Halozyme Therapeutics (HALO) Enters Tumor Study Collaborations; Includes Tecentriq Phase 1b/2 Trial

November 10, 2016 8:31 AM EST

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Halozyme Therapeutics, Inc. (Nasdaq: HALO) announced an agreement to collaborate on clinical studies evaluating up to eight different tumor types beginning in 2017.

The first study will be a Phase 1b/2 open-label, multi-arm randomized global study, led by Genentech to evaluate their cancer immunotherapy Tecentriq (atezolizumab), an anti-PD-L1 monoclonal antibody, in combination with Halozyme's investigational drug, PEGPH20 in six tumor types. Halozyme will supply drug only for the Genentech study. This study will have an initial focus on gastrointestinal malignancies, including pancreatic and gastric cancers.

The second study will be a Phase 1b open-label randomized study led by Halozyme to assess Tecentriq in combination with PEGPH20 and chemotherapy in advanced or metastatic biliary and gallbladder cancers.

"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," said Dr. Helen Torley, president and chief executive officer of Halozyme. "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."

PEGPH20 is an enzyme that temporarily degrades HA, a dense component of the tumor microenvironment that can accumulate in higher concentrations around certain cancer cells, potentially constricting blood vessels and impeding the access of other therapies.

Following the phase 1b portions to assess safety and tolerability of the combinations, the study designs may scale to registration trials. The Halozyme-led study will enroll only patients who are prospectively identified as having tumors with high levels of HA, while initial phases of the Genentech-led study will focus on an all-comer population with a target number of HA-high patients to be enrolled.

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