Presentation highlights first clinical study of ATX-295, a potentially best-in-class oral KIF18A inhibitor, in patients with advanced or metastatic solid tumors

LEXINGTON, Mass., May 21, 2026 /PRNewswire/ — Accent Therapeutics, a clinical-stage biopharmaceutical company pioneering novel small molecule precision cancer therapies, today announced it will present a Trial in Progress poster describing its ongoing Phase 1/2 first-in-human clinical study of ATX-295 at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 – June 2 in Chicago, Illinois.

“KIF18A inhibition offers a differentiated approach to exploiting a fundamental vulnerability in chromosomally instable tumors including high grade serous ovarian cancer (HGSOC) and squamous non-small cell lung cancer (sqNSCLC). ATX-295 is grounded in a strong body of preclinical evidence that continues to deepen our conviction in this program,” said Jason Sager, M.D., Chief Medical Officer of Accent Therapeutics. “We have built a rigorous clinical development plan focused on treating cancers with high unmet need, and we hope to ultimately deliver a meaningful new targeted oncology option for patients with limited therapeutic alternatives.”

ATX-295 is a potentially best-in-class inhibitor of KIF18A, a mitotic kinesin motor protein critical for cell division in select tumors with chromosomal instability.

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.

The study comprises an initial dose-escalation phase to determine the recommended Phase 2 dose (RP2D), followed by a dose-expansion phase to assess preliminary antitumor activity. Primary endpoints include evaluation of the safety and tolerability of ATX-295 and determination of the RP2D. Secondary endpoints include assessment of pharmacokinetics (PK), pharmacodynamic (PD) effects, and preliminary antitumor activity. The Phase 1/2 study is currently open and actively enrolling patients.

Details for the presentation are as follows:

• Poster Title: Trial in Progress: A Phase 1/2 First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients with Advanced or Metastatic Solid Tumors, Including Ovarian Cancer
• Abstract Number: TPS3167
• Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
• Session Date and Time: Saturday, May 30, 1:30 – 4:30 PM CDT
• Location: Hall A – Posters and Exhibits
• Presenter: Judy S. Wang, MD, Florida Cancer Specialists/Sarah Cannon Research Institute

The poster will be available on the Accent Therapeutics website following the meeting.

About ATX-295
Accent’s lead program, ATX-295, is a potential best-in-class inhibitor for KIF18A, a mitotic kinesin motor protein critical for cell division in select tumors with chromosomal instability. KIF18A inhibitor treatment results in rapid cell death for cancers with an abnormal number of chromosomes (aneuploid) in vitro and in vivo, while cells with normal numbers of chromosomes (euploid) are unaffected. ATX-295 may address a large patient population across several cancer indications, including ovarian and squamous non-small cell lung cancer. Accent retains full worldwide rights to the KIF18A program, currently being evaluated in an ongoing Phase 1/2 clinical study (NCT06799065) enrolling patients with locally advanced or metastatic solid tumors, including high-grade serous ovarian cancer and squamous non-small cell lung cancer.

About Accent Therapeutics
Accent Therapeutics is a clinical-stage biopharmaceutical company pioneering novel small molecule precision cancer therapies. Accent is leveraging its industry-leading expertise to prosecute novel tumor vulnerabilities in cancers with high genomic and chromosomal instability. Accent’s innovative therapies are designed for high-impact oncology targets with the potential to benefit large patient populations with significant unmet need. The company’s lead program — ATX-295, targeting KIF18A — is currently being evaluated in Phase 1/2 clinical studies. For more information on Accent’s mission to translate extraordinary science into life-changing therapeutics for patients living with cancer, visit www.accenttx.com  or follow us on LinkedIn.

Media Contact
Amanda Sellers, Deerfield Group
amanda.sellers@deerfieldgroup.com

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SOURCE Accent Therapeutics