Dynavax Presents Clinical Data from Lead Cancer Immunotherapy Candidate, SD-101, in Combination with Targeted Low-Dose Radiation, at ASH Annual Meeting
Data from the dose escalation and expansion phase of the study were reported from 28 evaluable patients. None of the patients had received prior treatment for their low-grade lymphoma. The primary endpoints of the trial are maximum tolerated dose (MTD) and evaluation of the safety of intratumoral SD-101 in combination with low dose radiotherapy. In addition, the trial is evaluating anti-tumor activity, pharmacodynamics, and duration of response. Doses ranged from 1 mg to 8 mg per injection in successive cohorts.
Key findings presented include:
- Of the 28 evaluable patients treated across all dose levels, 3 had a partial response (PR) and1 had a complete response (CR) as measured by Cheson criteria.
- Durable abscopal tumor shrinkage was observed in the majority of patients.
- Confirming observations in the dose escalation phase, the most common treatment-related treatment emergent adverse events (TEAEs) in the expansion phase were flu-like symptoms, consistent with the engagement of TLR9 and the induction of interferon-alpha.
- Increases in CD8+ cells were observed in the injected tumor, and correlated with an increased abscopal tumor shrinkage
"The clinical data emerging from our SD-101 program continues to be encouraging. We look forward to providing updates from our ongoing clinical trials," stated
For information about SD-101 trials that are currently recruiting patients, please visit www.clinicaltrials.gov.
Dynavax Forward Looking Statements
This press release contains "forward-looking" statements, including expectations for the conduct and timing of clinical trials of SD-101. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether we can timely provide adequate clinical supplies, initiate one or more studies, enroll a sufficient number of subjects and ultimately complete any study, and whether or not
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