Halozyme initiates Phase Ib/II oncology combination trial
US-based biotechnology firm Halozyme Therapeutics has initiated a Phase Ib/II clinical trial of PEGPH20 and atezolizumab (Tecentriq) combination to treat metastatic pancreatic ductal adenocarcinoma.
PEGPH20 is currently being developed as a form of the firm’s recombinant human hyaluronidase and is an enzyme designed to temporarily degrade hyaluronan (HA) component of tumour microenvironment, while atezolizumab is Genentech’s anti-PDL1 cancer immunotherapy.
The open-label, multi-centre, randomised Phase Ib/II trial is part of a clinical collaboration agreement signed last year by the firms to assess the combination in approximately eight types of tumours.
The trial will compare the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of the combination therapy with conventional chemotherapy treatments.
Halozyme Therapeutics president and CEO Dr Helen Torley said: "This clinical trial expands the study of PEGPH20 in pancreatic cancer, evaluating previously treated pancreas cancer patients and combining PEGPH20 with an anti-PDL1 monoclonal antibody for the first time.
"We are pleased to provide PEGPH20 in this collaboration study, to evaluate and potentially advance new treatment options for patients with pancreatic cancer, one of the hardest to treat cancers."
Planned to be performed in multiple countries, the Phase Ib/II trial will be funded by Genentech.
PEGPH20 is currently being developed to treat metastatic pancreatic cancer, gastric cancer, non-small-cell lung cancer and metastatic breast cancer, with the potential to be a combination therapy for various other cancers.
The US Food and Drug Administration also granted PEGPH20 with orphan drug designation for pancreatic cancer and fast-track designation in combination with gemcitabine and nab-paclitaxel for metastatic pancreatic cancer.