STC-15 is the first METTL3 inhibitor to enter clinical development

Clinical data will include safety, pharmacology, target modulation, and clinical activity

CAMBRIDGE, England, May 24, 2024 /PRNewswire/ -- STORM Therapeutics Ltd. (STORM), the clinical stage company pioneering cellular reprogramming through RNA modifications to treat disease, today announces that it will be presenting interim clinical data on its first-in-class lead product, STC-15 at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, US from May 31 to June 4, 2024.

The poster presentation, entitled 'Phase 1 Dose Escalation and Cohort Expansion Study Evaluating Safety, PK, PD and Clinical Activity of STC-15, a METTL3 Inhibitor, in Patients with Advanced Malignancies', describes findings from STORM's ongoing dose escalation and expansion Phase 1 clinical study to evaluate STC-15, an oral and highly selective small molecule inhibitor of METTL3, in advanced cancer patients. These interim results will focus on safety, pharmacokinetics, target modulation and tumor assessments to support future clinical studies. STC-15 is the first molecule specifically targeting an RNA methyltransferase enzyme to enter clinical development.

Preclinical data has demonstrated that METTL3 inhibition stimulates immune cells and activates interferon pathways, leading to the destruction of tumor cells. The poster presentation will detail the study design, patient demographics, safety data, pharmacokinetics, METTL3 target engagement, mechanistic biomarker data, and assessments of clinical activity.   

Details of the poster presentation are as follow:

Poster Title: Phase 1 dose escalation and cohort expansion study evaluating safety, PK, PD and clinical activity of STC-15, a METTL3 inhibitor, in patients with advanced malignancies
Presenter: Justin Moser at HonorHealth Research Institute
Authors: Justin Moser^[1], Kyriakos Papadopoulos^[2], Jordi Rodon Ahnert^[3], Yaara Ofir-Rosenfeld^[4], Josefin-Beate Holz^[4]
Organizations: ^[1]HonorHealth Research Institute, ^[2]START San Antonio, ^[3]The University of Texas MD Anderson Cancer Center, ^[4]Storm Therapeutics Ltd
Poster Session: Developmental Therapeutics—Immunotherapy
Session Date and Time: Saturday June 1, 2024, 9:00 AM - 12:00 PM CDT
Poster Board Number: 65
Abstract Presentation Number: 2586

The Abstract is available on the ASCO online itinerary planner here, and on the STORM website here.

NOTES TO EDITORS

About STORM Therapeutics
STORM Therapeutics is a clinical-stage biotechnology company pioneering cellular reprogramming through RNA modifications to treat disease. Its world leading understanding of RNA modifying enzymes (RME) has led to the discovery of breakthrough small molecule drugs that precisely reprogram cells through RNA biology for the treatment of cancer, inflammation, viruses and CNS diseases.

STORM's lead product, STC-15, is the first RNA modifying enzyme inhibitor to enter human clinical development. STC-15 is currently being evaluated in a Phase 1 study in patients with advanced solid tumors, establishing a data set allowing development in future clinical studies. Preclinical data have revealed that METTL3 inhibition stimulates immune cells and activates interferon pathways, leading to the destruction of tumor cells. Additional preclinical studies have demonstrated enhanced anti-tumor properties in combination with checkpoint inhibitors, supporting clinical development in tumor types where an augmented immune response may result in anti-cancer activity. STORM is building on its first-mover advantage by positioning additional RME inhibitor programs to advance into IND-track activities in 2024. STORM is seeking partners to collaborate and accelerate development of these novel drugs for disease applications outside of oncology.

STORM's specialist healthcare investors include M Ventures, Pfizer Ventures, Taiho Ventures LLC, Seroba Life Sciences, Cambridge Innovation Capital Limited, IP Group plc, UTokyo Innovation Platform Co., Ltd. and the Fast Track Initiative (FTI).

For more information, please visit www.stormtherapeutics.com

About STC-15
STORM's lead product, STC-15, is the first RME inhibitor to enter human clinical evaluation. This agent is an oral small molecule that inhibits METTL3, an RNA methyltransferase implicated in oncology and other diseases. Certain RNA methyltransferases are important regulators of RNA sensing and innate immune activation and, as such, represent novel immune-regulatory targets.

STC-15 has also been shown preclinically to inhibit tumor growth through mechanisms involving anti-cancer immune responses, such as changes in interferon signalling and synergy with T cell checkpoint blockade.

STORM is studying the safety and pharmacology of STC-15 in a Phase 1 clinical study in patients with solid tumors. Details of the study can be found on clinicaltrials.gov under the identifier NCT05584111.

About ASCO

Founded in 1964, the American Society of Clinical Oncology is the world's leading professional organization for physicians and oncology professionals caring for people with cancer.

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SOURCE STORM Therapeutics