# Ensem Therapeutics

Source: https://onco.cc/companies/ensem-therapeutics/  
OnCo record `ensem-therapeutics` (Company). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Ensem Therapeutics designs small-molecule medicines with computer modelling. Its lead drug, ETX-636, blocks a faulty version of the PI3K-alpha protein and is in an early trial in advanced breast cancer and other solid tumours.

## Summary

Ensem Therapeutics, headquartered in Waltham, Massachusetts, with a site in Shanghai, uses its Kinetic Ensemble platform, which applies AI and machine learning to structural ensemble-based drug design, to develop small-molecule precision medicines. The company was incubated by CBC Group from 2021 and reported a Series A total of USD 67 million in April 2022, after a Series A2 led by GGV Capital. Its lead, ETX-636, is described as an allosteric, pan-mutant-selective PI3K-alpha inhibitor and degrader designed to spare glucose homeostasis; first patient dosing in the global phase 1/2 study (NCT06993844), alone and with fulvestrant, was announced in July 2025, it received FDA Fast Track designation for advanced breast cancer in October 2025, and a first patient was dosed in China in February 2026. Preclinical programmes include ETX-929 (pan-KRAS), ETX-880 (covalent WRN helicase inhibitor for MSI-high cancers) and ETX-197 (CDK2), and in November 2023 it partnered a CDK2 inhibitor with BeiGene. Its first registered cancer trial as sponsor, NCT06993844, was posted on ClinicalTrials.gov in May 2025.

## Fields

- Kind: Company
- Last checked: 2026-10-29
- HQ: Waltham, MA
- Type: biotech
- Website: https://ensemtx.com/

## Notes

- Founding year not stated; the company says it was incubated by CBC Group since 2021.
- A June 2024 release reports a milestone when a CDK2 inhibitor entered trials; that programme was partnered with BeiGene and is not an Ensem-sponsored registry study.
- Company pipeline, news page and Series A release read on 29 October 2026.

## Sources

- Official website: https://ensemtx.com/
- Pipeline: https://ensemtx.com/science/pipeline/
- Series A release, April 2022: https://ensemtx.com/ensem-therapeutics-a-cbc-group-incubated-biopharma-company-raises-67-million-in-series-a-financing-to-develop-small-molecule-medicines-for-difficult-to-drug-targets-2/

## Connected records

- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- fronts: [AI & Computation](https://onco.cc/fronts/ai-computation/), [Targeted Therapy](https://onco.cc/fronts/targeted-therapy/)
- technologies: [AI-driven drug & target discovery](https://onco.cc/technologies/ai-drug-design/), [PI3K, AKT and mTOR inhibitors](https://onco.cc/technologies/pi3k-akt-mtor-inhibitors/)
- targets: [CDK2](https://onco.cc/targets/cdk2/), [KRAS](https://onco.cc/targets/kras/), [PIK3CA / PI3K-alpha](https://onco.cc/targets/pik3ca/), [WRN helicase (MSI-high cancers)](https://onco.cc/targets/wrn/)
- trials: [Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors](https://onco.cc/trials/nct06993844/)

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