An open-label, single oral dose, randomized, two-way crossover study to assess the relative bioavailability of two oral formulations of STC-15 and evaluate the effect of food on the pharmacokinetics of a single dose of STC-15 tablet in healthy participants

Start Date09 Dec 2025

Sponsor / Collaborator

STORM Therapeutics Ltd.

[+1]

NCT06975293

/ RecruitingPhase 1/2

Open-label, Non-randomized, Multi-cohort, Phase 1b/2 Trial Investigating the Safety, Tolerability, and Antitumor Activity of STC-15 (a METTL3 Inhibitor) as a Part of Combination Therapy With Toripalimab in Participants With Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas

This early phase oncology trial will be conducted at various study centers to investigate the safety, tolerability, and antitumor activity of STC-15 (a METTL3 inhibitor) in combination with toripalimab (anti- programmed cell death 1 [PD-1]) in advanced unresectable or metastatic tumors.
The Phase 2 Monotherapy part is an open-label, non-randomized, multicenter Simon's 2-stage design that investigates the safety, tolerability, and antitumor activity of STC-15 in participants with selected, relapsed sarcomas subtypes, dedifferentiated (DD) liposarcoma and leiomyosarcoma (uterine and non-uterine).

Start Date05 May 2025

Sponsor / Collaborator

STORM Therapeutics Ltd.

[+1]

NCT05584111

/ CompletedPhase 1

Phase 1 Study to Evaluate the Safety, PK, PD, and Clinical Activity of STC-15, a METTL-3 Inhibitor, in Subjects with Advanced Malignancies

This Phase 1, multi-center, open-label, first-in-human study evaluates multiple ascending daily oral doses of STC-15 in Q3W treatment cycles in a 3+3 cohort design with dose levels determined by a modified Fibonacci algorithm. The study is designed to systematically assess safety and tolerability, pharmacokinetics, pharmacodynamics and clinical activity of STC-15 in adult subjects with advanced malignancies. Dose levels for further evaluation in expansion cohorts will be selected based on all available PK, pharmacodynamic, target engagement, efficacy, safety, and tolerability data including long-term safety data beyond dose limiting toxicities (DLTs). The study may be amended to evaluate STC-15 in combination with a Food and Drug Administration-approved standard of care treatment regimen, which could encompass targeted/chemotherapy, radiation therapy and/or immunotherapy with immune checkpoint blockers.

Start Date15 Nov 2022

Sponsor / Collaborator

STORM Therapeutics Ltd.

100 Clinical Results associated with STC-15

100 Translational Medicine associated with STC-15

100 Patents (Medical) associated with STC-15

Literatures (Medical) associated with STC-15

01 Dec 2025·LEUKEMIA

Epitranscriptomic advances in normal and malignant hematopoiesis

Review

Author: Tzelepis, Konstantinos ; Eleftheriou, Maria ; Russell, James

Abstract:

RNA modifications, collectively termed the epitranscriptome, constitute a dynamic layer of post-transcriptional regulation that governs RNA splicing, stability, localization, translation, and decay. In the hematopoietic system, these chemical marks influence stem cell fate, lineage specification, immune surveillance, and malignant transformation through context-dependent regulation of mRNA, tRNA, rRNA, and non-coding RNAs. Here, we focus on RNA modifications and editing events with emerging mechanistic and translational relevance in normal and malignant hematopoiesis, highlighting those implicated in stem cell dynamics, leukemic progression, and therapeutic resistance. Specifically, we discuss N⁶-methyladenosine (m⁶A), 5-methylcytosine (m⁵C), N⁷-methylguanosine (m⁷G), N⁴-acetylcytidine (ac⁴C), pseudouridine (Ψ), adenosine-to-inosine (A-to-I) editing, and RNA glycosylation. Particular attention is given to enzymes such as METTL3, METTL1, ADAR1, and NAT10, whose dysregulation sustains leukemic stem cell programmes, promotes immune evasion, and confers treatment resistance. With the first-in-class METTL3 inhibitor STC-15 now in early-phase clinical trials in solid tumours (NCT05584111, NCT06975293), and additional RNA-modifying enzyme inhibitors advancing preclinically, these pathways are emerging as therapeutically tractable, including in hematological cancers. Furthermore, integrating epitranscriptomic profiles into genomic risk frameworks may also improve disease stratification, minimal residual disease (MRD) monitoring, and the identification of targetable vulnerabilities. Together, these insights position RNA modifications as central to blood cancer biology and support their integration into next-generation diagnostic, prognostic, and therapeutic strategies.

