Polyphor announces successful end of Phase I meeting with FDA on its innovative immuno-oncology candidate balixafortide
EQS Group-News: Polyphor AG / Key word(s): Regulatory Admission/Interim Report
Allschwil, Switzerland, March 9th, 2018
Possibility of proceeding with a single pivotal trial to file for approval in the U.S. for combination with eribulin as third line therapy for metastatic breast cancer
Polyphor announced today the successful completion of its end of Phase I meeting with the U.S. Food and Drug Administration (FDA) for its novel immuno-oncology candidate balixafortide (POL6326), 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 FDA indicated that Polyphor could possibly proceed with a single pivotal trial to file for approval in the U.S. for the combination of balixafortide and eribulin (Halaven(R)) for treatment of patients with metastatic breast cancer who previously received at least two chemotherapeutic regimens. This could allow balixafortide to be approved in the U.S. for this indication by 2021, and possibly by the end of 2020 in case of accelerated approval based on interim data of Overall Response Rate (ORR) with an acceptable duration of response.
The FDA's advice on the development program was based on promising preliminary data shown in Polyphor's Phase I trial in which balixafortide was the first CXCR4 inhibitor to demonstrate proof of concept in solid tumors. Balixafortide combined with eribulin has shown a 63% Clinical Benefit Rate (CBR) and a 38% Overall Response Rate (ORR)[i]. The safety and tolerability of the combination appeared comparable to published data on either eribulin or balixafortide monotherapy.
"This development significantly strengthens Polyphor's late-stage clinical pipeline and we now have two products entering the final stage of clinical development and with a clear path to market," said Giacomo Di Nepi, Chief Executive Officer of Polyphor. "Our highly constructive discussion with the FDA has resulted in specific next steps towards a pivotal trial to potentially support registration for balixafortide. We are grateful to the agency for its guidance and look forward to fully defining a development pathway to rapidly bring this new potential treatment option for women suffering from a disease that today still has poor prognosis and outcomes.
"We are also continuing to advance the Phase III program for our novel antibiotic, murepavadin, potentially the first representative of a new class against Gram-negative bacteria to enter Phase III in several decades."
"There is an ongoing need for novel treatments for patients with late stage HER2 negative breast cancers," said 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. "The preliminary anti-tumor activity and tolerability we have seen with balixafortide in combination with eribulin has been very encouraging and has potential to provide a new therapeutic option in these patients."
About Balixafortide (POL6326)
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Document: Mediarelease_Polyphor_Mar 08_2018_Balixafortide_FDA Meeting_E