Job Cuts As Polyphor Focuses On First-In-Class Anticancer
And Cystic Fibrosis Antibiotic
Executive Summary
Switzerland’s Polyphor has redefined its business strategy and is aiming to become a leaner organization, with a potential first-in-class immuno-oncologic, balixafortide, in late-stage clinical development for breast cancer.
After a Phase III new antibiotic program disappointment last year, Allschwil, Switzerland-based Polyphor Ltd. is refocusing its research efforts on a potential first-in-class immuno-oncology compound, while becoming a leaner organization with the loss of around 17 positions.
With current funds, Polyphor’s cash runway will last until the end of the first quarter of 2021, executives at the Swiss SIX Exchange-quoted company told an analyst briefing on 20 February.
The immuno-oncology product CXCR4 antagonist, balixafortide, has become Polyphor’s lead compound, and is currently being evaluated in a Phase III trial, FORTRESS, in patients with breast cancer. The pivotal study is evaluating balixafortide combined with eribulin (Eisai Co. Ltd.’s Halaven) for the treatment of patients with HER-negative, locally recurrent or metastatic breast cancer, following promising earlier clinical studies.
Around 192 patients have been randomized to date, ahead of plan; 385 in total should be randomized by the end of the third quarter, and first results for the co-primary objective response rate (ORR) endpoint should be available by the end of the first quarter 2021, Polyphor executives said. Data for the progression-free survival (PFS) co-primary endpoint are expected in the fourth quarter of 2021.
If approved, balixafortide could be the first-in-class CXCR4 antagonist to be approved for a solid tumor indication.
Polyphor intends to look beyond recurrent metastatic breast cancer to consider other different combination therapies for balixafortide, and new indications, said Polyphor’s new CEO, Gökhan Batur.
Batur, who was previously Polyphor’s chief commercial officer, was promoted to CEO in January, following the retirement of Giacoma DiNepi.
The Swiss company has discontinued the clinical development of an intravenous formulation of the candidate antibiotic, murepavadin, because of renal side effects reported last year in a Phase III study.
But it is aiming to continue development of an inhaled formulation of murepavadin for cystic fibrosis, with a Phase Ia study expected to start in the fourth quarter of 2020.
The preclinical program suggested there was a broader safety margin with the inhaled formulation than with the intravenous formulation, the company noted. And the data suggested that murepavadin could be the first of a new class of Pseudomonas aeruginosa-targeted antibiotics. (Also see "Polyphor's Stock Slides As Murepavadin Trials Are Halted" - Scrip, 13 May, 2019.)