Latest news with #STX-001
Business Wire
07-08-2025
- Business
- Business Wire
Strand Therapeutics Raises $153 Million Series B Financing to Further Advance Programmable mRNA Therapeutic Pipeline
BOSTON--(BUSINESS WIRE)-- Strand Therapeutics, a leader in next-generation mRNA-based therapeutics, today announced $153M Series B funding led by Kinnevik, with new investors Regeneron Ventures, ICONIQ, Amgen Ventures, Alderline Group (the family office of Alex Gorsky), JIC-VGI, LG Technology Ventures, and Gradiant Corporation, with continued participation from existing investors including FPV Ventures, Playground Global, Eli Lilly and Company, ANRI, and Potentum. To date, Strand has raised over $250M. As part of the financing, Ala Alenazi, Ph.D., of Kinnevik, will join the company's Board of Directors. 'We believe programmable RNA is the next frontier in therapeutics, and Strand has built the leading platform to unlock it.' Share The funding will advance Strand's pipeline, led by STX-001, a programmable mRNA therapy that expresses the cytokine interleukin-12 (IL-12) directly from the tumor microenvironment. The company recently announced promising initial Phase 1 clinical data for patients with advanced solid tumors at the 2025 ASCO annual meeting, noting multiple RECIST responses (including cases of complete response and complete metabolic response), multiple cases of prolonged disease stabilization, and a favorable safety profile in treatment-resistant patients. Earlier this year, Strand also presented preclinical data for STX-003, a world-first systemically administrable mRNA therapy with tumor targeting that is programmed to avoid off-target payload delivery (including liver avoidance), showing the first glimpse into the massive potential of their programmable mRNA genetic circuits. Data presented at the 2025 AACR and ASGCT annual meetings demonstrated the candidate's potential to target expression of IL-12 to tumors following systemic administration of the LNP-mRNA drug, creating an effective anti-tumor therapy that was well tolerated. IL-12 is a potent pro-inflammatory cytokine primarily produced by antigen-presenting cells such as macrophages and dendritic cells. IL-12 holds significant promise in cancer immunotherapy due to its robust immunostimulatory effects. STX-001 encodes IL-12 which Strand has designed so that it can reprogram the tumor microenvironment and stimulate a systemic anti-tumor immune response. Unlike traditional mRNA therapies, Strand's approach uses self-replicating mRNA, ensuring localized and durable therapeutic activity. 'We believe programmable RNA is the next frontier in therapeutics, and Strand has built the leading platform to unlock it,' said Christian Scherrer, Senior Investment Director and Head of Health and Bio at Kinnevik. 'Their early clinical data is outstanding, and the systemic delivery capability has the potential to reshape how we treat disease, starting with cancer, with more disease targets on the horizon. We look forward to partnering with founders Jake and Tasuku and the entire team as they move into this next phase of growth. ' 'With support from our investors, we're advancing our vision of developing safe, effective, and accessible therapies through programmable genetic medicines, especially for those patients with few treatment options,' said Jake Becraft, PhD, CEO and Co-founder of Strand Therapeutics. 'Our initial STX-001 Phase 1 data provides early and strong clinical validation of our platform's capabilities. We have observed systemic immune activation and anti-tumor responses, including responses in non-injected lesions, across multiple tumor types. Now is an exciting period of expansion for our existing clinical work, as well as the exciting breakthrough assets in our pipeline, all with the potential to transform the treatment of cancer and other serious diseases.' Strand's proprietary platform for programmable and potent mRNA therapeutics is the first of its kind. Its therapies combine best-in-class engineered next-generation mRNA modalities, such as self-replicating mRNA and circular RNA, with genetically programmed logic circuits, allowing for precise, controlled therapeutic payload delivery directly into the cells/tissues themselves. The novel approach brings the potential to effectively treat cancer and other deadly chronic diseases through its targeted therapies that are scalable, accessible, and expand the treatment landscape for patients desperately in need. About STX-001 STX-001 is an investigational multi-mechanistic, synthetic self-replicating mRNA technology that expresses an IL-12 cytokine for an extended period of time, directly administered to tumors in order to promote immune modulation and antitumor activity. The company received IND clearance from the U.S. Food and Drug Administration (FDA) in December 2023 to initiate a Phase 1/2 clinical trial for STX-001, announced its first patient dosed just before the 2024 ASCO Annual Meeting, and presented the first data of the trial at the 2025 ASCO Annual Meeting. Additional details can be found at using identifier: NCT06249048. About Strand Therapeutics Strand Therapeutics is leading the next generation of programmable mRNA therapies: where synthetic biology meets programmable biology to unlock the full potential of gene regulation and delivery inside the body. Unlike traditional mRNA technologies, Strand's platform programs RNA to think, enabling logic-controlled expression, precision delivery, and unprecedented control over therapeutic outcomes. Born out of MIT and led by world-class synthetic biologists, Strand is building the infrastructure to create medicines that respond to disease signals in real-time. With its computationally-driven design engine, self-amplifying/circular RNA modalities, and mRNA-only genetic circuits, the company is pioneering a new therapeutic modality poised to disrupt immuno-oncology, cell therapy, autoimmune diseases, and beyond. Strand's lead pipeline program, STX-001, is already in the clinic showing unprecedented response rates in late stage 'salvage' cancer patients, with multiple patients showing RECIST responses. Strand's modular platform opens a broad horizon of partnership and licensing opportunities. Strand isn't just another mRNA company: it's the operating system for the programmable medicines of tomorrow. Follow us on LinkedIn and on X at @strandtx.
