Dynavax Technologies Corporation (NASDAQ:DVAX) announced the presentation of findings in patients with metastatic melanoma in the dose escalation phase of an ongoing Phase 1b/2 study investigating SD-101, Dynavax’s intratumoral TLR9 agonist, in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy developed by Merck, known as MSD outside the United States and Canada. Results evaluating 17 patients for efficacy and 22 patients for safety were reported. In patients naïve to anti-PD-1 treatment, responses were observed in six out of seven patients, for an Overall Response Rate (ORR) of 86%. This includes two (29%) complete responses (CR) and four (57%) partial responses (PR). Target tumor shrinkage was observed in all 7 evaluable patients. In 10 patients with progressive disease who initiated KEYTRUDA anti-PD-1 monotherapy prior to enrollment, one PR was observed and five patients had stable disease (SD) while receiving KEYTRUDA and SD-101, with four of the 10 patients experiencing target tumor shrinkage. These data are being presented by Robert Janssen, M.D., chief medical officer for Dynavax, in an oral presentation at the International Congress on Targeted Anticancer Therapies which begins today in Paris, France.
“We are pleased with the response in the anti-PD-1 naïve group with 2 complete responses and tumor shrinkage in all 7 evaluable patients,” said Dr. Janssen. “In addition, we are encouraged to have seen a partial response at the highest dose in the anti-PD-1 refractory group with little toxicity. This allows us to explore higher doses of SD-101 in anti-PD-1 refractory patients in the expansion phase to further develop the best path forward for this hard to treat population.”
SD-101 in combination with KEYTRUDA generally 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. The most common treatment-emergent adverse events were injection site reactions and transient grade 1 to 2 flu-like symptoms, including fever, chills and myalgia that respond to over the counter medications such as acetaminophen. The study also includes 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.
Shares of Dynavax Technologies are currently trading at $5.97, down $0.28 or -4.40%. DVAX has a 1-year high of $23.62 and a 1-year low of $3.20. The stock’s 50-day moving average is $4.29 and its 200-day moving average is $7.75.
On the ratings front, Dynavax has been the subject of a number of recent research reports. In a report issued on January 6, Cowen analyst Phil Nadeau reiterated a Buy rating on DVAX, with a price target of $45, which represents a potential upside of 620% from where the stock is currently trading. Separately, on November 15, William Blair’s Y Katherine Xu maintained a Buy rating on the stock and has a price target of $17.
According to TipRanks, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Phil Nadeau and Y Katherine Xu have a yearly average return of 8.7% and 13.5% respectively. Nadeau has a success rate of 56% and is ranked #470 out of 4513 analysts, while Xu has a success rate of 50% and is ranked #623.
Dynavax Technologies Corp. is a clinical-stage biopharmaceutical company that uses toll-like receptor biology to discover and develop novel vaccines and therapeutics. The company’s development programs are organized under its three areas of focus: vaccine adjuvants, cancer immunotherapy, and autoimmune and inflammatory diseases. Its lead product candidate is HEPLISAV, a Phase III investigational adult hepatitis B vaccine. The company’s other products under pipeline are SD-101, DV1179 Autoimmune Disease and AZD1419 Asthma Therapy.