EQS-News: Polyphor announces publication of positive proof of concept data for innovative immuno-oncology candidate balixafortide in The Lancet Oncology
EQS Group-News: Polyphor AG / Key word(s): Scientific publication/Study results
Polyphor announces publication of positive proof of concept data for innovative
immuno-oncology candidate balixafortide in The Lancet Oncology
30.04.2018 / 07:00
--------------------------------------------------------------------------------
Allschwil, Switzerland, April 30, 2018
First CXCR4 antagonist to demonstrate proof of concept in solid
tumorsCombination with eribulin shows very promising anti-tumor activity in
heavily pre-treated metastatic breast cancer patientsMedian progression free
survival of 6.2 months and one-year survival rate of 75%
Polyphor announced today the publication inThe Lancet Oncology[i]of positive
data from its Phase Ib/proof of concept clinical trial for its novel
immuno-oncology candidate 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.
The open label study recruited 56 patients with metastatic breast cancer who had
previously received one to three chemotherapeutic regimens. Patients received
increasing doses of balixafortide (0.5 - 5.5 mg/kg) alongside eribulin. An
expanded cohort received the combination of eribulin and the recommended Phase
II dose of balixafortide.
In the expanded cohort (n=24), balixafortide combined with eribulin showed a
median progression free survival (PFS) of 6.2 months (n=20)[*]and a one-year
survival rate of 75%. This compares to a PFS for eribulin alone of 3.7 months
and survival rate of 53.9% in its registration trial for the USA
("EMBRACE")[ii]. The Clinical Benefit Rate (CBR) was 63% and Overall Response
Rate (ORR) was 38% compared to a CBR of 28% and an ORR of 13% for eribulin in
the EMBRACE trial.
The primary endpoints of the study were a number of safety parameters including
incidents of dose limiting toxicities, type frequency and severity of AEs,
determination of maximum tolerated dose, recommended Phase II dose and
pharmacokinetic parameters. The safety and tolerability of balixafortide
together with eribulin appeared comparable to published data on either eribulin
or balixafortide monotherapy.
Dr. Javier Cortes, Head of the Breast Cancer Program at Ramon y Cajal University
Hospital, Madrid, and senior Investigator at Vall d'Hebron Institute of Oncology
said: "To our knowledge, this is the first clinical study exploring a CXCR4
antagonist with chemotherapy in breast cancer and the results suggest the
combination of balixafortide with eribulin has potential to provide a new
therapeutic option and substantial clinical benefit in heavily pre-treated
metastatic breast cancer patients where there remains a significant unmet need."
"The publication of this study in one of the world's most prestigious oncology
journals reflects the quality of the research and the potential importance of
data which we believe shows balixafortide to be the first CXCR4 antagonist to
demonstrate proof of concept in solid tumors," said Dr. Debra Barker, Chief
Medical and Development Officer of Polyphor. "Following a successful end of
Phase I meeting with the U.S. Food and Drug Administration (FDA), we have
identified specific next steps towards a pivotal trial to potentially support
registration for balixafortide in the U.S. and look forward to advancing this
clinical program."
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[iii].
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[iv].
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 tumours, 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 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
againstPseudomonas aeruginosa- recognized as a critical priority 1 pathogen by
WHO. Polyphor is also developing an immuno-oncology candidate, balixafortide
(POL6326), which has achieved clinical proof of concept in a Phase Ib/proof of
concept study 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. For more information,
please visitwww.polyphor.com.
For further information please contact:
Franziska Daabour
Communications
Polyphor Ltd.
Tel: +41 61 567 16 00
Email:communications@polyphor.com
For Investors:
Kalina Scott
Chief Financial Officer
Polyphor Ltd.
Tel: +41 61 567 16 67
Email:IR@polyphor.com
_________________________________
[*]At the data cut of point four patients were still responding and on treatment
[i]Pernas S, Martin M et al. Balixafortide plus eribulin in HER2-negative
metastatic breast cancer: a phase 1, single-arm, dose-escalation trial. Lancet
Oncology 2018; http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(18
)30147-5/fulltext
[ii]"EMBRACE" registration trial for Eribulin
[iii]Otsuka S, Bebb G. J Thorac Oncol. 2008;3(12):1379-1383
[iv]Chatterjee S, Behnam Azad B, Nimmagadda S. Adv Cancer Res. 2014; 124:31-82
--------------------------------------------------------------------------------
Additional features:
Document:http://n.eqs.com/c/fncls.ssp?u=RBDXEALTTA
Document title: Polyphor Balixafortide Lancet 20180430
--------------------------------------------------------------------------------
End of Corporate News
--------------------------------------------------------------------------------
Language: English
Company: Polyphor AG
Hegenheimermattweg 125
4123 Allschwil
Switzerland
Phone: +41 61 567 1600
Fax: +41 61 567 1601
E-mail: info@polyphor.com
Internet: www.polyphor.com
ISIN: CH0106213793
End of News EQS Group News Service
--------------------------------------------------------------------------------
680657 30.04.2018
