Gendicine (rAd-p53 Gene Therapy) / Benda Pharma - LARVOL DELTA

Gene and Cell Therapy for Sarcomas: A Review. (PubMed, Cancers (Basel)) - "Rexin-G: the first tumor-targeted gene therapy vector designed to target all advanced solid malignancies, including chemo-refractory osteosarcomas and soft tissue sarcomas, was approved by the Philippine FDA in 2007. Gendicine was the first oncolytic virus approved for intratumoral delivery in China in 2003... The future of gene and cell therapy for sarcomas holds great promise, as research moves to late-stage clinical development. The integration of gene and cell therapies into standard sarcoma treatment protocols has the potential to significantly improve the quality of life and outcomes for patients with this rare and challenging group of cancers."

Journal • Review • Gene Therapies • Oncology • Osteosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Synovial Sarcoma

Twenty years of Gendicine® rAd-p53 cancer gene therapy: The first-in-class human cancer gene therapy in the era of personalized oncology. (PubMed, Genes Dis) - "Notably, the clinical studies suggest that the combination of Gendicine with chemotherapy and/or radiotherapy may produce more pronounced efficacy in slowing tumor growth and progression than gene therapy/chemotherapy alone. Finally, we summarize the methods of administration of recombinant human p53 adenovirus for different cancer types to provide a reference for future clinical trials."

Gene therapy • Journal • Review • Gene Therapies • Oncology

The Role of p53 in Nanoparticle-Based Therapy for Cancer. (PubMed, Cells) - "In fact, one p53-based therapeutic (gendicine) is currently approved for commercial use in China. However, the broad use of p53-based therapy in p53-inactivated cancers is severely restricted by its inadequate efficacy. This review highlights the current state-of-the-art in this area of biomedical research and also discusses novel approaches that may help overcome the shortcomings of p53-targeting nanomedicine."

Journal • Review • Gene Therapies • Oncology

Emergence of Small Interfering RNA-Based Gene Drugs for Various Diseases. (PubMed, ACS Omega) - "The importance of gene therapy as an alternative to traditional drugs has increased after the discovery of gene-based drugs such as Gendicine for cancer and Neovasculgen for peripheral artery disease...siRNA-based treatment for hereditary transthyretin-mediated amyloidosis (hATTR) using Onpattro and acute hepatic porphyria (AHP) by Givlaari and three more FDA-approved siRNA drugs has set up a milestone and further improved the confidence for the development of gene therapeutics for a spectrum of diseases...They include chemical instability, nontargeted biodistribution, undesirable innate immune responses, and off-target effects. This review provides a comprehensive view of siRNA-based gene drugs: challenges associated with siRNA delivery, their potential, and future prospects."

Journal • Review • Amyloidosis • Cardiovascular • Gene Therapies • Genetic Disorders • Hematological Disorders • Hepatology • Infectious Disease • Metabolic Disorders • Oncology • Peripheral Arterial Disease

Viral Vectors in Gene Therapy: Where Do We Stand in 2023? (PubMed, Viruses) - "Especially in the case of COVID-19 vaccines, adenovirus-based vaccines such as ChAdOx1 nCoV-19 and Ad26.COV2.S have demonstrated excellent safety and vaccine efficacy in clinical trials, leading to Emergency Use Authorization in many countries. Viral-based drugs have been approved for cancer, hematological, metabolic, neurological, and ophthalmological diseases as well as for vaccines. For example, the adenovirus-based drug Gendicine for non-small-cell lung cancer, the reovirus-based drug Reolysin for ovarian cancer, the oncolytic HSV T-VEC for melanoma, lentivirus-based treatment of ADA-SCID disease, and the rhabdovirus-based vaccine Ervebo against Ebola virus disease have been approved for human use."

Gene therapy • Journal • Review • Viral vector • Beta-Thalassemia • Gene Therapies • Genetic Disorders • Hematological Disorders • Hematological Malignancies • Hemophilia • Immunology • Infectious Disease • Lung Cancer • Melanoma • Muscular Dystrophy • Non Small Cell Lung Cancer • Novel Coronavirus Disease • Oncology • Ophthalmology • Ovarian Cancer • Primary Immunodeficiency • Rare Diseases • Sickle Cell Disease • Solid Tumor

Oncolytic virus-based suicide gene therapy for cancer treatment: a perspective of the clinical trials conducted at Henry Ford Health. (PubMed, Transl Med Commun) - "Currently, there are 12 gene therapy products approved by US-FDA, EMA and CFDA for cancer management, these include Rexin-G, Gendicine, Oncorine, Provange among other. Two phase I clinical trials are currently following patients long term and a phase I trial for recurrent glioma was initiated in November 2022. This systematic review provides an overview of gene therapy approaches and products employed for treating cancer patients including the products developed at Henry Ford Health."

Gene therapy • IO biomarker • Journal • Oncolytic virus • Review • Brain Cancer • CNS Tumor • Gene Therapies • Glioma • Oncology • Solid Tumor

Gene Therapy Cargos Based on Viral Vector Delivery. (PubMed, Curr Gene Ther) - "Clinical evaluation of drugs and vaccines in humans has showed high safety levels, good tolerance, and therapeutic efficacy. Several gene therapy drugs such as the adenovirus-based drug Gendicine® for non-small-cell lung cancer, the reovirus-based drug Reolysin® for ovarian cancer, lentivirus-based treatment of SCID-X1 disease, and the rhabdovirus-based vaccine Ervebo against Ebola virus disease, and adenovirus-based vaccines against COVID-19 have been developed."

Journal • Gene Therapies • Genetic Disorders • Hematological Disorders • Hemophilia • Immunology • Infectious Disease • Lung Cancer • Muscular Dystrophy • Non Small Cell Lung Cancer • Novel Coronavirus Disease • Oncology • Ovarian Cancer • Primary Immunodeficiency • Rare Diseases • Solid Tumor

Role of Adenoviruses in Cancer Therapy. (PubMed, Front Oncol) - "Gendicine was approved for treatment of squamous cell carcinoma of the head and neck by the Chinese Food and Drug Administration (FDA) agency in 2003 as a first-ever gene therapy product. Oncorine and ONYX-015 are oncolytic adenoviral vectors that have been shown to be effective against some types of cancer...However, the use of adenoviral vectors in gene therapy is limited by several factors such as pre-existing immunity to adenoviral vectors and high immunogenicity of the viruses. Thus, innovative strategies must be continually developed so as to overcome the obstacles of using adenoviral vectors in gene therapy."

IO biomarker • Journal • Review • Cardiovascular • Gene Therapies • Head and Neck Cancer • Heart Failure • Immune Modulation • Inflammation • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD40LG • CSF2 • IL2 • TNFA • TP53

Recombinant Human Adenovirus-p53 Therapy for the Treatment of Oral Leukoplakia and Oral Squamous Cell Carcinoma: A Systematic Review. (PubMed, Medicina (Kaunas)) - "Furthermore, there were no serious adverse events and the only adverse events reported were fever, pain at the local injection site, flu-like symptoms and lowered WBC count. Thus, we can conclude that this therapy has a potential for beneficial therapeutic effects and further clinical trials with more patients need to be performed to get better understanding of the effect of rAD-p53 therapy, which probably will pave the way to its approval in other parts of the world."

Clinical • Journal • Review • Gene Therapies • Head and Neck Cancer • Oncology • Oral Cancer • Pain • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Externally-Controlled Systems for Immunotherapy: From Bench to Bedside. (PubMed, Front Immunol) - "Immuno-gene therapy approaches have led to the approval of four advanced therapy medicinal products (ATMPs) for the treatment of p53-deficient tumors (Gendicine and Imlygic), refractory acute lymphoblastic leukemia (Kymriah) and large B-cell lymphomas (Yescarta). In the present manuscript, we will review the different inducible, versatile and externally controlled gene delivery systems that have been developed and their applications to the field of immunotherapy. We will highlight the advantages and disadvantages of each system and their potential applications in clinics."

