Allschwil, Switzerland, October 18, 2018
Polyphor to present new survival data for balixafortide at the 2018 European Society for Medical Oncology (ESMO) Congress
Polyphor announced today that new survival data from clinical and preclinical trials of balixafortide will be presented at the European Society for Medical Oncology (ESMO) 2018 Congress in Munich, Germany, October 19-23. Data at ESMO 2018 will include one poster presentation, highlighting the full efficacy results from the Phase I trial of balixafortide and eribulin in HER2-negative metastatic breast cancer patients. 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.
"We are excited by the clinical data we are presenting at ESMO this year. The posters and presentation cover the full Phase I efficacy results of balixafortide in combination with eribulin in patients who have undergone multiple prior chemotherapies and have very limited treatment options," said Dr. Debra Barker, Chief Medical and Development Officer of Polyphor. "We look forward to further developing this clinical program in a pivotal trial to potentially support registration for balixafortide in the U.S. and provide a new therapeutic option to help the patients in need."
Abstract #285PD: Balixafortide (a novel CXCR4 inhibitor) and eribulin in HER2-negative metastatic breast cancer patients: A phase I trial
Speaker: Javier Cortes
- Sunday, October 21, 09:15 AM CEST, ICM-Room 1
Abstract #322P: Anti-tumor cell activity and in vitro profile of the next generation CXCR4 antagonist Balixafortide
Speaker: Johann Zimmermann
- Monday, October 22, 12:45 - 13:45 PM CEST; Exhibit Hall A3 - Poster Area Networking Hub
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.
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.
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[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