On August 24, 2020 Celldex Therapeutics, Inc. (Nasdaq:CLDX) reported that enrollment has opened in its open-label, Phase 1 study of CDX-527 in patients with advanced or metastatic solid tumors that have progressed during or after standard of care therapy (Press release, Celldex Therapeutics, AUG 24, 2020, View Source [SID1234563980]). CDX-527 is the first candidate from Celldex’s bispecific antibody platform. It uses Celldex’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 costimulation with blockade of the PD-L1/PD-1 pathway to help prime and activate anti-tumor T cell responses through CD27 costimulation, while preventing PD-1 inhibitory signals that subvert the immune response.
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"CDX-527 builds on our prior clinical experience where the combination of CD27 activation and PD-1 blockade was well tolerated and demonstrated biological and clinical activity when the individual agents were dosed together," said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. "We believe this bodes well for the potential safety and activity profile of CDX-527, which incorporates the two mechanisms into one molecule. Importantly, preclinical studies of CDX-527 also demonstrated greater activity than the combination of individual antibodies, adding to our enthusiasm that this next-generation checkpoint inhibitor could be an important addition to the Celldex pipeline."
This study, which is expected to enroll up to approximately 90 patients with solid tumors, is designed to determine the maximum tolerated dose, or MTD, during a dose-escalation phase and to recommend a dose level for further study in a subsequent expansion phase. The expansion phase is designed to further evaluate the tolerability and biologic effects of selected dose level(s) of CDX-527 in specific tumor types. Secondary objectives of the study include analyses of safety and tolerability, pharmacokinetics, immunogenicity and assessment of anti-tumor activity across a broad range of endpoints, such as objective response rate, clinical benefit rate, duration of response, progression-free survival and overall survival. More information about this study is available on www.clinicaltrials.gov (Identifier: NCT04440943).
About CDX-527
CDX-527 is a bispecific antibody composed of Celldex’s proprietary PD-L1 and CD27 human antibodies. CDX-527 combines blockade of the PD-1 pathway with T cell costimulation through CD27 into one molecule using an IgG1-ScFv format. Preclinical data demonstrate CDX-527 is more potent than the combination of anti-PD-L1 and anti-CD27 antibodies in T cell activation and anti-tumor activity. CDX-527 has direct antibody-dependent cellular cytotoxicity (ADCC) against CD27 or PD-L1 expressing tumor cells. In addition, CDX-527 exhibits an antibody-like pharmacokinetic profile without concerning toxicity in preclinical models. Prior clinical data with Celldex’s CD27 antibody as monotherapy and in combination with PD-1 inhibitors supports combining these pathways in patients with cancer. The Company believes that the potential for CDX-527 will include both monotherapy and combination studies with other immunotherapies or conventional cancer treatments.