11 Sep 2025·JOURNAL OF MEDICINAL CHEMISTRY

Small-Molecule Inhibitors Targeting RNA m⁶A Modifiers for Cancer Therapeutics: Latest Advances and Future Perspectives

Review

Author: Zhang, Ao ; Zhang, Ruijia ; Tang, Hairong

As the most prevalent post-translational modification in eukaryotic RNA, N⁶-methyladenosine (m⁶A) modification is involved in RNA metabolism and protein expression and plays critical roles in various physiological and pathological processes, especially in cancer. Dysregulated m⁶A modifications caused by aberrant expression of m⁶A modifiers are closely associated with cancer initiation, progression, metastasis, metabolism, and immune evasion. Recently, the first-in-class METTL3 inhibitor STC-15 has been approved for a phase 1b/2 clinical study in cancer patients, rendering the pharmacological inhibition of dysregulated oncogenic m⁶A modifying proteins with small-molecule inhibitors a novel and effective cancer therapeutic strategy. In this perspective, we provide the latest advances in small molecular inhibitors targeting oncogenic m⁶A modifying proteins. Furthermore, limitations, challenges, and future development in the field of RNA m⁶A epigenetic drug discovery are discussed.

News (Medical) associated with STC-15

08 Jan 2026

·www.prnewswire.com

STORM Therapeutics and AlidaBio Announce Strategic Collaboration to Accelerate Development of Cancer Therapies Targeting RNA Modifications

CAMBRIDGE, England and SAN DIEGO, Jan. 8, 2026 /PRNewswire/ -- STORM Therapeutics Ltd. (STORM), the clinical stage company pioneering cellular reprogramming through RNA modifications to treat disease, today announced a strategic collaboration with Alida Biosciences Inc. (AlidaBio), a company at the forefront of epitranscriptomics and RNA modification analysis. STORM will utilize AlidaBio's advanced EpiPlex® and EpiScout® next-generation sequencing (NGS) platforms to detect and quantitatively measure transcript-specific N6-methyladenosine (m6A) RNA modifications resulting from METTL3 inhibition. This will be achieved using STORM's first-in-class METTL3 inhibitor, STC-15, which is the first small molecule drug targeting an RNA-modifying enzyme to enter human clinical trials. Post-transcriptional modification of RNA, including N6-methyladenosine (m6A), adds a crucial layer of regulation to RNA metabolism, influencing processes like synthesis, stability, maturation, transport, and translation. The METTL3/14 methyltransferase complex catalyzes the deposition of m6A, and inhibition of METTL3 reduces global m6A levels, disrupting RNA regulation. In this collaboration, STORM and AlidaBio will focus on the impact of METTL3 inhibition on RNA regulation, specifically m6A dynamics, in clinical samples from cancer patients treated with STC-15, currently in Phase 1/2 clinical trials. In collaboration, the teams will correlate changes in m6A modifications at the transcript level with clinical response to treatment and identify baseline m6A features that could predict sensitivity to METTL3 inhibition. The collaboration aims to validate m6A-regulated genes and cell types affected by METTL3 inhibition, exploring epitranscriptomic biomarkers to guide patient selection and enrichment strategies for future clinical trials. Dr. Eric Martin, Chief Development Officer of STORM Therapeutics, said: "AlidaBio has demonstrated exceptional expertise and leadership in the field of RNA modification analysis, particularly through the development of advanced NGS technologies capable of detecting key epitranscriptomic modifications in both healthy and diseased settings. Through this collaboration, our shared goal is to extend our understanding of transcript-specific m6A changes in relation to clinical benefit and patient response, to improve outcomes for cancer patients treated with STC-15." Dr. Gudrun Stengel, Chief Executive Officer of AlidaBio, commented: "By applying the advanced features of our EpiPlex® and EpiScout® platforms, we aim to advance the clinical development and efficacy evaluation of STC-15 through comprehensive m6A biology analysis in patient samples. Our collaborative efforts are focused on generating deeper insights to ultimately deliver greater benefits for patients." This collaboration highlights the growing importance of epitranscriptomics in drug development, combining targeted RNA-modifying enzyme inhibition with advanced molecular profiling to inform precision oncology strategies. 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 1b/2 study in combination with LOQTORZI®, (toripalimab-tpzi), a novel next-generation PD-1 inhibitor, in patients with NSCLC, HNSCC, melanoma, and endometrial cancer. Further information is available at NCT identifier: NCT06975293. For more information, please visit About AlidaBio Founded in 2020, Alida Biosciences is transforming epitranscriptomics with powerful, user-friendly tools for RNA modification analysis. Our technologies enable concurrent detection and quantification of multiple RNA modifications from clinically relevant samples, supporting breakthroughs in research, therapeutics, and diagnostics. AlidaBio is backed by Genoa Ventures, FusionX Ventures, General Inception and Vertical Venture Partners, and supported by SBIR grants from the NHGRI and NIGMS. For more information about AlidaBio's products and services, please visit SOURCE STORM Therapeutics 21% more press release views with Request a Demo

