Dynavax Initiates Phase 1/2 Study of TLR-9 Agonist Immunotherapy in B-Cell Lymphoma
"Beginning LYM-01 is an important milestone in the maturation of
LYM-01 Study Design
LYM-01 is an open-label, single arm, multicenter, dose-escalation and expansion study designed to evaluate the safety and preliminary efficacy of localized low-dose radiation therapy and intratumoral SD-101 injection into a single target lesion. It will include up to 25 patients diagnosed with untreated low-grade B-cell lymphomas who do not require immediate systemic therapy and are appropriate candidates for "watch and wait." Treatment consists of local radiation given over 2 days followed by 5 weekly intratumoral injections of 1, 2, 4, or 8 mg of SD-101. The total duration of patient participation in this study is up to 2 years.
The primary objectives of LYM-01 are:
- To assess safety and tolerability of escalating doses of SD-101 administered with low-dose radiation;
- To evaluate the pharmacodynamic profile of interferon-inducible genes in whole blood 24 hours after injection; and
- To determine the maximum tolerated dose or optimal dose.
A key secondary objective of the study is assessment of the objective response to SD-101 in untreated lesions distant from the lesion in which SD-101 and radiation were administered. All tumor responses are assessed according to the Cheson criteria.
About SD-101
SD-101 is a proprietary, second-generation, TLR 9 agonist CpG oligodeoxynucleotide (CPG ODN). SD-101 directly induces activation and maturation of plasmacytoid dendritic cells, leading to the production of type 1 interferons. Preclinical and early clinical data support the use of TLR 9 agonists in patients with solid tumors and hematologic malignancies. In preclinical studies, TLR 9 agonists have shown activity as monotherapy or in combination with various interventions, including immunotherapeutic and tumor-specific antibodies, cellular therapies, antiangiogenic agents, radiotherapy, and some chemotherapies. SD-101 has been evaluated in two Phase 1 studies to assess its preliminary safety and tolerability.
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Forward-Looking Statements
This press release contains "forward-looking" statements, including expectations for the conduct, timing and sufficiency of LYM-01. 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 enroll a sufficient number of subjects into LYM-01 and ultimately complete the study and other risks detailed in the "Risk Factors" section of our current periodic reports with the
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