7:15AM Emergent BioSolutions BioSolutions announces 'positive' preclinical efficacy and PK Data for its new bispecific adaptir protein therapeutic ES414 at AACR; Treatment with ES414 showed statistically significant inhibition (EBS) 13.76 : The ES414 molecule was constructed using Emergent's ADAPTIR technology platform and selectively binds to the T cell receptor on cytotoxic T cells and Prostate Specific Membrane Antigen (PSMA), an antigen commonly found on prostate cancer cells.
Co announced the first poster, Emergent scientists described the efficacy of ES414 to prevent growth of human prostate cancer cells in vivo that express the PSMA protein on their surface: "Anti-PSMA x anti-CD3 ADAPTIR molecule inhibits tumor growth in vivo" Treatment with ES414 showed statistically significant inhibition of subcutaneous tumor outgrowth in the presence of human T cells in two independent mouse xenograft models of prostate cancer (C4-2B, MDA-PCa-2b). In both models, all treatment groups also showed a statistically significant decrease in serum PSA compared to negative controls.
Co announced The second poster described initial PK and tolerability: "Pharmacokinetic evaluation and tolerability assessment of anti-PSMA x anti-CD3 ADAPTIR molecule" These non-clinical studies showed that ES414 is pharmacologically active, has an extended serum half-life compared to antibody fragments, is well tolerated at levels well above the expected human dose, and possesses suitable characteristics for further in vivo toxicology studies.
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