Celldex Presents Preliminary Data from Ongoing CDX-527 Phase 1 Dose Escalation Trial at the 2021 ASCO Annual Meeting

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[{"type":"text","content":"HAMPTON, N.J., June 04, 2021 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced preliminary data from the Company’s Phase 1 dose escalation study of PD-L1xCD27 bispecific antibody CDX-527 in patients with advanced malignancies. These data were presented in a poster session as part of the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting taking place June 4-8, 2021. These are the first-in-human data of CDX-527, the first candidate developed from Celldex’s bispecific platform which utilizes the Company’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway. “We are encouraged by this emerging initial data where we have observed a good safety profile along with promising pharmacodynamic and pharmacokinetic activity, which are important key hurdles for the development of bispecific antibodies,” said Tibor Keler, Ph.D., Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. “While we are still early in the dose escalation phase, we are excited to advance into higher dose cohorts and evaluate the data further as the study progresses. We believe this preliminary data provides further validation of our preclinical studies and demonstrates the potential of our bispecific platform to produce next generation candidates.” Summary of preliminary data from ongoing Phase 1 Trial of CDX-527: As of the data cut-off on April 16, 2021, 11 patients were enrolled in the first 5 dose escalation cohorts, 0.03 mg/kg through 3 mg/kg. CDX-527 was well tolerated, with no dose-limiting toxicities or treatment related serious adverse events observed.Pharmacokinetics and receptor occupancy demonstrate good exposure starting at the 1 mg/kg dose and no evidence of significant anti-drug antibodies impact.Pharmacodynamic parameters demonstrate biological activity consistent with immune activation including: transient increase in pro inflammatory cytokines/chemokines, upregulation of activation marker on T cells and particularly NK cells and a decrease in regulatory T cells.Patients continue to be enrolled in the dose escalation phase of the trial. The Phase 1 study is an open label dose-escalation and expansion study (0.03 mg/kg to 10 mg/mg) in 40 patients with advanced or metastatic solid tumors that have progressed du...

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