Dynavax Announces Publication of Two Papers in Leading Oncology Journal Highlighting Data From Clinical Studies of Its TLR9 Agonist, SD-101
“Promising data from multiple trials studying intratumoral administration of TLR9 agonists indicate that stimulating the innate immune system through the TLR9 pathway can enhance the adaptive immune response to both injected and non-injected tumors,” said
Dr. Ribas is the lead author for the paper titled SD-101 in Combination with Pembrolizumab in Advanced Melanoma: Results of a Phase 1b, Multicenter Study. This trial evaluated 22 patients who received intratumoral SD-101, a synthetic CpG-oligonucleotide that stimulates Toll-like receptor 9 (TLR9), in combination with a PD-1 inhibitor in patients with unresectable or metastatic malignant melanoma. The combination was well tolerated and the most common adverse events related to SD-101 were injection site reactions and transient, mild-to-moderate “flu-like” symptoms. Durable tumor responses were seen in both peripheral and visceral lesions. Among the 9 patients naïve to anti-PD-1 therapy, the overall response rate (ORR) was 78%. The estimated 12 month progression free survival (PFS) rate was 88%, and overall survival (OS) rate was 89%. Among 13 patients having prior anti-PD-1 therapy, the ORR was 15%. These clinical responses were supported by biomarker data indicating the induction of broad immune activation in the tumor microenvironment, including increased NK cells, cytotoxic cells, dendritic cells, B cells and CD8+ T cells and T cell infiltration. Increases in CD4+ and CD8+ T cells generally correlated with tumor responses. The paper can be found online here.
SD-101, the Company's lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide.
This press release contains "forward-looking" statements, including statements regarding conduct of clinical trials of SD-101, including results from the Phase 1b/2 trials, and the potential of SD-101 in the treatment of cancer. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including initiation, enrollment and completion of clinical trials of SD-101; the results of clinical trials and the impact of those results on the initiation or continuation of subsequent trials and issues arising in the regulatory process; the ability to successfully develop and commercialize SD-101; and whether or not
Source: Dynavax Technologies Corporation