On January 22, 2024 Strand Therapeutics, the programmable mRNA company developing breakthrough therapies for cancer and other diseases, reported 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 (Press release, Strand Therapeutics, JAN 22, 2024, View Source [SID1234639420]).
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"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 (Free AACR Whitepaper) 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.