Strand Therapeutics Receives IND Clearance for Programmable mRNA Therapy STX-001 to Treat Solid Tumors

January 22, 2024 |

2 min read

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.

BOSTON--(BUSINESS WIRE)-- Strand Therapeutics, the programmable mRNA company developing breakthrough therapies for cancer and other diseases, 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.

“STX-001 has the potential to become the first programmable mRNA therapy in oncology,” said Jake Becraft, Ph.D., CEO & Co-Founder, Strand Therapeutics. “We’re thrilled to receive IND clearance to advance our program into patients, which represents an important milestone for our company. STX-001 represents a promising new approach for the treatment of solid tumors. We’re excited to continue evaluating our programmable mRNA technology across a number of therapeutic areas.”

STX-001 shows promise as a new approach to improve the efficacy of current immunotherapies for solid tumors. STX-001’s self-replicating mRNA technology induces immunogenic cancer cell death and promotes recruitment of T cells and NK cells to the tumor microenvironment, as well as their activation.

“Although we have seen significant advances in immunotherapy for the treatment of various solid tumors, the reality is that most patients still eventually develop resistance and their cancer progresses on therapy,” said Tasuku Kitada, Ph.D., Co-Founder, President, and Head of R&D, Strand Therapeutics. “Over the past several years, we have pioneered the development of programmable mRNA therapies to provide targeted and precise immune activation to the tumor microenvironment. Our IND clearance for STX-001 marks an important next step for our immuno-oncology program, and we look forward to advancing our first candidate into clinical trials early this year.”

Data presented at AACR 2023 reported that STX-001 overcomes the limitations of current immunotherapy, and has the potential to radically improve clinical responses to solid tumors. STX-001 enables the delivery of therapeutic quantities of IL-12 with greater efficacy than conventional mRNA, and also induced durable anti-tumor response and enhanced efficacy when combined with PD-1/PD-L1 checkpoint inhibitors. STX-001 is the first drug from Strand’s solid tumor platform, which is capable of expressing any protein therapeutic(s) desired from directly within the tumor cells themselves, creating previous unattainable potential therapeutic indices.

About Strand Therapeutics

Strand Therapeutics is a next-generation biotechnology company committed to transforming the lives of patients by developing first-in-class programmable mRNA therapeutics. Founded by leaders in mRNA-based synthetic biology at MIT, Strand is creating the first platform for programmable, long-acting mRNA therapeutics that are bioengineered to enable precise control of the location, timing, intensity, and duration of therapeutic activity. Strand’s mission is to develop improved treatment options for cancer and other life-threatening diseases. The company is headquartered in Boston, MA. For more information, visit www.strandtx.com. Follow us @StrandTx.