Delving into the Latest Updates on INO-1400 with Synapse

Overview

Basic Info

Drug Type

DNA vaccine, Therapeutic vaccine

Synonyms

hTERT DNA cancer vaccine

Target

TERT

Action

modulators

Mechanism

TERT modulators(Telomerase reverse transcriptase modulators)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [3]

Active Indication-

Inactive Indication

Breast CancerColorectal CancerEsophageal Carcinoma+ [5]

Originator Organization

Inovio Pharmaceuticals, Inc.

Active Organization-

Inactive Organization

Inovio Pharmaceuticals, Inc.

License Organization-

Drug Highest PhasePendingPhase 1

First Approval Date-

Regulation-

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This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity of INO-1400 or INO-1401 alone or in combination with INO-9012, delivered by electroporation in subjects with high-risk solid tumor cancer with no evidence of disease after surgery and standard therapy. Subjects will be enrolled into one of ten treatment arms. Subjects will be assessed according to standard of care. Restaging and imaging studies will be performed to assess disease relapse per NCCN guidelines. RECIST will be used to validate the findings in cases of relapse.

Start Date01 Dec 2014

Sponsor / Collaborator

Inovio Pharmaceuticals, Inc.

[+6]

100 Clinical Results associated with INO-1400

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100 Translational Medicine associated with INO-1400

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100 Patents (Medical) associated with INO-1400

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3

Literatures (Medical) associated with INO-1400

01 Feb 2022·Endocrine, Metabolic & Immune Disorders - Drug TargetsQ4 · MEDICINE

Immunotherapy for Breast Cancer Treatment: Current Evidence and Therapeutic Options

Q4 · MEDICINE

Review

Author: Singh, Pramod Kumar ; Jain, Meenu ; Yadav, Dhananjay ; Singh, Kavita ; Jin, Jun-O

:Breast Cancer (BC) has the highest incidence among all forms of malignancies detected in women globally. The therapeutic approaches available for BC include chemotherapy, radiation therapy, hormonal therapy, and surgery. Recently, advanced immunology-based therapeutics with potential for BC treatment, including immune checkpoint blockades, vaccines, and combinations with other treatment strategies, have emerged. Although commonly used treatments such as trastuzumab/ pertuzumab for human epidermal growth factor receptor 2-positive BC and hormone therapy for estrogen receptor-positive and/or progesterone receptor-positive BC are specific, triple-negative BC cases remain a great challenge for treatment measures. Immune checkpoint inhibitors (anti- PD-1/anti-CTLA-4) and anti-cancer vaccines (NeuVax, MUC-1, AVX901, INO-1400, and CEA), either alone or in combination with other therapies, represent a new paradigm in cancer therapeutics. In this review, we highlight the current immunotherapeutic aspects and ongoing trials aimed at the development of better treatment regimens for BC.

01 Jul 2021·Journal for ImmunoTherapy of CancerQ2 · MEDICINE

Phase 1 study of safety, tolerability and immunogenicity of the human telomerase (hTERT)-encoded DNA plasmids INO-1400 and INO-1401 with or without IL-12 DNA plasmid INO-9012 in adult patients with solid tumors

Q2 · MEDICINE

ArticleOA

Author: Morrow, Matthew P ; McMullan, Trevor ; Kim, Joseph J ; Sun, Weijing ; Pawlicki, Jan ; Skolnik, Jeffrey M ; Kraynyak, Kimberly A ; McRee, Autumn J ; Humeau, Laurent ; Johnson, Jennifer M ; Boyer, Jean D ; Sylvester, Albert J ; Shields, Anthony F ; Vonderheide, Robert H ; Samuels, Robert ; Weiner, David ; Chintakuntlawar, Ashish V

