Roche will partner with Polyphor to develop and commercialize its Phase II-initiated investigational macrocycle antibiotic designed to fight bacterial infections linked to the multidrug-resistant Pseudomonas species, in a deal that could net Polyphor up to CHF 500 million ($547.4 million).
Polyphor said today it licensed POL7080 to Roche for bacterial infections caused by Pseudomonas aeruginosa, a “superbug” commonly found in hospitals. In return, under the companies’ exclusive worldwide license agreement, Roche will pay Polyphor CHF 35 million ($38.3 million) up front and up to CHF 465 million ($509.1 million) tied to undisclosed development, regulatory, and commercial milestones, as well as tiered double-digit royalties on product sales.
Polyphor said it will retain the option to co-promote an inhaled formulation of POL7080 in Europe under the deal, which is subject to customary regulatory clearances including termination of the Hart-Scott-Rodino waiting period and customary regulatory clearances.
“Roche is an ideal partner for POL7080, due to its long history of antibiotics development coupled with its strong scientific, clinical, and commercial capabilities,” Jean-Pierre Obrecht, Polyphor’s CEO and co-founder, said in a statement. “This agreement is also an important milestone for Polyphor, as it is a further validation of our macrocycle technologies and rewards more than 10 years of research and development efforts.”
POL7080 is the first of a new class of antibiotics derived from Polyphor’s protein epitope mimetics (PEM) technology platform, designed to discover and optimize drug candidates that interfere with targets difficult to modulate with classic small molecule approaches. PEM are medium-sized (0.7-2 kDa), fully synthetic cyclic peptide-like molecules designed to mimic the two most relevant secondary structure motifs involved in protein-protein interactions (PPIs): the β-hairpin and the α-helix.
The company says it successfully achieved all primary study objectives in completing a Phase I clinical trial demonstrating clinical safety and tolerability of POL7080 in healthy volunteers in Europe. In preclinical studies the compound was highly active on a variety of clinical isolates that included multidrug-resistant Pseudomonas bacteria, with in vivo efficacy in septicemia, lung, and thigh infection models that Polyphor characterized as outstanding.
POL7080 is one of Polyphor’s three lead product candidates. The others are the CXCR4 antagonist POL6326, now in ongoing and upcoming Phase II clinical trials for stem cell transplantation, tissue repair, and combination treatments in oncology; and POL6014, an inhaled inhibitor of neutrophil elastase that the company said is ready for IND-enabling studies for alpha-1 antitrypsin deficiency, cystic fibrosis, and other lung diseases.