efizonerimod (MEDI6383) / AgonOx, AstraZeneca - LARVOL DELTA

AstraZeneca: H1 FY 2016 Results (AstraZeneca) - Anticipated top-line data from P1 trial (NCT02318394) of durvalumab/tremelimumab + MEDI0562 for advanced malignancies in 2017; Anticipated completion of enrollment of P1 trial (NCT02221960) of durvalumab + MEDI6383 for advanced malignancies in H2 2016; Anticipated completion of enrollment of P1 trial (NCT02503774) of durvalumab + MEDI9447 for advanced malignancies in 2018; Anticipated top-line data from P1 trial (NCT02503774) of durvalumab + MEDI9447 for advanced malignancies in 2019

Anticipated enrollment status • Anticipated P1 data • Oncology

AstraZeneca: Q1 FY 2016 Update (AstraZeneca) - Anticipated top-line data from P1 trial (NCT02221960) of durvalumab + MEDI6383 for advanced malignancies in 2018

Anticipated P1 data • Oncology

A Phase 1 Study to Evaluate MEDI6383 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors (clinicaltrials.gov) - P1; N=39; Active, not recruiting; Sponsor: MedImmune LLC; Recruiting ➔ Active, not recruiting; N=224 ➔ 39

Enrollment change • Enrollment closed • Biosimilar • Immunology • Oncology

Potent Immune Modulation by MEDI6383, an Engineered Human OX40 Ligand IgG4P Fc Fusion Protein. (PubMed, Mol Cancer Ther) - "Consistent with the role of OX40 costimulation in the expansion of memory T cells, MEDI6383 administered to healthy non-human primates elicited peripheral blood CD4 and CD8 central and effector memory T cell proliferation as well as B cell proliferation. Together, these results suggest that OX40 agonism has the potential to enhance anti-tumor immunity in human malignancies."

Journal

A Phase 1 Study to Evaluate MEDI6383 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors (clinicaltrials.gov) - P1; N=39; Completed; Sponsor: MedImmune LLC; Active, not recruiting ➔ Completed; Trial completion date: Oct 2019 ➔ Jul 2017; Trial primary completion date: Apr 2018 ➔ Jul 2017

Clinical • Combination therapy • PD(L)-1 Biomarker • Trial completion • Trial completion date • Trial primary completion date