AstraZeneca said today its biologics R&D arm agreed to acquire Definiens for $150 million-plus, while the pharma giant launched a Phase I/II clinical trial collaboration with Pharmacyclics and Johnson & Johnson’s Janssen Biotech for a combination treatment—a pair of actions that are intended to bolster its core cancer therapeutic area.
AstraZeneca said MedImmune will acquire all shares of privately-held Definiens for $150 million upfront, plus additional predetermined but undisclosed milestone payments. The acquisition is expected to close in the fourth quarter of this year.
Definiens provides image analysis and data mining solutions for tissue diagnostics and clinical digital pathology. The company’s technology provides detailed cell-by-cell readouts from target structures on tissue slides and allows the correlation of that information with data derived from other sources.
In snapping up Definiens, MedImmune aims to sharpen its focus on discovering predictive biomarkers in immuno-oncology in order to advance promising combination therapies across AstraZeneca’s combined small molecule and biologics pipeline, about 80% of which incorporates a personalized healthcare approach.
Oncology is one of AstraZeneca’s three core therapy areas, along with cardiovascular and metabolic disease; and respiratory, inflammation, and autoimmunity diseases.
The deal gives MedImmune control of Definiens’ Tissue Phenomics™ imaging and data analysis technology, designed to improve the identification of biomarkers in tumor tissue. Tissue Phenomics is based on Cognition Network Technology® developed by professor Gerd Binnig, winner of the 1986 Nobel Prize in Physics. His technology measured the identity, locations and relationships between components of the tumor microenvironment, with the goal of unlocking information from cancer tissue samples.
“Definiens’ technology will complement our immuno-oncology approach and allow us to accelerate further our clinical programs through its highly precise predictive and prognostic biomarker testing,” Bahija Jallal, Ph.D., evp, MedImmune, said in a statement.
Separately, AstraZeneca said it will study a combination of its investigational anti-PD-L1 immune checkpoint inhibitor MEDI4736 with the oral Bruton's tyrosine kinase inhibitor Imbruvica® (ibrutinib), co-developed and co-commercialized by Janssen and Pharmacyclics.
The study will assess the safety and efficacy of the combination treatment for patients with blood cancers that include diffuse large B-cell lymphoma and follicular lymphoma.
The trial will consist of a Phase I portion that is expected to establish a recommended dose regimen for the combination of MEDI4736 and ibrutinib; and a Phase II portion that will assess the safety and efficacy of the investigational combination.
Preclinical evidence has suggested that the combination of these two compounds may result in an enhanced anti-tumor immune response, the companies said.
Financial terms of the clinical collaboration have not been disclosed, though the companies did say that Pharmacyclics will conduct the trial.
“Our partnership with Pharmacyclics and Janssen supports our exploration of the potential of anti-PD-L1 in hematological cancers and is further evidence of our belief that combination therapies have the potential to be one of the most effective ways of treating cancer,” Briggs Morrison, AstraZeneca’s evp, global medicines development and CMO, said in the announcement of the trial collaboration.
MEDI4736 is designed to fight cancer by blocking signals that help tumors avoid detection by the immune system, countering the tumor's immune-evading tactics.
MEDI4736 is in development as monotherapy in solid tumors, with Phase III clinical trials due to commence by year’s end for patients with non-small cell lung cancer and squamous cell carcinoma of the head of neck.
AstraZeneca and MedImmune are also studying MEDI4736 in trials assessing several in-house combinations including MEDI4736 + tremelimumab (CTLA-4); MEDI4736 + MEDI0680 (PD-1) and MEDI4736 + MEDI6469 (OX40); and MEDI4736 + Iressa™ (gefitinib; epidermal growth factor receptor-tyrosine kinase inhibitor).
Imbruvica blocks signals that tell malignant B cells (white blood cells that produce antibodies) to multiply and spread uncontrollably. The first-in-class, oral, once-daily therapy is already indicated for mantle cell lymphoma in patients who have received at least one prior therapy; chronic lymphocytic leukemia (CLL) in patients who have received at least one prior therapy; and CLL with 17p deletion.
Imbruvica is one the first medicines to receive U.S. FDA approval through the Breakthrough Therapy Designation pathway, and is the only product to have received three Breakthrough Therapy Designations.