Biothera Pharmaceuticals Announces Immuno-Oncology Clinical Trial Collaboration With AstraZeneca

Biothera Pharmaceuticals, Inc. recently announced a clinical collaboration with AstraZeneca to evaluate whether the combination of Biothera’s Imprime PGG and AstraZeneca’s durvalumab (IMFINZI) can decrease tumor volume in patients with primary untreated locally advanced head and neck cancer prior to surgical resection. Imprime PGG is an innate immune trigger that activates anti-cancer T cells. Durvalumab is a human monocolonal antibody that blocks the immune checkpoint protein, programmed death-ligand (PD-L1), and allows activated T cells to attack tumor cells.

Under terms of the agreement, Biothera and AstraZeneca will collaborate on a non-exclusive basis to evaluate the combination of the two drugs in head and neck squamous cell carcinoma, in the neoadjuvant setting. Biothera expects to initiate the randomized Phase 2 study in the second half of 2018. Biothera will sponsor and fund the study, and AstraZeneca will supply durvalumab for the study. The trial will be conducted at several clinical sites, including Sanford Health, one of the largest nonprofit healthcare systems in the US. Completion of patient enrollment is expected in 2019.

“We are pleased to work with AstraZeneca in hopes of addressing the high unmet clinical needs of patients with head and neck cancer,” said Barry Labinger, Biothera Pharmaceuticals’ President and Chief Executive Officer. “Previous clinical and preclinical studies demonstrated that Imprime PGG consistently repolarized the immunosuppressive tumor microenvironment and increased T cell infiltration and activation, which we believe will have a synergistic effect with durvalumab’s targeting of PD-L1.”

Durvalumab, a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumor’s immune-evading tactics and inducing an immune response.  As part of a broad development program, durvalumab is being investigated as monotherapy and in combination with immune-oncology, small molecules, and chemotherapies across a range of tumors and stages of disease.

 Imprime PGG is a Phase 2 cancer immunotherapy that has been shown in preclinical studies to enhance the efficacy of anti-cancer immune responses in combination with immune checkpoint inhibitor, tumor-targeting and anti-angiogenic antibodies.

Biothera Pharmaceuticals is a privately held clinical stage immuno-oncology company developing Imprime PGG.  In addition to its collaboration with AstraZeneca, the company has clinical research agreements with:

-Merck to evaluate Imprime PGG and KEYTRUDA^® (pembrolizumab), Merck’s anti-PD-1 therapy, in Phase 2 studies in advanced melanoma, metastatic triple negative breast cancer and head and neck squamous cell cancer.

-Genentech to study Imprime PGG in combination with TECENTRIQ^® (atezolizumab) and AVASTIN^® (bevacizumab) in metastatic colorectal cancer.

-The Big Ten Cancer Research Consortium, which is evaluating Imprime PGG and KEYTRUDA in a Phase 1b/2 trial in patients with non-small cell lung cancer.