Date: 2016-11-10
Type of information: Clinical research agreement
Compound: PEGPH20 and Tecentriq® (atezolizumab)
Company: Genentech, a member of Roche Group (USA - CA - Switzerland) Halozyme Therapeutics (USA - CA)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: enzyme/immunotherapy product/monoclonal antibody. PEGPH20 (PEGylated recombinant human hyaluronidase) targets the degradation of hyaluronan (HA), a chain of natural sugars that can accumulate around cancer cells, inhibiting other therapies. By degrading HA, PEGPH20 may increase the access of co-administered chemotherapeutic and immunotherapeutic agents. FDA granted orphan drug designation to PEGPH20 for treatment of pancreatic cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. Additionally, the European Commission designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreatic cancer. Atezolizumab is anti-PDL1 monoclonal antibody designed to make cancer cells more vulnerable to the body’s immune system by interfering with PD-L1. PD-L1 is found on the surface of cells in tumours and is believed to act as a “stop sign,” preventing the immune system from destroying cancer cells. By inhibiting PD-L1, atezolizuma may enable the activation of T cells, restoring their ability to effectively detect and attack tumour cells. MPDL3280A is being studied in clinical trials to understand whether blocking PD-L1 will help the immune system respond to cancer.
Disease: eight undisclosed different tumor types
Details: * On November 10, 2016, Halozyme Therapeutics and Genentech, a member of the Roche Group, 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. 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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