STC-15 / STORM Therap - LARVOL DELTA

A phase 1b dose escalation study of STC-15, a METTL3 inhibitor, in combination with toripalimab, an anti-PD-1 antibody, in patients with advanced solid tumors (SITC 2026) - No abstract available

Clinical • Combination therapy • Metastases • P1 data • Oncology • Solid Tumor • METTL3

METTL3 inhibition by STC-15 depletes cancer stem-like cells, drives adipocytic differentiation, and regresses dedifferentiated liposarcoma in vivo (EORTC-NCI-AACR 2026) - "Abstract will be available as of 4 November (with consent of the author)"

Preclinical • Liposarcoma • Oncology • Sarcoma • Solid Tumor • METTL3

Phase 1b/2 dose escalation and expansion study of STC-15, a METTL3 inhibitor, in combination with Toripalimab, an anti-PD-1 antibody, in patients with advanced solid tumors (SITC 2025) - "Dose escalation is ongoing.Trial Registration NCT06975293Ethics Approval This study was approved by site IRBs. Protocol STC15-24202."

Clinical • Combination therapy • IO biomarker • Metastases • P1/2 data • Endometrial Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8 • METTL3 • PD-L1

A subset analysis of clinical activity and pharmacodynamic biomarkers in patients with sarcomas in the phase 1 dose-escalation study of STC-15, a METTL3 inhibitor. (ASCO 2026) - P1 | "Treatment with STC-15 offers a new paradigm for the treatment of a broad range of sarcomas by halting the cell differentiation process from mesenchymal progenitors. Early biomarker data provide proof of mechanism in target engagement and changes in gene expression, consistent with pharmacological activity and clinical response. Further investigation of efficacy and biomarkers of STC-15 in a Phase 2 sarcoma study is ongoing."

Biomarker • Clinical • First-in-human • P1 data • PK/PD data • Angiosarcoma • Osteosarcoma • Sarcoma • Solid Tumor • METTL3

STORM Therapeutics to Present Promising Phase 1 Sarcoma Data Demonstrating Activity of First‑in‑Class METTL3 Inhibitor STC‑15 at ASCO 2026 (GlobeNewswire) - "Thirteen patients in the study had sarcomas and had received a mean of three prior lines of therapy....Evidence of clinical activity consistent with a differentiation‑driven mechanism of action, with disease control observed across multiple sarcoma subtypes. Disease control rate (DCR) of 54% at 12 weeks, including one confirmed partial response, and a median progression‑free survival of 6 months. Robust target engagement, demonstrated by an average >50% reduction in m6A (methylated adenosine) marks on mRNA within 24 hours of dosing across dose cohorts."

P1 data • Sarcoma

STORM Therapeutics Secures $56 Million Series C Financing and Doses First Patient in Phase 2 Sarcoma Trial of STC‑15 (GlobeNewswire) - "The proceeds will support the advancement of STC-15, a first‑in‑class, oral small-molecule inhibitor of METTL3, including funding the Company’s Phase 2 monotherapy study in selected sarcoma indications, in which the first patient has now been successfully dosed....In a Phase 1 monotherapy study, STC-15 demonstrated durable tumor regression across multiple sarcoma subtypes, underscoring its potential to target and reprogram progenitor cells that transform into cancer cells. These results will be presented at an upcoming medical conference in 2026."

Financing • P1 data • Trial status • Sarcoma

STC-15-24202: STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas (clinicaltrials.gov) - P1/2 | N=107 | Recruiting | Sponsor: STORM Therapeutics LTD | N=188 ➔ 107 | Trial completion date: Jun 2027 ➔ Jun 2028 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Leiomyosarcoma • Liposarcoma • Oncology • Sarcoma • Solid Tumor

STC-15-24202: STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers (clinicaltrials.gov) - P1/2 | N=188 | Recruiting | Sponsor: STORM Therapeutics LTD | Trial completion date: Jan 2026 ➔ Jun 2027 | Trial primary completion date: Oct 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Endometrial Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Coherus Announces Clinical Collaboration with STORM Therapeutics to Evaluate STC-15 in Combination with LOQTORZI (toripalimab-tpzi) (The Manila Times) - "Coherus BioSciences, Inc...today announced a clinical collaboration with STORM Therapeutics, Ltd...to evaluate STC-15, a METTL3 inhibitor, in combination with LOQTORZI (toripalimab-tpzi), a next-generation PD-1 inhibitor, in a Phase 1b/2 study for the treatment of non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma and endometrial cancer....Under the terms of the clinical trial collaboration and supply agreement, Coherus will provide LOQTORZI to STORM, which will be the sponsor of the Phase 1b/2 clinical combination trial....First patient dosed in a Phase 1b/2 study evaluating STC-15, a METTL3 inhibitor, in combination with LOQTORZI, a next-generation PD-1 inhibitor."

