Dynavax Technologies Corporation (NASDAQ:DVAX) opened Monday with a 27% jump from Friday’s close. The surge in DVAX stock comes on the heels of updated results from its ongoing Phase 1b/2 clinical trial of its toll-like receptor 9 agonist, SD-101.
Dynavax shares have since fallen a bit to some profit-taking, but share holders are still sitting pretty on 15% gains as of this writing.
Dynavax’s trial studied the effects of SD-101 in conjunction with Keytruda, a Merck & Co., Inc. (NYSE:MRK) developed anti-PD-1 therapy, in patients with advanced melanoma. The trial, which tested 19 patients for efficacy and 22 for safety, showed several positive results.
Three key points from the trial:
- The combination of SD-101 with Merck’s Keytruda produced an overall response rate (ORR) of 100% in seven patients who hadn’t undergone treatment with a PD-1/L1 inhibitor. The complete response (CR) rate was 29%. Both of which surpassed the use of Keytruda alone.
- SD-101 saw a 42% rate of tumor shrinkage in 12 patients, of which all had previously failed an anti-PD-1 treatment. 17% experienced a partial response (PR).
- SD-101 and Keytruda resulted in tumor shrinkage in “non-injected visceral lesions,” while activating both innate and adaptive immune responses.
The results were “very encouraging,” according to the lead investigator of the trial, Antoni Ribas, M.D., Ph.D., of Jonsson Comprehensive Cancer Center at the University of California.
“These results are supported by tumor shrinkage in patients who had previously progressed on anti-PD-1 treatment and by confirmatory laboratory biomarker assessments in tumor biopsies. If these clinical results are sustained in the ongoing trial, this combination, which mobilizes both innate and adaptive immune responses in patients, could represent an important advancement in immuno-oncology.”
SD-101 for advanced melanoma is just one of a handful of drugs in Dynavax’s pipeline, which includes a hepatitis B vaccine and treatments for asthma and lung cancer.
SD-101 itself is currently undergoing trials under several different combinations.
DVAX stock is now up about 75% for the year-to-date, clawing into massive losses sustained since mid-2015, when shares traded above the $30 level.