# Ensem Therapeutics

> Ensem Therapeutics is a Waltham, Massachusetts clinical-stage biotech using its Kinetic Ensemble platform - a blend of AI/ML, molecular simulation, and experimental biophysics - to find cryptic and allosteric pockets in proteins that are otherwise considered difficult to drug. The company designs small-molecule precision medicines for cancer, with two lead programs: ETX-636, an allosteric pan-mutant-selective PI3Kalpha inhibitor and degrader for breast cancer (FDA Fast Track), and ETX-197/BG-68501, a selective CDK2 inhibitor partnered with BeiGene.

- **Founded:** 2021
- **Headquarters:** Waltham, Massachusetts, United States
- **Founders:** Shengfang Jin (Co-founder, President & CEO)
- **Team size:** ~21 employees
- **Products:** Kinetic Ensemble platform, ETX-636, ETX-197 / BG-68501
- **Notable:** Raised $67M Series A led by GGV Capital, Advanced two distinct programs into human clinical trials, ETX-197/BG-68501 CDK2 inhibitor entered clinical trials with partner BeiGene (2024)

## Products & services

- **Kinetic Ensemble platform** — A suite of AI/ML, molecular-dynamics simulation, and experimental biophysics technologies that model proteins as dynamic ensembles to uncover cryptic, allosteric, and transient binding pockets for structure-based drug design.
- **ETX-636** — A clinical-stage allosteric pan-mutant-selective PI3Kalpha inhibitor and degrader for PIK3CA-mutant, HR+/HER2- advanced breast cancer; designed to spare wild-type PI3Kalpha. Granted FDA Fast Track designation.
- **ETX-197 / BG-68501** — A highly potent and selective (~100x over other CDK family members) CDK2 inhibitor for solid tumors, partnered with and advanced into the clinic by BeiGene.

## Achievements

- Raised $67M Series A led by GGV Capital
- Advanced two distinct programs into human clinical trials
- ETX-197/BG-68501 CDK2 inhibitor entered clinical trials with partner BeiGene (2024)
- ETX-636 granted FDA Fast Track designation for advanced breast cancer (2025)
- Dosed first patient in the US (June 2025) and first patient in China (February 2026) in ETX-636 global Phase 1/2 study
- Presented preclinical CDK2 data at the San Antonio Breast Cancer Symposium (2024)

## Latest updates

- **2026-02** — Dosed first patient in China at Fudan University Shanghai Cancer Center in the ETX-636 global Phase 1/2 study, aiming to accelerate enrollment; preliminary proof-of-concept data expected H2 2026.
- **2025-10** — FDA granted Fast Track designation to ETX-636 for PIK3CA-mutant, HR+/HER2- advanced breast cancer.
- **2025-06** — First patient dosed in the US in the Phase 1/2 trial of ETX-636.
- **2025-01** — Presented at the 43rd Annual J.P. Morgan Healthcare Conference.
- **2024-12** — Presented preclinical data for its oral CDK2 inhibitor at the San Antonio Breast Cancer Symposium.
- **2024-06** — Achieved milestone as CDK2 inhibitor ETX-197/BG-68501 entered clinical trials for solid tumors via partner BeiGene.

## Links

- Website: https://ensemtx.com
- LinkedIn: https://www.linkedin.com/company/ensemtx/

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Profile page: https://yespress.io/ensem-therapeutics
Published by YesPress — https://yespress.io
Last updated: 2026-07-21