BackgroundHuman telomerase reverse transcriptase (hTERT) is frequently classified as a ‘universal’ tumor associated antigen due to its expression in a vast number of cancers. We evaluated plasmid DNA-encoded hTERT as an immunotherapy across nine cancer types.MethodsA phase 1 clinical trial was conducted in adult patients with no evidence of disease following definitive surgery and standard therapy, who were at high risk of relapse. Plasmid DNA encoding one of two hTERT variants (INO-1400 or INO-1401) with or without plasmid DNA encoding interleukin 12 (IL-12) (INO-9012) was delivered intramuscularly concurrent with the application of the CELLECTRA constant-current electroporation device 4 times across 12 weeks. Safety assessments and immune monitoring against native (germline, non-mutated, non-plasmid matched) hTERT antigen were performed. The largest cohort of patients enrolled had pancreatic cancer, allowing for additional targeted assessments for this tumor type.ResultsOf the 93 enrolled patients who received at least one dose, 88 had at least one adverse event; the majority were grade 1 or 2, related to injection site. At 18 months, 54.8% (51/93) patients were disease-free, with median disease-free survival (DFS) not reached by end of study. For patients with pancreatic cancer, the median DFS was 9 months, with 41.4% of these patients remaining disease-free at 18 months. hTERT immunotherapy induced a de novo cellular immune response or enhanced pre-existing cellular responses to native hTERT in 96% (88/92) of patients with various cancer types. Treatment with INO-1400/INO-1401±INO-9012 drove hTERT-specific IFN-γ production, generated hTERT-specific CD4+ and CD8+ T cells expressing the activation marker CD38, and induced hTERT-specific activated CD8 +CTLs as defined by cells expressing perforin and granzymes. The addition of plasmid IL-12 adjuvant elicited higher magnitudes of cellular responses including IFN-γ production, activated CD4+ and CD8+ T cells, and activated CD8+CTLs. In a subset analysis of pancreatic cancer patients, the presence of immunotherapy-induced activated CD8+ T cells expressing PD-1, granzymes and perforin correlated with survival.ConclusionsPlasmid DNA-encoded hTERT/IL-12 DNA immunotherapy was well-tolerated, immune responses were noted across all tumor types, and a specific CD8+ phenotype increased by the immunotherapy was significantly correlated with survival in patients with pancreatic cancer.

Frontiers in Endocrinology

Breast Cancer Vaccines: New Insights

Review

Author: Altucci, Lucia ; Giorgio, Cristina ; Dell'Aversana, Carmela ; Benedetti, Rosaria ; Astorri, Roberta

Breast cancer (BC) is a persistent global challenge for its high frequency in women (although it seldom occurs in men), due to the large diffusion of risk factors and gene mutations, and for its peculiar biology and microenvironment. To date, BC can benefit from different therapeutic strategies involving surgery, ablation, chemotherapy, radiotherapy, and more specific approaches such as hormone therapy and the administration of various substances impairing cancer growth, aggressivity, and recurrence with different modalities. Despite these relatively wide chances, also used in combinatory protocols, relevant mortality and relapse rates, often associated with resistant phenotypes, stress the need for a personalized-medicine based on prompting the patient's immune system (IS) against cancer cells. BC immunogenicity was latterly proven, so the whole immunotherapy field for BC is still at a very early stage. This immunotherapeutic approach exploits both the high specificity of adaptive immune response and the immunological memory. This review is focused on some of the majorly relevant BC vaccines available (NeuVax, AVX901, and INO-1400), providing a description of the more promising clinical trials. The efficacy of cancer vaccines highly depends on the patient's IS, and a wide optimization is needed in terms of targets' selection, drug design and combinations, dose finding, protocol structuring, and patients' recruitment; moreover, new standards are being discussed for the outcome evaluation. However, early-phases excellent results suggest that the manipulation of the IS via specific vaccines is a highly attractive approach for BC.

100 Deals associated with INO-1400

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Breast Cancer	Phase 1	United States	Inovio Pharmaceuticals, Inc.	01 Dec 2014
Colorectal Cancer	Phase 1	United States	Inovio Pharmaceuticals, Inc.	01 Dec 2014
Esophageal Carcinoma	Phase 1	United States	Inovio Pharmaceuticals, Inc.	01 Dec 2014
Hepatocellular Carcinoma	Phase 1	United States	Inovio Pharmaceuticals, Inc.	01 Dec 2014
Lung Cancer	Phase 1	United States	Inovio Pharmaceuticals, Inc.	01 Dec 2014
Ovarian Cancer	Phase 1	United States	Inovio Pharmaceuticals, Inc.	01 Dec 2014
Pancreatic Cancer	Phase 1	United States	Inovio Pharmaceuticals, Inc.	01 Dec 2014
Stomach Cancer	Phase 1	United States	Inovio Pharmaceuticals, Inc.	01 Dec 2014