Strand Therapeutics Doses First Patient with STX-001 mRNA Therapy in Phase 1 Solid Tumor Trial

BOSTON--Strand Therapeutics, a pioneering company in programmable mRNA technologies for cancer and autoimmune disease therapies, has announced the commencement of a Phase 1, first-in-human trial for their investigational mRNA therapy, STX-001. This trial marks the first time a programmable mRNA treatment for solid tumors has entered clinical testing.

STX-001 employs a synthetic, self-replicating mRNA platform to deliver an IL-12 cytokine directly into the tumor microenvironment, offering a potential new treatment modality for solid tumors. The mRNA technology is designed to induce cancer cell death and recruit and activate immune cells such as T cells and NK cells, directly within the tumor site.

Jake Becraft, Ph.D., CEO and Co-Founder of Strand Therapeutics, expressed pride in moving STX-001 from the laboratory to clinical trials, underscoring the potential impact of this innovative treatment approach for patients with solid tumors.

The self-replicating mRNA technology of STX-001 has shown promise in preclinical animal models by effectively triggering immune responses and promoting cancer cell death. This novel approach aims to enhance the efficacy of existing immunotherapies while minimizing associated toxicities, which have been significant hurdles in current treatment options for various solid tumors.

Tasuku Kitada, Ph.D., Co-Founder, President, and Head of R&D at Strand Therapeutics, highlighted the ongoing efforts to advance programmable mRNA therapies. Kitada emphasized the goal of providing targeted and precise immune activation within the tumor environment, which is critical for achieving durable clinical responses and improving patient outcomes.

The initiation of the Phase 1 trial for STX-001 coincides with the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled for May 31 to June 4 in Chicago. Strand Therapeutics will present a detailed poster on the trial design at this event. The Phase 1 trial is an open-label, multi-center study, focusing on evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of STX-001. The study will assess the therapy both as a standalone treatment and in combination with pembrolizumab for patients with advanced solid tumors that are refractory to existing treatments.

The presentation details for the ASCO meeting are as follows:
- Presentation Title: A phase I trial of intratumoral STX-001: A novel self-replicating mRNA expressing IL-12 alone or with pembrolizumab in advanced solid tumors.
- Session Type: Poster Session
- Session Title: Developmental Therapeutics -- Immunotherapy
- Track: Developmental Therapeutics – Immunotherapy
- Sub-Track: New Targets and Technologies (IO)
- Session Date and Time: Saturday, June 1, 9:00AM – 12:00PM CDT
- Location: McCormick Place, Chicago, Illinois, Hall A
- Poster Board Number: 161b
- Permanent Abstract Number: TPS2696

Strand Therapeutics, headquartered in Boston, MA, is dedicated to revolutionizing patient care by developing first-in-class programmable mRNA therapeutics. Founded by experts in mRNA-based synthetic biology from MIT, the company aims to create long-acting mRNA treatments with precise control over therapeutic activity. This innovative platform is focused on addressing cancer and other severe diseases, striving to offer patients improved treatment options and hope for better health outcomes.

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