Dynavax is developing SD-101, a potent immune-stimulator, as a meaningful addition to the treatment of cancer patients. We believe this area will become increasingly dominated by combinations to improve response rates with checkpoint inhibitors and other standards of care, without increasing toxicities. SD-101 has completed two Phase 1 trials which provided safety data and dose optimization for biological activity. The Phase 1 studies also showed dose dependent increases in interferon induction in patients treated with SD-101.
We are conducting a Phase 1/2 study (LYM-01) to assess the safety and proof of mechanism of intratumoral SD-101 in adults with untreated low-grade B-cell lymphoma in combination with low-dose radiation. LYM-01 is a dose escalation and expansion study where subjects receive treatment in a single radiated lesion. Data reported previously confirm the safety of SD-101 in a range of doses and its ability to elicit a systemic immune response as measured by local and abscopal (distant) tumor reductions over time. For additional information about LYM-01, please visit ClinicalTrials.gov Identifier NCT02266147
In addition to LYM-01, SD-101 is currently being studied in combination with other agents in several ongoing clinical trials as outlined below.
Combination Drug Studies with SD-101
On the basis of synergy observed in pre-clinical models studying the combination of SD-101 and anti-PD1 antibodies we are conducting a study of intratumoral SD-101 in combination with Keytruda®, an approved anti-PD-1 monoclonal antibody, in collaboration with Merck&Co., Kenilworth, NJ.
Title: A Phase 1b/2, Open-label, Multicenter, Dose Escalation and Expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma
Objective: To evaluate the safety, tolerability and preliminary efficacy of intratumoral SD-101 injections in combination with pembrolizumab in patients with advanced or metastatic melanoma.
More information: ClinicalTrials.gov Identifier NCT02521870
An expansion of this study into squamous cell head and neck cancer, a tumor type amenable to intratumoral injection, is planned.
SD-101 and MK-1966
Merck & Co. is conducting a clinical study combining SD-101 and MK-1966, a monoclonal antibody against IL-10, in patients with advanced malignancies.
Title: A Phase 1/1b Trial of MK-1966 in Combination With SD-101 in Subjects With Advanced Malignancies
More information: ClinicalTrials.gov Identifier NCT02731742
Investigator Sponsored Research
SD-101 is also being studied in novel combinations and additional tumor types by our academic collaborators.
Title: Intratumoral Injection of SD-101, an Immunostimulatory CpG, in Combination With Ibrutinib and Local Radiation in Relapsed or Refractory Low-Grade Follicular Lymphoma
More information: ClinicalTrials.gov Identifier: NCT02927964
Title: Phase 2 Trial Pembrolizumab or Pembrolizumab in Combination With Intratumoral SD-101 Therapy in Patients With Hormone-Naïve Oligometastatic Prostate Cancer Receiving Definitive Prostatic Radiation and Intermittent Androgen Deprivation Therapy
Status: Open, not yet recruiting
More information: ClinicalTrials.gov Identifier NCT03007732