STX-001 / Strand Therap - LARVOL DELTA

Phase I dose escalation trial of STX-001, an LNP-encapsulated self-replicating mRNA expressing IL-12, in patients (pts) with advanced solid tumors. (ASCO 2025) - P1/2 | "STX-001 demonstrates promising preliminary efficacy, robust immune activation, and a favorable safety profile. These results support the continued development of STX-001 both as monotherapy and in combination with immune checkpoint inhibitors. Dose optimization is ongoing."

Clinical • IO biomarker • Metastases • P1 data • Febrile Neutropenia • Hepatology • Immune Modulation • Immunology • Liver Failure • Melanoma • Neutropenia • Oncology • Solid Tumor • CD4 • CD8 • IFNG • IL12A • LAG3 • PD-L1

Strand Therapeutics Announces Initial First-in-human Phase 1 Data for STX-001 in Patients with Advanced Solid Tumors at The 2025 ASCO Annual Meeting (Businesswire) - P1/2 | N=108 | NCT06249048 | Sponsor: Strand Therapeutics Inc. | "Key highlights from the Phase 1 trial include: Preliminary Clinical Activity: Multiple RECIST responses were observed, including a confirmed complete response and multiple partial responses. Furthermore, there were multiple cases of prolonged disease stabilization; Safety and Tolerability: STX-001 was well-tolerated up to 300 µg. Treatment-related adverse events were consistent with STX-001’s intended mechanism of action of immune activation; Pharmacodynamic Activity: Biomarker analysis confirmed dose-dependent increase in plasma IL-12 and IFN-γ, as well as infiltration of immune cells within the tumor microenvironment."

P1 data • Solid Tumor

A phase I trial of intratumoral STX-001: A novel self-replicating mRNA expressing IL-12 alone or with pembrolizumab in advanced solid tumors. (ASCO 2024) - P1/2 | "Tumor response will be assessed using RECIST 1.1 criteria. Exploratory pharmacodynamic analyses will assess tumor-infiltrating lymphocytes and STX-001 mRNA in baseline and on-treatment biopsies, evaluate inflammatory cytokine profiles in plasma, determine immune activation in circulating immune cells, and measure circulating tumor DNA (ctDNA) for molecular response assessment."

Metastases • P1 data • Oncology • Solid Tumor • IL12A

Strand Therapeutics Announces First Patient Dosed with Programmable mRNA Therapy STX-001 in Phase 1 Trial for Solid Tumors (Businesswire) - "Strand Therapeutics...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....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."

Clinical protocol • Trial status • Oncology • Solid Tumor

STX-001-01: Study of IT STX-001 in Patients With Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab (clinicaltrials.gov) - P1/2 | N=108 | Recruiting | Sponsor: Strand Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Melanoma • Oncology • Solid Tumor • Triple Negative Breast Cancer

Korean, US partners speed up developing mRNA-based solid cancer therapies (Korea Biomedical Review) - "Gradiant Bioconvergence said Thursday that it has entered into a research collaboration agreement with U.S. messenger ribonucleic acid (mRNA) therapeutics developer Strand Therapeutics to develop next-generation mRNA therapeutics....Under the agreement, the companies will collaborate on developing a follow-up pipeline to advance Strand Therapeutics' mRNA-based solid tumor therapy STX-001."

Licensing / partnership • Solid Tumor

Phase 1/2 Study of IT STX-001 in Patients With Advanced Solid Tumors as Monotherapy or in Combination With Pembrolizumab (clinicaltrials.gov) - P1/2 | N=108 | Not yet recruiting | Sponsor: Strand Therapeutics Inc.

New P1/2 trial • Oncology • Solid Tumor • Triple Negative Breast Cancer

Strand Therapeutics Receives IND Clearance for Programmable mRNA Therapy STX-001 to Treat Solid Tumors (Businesswire) - "Strand Therapeutics...today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 1, first-in-human trial of STX-001, a multi-mechanistic synthetic self-replicating mRNA technology that expresses an IL-12 cytokine for an extended period of time, directly into the tumor microenvironment."

IND • New P1 trial • Oncology • Solid Tumor

STX-001, a locally administered LNP-formulated self-replicating mRNA that encodes the therapeutic payload IL-12, induces deep systemic immune responses to solid tumors (AACR 2023) - "Lastly, combination of STX-001 with PD-1/PD-L1 axis inhibitors further enhances efficacy in PD-1 refractory preclinical models. Taken together, our preclinical data demonstrates that STX-001 has potential to overcome limitations of current immunotherapy approaches to improve clinical responses to solid tumors."

Oncology • Solid Tumor • IL12A

Strand Therapeutics Presents Preclinical Data on Programmable mRNA Therapy STX-001 at AACR 2023 (Businesswire) - "Strand Therapeutics...announced today preclinical data from its programmable mRNA therapy STX-001, a multi-modal synthetic self-replicating mRNA technology that delivers a prolonged and locally-acting IL-12 cytokine to the tumor microenvironment....STX-001, when delivered directly to the tumor, induces a highly immunogenic tumor cell death while the mRNA-encoded IL-12 payload promotes recruitment of effector T cells and NK cells into the tumor microenvironment....'STX-001 represents a promising new approach for the treatment of solid tumors, and we look forward to advancing this candidate into clinical trials later this year'."

New trial • Preclinical • Oncology • Solid Tumor

Strand Therapeutics Announces Poster Presentation on STX-001 at the 2023 AACR Annual Meeting (Businesswire) - "Strand Therapeutics...announced the details of its poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023....Strand will present preclinical data from its lead programmable mRNA candidate STX-001, a multi-modal synthetic self-replicating mRNA technology that delivers a prolonged and locally-acting IL-12 cytokine to the tumor microenvironment. STX-001, when delivered directly to the tumor, induces a highly immunogenic tumor cell death while the mRNA-encoded IL-12 payload promotes recruitment of effector T cells and NK cells into the tumor microenvironment."

Preclinical • Oncology