Halozyme Therapeutics and Genentech have entered a collaborative agreement to assess the combination of their drug candidates PEGPH20 and Tecentriq (atezolizumab) in two clinical trials that will evaluate up to eight tumor types and begin in 2017.
Genentech will lead an open-label, multi-arm, randomized, global Phase 1b/2 clinical trial, designed to evaluate the PD-L1 blocking antibody Tecentriq in combination with PEGPH20 in six tumor types, with an initial focus on pancreatic, gastric and other gastrointestinal cancers.
Halozyme will lead an open-label, randomized Phase 1b clinical trial designed to evaluate Tecentriq in combination with PEGPH20 and chemotherapy in patients with advanced or metastatic biliary and gallbladder cancers.
Halozyme’s lead drug candidate, PEGPH20, is based on the company’s proprietary rHuPH20 enzyme, a recombinant human hyaluronidase enzyme that temporarily degrades the natural sugar chain hyaluronan. This chain of natural sugars accumulates around certain tumors and constricts blood vessels, impairing the ability of chemotherapies and immunotherapies to penetrate the tumor and inhibit its growth.
“High levels of hyaluronan (HA) have been shown in retrospective clinical reviews to be associated with a poor prognosis when compared to low-HA and in animal models to potentially impede the access of cancer therapy,” Dr. Helen Torley, president and chief executive officer of Halozyme, said in a recent press release. “We look forward to exploring this combination therapy with our partner in a range of tumors, given our shared focus on the tumor microenvironment and longstanding relationship working together on the development of Roche’s Herceptin SC and MabThera SC products for the EU market,” she said.
Following the Phase 1b portions, which will evaluate safety and tolerability of the combo therapies, both studies’ protocols may scale to registration trials.
The trial led by Halozyme will enroll only patients whose tumors have high levels of HA, while the initial phases of the trial led by Genentech will focus on an all-comer population with a target number of patients with high levels of HA to be enrolled.
Tecentriq is a monoclonal antibody targeting the PD-L1 protein (short for programmed death-ligand 1), whose expression is increased in tumor cells to protect them cells from the cytotoxic action of the immune system.
In May, the U.S. Food and Drug Administration granted accelerated approval for Tecentriq (atezolizumab) for the treatment of some patients with locally advanced or metastatic urothelial carcinoma (mUC), which represents nearly 90% of all bladder cancers.