On October 15, 2018 Dynavax Technologies Corporation (NASDAQ:DVAX) and Quantum Leap Healthcare Collaborative (QLHC) reported that the immunotherapy combination of Dynavax’s proprietary investigational compound SD-101 and KEYTRUDA (pembrolizumab) will be evaluated in a new randomized, investigational treatment arm for the ongoing I-SPY 2 TRIAL for neoadjuvant treatment of locally advanced breast cancer (Press release, Dynavax Technologies, OCT 15, 2018, View Source [SID1234530123]).
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SD-101 is an intratumoral TLR9 agonist that modulates the tumor microenvironment and optimally primes T cells to generate a systemic anti-tumor response. SD-101 is expected to augment responses to anti-PD-1 therapy as has been reflected in early clinical studies of other tumor types. The combination will be added to standard of care in a new I-SPY 2 TRIAL treatment arm.
"The I-SPY TRIAL is designed to evaluate multiple emerging new agents simultaneously with the goal of getting effective and potentially less toxic treatments to patients much more quickly. We are excited to add SD-101 into I-SPY 2, and combine it with pembrolizumab with the goal of extending responses previously observed with pembrolizumab alone," stated Dr. Laura J. Esserman, MD, MBA, Principal Investigator of I-SPY 2 and Director of the Carol Franc Buck Breast Care Center at the UCSF Helen Diller Family Comprehensive Cancer Center.
"We are excited SD-101 has been chosen to be included in the I-SPY 2 trial and see this as an excellent opportunity to potentially expand its use into the emerging field of neoadjuvant immunotherapy," stated Eddie Gray, chief executive officer of Dynavax.
The I-SPY 2 TRIAL, sponsored by QLHC, is a standing phase 2 randomized, controlled, multicenter study with an innovative Bayesian adaptive design aimed to rapidly screen and identify promising new treatments in specific subgroups of women with newly-diagnosed, high-risk (high likelihood of recurrence), locally-advanced breast cancer (Stage II/III). Dynavax will provide funding and SD-101; Merck will provide pembrolizumab. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
About the I-SPY TRIALs
The I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 16 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit www.ispytrials.org.
About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative (QLHC) is a 501C(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients, and researchers. Quantum Leap provides operational, financial, and regulatory oversight to I-SPY. For more information, visit www.quantumleaphealth.org.
About SD-101
SD-101, Dynavax’s lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in clinical studies to assess its safety and activity, including a Phase 2 study in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.