Commercial • Trial status • Endometrial Cancer • Melanoma • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers (clinicaltrials.gov) - P1/2 | N=188 | Recruiting | Sponsor: STORM Therapeutics LTD

New P1/2 trial • Endometrial Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

STC15-22101: Oral Administration of STC-15 in Subjects with Advanced Malignancies (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: STORM Therapeutics LTD | Active, not recruiting ➔ Completed | Trial completion date: Mar 2025 ➔ Dec 2024 | Trial primary completion date: Dec 2024 ➔ Aug 2024

Trial completion • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

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 (SITC 2024) - P1 | "Salus IRB, Protocol STC15-22101. All patients gave informed consent before participation."

Clinical • Metastases • P1 data • Angiosarcoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • Thymoma • Thymus Cancer • METTL3

STORM Therapeutics Presents New Clinical Data on its First-in-Class METTL3 Inhibitor STC-15 at SITC 2024 (PRNewswire) - P1 | N=42 | NCT05584111 | Sponsor: STORM Therapeutics LTD | "STORM Therapeutics Ltd...announces that it presented promising data from its Phase 1 clinical study evaluating its METTL3 RNA methyltransferase inhibitor, STC-15, at the Society of Immunotherapy for Cancer (SITC) 39th Annual Meeting, held in Houston, US, from 6-10 November 2024....Gene expression pathways related to Interferon (IFN) signalling, response to virus and dsRNA binding were enriched in patients with longer duration of STC-15 treatment; Tumor regressions were achieved at all dose levels, 60 mg - 200 mg three times a week (TIW), with three sustained Partial Responses (PRs) at 60 mg, 100 mg, and 200 mg TIW in multiple tumor types; Treatment emergent adverse events, including target-related AE's (e.g. platelet reductions, rash, pruritis) were mainly mild, transient and well managed with supportive care and were not treatment limiting."

P1 data • Oncology • Solid Tumor

First results of a Phase 1 study evaluating safety, PK, PD and clinical activity of STC-15, aMETTL3 inhibitor, in patients with advanced malignancies (EORTC-NCI-AACR 2024) - "Treatment with STC-15 is well tolerated across pharmacologically active dose range with encouraging signs of clinical activity. Early biomarker data provide proof of mechanism in target engagement, strong activation of innate immune responses and correlation of pharmacological activity with clinical response. The study is ongoing and combination cohorts with an immune checkpoint inhibitor are planned at optimized pharmacologically active doses."

Clinical • IO biomarker • Metastases • P1 data • Angiosarcoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • Thymoma • Thymus Cancer • METTL3

STC15-22101: Oral Administration of STC-15 in Subjects With Advanced Malignancies (clinicaltrials.gov) - P1 | N=42 | Active, not recruiting | Sponsor: STORM Therapeutics LTD | Recruiting ➔ Active, not recruiting | N=66 ➔ 42 | Trial primary completion date: May 2024 ➔ Dec 2024

Enrollment change • Enrollment closed • Metastases • Trial primary completion date • Oncology • Solid Tumor • METTL3

Phase 1 dose escalation and cohort expansion study evaluating safety, PK, PD and clinical activity of STC-15, a METTL-3 inhibitor, in patients with advanced malignancies. (ASCO 2024) - P1 | "Treatment with STC-15 is well tolerated across pharmacologically active dose range with encouraging signs of clinical activity. Early biomarker data provide proof of mechanism in target engagement, strong activation of innate immune responses and correlation of pharmacological activity with clinical response. The study is ongoing and expansion cohorts are underway to further evaluate PK/PD, safety and clinical efficacy at optimized pharmacologically active doses."

Clinical • Metastases • P1 data • Angiosarcoma • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pruritus • Sarcoma • Solid Tumor • Thrombocytopenia • METTL3

STORM Therapeutics Presented Interim Phase 1 Clinical Data on its METTL3 RNA Methyltransferase Inhibitor STC-15 at ASCO 2024 (PRNewswire) - P1 | N=66 | NCT05584111 | Sponsor: STORM Therapeutics LTD | "STORM Therapeutics Ltd...today announces that interim Phase 1 clinical data from its first-in-class lead product, STC-15, was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago, US...STC-15 is well tolerated across the pharmacologically active dose range; Treatment emergent adverse events (TEAEs) were manageable...As of April 15, 2024...Clinical activity was observed, comprising of; 11% Overall Response Rate (3 partial responses); 63% Disease Control Rate (14 stable disease, 3 partial responses)...Recommended Phase 2 doses were identified as between 60mg and 200mg TIW; Advancement of STC-15 into combination studies with checkpoint inhibitors is expected to commence in 2024."

