Intismeran autogene

Phase 3Biologic

Intismeran autogene is one of 227 biologic programs targeting Cutaneous Squamous Cell Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

226

Competitors

Pipeline

Status by Indication[3][1]

Indication

Cutaneous Squamous Cell CarcinomaActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

MelanomaActive, not recruiting

Bladder CancerActive, not recruiting

Renal Cell CarcinomaActive, not recruiting

Malignant MelanomaRecruiting

Carcinoma, Non-Small-Cell LungRecruiting

Urinary Bladder NeoplasmsRecruiting

Non-Small Cell Lung CarcinomaRecruiting

Cutaneous Squamous Cell CarcinomaPhase 2/Phase 3

Active, not recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

MelanomaPhase 3

Active, not recruiting

Bladder CancerPhase 2

Active, not recruiting

Renal Cell CarcinomaPhase 2

Active, not recruiting

Malignant MelanomaPhase 2

Recruiting

Carcinoma, Non-Small-Cell LungPhase 3

Recruiting

Urinary Bladder NeoplasmsPhase 2

Recruiting

Non-Small Cell Lung CarcinomaPhase 2

Recruiting

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Intismeran autogene

Merck & Co.

Phase 3

1 2

Gemzar

GGynecologic Oncology Group

Preclinical

72 3

PORTRAZZA

Eli Lilly

Preclinical

8 4

Imjudo

AstraZeneca

Preclinical

5 5

Vizimpro

Pfizer

Preclinical

4 6

Gilotrif

Boehringer Ingelheim

Preclinical

12 7

Remeron

OOrganon and Co

Preclinical

1 8

PD-1 Inhibitor

Johnson & Johnson

Preclinical

2 9

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—10

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—

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

Timeline

Expected Milestones

Q3 2030

Phase 3Active, not recruiting

Melanoma

NCT05933577

Q2 2031

Phase 2Recruiting

Non-Small Cell Lung Carcinoma

NCT07221474

Q3 2031

Phase 2Recruiting

Urinary Bladder Neoplasms

NCT06833073

Phase 2Recruiting

Malignant Melanoma

NCT06961006

Q4 2031

Phase 1/2Active, not recruiting

Bladder Cancer

NCT06305767

Clinical

Trials by Indication[1]

Cutaneous Squamous Cell Carcinoma1 trial

A Study of (Neo)Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 2/3·NCT06295809·46 enrolled

Bladder Cancer1 trial

A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT06305767·230 enrolled

Melanoma1 trial

A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT05933577·1,089 enrolled

Renal Cell Carcinoma1 trial

A Phase 2, Randomized, Double-blind, Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Participants With Renal Cell Carcinoma (INTerpath-004).

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT06307431·272 enrolled

Non-Small Cell Lung Cancer1 trial

A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06077760·868 enrolled

4 more indications

Non-Small Cell Lung Carcinoma1 trial

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of V940 in Combination With Pembrolizumab and Chemotherapy as First-Line Treatment for Participants With Metastatic Squamous NSCLC (INTerpath-013)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT07221474·180 enrolled

Carcinoma, Non-Small-Cell Lung1 trial

A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06623422·680 enrolled

Urinary Bladder Neoplasms1 trial

A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT06833073·308 enrolled

Malignant Melanoma1 trial

A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab Versus Placebo Plus Pembrolizumab in Participants With First-Line Advanced Melanoma (INTerpath-012)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT06961006·160 enrolled

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for Intismeran autogene. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Intismeran autogene compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Intismeran autogene. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Merck & Co. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Phase 3[1]
Company: Merck & Co.

Intismeran autogene

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2030

Q2 2031

Q3 2031

Q4 2031

Trials by Indication[1]

Cutaneous Squamous Cell Carcinoma1 trial

Bladder Cancer1 trial

Melanoma1 trial

Renal Cell Carcinoma1 trial

Non-Small Cell Lung Cancer1 trial

Non-Small Cell Lung Carcinoma1 trial

Carcinoma, Non-Small-Cell Lung1 trial

Urinary Bladder Neoplasms1 trial

Malignant Melanoma1 trial

References

Drug Info

Quick Facts

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