OnKure Therapeutics discovers and develops tumor‑agnostic small‑molecule therapies that target shared oncogenic driver mutations across cancer types. It leverages pan‑cancer genomic mining, structure‑based drug design, and preclinical models (PDX, organoids) to validate compounds and co‑develop companion diagnostics, enabling biomarker‑driven adaptive trials for oncology clinicians and pharmaceutical partners.
Funding
Funding not disclosed
Founders
Product
Problem
Patients with advanced cancers often receive therapies that are specific to the tissue of origin, leaving those with rare or shared molecular alterations without effective treatment options. This histology‑centric approach limits access to targeted interventions that could address the underlying driver mutations across multiple tumor types.
Solution
OnKure Therapeutics focuses on discovering and developing next‑generation precision medicines that are tumor‑agnostic, targeting molecular drivers irrespective of cancer lineage. The company integrates large‑scale pan‑cancer genomic analyses with structure‑based drug design to identify high‑value targets. Candidate compounds are advanced through a rigorous preclinical pipeline that includes patient‑derived xenograft (PDX) and organoid models to validate on‑target activity and predictive biomarkers. Clinical programs employ adaptive trial designs and companion diagnostic co‑development to accelerate regulatory pathways and deliver targeted therapies to patients who share the same oncogenic alteration, regardless of tumor site.
Target Audience
Primary customers are oncology clinicians, molecular tumor boards, and pharmaceutical partners seeking tumor‑agnostic agents that address shared oncogenic drivers across diverse cancer types.
Features
- Proprietary target discovery platform that mines pan‑cancer sequencing databases to prioritize actionable driver mutations across histologies.
- Structure‑guided small‑molecule design pipeline enabling rapid optimization of potency, selectivity, and pharmacokinetic properties.
- Preclinical validation suite featuring PDX, organoid, and CRISPR‑engineered models to assess efficacy and biomarker correlation.
- Integrated companion diagnostic development aligned with FDA tumor‑agnostic approval frameworks.
- Adaptive, biomarker‑driven clinical trial architecture that allows seamless expansion across cancer types sharing the target alteration.
- Scalable GMP manufacturing process designed for small‑molecule and biologic candidates to support multi‑indication launches.
- Comprehensive regulatory strategy leveraging accelerated pathways (e.g., Breakthrough Therapy, Tissue‑agnostic designations).