BERKELEY, CA, USA I October 13, 2014 I Dynavax Technologies Corporation (NASDAQ: DVAX) today announced initiation of a phase 1/2 clinical trial to assess the safety and preliminary efficacy of SD-101, an investigational Toll-like receptor (“TLR”) 9 agonist, in adults with untreated low-grade B-cell lymphoma. In this multicenter study (known as LYM-01), SD-101 is administered intratumorally in combination with localized low-dose radiation. The open-label, dose escalation and expansion design of LYM-01 is intended to accelerate dose optimization while simultaneously assessing the safety, tolerability and initial local and distant antitumor activity of SD-101.
“Beginning LYM-01 is an important milestone in the maturation of Dynavax’s TLR-based cancer immunotherapy research and development efforts” said Eddie Gray, Dynavax CEO. “This study will provide a range of data that will be integral to our strategy for evaluating SD-101 both alone and in combination with other immuno-oncology agents, such as checkpoint inhibitors.”
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.
About Dynavax
Dynavax, a clinical-stage biopharmaceutical company, uses TLR biology to discover and develop novel vaccines and therapeutics in the areas of infectious and inflammatory diseases and oncology. Dynavax’s lead product candidate is HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine. For more information visit www.dynavax.com.
SOURCE: Dynavax
Post Views: 138
BERKELEY, CA, USA I October 13, 2014 I Dynavax Technologies Corporation (NASDAQ: DVAX) today announced initiation of a phase 1/2 clinical trial to assess the safety and preliminary efficacy of SD-101, an investigational Toll-like receptor (“TLR”) 9 agonist, in adults with untreated low-grade B-cell lymphoma. In this multicenter study (known as LYM-01), SD-101 is administered intratumorally in combination with localized low-dose radiation. The open-label, dose escalation and expansion design of LYM-01 is intended to accelerate dose optimization while simultaneously assessing the safety, tolerability and initial local and distant antitumor activity of SD-101.
“Beginning LYM-01 is an important milestone in the maturation of Dynavax’s TLR-based cancer immunotherapy research and development efforts” said Eddie Gray, Dynavax CEO. “This study will provide a range of data that will be integral to our strategy for evaluating SD-101 both alone and in combination with other immuno-oncology agents, such as checkpoint inhibitors.”
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.
About Dynavax
Dynavax, a clinical-stage biopharmaceutical company, uses TLR biology to discover and develop novel vaccines and therapeutics in the areas of infectious and inflammatory diseases and oncology. Dynavax’s lead product candidate is HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine. For more information visit www.dynavax.com.
SOURCE: Dynavax
Post Views: 138
