PRECISION ONCOLOGY.
MEASURED IN OUTCOMES.

OLVEX engineers targeted therapies against validated oncogenic drivers — with Phase II evidence to prove efficacy in patient populations where current standards fail.

ACCESS CLINICAL DATA View Pipeline →
Phase II data published in The Lancet Oncology. 3 IND approvals.
Primary Endpoint Reached

OLX-401 Cohort A

PHASE II
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Objective Response Rate (%)
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Median OS (Months)
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Patient Cohort (n)
FULL REPORT
0.0%
Objective response rate.
Phase II, n=84
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Median overall survival.
vs 8.1mo standard of care
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Active IND approvals.
FDA, EMA, PMDA
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Patients enrolled to date.
Across 6 clinical sites
[02] THE SCIENCE

ONE TARGET. VALIDATED ACROSS THREE TUMOR TYPES.

OLX-401 selectively inhibits the KRAS G12C oncogenic driver — the most prevalent undruggable mutation in solid tumors. Three independent clinical datasets confirm durable response.

OLX-401 MECHANISM TGT-K-01

Covalent irreversible inhibition of KRAS G12C in the inactive GDP-bound state. Selectivity ratio: >1000-fold versus wild-type KRAS in cellular assays.

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Combination approach with SHP2 inhibitor prevents the adaptive feedback activation that limits single-agent KRAS inhibitors. No acquired resistance observed at 12-month follow-up in Phase I cohort.

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RESISTANCE PATHWAY COVERAGE CMB-S-02
BIOMARKER STRATEGY BMRK-D-03

ctDNA monitoring as a pharmacodynamic biomarker enables early response assessment within 21 days of treatment initiation. Validated in 3 retrospective cohorts.

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[03]

PIPELINE.

OLX-401 Small molecule inhibitor
NSCLC (KRAS G12C)
Phase II PARTNER: Academic Medical Center
PRE PH I PH II PH III
OLX-402 Combination (OLX-401 + SHP2i)
Pancreatic adenocarcinoma
Phase I/II Status: Enrollment open
OLX-403 Small molecule inhibitor
Colorectal (KRAS G12C)
Phase I Status: Dose escalation
OLX-501 Next-generation inhibitor
NSCLC (KRAS G12D)
Preclinical IND targeted: Q3 2026
[04]

THE TEAM.

Dr. Sarah Okonkwo

DR. SARAH OKONKWO, MD PhD

Professor of Medical Oncology, Dana-Farber Cancer Institute. KRAS biology pioneer, 140+ peer-reviewed publications.

"We don't pursue targets because they're druggable. We pursue them because the biology demands it."

Dr. James Varga

DR. JAMES VARGA, PhD

Former Head of Oncology Chemistry, Genentech. 22 years IND-enabling research.

"Every structural decision in OLX-401 is documented, rationalized, and reproducible. That's how drugs get approved."

[05]

PRIMARY EVIDENCE.

The Lancet Oncology 2025

Durable response to OLX-401 in KRAS G12C-mutated NSCLC: Phase II results.

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NEJM Evidence 2023

Phase I dose-escalation study of OLX-401 in refractory solid tumors.

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Nature Medicine 2024

Combination KRAS/SHP2 inhibition prevents adaptive resistance in solid tumors.

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FEATURED PUBLICATION
Cancer Cell 2024

KRAS G12C inhibitor OLX-401: mechanism, selectivity, and clinical translation.

Abstract: We report the discovery and characterization of OLX-401, a highly selective covalent inhibitor locking KRAS G12C in the inactive state. Preclinical models demonstrate profound and durable tumor regression without wild-type KRAS toxicity...

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[06]

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WITH OLVEX.

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