ATX-295 / Accent Therap - LARVOL DELTA

ATX-295-001: First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, as Monotherapy and in Combination With Anticancer Therapy in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer (clinicaltrials.gov) - P1/2 | N=218 | Recruiting | Sponsor: Accent Therapeutics | Phase classification: P1 ➔ P1/2 | N=90 ➔ 218

Enrollment change • First-in-human • Monotherapy • Phase classification • Breast Cancer • High Grade Serous Ovarian Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer

A first-in-human study of ATX-295, an oral inhibitor of KIF18A, in patients with advanced or metastatic solid tumors, including ovarian cancer. (ASCO 2026) - P1 | "The study is actively recruiting. Clinical trial information: NCT06799065."

Clinical • First-in-human • Metastases • P1 data • High Grade Serous Ovarian Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • KIF18A

Accent Therapeutics to Present Trial in Progress Poster for Phase 1/2 Study of ATX-295 at the 2026 American Society of Clinical Oncology Annual Meeting (PRNewswire) - "The Trial in Progress poster will describe the design and scientific rationale for Accent's first-in-human Phase 1/2 dose-escalation and expansion study evaluating the safety, tolerability, and preliminary efficacy of ATX-295 in patients with locally advanced or metastatic solid tumors (NCT06799065), including HGSOC and sqNSCLC."

Trial status • High Grade Serous Ovarian Cancer • Non Small Cell Lung Cancer • Solid Tumor

Robust anti-tumor activity of the novel KIF18A inhibitor, ATX-295, in preclinical models of chromosomally instable tumors (AACR 2026) - P1 | "The model achieved >0.8 AUC on a held-out test set within minutes, demonstrating proof-of-concept for AI-based WGD detection in clinical samples. ATX-295 is currently being evaluated in a first-in-human, Phase 1/2 open-label study assessing safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity in patients with advanced solid tumors and ovarian cancer (NCT06799065)."

First-in-human • Preclinical • Breast Cancer • High Grade Serous Ovarian Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • KIF18A

Activity of the novel KIF18A inhibitor, ATX-295, is enriched in whole genome doubled ovarian cancer pre-clinical models (AACR 2025) - "Within responding PDX models, the majority (73%) were WGD(+), including all models with deep response (regression). These data identify WGD as a potential enrichment biomarker of ATX-295 sensitivity in ovarian cancer models."

Preclinical • Breast Cancer • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • KIF18A

Accent Therapeutics to Present Preclinical Data on Lead Clinical Program, ATX-295, at the 2026 American Association for Cancer Research Annual Meeting (PRNewswire) - "The poster presentation will feature robust in vitro and in vivo data demonstrating ATX-295's anti-tumor activity in models of high-grade serous ovarian cancer (HGSOC), squamous non-small cell lung cancer (sqNSCLC), and triple-negative breast cancer (TNBC)."

Preclinical • High Grade Serous Ovarian Cancer • Lung Non-Small Cell Squamous Cancer • Triple Negative Breast Cancer

KIF18A inhibition and its rising role in cancer therapy trials: from bench to bedside. (PubMed, Expert Opin Investig Drugs) - "We summarize the development of small-molecule inhibitors, from early compounds like BTB-1 to second-generation agents including Sovilnesib and VLS-1488, the latter currently in Phase I/II trials...New entrants like ATX-295 and GH2616 further expand the landscape...As clinical trials progress, optimizing patient stratification and exploring synergistic combinations will be crucial. Broadening the range of druggable sites on KIF18A, especially beyond the motor domain, could mitigate resistance and help expand therapeutic potential."

Journal • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • KIF18A

ATX-295-001: First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: Accent Therapeutics | N=65 ➔ 90

Enrollment change • First-in-human • Breast Cancer • High Grade Serous Ovarian Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer

Activity of the novel KIF18A Inhibitor, ATX-295, is enriched in whole genome doubled ovarian and TNBC preclinical models (AACR-NCI-EORTC 2025) - P1 | "Together, these results demonstrate that inhibition of KIF18A via ATX-295 is a compelling strategy in chromosomally instable, whole genome doubled tumors such as HGSOC and TNBC and identify WGD as a potential enrichment biomarker of ATX-295 sensitivity in these indications. Furthermore, AI-based detection of WGD from patient H&E-stained tissue slides demonstrates promise as a stratification tool for identifying patients most likely to respond to ATX-295 therapy. ATX-295 is currently being evaluated in a first-in-human, Phase 1/2 open-label study assessing safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity in patients with advanced solid tumors and ovarian cancer (NCT06799065)."

