Recent Updates
Recently added Catalysts

INO-1400

Phase 1

Breast Cancer | Monoclonal antibody | Oncology |Inovio Pharmaceuticals, Inc.|Trials Updated: Nov 19, 2018

INO-1400 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2016

INO-1400 target and mechanism

Molecular targethTERT
Target classGene
ModalityMonoclonal antibody

Also known as hTERT

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment93

FDA Designations

No designations recorded

INO-1400 clinical trials

INO-1400 · 1 trial · 9 indications

Phase 1 1
NCT02960594hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of RelapseBreast Cancer
COMPLETED93 Analytics
PHASE1COMPLETED
hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse events graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03
Up to 2 years from first study treatment
Injection site reactions including, but not necessarily limited to, local skin erythema, induration, pain and tenderness at administration site
Up to 14 weeks
Changes in safety laboratory parameters
Up to 2 years from first study treatment
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL2 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 2EXPERIMENTAL8 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 3EXPERIMENTAL2 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 4EXPERIMENTAL2 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 5EXPERIMENTAL8 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 6EXPERIMENTAL8 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 7EXPERIMENTAL2 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 8EXPERIMENTAL8 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 9EXPERIMENTAL8 mg INO-1401 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Arm 10EXPERIMENTAL8 mg INO-1401 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Interventions

NameTypeDescription
INO-1400BIOLOGICAL -
INO-9012BIOLOGICAL -
INO-1401BIOLOGICAL -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * 1\. Signed and dated written IRB approved informed consent; * 2\. Males or females aged ≥18 years; * 3\. Subjects with breast, lung or pancreatic carcinoma who are at high risk of relapse post definitive therapy at least 4 and no more than 24 weeks from completion of definitiv...

Countries:United States
Unlock Eligibility Criteria

Competitive Landscape -Breast Cancer 609 trials

Frequently asked questions about INO-1400

What is INO-1400?

INO-1400 is an investigational monoclonal antibody developed by Inovio Pharmaceuticals, Inc. (ticker: INO). It is being studied in oncology, specifically in breast cancer, and targets the hTERT gene. INO-1400 has completed a Phase 1 clinical trial and is not approved for any indication.

What is INO-1400 used for in breast cancer?

INO-1400 is being developed for the treatment of breast cancer. It is an investigational therapy that has been studied in a Phase 1 clinical trial. It has not been approved by the FDA for breast cancer or any other indication, and further clinical development would be required before any potential use.

What does INO-1400 target?

INO-1400 targets hTERT, the gene encoding human telomerase reverse transcriptase. By directing an immune response against hTERT, the therapy is designed to target cells expressing this gene. hTERT is a gene target, and INO-1400 is a monoclonal antibody being studied in breast cancer.

Who is developing INO-1400?

INO-1400 is being developed by Inovio Pharmaceuticals, Inc., which trades under the ticker INO. The company is the sponsor of the clinical program evaluating INO-1400 in oncology, including breast cancer.

What phase is INO-1400 in?

INO-1400 is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently in an active trial. INO-1400 is investigational and has not received FDA approval for breast cancer or any other indication.

What clinical trials is INO-1400 in?

INO-1400 has been evaluated in one completed Phase 1 trial, NCT02960594, titled hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse. The trial enrolled 93 participants across multiple solid tumor types, including breast cancer, and was conducted in the United States.