On April 18, 2016 Dynavax Technologies Corporation (NASDAQ: DVAX) reported encouraging additional data from Part 1 of a Phase 1/2 study (LYM-01) evaluating the company’s lead immunotherapy product candidate, SD-101, in combination with low-dose radiation in lymphoma patients (Press release, Dynavax Technologies, APR 18, 2016, View Source [SID:1234510995]). The data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in New Orleans, Louisiana.

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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 Ronald Levy, M.D., professor and chief of the Division of Oncology at Stanford School of Medicine and the study’s lead clinical investigator. "We are pleased to have already demonstrated a safety profile, pharmacodynamics and preliminary efficacy in this study," he said.

"These additional data bolster the findings that were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) conference in December, demonstrating SD-101’s ability to promote beneficial changes in the tumor microenvironment to induce a systemic antitumor immune response," stated Eddie Gray, chief executive officer for Dynavax.

Two additional presentations relating to SD-101 are being made at the AACR (Free AACR Whitepaper) Conference — abstract 2322 this afternoon and abstract 4985 on Wednesday morning. Both presentations contain preclinical data relating to SD-101, and all three data presentations will be available on Dynavax’s website (www.dynavax.com) at the "Events and Presentations" tab under the "Investors and Media" section of the website.

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.

About SD-101

SD-101, the subject of AACR (Free AACR Whitepaper) abstracts CT047, 2322 and 4985, is Dynavax’s proprietary, second-generation, CpG-C class oligodeoxynucleotide TLR 9 agonist. SD-101 activates multiple anti-tumor mechanisms of innate immune cells and activates plasmacytoid dendritic cells to stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as SD-101 enhance T and B cell responses and induce high levels of Type I interferons and maturation of plasmacytoid dendritic cells and B cells. SD-101 is being evaluated in several Phase 1/2 oncology studies to assess its preliminary safety and activity.