Dynavax Presents Encouraging Data From Clinical Trial of Immuno-Oncology Product Candidate, SD-101
Clinical Findings Included:
- SD-101 was reported to be well tolerated across all dose cohorts with no dose limiting toxicities.
- The combination of direct injection of SD-101 into a tumor and low-dose radiation resulted in changes in the tumor microenvironment that potentially induced a systemic anti-tumor response.
- Tumors not directly injected with SD-101 also decreased in volume across all dose groups, and in most patients, remained stable for at least 180 to 360 days.
- No evidence of a dose response was observed, although limited numbers of patients were examined.
"This clinical trial design is unique and takes advantage of the fact that lymphoma patients have easily injectable sites of disease. The local injections are conveniently added to low dose radiotherapy, a standard treatment for low grade lymphoma," stated
"These additional data bolster the findings that were presented at the
Two additional presentations relating to SD-101 are being made at the
About LYM-01, a Phase 1/2 Trial of SD-101 in Lymphoma
In the Phase 1/2 non-randomized, open-label, multicenter, dose-escalation and expansion study, patients had untreated low-grade B-cell lymphoma. At least two sites of measurable disease were required for participation -- one of which was treated with low dose radiation and was then injected with SD-101 on days 1, 8, 15, 22 and 29. Other lesions received no treatment.
In Part 1-- the dose escalation portion of the study -- four dose cohorts with three patients each, received SD-101 at either 1 mg, 2 mg, 4 mg, or 8 mg. The Phase 2 expansion portion of the study is ongoing and is currently enrolling two dose cohorts. 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. For more information about trial enrollment, please look for SD-101 at www.clinicaltrials.gov.
SD-101, the subject of AACR abstracts CT047, 2322 and 4985, is
This press release contains forward-looking statements regarding clinical studies involving SD-101,
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