Business Wire
28-05-2025
- Business
- Business Wire
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
BOSTON--(BUSINESS WIRE)-- Strand Therapeutics, a leader in next-generation mRNA-based therapeutics, today announced exciting preliminary Phase 1 clinical data for its lead investigational candidate, STX-001, in patients with advanced solid tumors. The study marks the first clinical evidence of Strand's proprietary programmable mRNA technology platform and represents a major milestone in the company's mission to bring next-generation mRNA therapies to patients with cancer. 'This is a transformative moment for Strand and for the field of synthetic mRNA therapeutics,' said Jake Becraft, PhD, CEO and Co-founder of Strand Therapeutics. 'The Phase 1 data for STX-001 provide early clinical validation of our platform." Share In the ongoing first-in-human Phase 1, open-label, dose-escalation clinical trial, STX-001 demonstrated a favorable safety profile and encouraging signs of anti-tumor activity as a monotherapy in patients with immune checkpoint inhibitor-refractory solid tumors, including melanoma and other solid tumor indications. As of the April 3rd, 2025 data cutoff, the trial had enrolled 22 patients across multiple sites in the United States and Australia. All patients were treated with STX-001 as a monotherapy (without combination with immune checkpoint inhibitors, etc.) with injections to surface accessible lesions. The data will be presented at The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on June 1 by Sarina Piha-Paul, M.D., professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center. 'This investigational therapy has the potential to address an important unmet need in patients with checkpoint inhibitor-refractory advanced cancers,' said Dr. Piha-Paul. 'We're observing systemic immune activation and antitumor responses, including in non-injected lesions, across multiple tumor types, which is encouraging and supports continued evaluation.' 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. 'This is a transformative moment for Strand and for the field of synthetic mRNA therapeutics,' said Jake Becraft, PhD, CEO and Co-founder of Strand Therapeutics. 'The Phase 1 data for STX-001 provide early clinical validation of our platform's ability to deliver programmable, tumor-localized immunotherapy safely and effectively. Our mRNA medicines as a therapeutic modality offer the potential capability to broaden pathways to treatment for patients while seamlessly integrating into the existing healthcare ecosystem.' STX-001 encodes IL-12, an immunomodulatory protein, which the company has designed such that it can reprogram the tumor microenvironment and stimulate a systemic anti-tumor immune response. Unlike traditional mRNA therapies, Strand's approach uses self-replicating mRNA, ensuring localized and durable therapeutic activity. The company is currently conducting dose expansion in the Phase 1 trial. Upon completion, the company plans to transition into a Phase 2 trial of STX-001 as a monotherapy. The company also plans to initiate dose escalation of STX-001 in combination with checkpoint inhibitors and expand into additional solid tumor indications. In addition, Strand is advancing a broader pipeline powered by the company's first-in-class cell-type specific mRNA engineering platform, including advancing STX-003, an intravenously administered version of STX-001, to patients in 2026. ASCO Poster Presentation Information: Abstract Title: Phase I dose escalation trial of STX-001, an LNP-encapsulated self-replicating mRNA expressing IL-12, in patients (pts) with advanced solid tumors. Session Type: Poster Date and Time: June 1, 9:00 AM-12:00 PM CDT Abstract Number: 9556 Location: Hall A Full abstract is available on the ASCO Annual Meeting Website. The study, an open-label, dose escalation trial, evaluated the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of STX-001 in patients with advanced solid tumors. STX-001 was well-tolerated up to 300 µg, with dose-dependent and manageable treatment-related adverse events. Promising early clinical activity was observed, including multiple RECIST responses and durable disease stabilization. Findings support the further development of STX-001 as a monotherapy and in combination with checkpoint inhibitors for the treatment of solid tumors. Additional Commentary Professor Georgina Long AO, BSc, PhD, MBBS, FRACP, FAHMS, AAHMS, FAA, Medical Director of Melanoma Institute Australia (MIA), and Chair of Melanoma Medical Oncology and Translational Research at MIA and Royal North Shore Hospital, The University of Sydney: 'I am encouraged by this early data. While intratumoral therapies offer a promising approach by initiating immune activation at the injected tumor site, they have historically struggled to generate robust systemic responses. STX-001 may represent a meaningful step forward, with early clinical evidence showing cases of regression of non-injected lesions, a sign of systemic immune engagement.' Tasuku Kitada, PhD, Co-Founder, President, and Head of R&D at Strand Therapeutics: 'Patients who are refractory to immune checkpoint inhibitors urgently need new treatment options. While IL-12 has long been recognized as a powerful immune stimulator, its clinical potential has been limited by toxicity, and to date, no IL-12–based therapies have been approved by the FDA. STX-001 is designed to overcome these challenges, delivering localized IL-12 expression to activate the tumor microenvironment and drive systemic immune responses, all while seeking to minimize toxicities. These early data suggest we may finally be able to realize the promise of IL-12 in cancer therapy.' About STX-001 STX-001 is an investigational multi-mechanistic, synthetic self-replicating mRNA technology that expresses an IL-12 cytokine for an extended period of time, directly injected into the tumor microenvironment in order to promote immune modulation and antitumor activity. The company received IND clearance from the U.S. Food and Drug Administration (FDA) in December 2023 to initiate a Phase 1/2 clinical trial for STX-001, and announced its first patient dosed just before the 2024 ASCO Annual Meeting. Additional study details can be found at using identifier: NCT06249048. About Strand Therapeutics Strand Therapeutics is a clinical-stage biotechnology company developing programmable mRNA therapeutics to transform the treatment of cancer and other serious diseases. Founded by synthetic biology pioneers from MIT, Strand's proprietary platform integrates synthetic gene circuits with mRNA delivery to enable targeted, controlled, and intelligent therapies. The company is based in Boston, Massachusetts. For more information, visit Follow us on LinkedIn and on X at @StrandTx.
