Polyphor: Balixafortide combination with eribulin in metastatic breast cancer data presented at ESMO 2018 show consistent positive trend for all efficacy endpoints, including overall survival Mittwoch, 24. Oktober 2018 - 07:05

Polyphor AG / Key word(s): Conference
Balixafortide combination with eribulin in metastatic breast cancer data
presented at ESMO 2018 show consistent positive trend for all efficacy
endpoints, including overall survival

24-Oct-2018 / 07:05 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, October 24, 2018

Balixafortide combination with eribulin in metastatic breast cancer data
presented at ESMO 2018 show consistent positive trend for all efficacy
endpoints, including overall survival

Polyphor presented new efficacy data on its immuno-oncology candidate,
balixafortide, at the European Society for Medical Oncology (ESMO) 2018
Congress in Munich, Germany.

Final efficacy data of the Phase I study on the full expanded cohort of 24
patients were presented at an oral presentation, including the new overall
survival analysis. Key findings included:

- For the expanded cohort population, the trial has shown a consistent
positive trend for all the efficacy read-outs including overall response
rate (ORR) of 37.5%, median progression free survival (PFS) of 6.2 months
and median overall survival (OS) of 18 months. The data for eribulin alone
in its registration trial for the USA ("EMBRACE") [*] were 13%, 3.7 months
and 13.1 months, respectively.

- Safety and tolerability of balixafortide + eribulin appeared comparable to
published data on balixafortide or eribulin alone.

- These promising results suggest that balixafortide + eribulin might
provide a new therapeutic option in heavily pre-treated metastatic breast
cancer (MBC) patients and warrant further investigation in a randomized
clinical trial.

Dr. Javier Cortes, Head of the Breast Cancer Program at IOB Institute of
Oncology, Barcelona & Madrid and senior Investigator at Vall d'Hebron
Institute of Oncology said: "This trial has shown the potential anti-tumor
activity of a new class of agent, CXCR4 antagonist, in heavily pre-treated
HER2 negative patients with metastatic breast cancer. The 6.2 months
progression free survival and overall survival results of 18 months suggest
the combination of balixafortide with eribulin has potential to provide a
new therapeutic option for these patients in need and warrants further
investigation in a Phase III trial as well as exploration of additional
combinations of balixafortide with other anti-cancer therapies."

In addition, new preclinical data were presented in a poster session, where
it was shown how balixafortide, after a substantial optimization process,
represents the latest generation in CXCR4 antagonists with high potency and
selectivity, strong receptor occupancy and a favourable ADME profile.
Specifically, balixafortide showed superior potency in a panel of in vitro
assays including receptor binding and occupancy, signaling pathways and
chemotaxis.

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 conditional 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:


For Investors:

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


For Media:

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


[*] "EMBRACE" registration trial for Eribulin
[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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