DeltaRex-G (DNG64) / GenVivo - 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

DeltaRex-G, tumor targeted retrovector encoding a CCNG1 inhibitor, for CAR-T cell therapy induced cytokine release syndrome. (PubMed, Front Mol Med) - "DeltaRex-G received United States Food and Drug Administration Emergency Use Authorization to treat Covid-19-induced acute respiratory distress syndrome, which is due to hyperactivated immune cells. A brief administration of DeltaRex-G would inhibit a certain proportion of hyperactive chimeric T cells, consequently reducing cytokine release while retaining chimeric T cell efficacy."

CAR T-Cell Therapy • Cytokine release syndrome • Journal • Acute Respiratory Distress Syndrome • Infectious Disease • Inflammation • Novel Coronavirus Disease • Oncology • Pulmonary Disease • Respiratory Diseases • CCNG1

Editorial: Celebrating the 200th mendel's anniversary: gene-targeted diagnostics and therapies for cancer. (PubMed, Front Mol Med) - No abstract available

Journal • Breast Cancer • Gastrointestinal Cancer • Gene Therapies • Hepatology • Oncology • Pancreatic Cancer • Sarcoma • Solid Tumor

Proceedings of the Think Tank for Osteosarcoma Medical Advisory Board. (PubMed, Anticancer Res) - "Osteosarcoma metabolism and the genomic instability of osteosarcoma, immunotherapy for osteosarcoma, CAR-T cell therapy, DeltaRex-G tumor-targeted gene therapy, repurposed drugs, alternative medicines, and personalized medicine were discussed...Moreover, unmodified IL-2 primed Gamma Delta (NK) cell therapy may be used to prevent recurrence. Lastly, rapid development of CAR-T cell therapy is recommended, and an institute dedicated to the study of osteosarcoma is needed."

Journal • Review • Gene Therapies • Oncology • Osteosarcoma • Sarcoma • Solid Tumor • IL2

BostonGene Announces Seven Abstract Acceptances at the 2024 American Society of Clinical Oncology Annual Meeting (Businesswire) - P=NA | N=NA | "This study investigated the use of DeltaRex-G, a CCNG1 inhibitor, administered either alone or in combination with an FDA-approved drug (DeltaRex-G Plus) in advanced cancers. RNA sequencing identified enhanced CCNG1 expression in all analyzed tumors and analysis showed that the five patients treated with DeltaRex-G Plus had a partial response or stable disease, supporting the use of DeltaRex-G Plus as a promising therapy."

Clinical data • Breast Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Sarcoma • Solid Tumor

Sarcoma Oncology Center Leverages BostonGene’s AI-Driven Molecular and Immune Profiling Platform to Identify Novel Treatment Options for Patients with Advanced Cancers (Businesswire) - "BostonGene...and the Sarcoma Oncology Center, announced a collaboration to expedite the availability of DeltaRex-G. This groundbreaking platform therapy, authorized by the FDA's Center for Biologics Evaluation and Research (CBER), holds immense promise for patients battling advanced pancreatic cancer, osteosarcoma, soft tissue sarcoma, and breast cancer. The designation of DeltaRex-G, a CCNG1 inhibitor, as a platform therapy with the potential to incorporate other FDA-approved drugs, was enabled by BostonGene's pivotal identification of elevated CCNG1 levels in these different cancer types."

Licensing / partnership • Breast Cancer • Gastrointestinal Cancer • Oncology • Osteosarcoma • Pancreatic Cancer • Sarcoma • Solid Tumor

From Mendel to Gene Therapy. (PubMed, Anticancer Res) - No abstract available

Gene therapy • Journal • Gene Therapies

CORONA: A Study Using DeltaRex-G Gene Therapy for Symptomatic COVID-19 (clinicaltrials.gov) - P1/2 | N=0 | Withdrawn | Sponsor: Aveni Foundation | N=18 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Gene therapy • Trial withdrawal • Acute Respiratory Distress Syndrome • Gene Therapies • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • ALK • IL6 • TNFA

"@Ayjchan @Daoyu15 @DavidLMayhew @Doctor_I_am_The @Kevin_McKernan @NestCommander @RWMaloneMD @tony_vandongen anybody? Also,maybe(@WashburneAlex you too)know about a strange named DeltaRex-G drug as termed"Not yet recruiting"? Or @observadora007 @CuecaLabs @mlperk1 we will find,ha? https://t.co/LCG9mtxHzI" (@DlakaDarko)

Early-stage CCNG1+ HR+ HER2+ Invasive Breast Carcinoma in Older Women: Current Treatment and Future Perspectives for DeltaRex-G, a CCNG1 Inhibitor. (PubMed, Anticancer Res) - "This article reviews the current treatment of early-stage triple receptor positive breast cancer, the risks of chemotherapy in older women, and CCNG1, a novel biomarker in development for the use of DeltaRex-G, a CCNG1 inhibitor. Further, future perspectives for DeltaRex-G in older women with early stage CCNG1+ HR+ HER2+ breast cancer are discussed."

