Strand Therapeutics has achieved a significant milestone in programmable mRNA therapeutics by dosing the first patient with STX-001, an investigational multi-mechanistic, synthetic self-replicating mRNA therapy designed to express IL-12 cytokine for extended duration directly into the tumor microenvironment. This marks the first programmable mRNA therapy in oncology to enter clinical trials for the treatment of solid tumors.
Novel Approach to Cancer Immunotherapy
STX-001 represents a new approach to improve the efficacy of immunotherapy for solid tumors through its unique programmable mRNA platform. The therapy utilizes self-replicating mRNA technology that enables precise control of the location, timing, intensity, and duration of therapeutic activity.
"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 of 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."
Promising Preclinical Results
In animal models, STX-001's self-replicating mRNA technology demonstrated significant immunological activity. The therapy 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 at 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."
Phase 1 Trial Design
The Phase 1 trial is an open-label, multi-center first-in-human dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of STX-001. The trial will assess STX-001 both as a monotherapy and in combination with pembrolizumab in patients with treatment refractory advanced solid tumors.
Clinical Development Context
According to the Synapse Database, as of June 5, 2024, there are 105 investigational drugs targeting IL-12, including 132 indications, 149 R&D institutions involved, with related clinical trials reaching 326, and as many as 44,220 patents. STX-001's advancement to the Phase 1/2 stage of clinical development indicates potential promise in this competitive landscape.
The first patient dosing occurred just days before the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31 – June 4 in Chicago, where Strand Therapeutics presented a poster on the Phase 1 trial design during the Developmental Therapeutics – Immunotherapy session.
