# Incyclix Bio

> Incyclix Bio is a clinical-stage oncology company in Research Triangle Park developing INX-315, an oral, selective CDK2 inhibitor for advanced cancers that are driven by CCNE1 amplification or have progressed after CDK4/6 treatment. Founded in 2020 as ARC Therapeutics by veterans of G1 Therapeutics, the company licensed G1's preclinical CDK2 program, refined it into a biomarker-led drug candidate, and moved it into a recruiting Phase 1/2 trial. Its business is still the classic venture-backed biotech wager: spend private capital to turn one carefully chosen molecule into persuasive clinical evidence, then pursue approval and commercialization directly or with partners.

- **Founded:** 2020
- **Headquarters:** Research Triangle Park, North Carolina, United States
- **Founders:** Patrick Roberts (CEO and Co-Founder), Jay Strum (Chief Scientific Officer and Co-Founder), John Bisi (Senior Vice President of Research and Development and Co-Founder), Fred Eshelman (Chairman and Co-Founder)
- **Team size:** Approximately 13 employees based on supplied company intelligence; the company does not publish a current headcount.
- **Products:** INX-315
- **Notable:** Licensed G1 Therapeutics' preclinical CDK2 inhibitor program and launched as ARC Therapeutics in 2020., Advanced INX-315 from preclinical development to FDA-cleared first-in-human testing in 2023., Reported interim dose-escalation data in 2024: 31 patients treated, one dose-limiting toxicity, no treatment discontinuations due to adverse events, three partial responses among 30 evaluable patients and stable disease in 19.

## Products & services

- **INX-315** — An investigational oral, potent and selective small-molecule CDK2 inhibitor in a first-in-human Phase 1/2 trial as monotherapy and in combinations for advanced or metastatic breast cancer, CCNE1-amplified ovarian cancer and other CCNE1-amplified solid tumors.

## Achievements

- Licensed G1 Therapeutics' preclinical CDK2 inhibitor program and launched as ARC Therapeutics in 2020.
- Advanced INX-315 from preclinical development to FDA-cleared first-in-human testing in 2023.
- Reported interim dose-escalation data in 2024: 31 patients treated, one dose-limiting toxicity, no treatment discontinuations due to adverse events, three partial responses among 30 evaluable patients and stable disease in 19.
- Published peer-reviewed INX-315 research in Cancer Discovery in 2024 and Nature Communications in 2025.
- Received FDA Fast Track designation in April 2025 for CCNE1-amplified platinum-resistant or refractory ovarian cancer.
- Named a Fierce 15 biotechnology company in 2025.
- Raised at least $52.25 million in publicly announced financing from 2020 through April 2026.

## Latest updates

- **2026-04** — Raised an additional $5 million from Hatteras Venture Partners to support the ongoing Phase 1/2 INX-315 trial; the federal trial record remained recruiting and listed estimated primary completion in July 2027.
- **2025-12** — Appointed oncology drug-development veteran Kimberly Blackwell, MD, as an independent director.
- **2025-09** — Named to Fierce Biotech's 2025 Fierce 15 list.
- **2025-08** — Closed an $11.25 million Series B extension backed by Eshelman Ventures, Eli Lilly, Pharmacosmos and Cape Fear BioCapital.
- **2025-04** — Received FDA Fast Track designation for INX-315 in CCNE1-amplified platinum-resistant or refractory ovarian cancer.
- **2025-02** — Announced a Nature Communications paper identifying context-dependent biomarkers and combination opportunities for CDK2 inhibition.

## Links

- Website: https://incyclixbio.com
- LinkedIn: https://www.linkedin.com/company/incyclix-bio-llc
- Twitter/X: https://twitter.com/incyclixbio

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Profile page: https://yespress.io/incyclix-bio
Published by YesPress — https://yespress.io
Last updated: 2026-08-22