New trial • P1 data • Oncology • Solid Tumor

STORM Therapeutics to Present Interim Phase 1 Clinical Data on its METTL3 RNA Methyltransferase Inhibitor STC-15 at ASCO 2024 (PRNewswire) - "STORM Therapeutics...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',...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."

P1 data • Oncology • Solid Tumor

Oral Administration of STC-15 in Subjects With Advanced Malignancies (clinicaltrials.gov) - P1 | N=66 | Recruiting | Sponsor: STORM Therapeutics LTD | Trial completion date: Dec 2024 ➔ May 2025 | Trial primary completion date: Dec 2023 ➔ May 2024

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • METTL3

STORM Therapeutics Presented Novel Pre-Clinical Data on STC-15 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (PRNewswire) - "STORM Therapeutics Ltd...is pleased to announce that Dr. Yaara Ofir-Rosenfeld, Director of Translational Oncology at STORM, presented novel pre-clinical data investigating the combination of METTL3 inhibitors (METTL3i) with DNA damaging therapies at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, Massachusetts on the 11-15 October 2023....METTL3 inhibition enhances cytotoxicity of DNA damaging chemotherapies such as doxorubicin. Combination of STC-15 with chemotherapies activates cancer cell intrinsic interferon signalling that contributes to the induction of immunogenic cell death....STC-15 reshapes the tumor microenvironment, shifting it from an immunosuppressive, pro-tumorigenic to an immune stimulatory, anti-tumor state."

Preclinical • Oncology • Solid Tumor

Oral Administration of STC-15 in Subjects With Advanced Malignancies (clinicaltrials.gov) - P1 | N=66 | Recruiting | Sponsor: STORM Therapeutics LTD | Trial completion date: Sep 2024 ➔ Dec 2024 | Trial primary completion date: Sep 2023 ➔ Dec 2023

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

STC-15, a small molecule inhibitor of the RNA methyltransferase METTL3, activates anti-tumor immunity and reshapes the tumor microenvironment. (AACR-NCI-EORTC 2023) - No abstract available

Biomarker • Tumor microenvironment • Oncology • METTL3

STORM Therapeutics publishes data in Cancer Discovery showing induction of anti-tumour immunity by METTL3 inhibition (PRNewswire) - "STORM Therapeutics Ltd...is pleased to announce that it has published a scientific manuscript in the internationally recognised scientific journal Cancer Discovery....Using pre-clinical cancer models, the study shows that pharmacological inhibition of METTL3 induces double-stranded RNA formation and a profound cell-intrinsic interferon response that potentiates T-cell killing of cancer cells. Whilst METTL3 inhibitors are equally efficacious to anti-PD1 therapy in pre-clinical models, the combination of the two agents has far greater activity, leading to tumour regression and durable anti-cancer immunity....'This exciting new data strengthens our hypothesis for the clinical development of STC-15 as a novel anticancer therapeutic in monotherapy and in combination with standard of care, including checkpoint inhibitors.'"

Preclinical • Oncology • Solid Tumor

Discovery of STC15, an orally bioavailable, highly selective METTL3 inhibitor for the treatment of AML and solid tumours: The first molecule specifically targeting an RNA methyltransferase enzyme to enter clinical development (ACS-Fall 2023) - "This work has delivered the first RNA methyltransferase inhibitor into the clinic. We will describe the discovery of METTL3 inhibitor STC15 and share emerging data from the phase one clinical trial."

Clinical • Acute Myelogenous Leukemia • Oncology • Solid Tumor • METTL3

STORM Therapeutics Presents STC-15 Preclinical Data Supporting Treatment of Patients with AML at the AACR Acute Myeloid Leukemia and Myelodysplastic Syndrome Conference (PRNewswire) - "STORM Therapeutics Ltd. (STORM)...presented new data on its lead candidate, the METTL3 inhibitor STC-15. The new data in AML preclinical models was presented at the American Association for Cancer Research (AACR) Special Conference: Acute Myeloid Leukemia and Myelodysplastic Syndrome, hosted in Austin, Texas on the 23-25 January....STC-15 showed synergistic inhibition of tumor cell growth in vitro when combined with venetoclax. In an AML patient-derived in vivo model, STC-15 extended survival when compared to a vehicle-treated control group and a venatoclax-treated group of animals."

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology