Last reviewed 2026-05-28 · How we verify

YE-NEO-001

NantBioScience, Inc. · Phase 1 active Biologic ✓ Verified May 2026

YE-NEO-001 is a Biologic drug developed by NantBioScience, Inc.. It is currently in Phase 1 development. Also known as: YE-NEO-001 Injectable Suspension.

YE-NEO-001 is a personalized neoepitope yeast-based vaccine used in a clinical trial for adjuvant immunotherapy in subjects with previously treated cancers. The conditions studied in this trial include Colorectal Cancer, Breast Cancer, Head and Neck Squamous Cell Carcinoma, Melanoma, and Non Small Cell Lung Cancer.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	YE-NEO-001
Also known as	YE-NEO-001 Injectable Suspension
Sponsor	NantBioScience, Inc.
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

QUILT-2.025 NANT Neoepitope Yeast Vaccine (YE-NEO-001): Adjuvant Immunotherapy Using a Personalized Neoepitope Yeast-Based Vaccine To Induce T-Cell Responses In Subjects W/ Previously Treated Cancers. (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

YE-NEO-001 CI brief — competitive landscape report
YE-NEO-001 updates RSS · CI watch RSS
NantBioScience, Inc. portfolio CI

Frequently asked questions about YE-NEO-001

What is YE-NEO-001?

YE-NEO-001 is a Biologic drug developed by NantBioScience, Inc..

Who makes YE-NEO-001?

YE-NEO-001 is developed by NantBioScience, Inc. (see full NantBioScience, Inc. pipeline at /company/nantbioscience-inc).

Is YE-NEO-001 also known as anything else?

YE-NEO-001 is also known as YE-NEO-001 Injectable Suspension.

What development phase is YE-NEO-001 in?

YE-NEO-001 is in Phase 1.

Manufacturer: NantBioScience, Inc. — full pipeline
Also known as: YE-NEO-001 Injectable Suspension

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing