BOSTON– Strand Therapeutics, the world’s first programmable mRNA company developing curative therapies for cancer, autoimmune diseases, and beyond, today announced the first patient has been dosed in their Phase 1, first-in-human trial of STX-001, an investigational multi-mechanistic, synthetic self-replicating mRNA technology that expresses an IL-12 cytokine for an extended duration, directly into the tumor microenvironment.
“STX-001 represents the first programmable mRNA therapy in oncology to enter the clinic for the treatment of solid tumors,” said Jake Becraft, Ph.D., CEO & Co-Founder, Strand Therapeutics. “We are proud of this remarkable achievement for patients and for Strand Therapeutics to be able to take STX-001 from the lab to the clinic to evaluate the potential of this novel treatment approach for cancer patients with solid tumors.”
STX-001 shows promise as a new approach to improve the efficacy of immunotherapy for solid tumors. In animal models, STX-001’s self-replicating mRNA technology induced immunogenic cancer cell death and promoted recruitment of T cells and NK cells to the tumor microenvironment, as well as their activation, by directly expressing an IL-12 payload from the synthetic mRNA directly from the tumor cells themselves.
“Significant progress has been made to date with current immunotherapies to address unmet patient needs in various solid tumors, but more work needs to be done to induce durable clinical responses in patients with minimal toxicities,” said Tasuku Kitada, Ph.D., Co-Founder, President, and Head of R&D, Strand Therapeutics. “We are eager to advance our work with STX-001 and continue to pioneer the development of programmable mRNA therapies to provide targeted and precise immune activation to the tumor microenvironment.”
The first patient dosed with STX-001 comes days before the start of the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31 – June 4 in Chicago. Strand will present a poster on the Phase 1 trial design. The Phase 1 trial is an open-label, multi-center first-in-human dose-escalation trial, evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of STX-001 alone, or in combination with pembrolizumab in patients with treatment refractory advanced solid tumors.