IO Biomarker • Journal • Review • Acute Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Gene Therapies • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • CD19

Applications of Recombinant Adenovirus-p53 Gene Therapy for Cancers in the Clinic in China. (PubMed, Curr Gene Ther) - "To date, Gendicine has been clinically used in China for treatment of cancers other than HNSCC for more than ten years, mainly for patients with advanced or unresectable malignant tumors. However, the establishment of standard treatment regimens using TP53 gene therapy is still needed in order to advance its use in clinical practice."

Journal • Gastrointestinal Cancer • Gastrointestinal Disorder • Gene Therapies • Gynecologic Cancers • Head and Neck Cancer • Hepatology • Liver Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • TP53

Current Prospects of Molecular Therapeutics in Head and Neck Squamous Cell Carcinoma. (PubMed, Pharmaceut Med) - "Tumor protein 53 (TP53)-based gene therapeutics such as Gendicine and Advexin, and oncolytic viral therapeutics such as ONYX-015 and H101 have shown encouraging results and are gaining momentum. Cetuximab, the first US Food and Drug Administration-approved targeted therapeutic in HNSCC, although had a promising run initially, failed to garner enough attention subsequently due to its poor results in locally advanced HNSCC. Currently, its major utility is in palliation of recurrent and/or metastatic HNSCC as a part of the EXTREME regimen alongside cisplatin/carboplatin and fluorouracil...Recent accelerated approval of two immune checkpoint receptor blockers, pembrolizumab and nivolumab, has rejuvenated enthusiasm among clinicians and researchers by opening up a new domain for targeted and co-targeted therapeutics...Immunotherapeutic agents belonging to different classes, such as durvalumab, epacadostat, motolimod, and T4 immunotherapy, are all being..."

Journal • Head and Neck Cancer • Immune Modulation • Inflammation • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

An overview of development in gene therapeutics in China. (PubMed, Gene Ther) - "In history, China carried out the world's second gene therapy clinical trial in 1991 for hemophilia B and approved the world's first gene therapy product-Gendicine-in 2003...Here, we reviewed the past of gene therapy in China and highlighted recent advances. We also discussed the regulations and future perspectives of gene therapy in China."

Journal • Review • Gene Therapies • Hematological Disorders • Hemophilia • Oncology • Rare Diseases

Combination of p53-DC vaccine and rAd-p53 gene therapy induced CTLs cytotoxic against p53-deleted human prostate cancer cells in vitro. (PubMed, Cancer Gene Ther) - "Recently, the US FDA approved sipuleucel-T, which is composed of autologous DCs stimulated with a recombinant fusion protein of prostatic acid phosphatase (PAP) and granulocyte-macrophage colony-stimulating factor (GM-CSF), as the first immunotherapeutic agent for metastatic castration resistant prostate cancer (mCRPC)...In addition, rAd-p53 infection can induce overexpression of p53 and thus the cytotoxicity of CTLs differentiated by the p53-DC vaccine in p53 non-expressing prostate cancer cells. These findings suggest that this combination therapy using p53-DC vaccine and rAd-p53 gene therapy together may represent a new paradigm for the treatment of mCRPC.Cancer Gene Therapy advance online publication, 16 June 2017; doi:10.1038/cgt.2017.21."

Journal • Biosimilar • Genito-urinary Cancer • Immunology • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

In vitro and clinical studies of gene therapy with recombinant human adenovirus-p53 injection for malignant melanoma. (PubMed, Hum Gene Ther Clin Dev) - "In this study, high expression of the p53 gene could regulate the gene expression and reduce the invasive and metastatic abilities of the tumor cells. What's more, rAd-p53 effectively improved the survival of patients with malignant melanoma. Therefore, rAd-p53 may be a potential treatment method for human malignant melanoma."

Journal

Investigation on the genomic characterization of uterine sarcoma for rAd-p53 combined with chemotherapy treatment. (PubMed, Hum Gene Ther) - "Our results demonstrated that the TP53 signaling pathway plays an important rule in uterine sarcoma tumorigenesis.TP53 and the upstream gene such as CREBBP, LYN, CDKN2A, and JAK2 may be the genomic characterization for rAd-p53 （Gendicine®）combined with chemotherapy in uterine sarcoma. Besides, the average amount of mutated genes from every patient is large."

Journal • CDKN2A • CREBBP • JAK2 • TMB • TP53