Clinical StudyOligonucleotidesiRNA

29 May 2025

·www.globenewswire.com

Coherus Announces Clinical Collaboration with STORM Therapeutics to Evaluate STC-15 in Combination with LOQTORZI® (toripalimab-tpzi)

– 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 – May 27, 2025 -- Coherus BioSciences, Inc. (“Coherus,” NASDAQ: CHRS), today announced a clinical collaboration with STORM Therapeutics, Ltd. (“STORM”) 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. “We are excited to partner with STORM on the development of the LOQTORZI/STC-15 combination, with patient dosing underway in the Phase 1b/2 study,” said Theresa LaVallee, Ph.D., Chief Scientific and Development Officer of Coherus. “This collaboration is another example of our strategy for expanding potential LOQTORZI indications beyond NPC through cost-efficient drug supply agreements and evaluating LOQTORZI with novel mechanisms in prioritized tumor types such as NSCLC, HNSCC, and others.” The phase 1b study will evaluate STC-15, a METTL3 inhibitor, in combination with LOQTORZI to determine the safety and efficacy of the combination. The phase 2 portion of the study will evaluate expansion cohorts in NSCLC, HNSCC, endometrial cancer and melanoma, in up to 188 patients in the United States. (NCT06975293) 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. STORM and Coherus each retain all commercial rights to their respective compounds, including as monotherapies or as combination therapies. Coherus is a fully integrated commercial-stage innovative oncology company with an approved next-generation PD-1 inhibitor, LOQTORZI® (toripalimab-tpzi), growing revenues and a promising pipeline that includes two mid-stage clinical candidates targeting liver, lung, head & neck, and other cancers. Our strategy is to grow sales of LOQTORZI in nasopharyngeal carcinoma and advance the development of new indications for LOQTORZI in combination with both our pipeline candidates as well as our partners’, driving sales multiples and synergies from proprietary combinations. Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust antitumor response and enhance outcomes for patients with cancer. Casdozokitug is a novel IL-27 antagonistic antibody currently being evaluated in multiple Phase 1/2 and Phase 2 studies in patients with advanced solid tumors, including non-small cell lung cancer and hepatocellular carcinoma. CHS-114 is a highly selective cytolytic anti-CCR8 antibody currently in Phase 1b studies in patients with advanced solid tumors, including head and neck squamous cell carcinoma and gastric cancer. The content above comes from the network. if any infringement, please contact us to modify.

ImmunotherapyLicense out/in

27 May 2025

·www.prnewswire.com

STORM Therapeutics Announces First Patient Dosed in Clinical Collaboration to Evaluate STC-15 in Combination with LOQTORZI® and Appointment of Atif Abbas, M.D., as Chief Medical Officer