Preclinical • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Triple Negative Breast Cancer • KIF18A

Title: Activity of the Novel KIF18A Inhibitor, ATX-295, is Enriched in Whole Genome Doubled Ovarian and TNBC Preclinical Models (PRNewswire) - "Accent Therapeutics Presents New Preclinical Data...at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics....Inhibition of KIF18A by ATX-295 is a compelling strategy for chromosomally unstable cancers, supported by new data identifying whole genome doubling (WGD) as a strong predictive biomarker for tumors such as ovarian cancer and TNBC."

Biomarker • Preclinical • Ovarian Cancer • Triple Negative Breast Cancer

Accent Therapeutics Presents Data Supporting Therapeutic Potential of…Novel KIF18A Inhibitor, ATX-295, at the AACR Annual Meeting 2025 (PRNewswire) - "For Accent's second lead program, preclinical data included in the company's oral presentation demonstrates sensitivity to KIF18A inhibition across several solid tumor indications with high chromosomal instability, signaling significant opportunity for patient impact by leveraging KIF18A as a selective oncology target. Results further characterize ATX-295 as a potent and selective KIF18A inhibitor capable of inducing mitotic arrest, cell death, and anti-tumor activity in cancer models with high chromosomal instability. Studies in relevant cellular and xenograft models exhibiting whole genome doubling confirm selective anti-cancer activity, providing rationale for whole genome doubling as a predictive biomarker of ATX-295 sensitivity in ovarian and triple negative breast cancer."

Biomarker • Preclinical • Ovarian Cancer • Triple Negative Breast Cancer

First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer (clinicaltrials.gov) - P1 | N=65 | Recruiting | Sponsor: Accent Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Platinum resistant • Breast Cancer • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer

Accent Therapeutics Announces First Patient Dosed in Phase 1/2 Trial of Novel KIF18A Inhibitor ATX-295 and Receives FDA Fast Track Designation for Lead Assets ATX-295 and DHX9 Inhibitor ATX-559 (PRNewswire) - "Accent Therapeutics...announced that the first patient has been dosed in a first-in-human Phase 1/2 clinical trial evaluating the safety and tolerability of ATX-295, a potential best-in-class oral KIF18A inhibitor. In addition, the company has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for ATX-295 for the treatment of adult patients with advanced/metastatic platinum-resistant or refractory ovarian cancer, and for ATX-559, a first-in-class potent and selective inhibitor of DHX9, for the treatment of adult patients with unresectable/metastatic dMMR/MSI-H colorectal cancer post checkpoint inhibitor treatment."

dMMR • Fast track • MSI-H • Platinum resistant • Trial status • Colorectal Cancer • Microsatellite Instability • Ovarian Cancer

Accent Therapeutics to Present Data on Lead Programs ATX-559 and ATX-295 at the 2025 American Association for Cancer Research Annual Meeting (PRNewswire) - "Accent Therapeutics...announced that it will present new data on its first-in-class oral DHX9 inhibitor, ATX-559, and its potentially best-in-class KIF18A inhibitor, ATX-295, at the 2025 AACR Annual Meeting taking place April 25-30 in Chicago, Illinois....Preclinical data supporting continued clinical evaluation of ATX-559 will characterize the compound's activity across in vivo models of cancers exhibiting genomic instability and replication stress, including in dMMR/MSI-H colorectal cancer and BRCA altered triple negative breast cancer. An oral presentation will discuss the preclinical activity of ATX-295 across a panel of ovarian cancer cell lines and provide rationale for whole genome doubling as a viable enrichment biomarker of ATX-295 sensitivity in ovarian cancer models....Accent's potentially best-in-class KIF18A inhibitor, ATX-295, is anticipated to enter the clinic in the first half of 2025."

New trial • Preclinical • Colorectal Cancer • Microsatellite Instability • Ovarian Cancer • Triple Negative Breast Cancer

Accent Therapeutics Announces First Patient Dosed in Phase 1/2 Trial of ATX-559... (PRNewswire) - "In addition to ATX-559, Accent anticipates initiating a Phase 1 trial in 1H 2025 for its second program targeting KIF18A in chromosomally instable tumors."

New P1 trial • Trial status • Breast Cancer • Colon Cancer • Colorectal Cancer • Endometrial Cancer • Rectal Adenocarcinoma

Accent Therapeutics Presents Data Supporting Two Lead Programs at AACR 2024 Annual Meeting (PRNewswire) - "Accent Therapeutics...presents advances in cancer targeting, including data on...KIF18A inhibitor activity in multiple tumor types, at the 2024 American Association for Cancer Research (AACR) Annual Meeting....In a poster...they show data that Accent's novel, potent and selective small molecule inhibitors of KIF18A: (i) Exhibit robust anti-proliferative activity, and result in fragmented nuclei and malformed mitotic spindles in chromosomally instable ovarian cancer cell lines;...(ii) Lead to dose-dependent tumor growth inhibition in an OVCAR-3 cancer cell line-derived xenograft model, while sparing tumors that are insensitive to KIF18A loss."

Preclinical • Ovarian Cancer