STC-15 / STORM Therap - LARVOL DELTA

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

STORM Therapeutics Expands R&D Leadership Team (PRNewswire.co.uk) - "The appointment and promotion follow on from STORM's recent closing of a USD $30M Series B financing and the commencement of a Phase 1 clinical study of its first-in-class candidate STC-15, an orally bioavailable, highly selective METTL3 inhibitor which began a clinical trial in cancer patients with solid tumors in November 2022....Initial results from the Phase 1 study are anticipated to be presented in 2023."

P1 data • Oncology • Solid Tumor

STORM Therapeutics doses first patient with oral METTL3 targeting drug candidate in a solid tumor Phase 1 study (PRNewswire) - "STORM Therapeutics Ltd...announces that the first patient has been dosed with STC-15, the Company's first-in-class clinical candidate....This Phase 1 study is a multiple ascending dose escalation trial aiming to enroll 40-60 patients to measure safety, pharmacokinetics, target engagement, biomarkers related to mechanism, and anti-tumor efficacy in patients with solid tumors."

Trial status • Oncology • Solid Tumor

STC-15, an oral small molecule inhibitor of the RNA methyltransferase METTL3, inhibits tumour growth through activation of anti-cancer immune responses and synergises with immune checkpoint blockade (SITC 2022) - "These data provide the rationale for the development of STC-15 both as monotherapy and in combination with checkpoint inhibition for the treatment of solid tumour malignancies. A Phase I, First-in-Human clinical trial is planned to begin in 2022 Ethics Approval Animal welfare for this study complies with the UK Animals Scientific Procedures Act 1986 (ASPA) in line with Directive 2010/63/EU of the European Parliament and the Council of 22 September 2010 on the protection of animals used for scientific purposes."

Checkpoint inhibition • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • Ovarian Cancer • Solid Tumor • CD8 • METTL3

STC-15, an oral small molecule inhibitor of the RNA methyltransferase METTL3, inhibits tumour growth through activation of anti-cancer immune responses associated with increased interferon signalling, and synergises with T cell checkpoint blockade (AACR-NCI-EORTC 2022) - "These data provide the rationale for the development of STC-15 both as monotherapy and in combination with checkpoint inhibition for the treatment of solid tumour malignancies. A Phase I, First-in-Human clinical trial is planned to begin in 2022."

Checkpoint inhibition • IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • Ovarian Cancer • Solid Tumor • METTL3

STORM Therapeutics to present new data on its lead program STC-15 at the 34th EORTC-NCI-AACR Symposium and the 37th SITC Meeting (PRNewswire) - "STORM Therapeutics...is pleased to announce that it will be presenting novel data on its lead program STC-15, a first-in-class clinical candidate, at the upcoming 34th EORTC-NCI-AACR (ENA) Molecular Targets and Cancer Therapeutics Symposium and the 37th Society for Immunotherapy of Cancer (SITC) Annual Meeting....'These data provide the rationale for the development of STC-15 both as monotherapy and in combination with checkpoint inhibition for the treatment of solid tumour malignancies'....STORM's first-in-class lead program to enter clinical development in solid tumors in 2022."

New trial • Preclinical • Oncology • Solid Tumor

Oral Administration of STC-15 in Subjects With Advanced Malignancies (clinicaltrials.gov) - P1 | N=66 | Recruiting | Sponsor: STORM Therapeutics LTD

New P1 trial • Immune Modulation • Oncology • Solid Tumor

Fierce Biotech names STORM Therapeutics as one of its "Fierce 15" Biotech Companies of 2022 (PRNewswire) - "STORM's first-in-class clinical candidate STC-15, an orally bioavailable, highly selective METTL3 inhibitor, is on track to begin initial clinical studies in solid tumors in 2022 and will be the first molecule specifically targeting an RNA modifying enzyme to enter clinical development."

New trial • Oncology

STORM Therapeutics publishes data in Nature showing its first-in-class inhibitor of METTL3 is effective as a new therapeutic strategy against AML (PharmiWeb) - “STORM Therapeutics…announces that it has published a…paper entitled ‘Small molecule inhibition of METTL3 as a strategy against myeloid leukaemia’ reveals findings that further establish and validate STORM’s ground-breaking work on targeting RNA modifying enzymes for the development of new anti-cancer therapeutics and describes recent progress made with the METTL3 inhibitor programme…The paper demonstrates that METTL3 small molecule inhibition is effective as a new therapeutic strategy against AML, prolonging survival in a variety of AML models…STORM announced that STC-15, its first-in-class drug candidate targeting METTL3, had been selected for development towards first in human clinical studies in 2022.”

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

STORM Therapeutics selects first-in-class clinical candidate targeting METTL3 (PRNewswire) - "STORM...today announces that STC-15, its first-in-class drug candidate targeting METTL3, has been selected for development towards first in human clinical studies. The Company intends to submit an IND application in 2021. STC-15 is an orally bioavailable, small molecule METTL3 inhibitor targeting an entirely new mechanism of action (modulation of RNA epigenetics) to treat acute myeloid leukaemia (AML) and other solid and haematological cancers."

IND • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology • Solid Tumor