Hiltonol

Phase 1Small molecule

PPCI Biotech AS

Hiltonol is one of 78 small molecule programs targeting Ductal Carcinoma in Situ. It is currently in Phase 1.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Ductal Carcinoma in SituRecruiting

LenalidomideActive, not recruiting

VaccineActive, not recruiting

Breast CancerActive, not recruiting

Ductal Carcinoma in SituPhase 1

Recruiting

LenalidomidePhase 1

Active, not recruiting

VaccinePhase 1

Active, not recruiting

Breast CancerPhase 1

Active, not recruiting

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Adenocard

Astellas

Preclinical

2 2

Lexiscan

Astellas

Preclinical

1 3

Hiltonol

PPCI Biotech AS

Phase 1

1 4

Tianeptine

Pfizer

Preclinical

1 5

Ablavar

LLantheus Medical Imaging

Preclinical

2 6

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 7

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

1 8

Naltrexone/bupropion

Novo Nordisk

Preclinical

1 9

Sertraline ODT

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 10

4SCAR T Cells

SShenzhen Geno-Immune Medical Institute

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 1Active, not recruiting

Breast Cancer

NCT02826434

Q1 2028

Phase 1Active, not recruiting

Vaccine

NCT05283109

Q4 2029

Phase 1Recruiting

Ductal Carcinoma in Situ

NCT06218303

Clinical

Trials by Indication[1]

Breast Cancer1 trial

Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer

Active, not recruiting·MMassachusetts General Hospital·Phase 1·NCT02826434·22 enrolled

Squamous Cell Carcinoma1 trial

Safety and Efficacy Study of GL-0817 (With Cyclophosphamide) for the Prevention of Recurrence of Squamous Cell Carcinoma of the Oral Cavity

Completed·GGliknik Inc.·Phase 2·NCT02873819·80 enrolled

Lenalidomide1 trial

A Study of PVX-410, a Cancer Vaccine, and Citarinostat +/- Lenalidomide for Smoldering MM

Active, not recruiting·MMassachusetts General Hospital·Phase 1·NCT02886065·19 enrolled

Vaccine1 trial

ETAPA I: Peptide-based Tumor Associated Antigen Vaccine in GBM

Active, not recruiting·MMustafa Khasraw, MBChB, MD, FRCP, FRACP·Phase 1·NCT05283109·24 enrolled

Immune Response1 trial

Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation of Antigen/Adjuvant

Completed·PPCI Biotech AS·Phase 1·NCT02947854·96 enrolled

3 more indications

Immunogenicity1 trial

Study to Evaluate the Safety and Immunogenicity of Poly ICLC (Hiltonol) in Healthy Volunteers

Completed·RRockefeller University·Phase 1·NCT01012700·24 enrolled

Solid Cancers1 trial

In Situ, Autologous Therapeutic Vaccination Against Solid Cancers With Intratumoral Hiltonol®

Completed·OOncovir, Inc.·Phase 2·NCT02423863·26 enrolled

Ductal Carcinoma in Situ1 trial

A Clinical Study of a Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ

Recruiting·FFinn, Olivera, PhD·Phase 1·NCT06218303·50 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Hiltonol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Hiltonol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Hiltonol. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — PCI Biotech AS company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 1[1]
Company: PPCI Biotech AS

Hiltonol

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q1 2028

Q4 2029

Trials by Indication[1]

Breast Cancer1 trial

Squamous Cell Carcinoma1 trial

Lenalidomide1 trial

Vaccine1 trial

Immune Response1 trial

Immunogenicity1 trial

Solid Cancers1 trial

Ductal Carcinoma in Situ1 trial

References

Drug Info

Quick Facts

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