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Aptevo Regains Worldwide Rights to Novel Bispecific Prostate Cancer Immunotherapeutic MOR209/ES414
Preliminary Phase I Data Show Markedly Lower Anti-Drug Antibody Titers Demonstrating Effectiveness of New Dosing Regimen
“We’re encouraged by the latest preliminary data from the ongoing Phase 1 clinical study of APVO414,” said Dr.
In the initial cohorts of the Phase 1 dose escalation study, twelve patients with mCRPC were treated with weekly intravenous infusions of APVO414. Seven of these patients (58%) developed ADA with very high titers (as high as 1:250,000). None of the patients had any adverse reactions due to the ADA, but patients with high ADA titers cleared the drug from their blood to undetectable levels.
The amended protocol utilizes continuous intravenous infusion and two cohorts of patients have completed dosing without any dose limiting toxicities. Three of six patients (50%) developed ADA but with markedly lower titers of ADA (1:160 or 1:320). Additionally, drug was detected in the serum of all patients.
“These results clearly demonstrate that the administration regimen markedly reduced the generation of ADA. Additionally, we have seen early pharmacodynamic effects of the drug such as redistribution of T cells. We are encouraged and plan to continue dose escalation in order to determine the maximum tolerated dose and to examine the clinical activity of APVO414,” said Dr. Stromatt.
APVO414 is a first-generation bispecific antibody candidate, developed using Aptevo’s ADAPTIR™ protein therapeutic platform. APVO414 is engineered to simultaneously target PSMA on prostate cancer cells, and CD3 on T-cells, and functions by redirecting cytotoxic T cell activity towards PSMA-expressing tumor cells.
Promising preclinical data demonstrating the ability of APVO414 to induce target-dependent tumor cell killing as well as target-dependent T cell proliferation were previously presented at the
“Aptevo has made a number of significant improvements to our ADAPTIR platform since the development of our first-generation bispecific candidates, like APVO414,” commented
About Prostate Cancer
Although screening, radiation, surgery and hormone ablation therapy have greatly improved the detection and treatment of early-stage prostate cancer, the relapse rate following initial anti-androgen therapy remains high, and there remains a significant unmet medical need for patients with metastatic castration resistant prostate cancer for whom current therapies have demonstrated only a limited increase in overall survival. The global market for CRPC therapeutics is expected to reach
About the ADAPTIR Pipeline
Two first generation ADAPTIR molecules are currently in clinical development: APVO414, which is being investigated in a Phase 1, dose escalation, continuous infusion study to evaluate safety and tolerability in patients with metastatic castration resistant prostate cancer; and, otlertuzumab, a monospecific antibody targeting CD37 under investigation for the treatment of chronic lymphocytic leukemia. In addition, Aptevo has several ADAPTIR candidates in preclinical development, including: APVO436, an optimized, next generation bispecific antibody candidate designed to simultaneously target CD123 and CD3 and redirect T cell cytotoxicity for the treatment of acute myelogenous leukemia (AML), a form of blood and bone marrow cancer; ALG.APV-526, a bispecific antibody candidate, partnered with
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Aptevo Therapeutics Stacey JurchisonSenior Director, Investor Relations and Corporate Communications Tel: +1 206-859-6628 JurchisonS@apvo.com