On August 28, 2018 Dynavax Technologies Corporation (NASDAQ: DVAX) reported that two peer-reviewed papers reporting clinical studies of SD-101 have been published by Cancer Discovery, a journal publication from American Association of Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Dynavax Technologies, AUG 28, 2018, View Source [SID1234530119]). The investigators report clinical activity and broad immune activation in the tumor microenvironment when SD-101 is administered in combination with either low dose radiation in patients with indolent lymphoma or in combination with PD-1 blockade in patients with unresectable or metastatic melanoma. Top-line results from these studies have previously been presented at major oncology conferences.
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"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 Antoni Ribas, M.D., Ph.D., Director of the Tumor Immunology Program at the Jonsson Comprehensive Cancer Center. "TLR9 agonists are showing potential as an important component of combination immuno-therapy for the treatment of cancer. With further research we hope to realize the full value that this approach can create for immuno-oncology."
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.
Ronald Levy, M.D., Robert K. and Helen K. Summy Professor in the School of Medicine at Stanford University, is the lead author of the paper titled In situ vaccination with a TLR 9 agonist and local low dose radiation induces systemic responses in untreated indolent lymphoma. It reports on a phase 1/2 multicenter study in which 29 patients received 4 Gy of radiation followed by five weekly intratumoral injections of SD-101 at a single tumor site. The paper can be found online here.
About SD-101
SD-101, the Company’s lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 2 study in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, in patients with advanced melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.