Rapid Oral presentation will report initial Phase I data for ISM6331 in patients with advanced solid tumors
FDA Fast Track- and Orphan Drug-designated program reflects Insilico’s strategy to advance AI-designed medicines against difficult-to-treat, age-associated diseases
CAMBRIDGE, Mass. — September 22, 2026 — Insilico Medicine ("Insilico"; HKEX: 3696), a clinical-stage generative artificial intelligence (AI)-driven drug discovery company, today reminded the oncology community that initial Phase I data for ISM6331, its investigational pan-TEAD inhibitor, will be presented in a Rapid Oral session at the European Society for Medical Oncology (ESMO) Congress 2026, taking place October 23–27 in Madrid, Spain.
The presentation will provide the first reported clinical findings from the global, multicenter first-in-human study of ISM6331 in patients with advanced solid tumors. ISM6331 is designed to inhibit all four TEAD family transcription factors and disrupt tumor-promoting signals driven by dysregulation of the Hippo pathway, a central regulator of cell growth, survival, tissue homeostasis and regeneration.
Presentation details
Title: First-in-human Multicenter Phase 1 Study of ISM6331, an AI-Designed Pan-TEAD Inhibitor, in Patients with Mesothelioma or Other Advanced Solid Tumors
Abstract number: #997
Session: Rapid Oral Presentation: Developmental Therapeutic
Format: Rapid Oral presentation
Presenter: Melina E. Marmarelis, MD, Hematology and Oncology, Abramson Cancer Center, University of Pennsylvania
Date: Sunday, October 25, 2026
Time: 8:30–10:00 a.m. CEST
Location: Cordoba Auditorium – Hall 4
“The ESMO presentation is an important opportunity to share the first clinical findings from ISM6331 with the global oncology community,” said Halle Zhang, PhD, Vice President, Clinical Development – Oncology at Insilico Medicine. “Patients with advanced mesothelioma and other Hippo pathway-dysregulated tumors have a significant unmet medical need. We look forward to presenting the emerging safety, pharmacokinetic and antitumor findings from this first-in-human study and discussing the next stage of the program.”
From generative chemistry to clinical validation
Insilico nominated ISM6331 as a preclinical candidate in June 2023. Its novel, non-covalent scaffold was generated with support from Chemistry42, the company’s generative chemistry platform, using structure-based design and multiparameter scoring to optimize potency, selectivity, drug-like properties and developability.
Preclinical studies demonstrated broad antitumor activity across Hippo pathway-dysregulated tumor models, potent activity at low doses, combination potential and a favorable preclinical safety and ADMET profile. ISM6331 entered a global multicenter Phase I clinical trial in January 2025.
In June 2024, the U.S. Food and Drug Administration granted ISM6331 Orphan Drug Designation for mesothelioma. In July 2026, the program received Fast Track Designation for adults with unresectable malignant pleural mesothelioma whose disease has progressed on or after anti-PD-1 therapy, with or without anti-CTLA-4 therapy, and platinum-based chemotherapy. ISM6331 is the first program in Insilico’s AI-driven pipeline to receive Fast Track Designation.
“ISM6331 shows how our end-to-end platform can move from computational design to clinical testing against a biologically important and historically challenging pathway,” said Feng Ren, PhD, co-CEO and Chief Scientific Officer of Insilico Medicine. “The program combines a differentiated pan-TEAD design with biomarker-led development for tumors driven by Hippo pathway dysregulation. Its selection for oral presentation at ESMO represents a meaningful step in the clinical validation of our AI-enabled oncology strategy.”
Oncology, aging biology and healthy longevity
Cancer is one of the most consequential age-associated diseases, with incidence rising substantially as people grow older. The Hippo–YAP/TAZ–TEAD signaling network is also involved in processes that connect cancer and aging biology, including tissue maintenance, regeneration, cellular plasticity and the response to accumulated damage. When this tightly regulated system becomes dysregulated, persistent TEAD-mediated transcription can support tumor-cell proliferation, survival, treatment resistance and immune evasion.
Insilico’s longevity strategy begins with the biology of aging and uses AI to identify and develop medicines for diseases that limit healthy lifespan. Within oncology, that strategy does not mean treating aging itself; it means pursuing molecular mechanisms that drive serious age-associated cancers and translating those insights into precisely designed therapeutics. ISM6331 exemplifies this approach by targeting a pathway that is fundamental to tissue homeostasis but can be hijacked by cancer.
The program is part of a broader oncology portfolio built around biologically informed target selection, generative molecular design, iterative design-make-test-analyze cycles, biomarker strategy and translational development. Across its pipeline, Insilico is advancing programs directed at transcriptional regulation, synthetic lethality, tumor metabolism, immune suppression and other mechanisms underlying difficult-to-treat cancers.
About ISM6331
ISM6331 is an investigational, orally available, non-covalent small-molecule pan-TEAD inhibitor designed to block TEAD-dependent transcription downstream of the Hippo pathway. The candidate is being evaluated in a global, multicenter Phase I study in patients with advanced solid tumors, including tumors with NF2 alterations or other evidence of Hippo pathway dysregulation. ISM6331 has received U.S. FDA Orphan Drug Designation and Fast Track Designation for mesothelioma. It has not been approved for commercial use in any jurisdiction, and its safety and efficacy have not been established.
Clinical trial: NCT06566079
https://clinicaltrials.gov/study/NCT06566079
About Insilico Medicine
Insilico Medicine is a pioneering global biotechnology company dedicated to integrating artificial intelligence and automation technologies to accelerate drug discovery, drive innovation in the life sciences, and extend healthy longevity to people on the planet. The company was listed on the Main Board of the Hong Kong Stock Exchange on December 30, 2025, under the stock code 03696.HK.
By integrating AI and automation technologies and deep in-house drug discovery capabilities, Insilico is delivering innovative drug solutions for unmet needs including fibrosis, oncology, immunology, pain, and obesity and metabolic disorders. Additionally, Insilico extends the reach of Pharma. AI across diverse industries, such as advanced materials, agriculture, nutritional products and veterinary medicine.
For more information, please visit www.insilico.com