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INO-1400

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment93

FDA Designations

No designations recorded

Clinical trial landscape

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
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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 -
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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
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Competitive Landscape -Breast Cancer 402 trials

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about INO-1400

What is INO-1400 used for?

INO-1400 is an investigational immunotherapy being studied for use in breast cancer and other solid tumors at high risk of relapse, including lung, pancreatic, head and neck, ovarian, colorectal, gastric, esophageal, and hepatocellular cancers. It is currently in Phase 1 clinical development.

What does INO-1400 target?

INO-1400 is a monoclonal antibody designed to target hTERT, the catalytic subunit of telomerase, which is commonly expressed in cancer cells. By targeting hTERT, the therapy aims to stimulate an immune response against tumors that express this antigen.

Who makes INO-1400?

INO-1400 is being developed by Inovio Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol INO. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy.

What phase is INO-1400 in?

INO-1400 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety and potential effectiveness in patients.

What clinical trials is INO-1400 in?

INO-1400 has been studied in one completed Phase 1 clinical trial, NCT02960594, which evaluated 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 in the United States.

Is INO-1400 the same as hTERT immunotherapy?

INO-1400 is an hTERT immunotherapy, and the clinical trial NCT02960594 refers to it as such. The drug targets hTERT, a protein involved in cancer cell immortality, and is being investigated for its potential to treat multiple solid tumor types.