Dynavax (DVAX) Announces Presentation of Early Data from SD-101 Combo Phase 1b/2; ORs Noted in 80% of Patients

November 9, 2016 11:02 AM EST

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Dynavax Technologies Corporation (Nasdaq: DVAX) announced the presentation of findings from an ongoing Phase 1b/2 study investigating SD-101, Dynavax's intratumoral TLR9 agonist, in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy. Early results investigating 13 patients with metastatic melanoma for efficacy and 19 patients for safety were reported. In patients naïve to anti-PD-1 treatment, objective responses were observed in four out of five (80%) patients, including one complete response (CR) and three partial responses (PR's). Four patients with progressive disease, while receiving anti-PD-1 monotherapy prior to enrollment, were observed to have stable disease (SD) while receiving KEYTRUDA and SD-101. These data were presented by Dr. Antoni Ribas in the late-breaking clinical update session on Wednesday, November 9, at the Society for Melanoma Research (SMR) 13th International Congress in Boston, MA, USA.

SD-101 in combination with KEYTRUDA was well-tolerated. No dose-limiting toxicities of the combination were observed in any dose cohort, and a maximum tolerated dose (MTD) was not identified. No immune-related adverse events were reported, and the most common treatment-emergent adverse events were grade 1 to 2 flu-like symptoms, including fever, chills and myalgia consistent with the engagement of TLR9 and production of interferon alpha. The study also included biomarker assessments, suggesting that treatment with SD-101 and KEYTRUDA resulted in elevation of gene signatures consistent with an increase in Th1 immune cell types as well as an increase in immune cell infiltrates such as CD8+ T-cells in the tumor microenvironment.

"We are encouraged with the early stage data we are observing from our immuno-oncology program and will continue to advance SD-101 in melanoma and other indications," stated Eddie Gray, chief executive officer of Dynavax.



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