient enrolled by Q2/19," said Giacomo Di Nepi,
Chief Executive Officer of Polyphor.

About Balixafortide (POL6326)
Balixafortide is a potent and highly selective antagonist of CXCR4, a
G-protein coupled receptor (GPCR) that regulates the trafficking and homing
of both cancer cells and cells of the patient's immune system. CXCR4 plays a
critical role in tumor growth, survival, angiogenesis and metastasis [i].
High CXCR4 levels have been detected in almost all human tumor types,
including breast cancer. High CXCR4 expression is known to correlate with
aggressive metastatic behavior of cancer cells and a poor prognosis [ii].

Balixafortide is being developed to improve therapy outcomes in cancer, when
used in combination with other agents. Balixafortide is the only CXCR4
antagonist in development for breast cancer and is the most advanced CXCR4
antagonist, being developed in solid tumors, being the first product
candidate to reach proof of concept. The molecule was discovered based on
Polyphor's proprietary macrocycle technology platform. Balixafortide showed
strong results in a Phase Ib/proof of concept clinical trial in combination
with eribulin in patients affected with advanced metastatic breast cancer.
The development path identified with the input of the FDA is to conduct a
single pivotal study to achieve approval in HER-2 negative metastatic breast
cancer patients who previously received at least two chemotherapeutic
regimens in the metastatic setting. Additionally, there is the possibility
of achieving an accelerated approval based on interim results. Polyphor is
also conducting preclinical work to establish the potential for
balixafortide in combination with other drugs and in other oncology
indications.

About Polyphor
Polyphor is a clinical stage, Swiss biopharmaceutical company which has
discovered and is developing the OMPTA (Outer Membrane Protein Targeting
Antibiotics). The OMPTA are potentially the first new class of antibiotics
against Gram-negative bacteria to have reached phase III stage in the last
50 years. The company's lead product, murepavadin, (POL7080) is in Phase III
development against Pseudomonas aeruginosa - recognized as a critical
priority 1 pathogen by WHO. Polyphor is also developing an immuno-oncology
candidate, balixafortide (POL6326), which is in preparation for a pivotal
trial program in combination with eribulin in patients with advanced breast
cancer, and a pipeline of further preclinical antibiotics based on its OMPTA
platform. 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.

For further information please contact:

Investors:
Kalina Scott
Chief Financial Officer
Polyphor Ltd.
Tel: +41 61 567 16 67
Email: IR@polyphor.com

Media:

Alexandre Müller
Dynamics Group AG
Tel: +41 43 268 32 31
Email: amu@dynamicsgroup.ch

[i] Otsuka S, Bebb G. J Thorac Oncol. 2008;3(12):1379-1383
[ii] Chatterjee S, Behnam Azad B, Nimmagadda S. Adv Cancer Res. 2014;
124:31-82


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End of ad hoc announcement

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