STC-15 has demonstrated durable clinical activity and tolerability to progress into a combination study with a checkpoint inhibitor Collaboration enables Phase 1b/2 study with STORM's lead product, STC-15 in combination with Coherus's next generation PD-1 inhibitor, LOQTORZI® (toripalimab) in patients with NSCLC, HNSCC, melanoma, and endometrial cancer Atif Abbas, M.D. joins as Chief Medical Officer CAMBRIDGE, England, May 27, 2025 /PRNewswire/ -- STORM Therapeutics Ltd. (STORM), the clinical stage company pioneering cellular reprogramming through RNA modifications to treat disease, today announced dosing of its first patient in a collaboration with Coherus BioSciences, Inc., commencing a Phase 1b/2 study evaluating STC-15, its first-in-class lead program, in combination with LOQTORZI (toripalimab-tpzi), the anti-PD-1 antibody, for the treatment of non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma and endometrial cancer, and the appointment of Atif Abbas, M.D. as Chief Medical Officer. Under the terms of the agreement with Coherus, a Phase 1b study will evaluate STC-15, a METTL3 inhibitor, in combination with LOQTORZI in a dose escalation study to determine the safety of the combination and recommended dose for STC-15. Further to this, the Phase 2 portion of the study will evaluate expansion cohorts in NSCLC, HNSCC, melanoma, and endometrial cancer, in up to 188 patients in the United States. During his two-decade career, Dr. Abbas has played key roles in immuno-oncology drug development, encompassing IND to NDA/BLA submissions, product launches and life cycle management. Atif received his medical degree from King Edward Medical University in Pakistan, with additional postdoctoral training at Yale University and Harvard Medical School. He has held roles of increasing responsibility in clinical development at Merck KGaA, Abbvie, Astellas and Boehringer Ingelheim, most recently as VP at Servier Pharmaceuticals. Jerry McMahon, Chief Executive Officer of STORM Therapeutics, said: "We are excited that the first patient is receiving treatment on our collaborative clinical study, evaluating the potential of STC-15 to enhance responses to immune checkpoint inhibitors. Our clinical data has demonstrated that STC-15 can achieve durable responses for patients who are refractory to immune checkpoint inhibitors, therefore combining it with LOQTORZI may further validate our hypothesis of treating cancer through cellular reprogramming and RNA modifications. We are thrilled that Atif has joined Storm as Chief Medical Officer to lead this effort, and to chart the development strategy for STC-15 with future studies." 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. STORM and Coherus each retain all commercial rights to their respective compounds, including as monotherapies or as combination therapies. Final clinical results from a Phase 1 study of STC-15 in patients with advanced malignancies demonstrated that it is well tolerated and achieved tumor regressions at all dose levels evaluated, with an overall response rate of 9% and disease control rate of 67%. Pharmacokinetic simulations and safety data support advancing STC-15 into combination studies with checkpoint inhibitors, such as LOQTORZI. 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 1b/2 study in combination with LOQTORZI®, (toripalimab-tpzi), a novel next-generation PD-1 inhibitor, in patients with NSCLC, HNSCC, melanoma, and endometrial cancer. Further information is available at NCT identifier: NCT06975293. For more information, please visit SOURCE STORM Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Executive ChangeLicense out/inClinical Result

100 Deals associated with STC-15

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced cancer	Phase 2	United States	STORM Therapeutics Ltd.	05 May 2025
Dedifferentiated Liposarcoma	Phase 2	United States	STORM Therapeutics Ltd.	05 May 2025
Leiomyosarcoma	Phase 2	United States	STORM Therapeutics Ltd.	05 May 2025
Solid tumor	Phase 2	United States	STORM Therapeutics Ltd.	05 May 2025
Advanced Malignant Solid Neoplasm	Phase 1	United States	STORM Therapeutics Ltd.	15 Nov 2022
Acute Myeloid Leukemia	Preclinical	United Kingdom	Evotec SE	-
Acute Myeloid Leukemia	Preclinical	United Kingdom	STORM Therapeutics Ltd.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06975293 (STC15-24202, SITC2025)	Phase 1/2	Advanced Malignant Solid Neoplasm	18	STC-15 + Toripalimab	kubmczzeap(ztccuubrir) = qwzjmwdnex zpqloeybds (pcdcxzgnbp )	Positive	05 Nov 2025
NCT05584111 (SITC2024) Manual	Phase 1	Advanced cancer	40	STC-15	zwnhrxwjlp(yhwdeqwlgd) = mainly mild to moderate egmqivxodu (qxelaeyjpw )	Positive	05 Nov 2024
NCT05584111 (ASCO2024) Manual	Phase 1	Advanced Malignant Solid Neoplasm	31	STC-15	xrxlbmwevr(gnexwixijx) = sxuhxjtvip uhgqmygbnr (wiaecbvzgl ) View more	Positive	25 May 2024
NCT05584111 (AACR_AML and MS2023)	Phase 1	Acute Myeloid Leukemia METTL3 \| BCL2	-	STC-15	mjtibdmoqv(xncyxgrxzb) = lntjillcnx xhzmmlbufi (fiuxhlpzyg )	-	01 May 2023
NCT05584111 (AACR_AML and MS2023)	Phase 1	Acute Myeloid Leukemia METTL3 \| BCL2	-	Venetoclax	mjtibdmoqv(xncyxgrxzb) = lujpltknby xhzmmlbufi (fiuxhlpzyg )	-	01 May 2023

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