Journal • Review • Breast Cancer • Gene Therapies • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

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

CORONA: A Study Using DeltaRex-G Gene Therapy for Symptomatic COVID-19 (clinicaltrials.gov) - P1/2 | N=18 | Not yet recruiting | Sponsor: Aveni Foundation | Trial completion date: Mar 2022 ➔ Jul 2024 | Trial primary completion date: Jan 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Gene Therapies • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • ALK • IL6 • TNFA

"Sharing/ amplifying new website from @HHSGov & @WhiteHouse Please do the same @christen_rexing @Millicent8 @dsc250 @moriah_roses @WolfAbigail @DJSci @vincenzoberghel @EHernzMD @_earth2brittany @katefoxdrph @ValArkooshPA @AlisterFMartin #KnowYourRights https://t.co/JYGez417Wu" (@PEMammen)

Tumor protein p53 mutation in archived tumor samples from a 12-year survivor of stage 4 pancreatic ductal adenocarcinoma may predict long-term survival with DeltaRex-G: A case report and literature review. (PubMed, Mol Clin Oncol) - "TP53 is a well-characterized tumor suppressor gene, and a critical regulatory component of the executive CCNG1/CDK/Myc/Mdm2/p53 axis, which regulates proliferative cell competence, DNA fidelity and survival. Studies are underway to determine whether TP53 mutations in pancreatic cancer can help identify a subset of patients with advanced metastatic cancer with an otherwise poor prognosis who would respond favorably to DeltaRex-G, which would broaden the treatment options for patients with otherwise lethal PDAC."

Clinical • Journal • Review • Fatigue • Gastrointestinal Cancer • Gene Therapies • Hematological Malignancies • Hepatology • Leukemia • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • MDM2 • TP53

".@christen_rexing @frasso_rosemary @rx_prof @PhillyLeader @McIntireRuss @katefoxdrph @Millicent8 @PHLPublicHealth @DBHIDS @CollegeofPhys @teddycorbin @DrexelCNVSJ @LindyInstitute @MisticQuest @cspahr01 @EdithMitchellMD @JuliaHallerMD @Eugenia_South @ShMrnRhds @Rue_Landau" (@PEMammen)

Deltarex-G Gains Emergency Use Authorization For Severe Covid-19 (EIN News) - "The Aveni Foundation...in collaboration with Larkin Community Hospital...is proud to announce that the USFDA has granted Emergency Use Authorization (EUA) for DeltaRex-G, a disease-targeted gene therapy, for the treatment of a patient with severe COVID-19 infection....The Emergency Use Authorization of DeltaRex-G establishes a precedent for many patients with severe COVID-19 who have run out of therapeutic options..."

Cytokine release syndrome • Cytokine storm • FDA event • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease

".@christen_rexing @frasso_rosemary @teddycorbin @JArmandRich @sonalirajan @JeffKHom @DrTomFarley @DavidTJones5 @JohnFetterman @GovernorTomWolf @SecretaryLevine @VAArk @LindyInstitute @CollegeofPhys @JuliaHallerMD @knightfdn @WilliamPennFdn @ScattergoodFdn @pewhealth @PhillyMayor" (@PEMammen)

Corona Study Using Deltarex-G for Covid-19 (EIN News) - "'DeltaRex-G is the first, and so far, only, disease-targeted gene therapy that has the potential of effectively treating COVID-19 induced Cytokine Storm and Respiratory Distress Syndrome'....The CORONA STUDY is a Phase 1/2 study that will test whether DeltaRex-G is safe, will improve the symptoms of COVID-19, will hasten patient recovery from pneumonia/ARDS and will prevent chronic lung disease induced by COVID-19....However, available now is a limited supply of DeltaRex-G for 'Right to Try' EMERGENCY USE."

Cytokine storm • New P1/2 trial • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease

CORONA: A Study Using DeltaRex-G Gene Therapy for Symptomatic COVID-19 (clinicaltrials.gov) - P1/2; N=18; Not yet recruiting; Sponsor: Aveni Foundation; Trial completion date: Mar 2021 ➔ Mar 2022; Initiation date: Aug 2020 ➔ Nov 2020; Trial primary completion date: Jan 2021 ➔ Nov 2021

Trial completion date • Trial initiation date • Trial primary completion date • Acute Respiratory Distress Syndrome • Gene Therapies • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Reporting Long Term Survival Following Precision Tumor-Targeted Gene Delivery to Advanced Chemotherapy-Resistant Malignancies: An Academic Milestone (ASGCT 2019) - "... We reviewed long-term data of patients with advanced chemotherapy- resistant malignancies, previously-treated patients with two tumor-targeted retrovectors: (1) encoding cytotoxic dominant negative cyclin G1, DeltaRex-G (formerly Rexin-G), and (2) encoding cytokine GMCSF plus suicide gene HStk, DeltaVax (formerly Reximmune-C)...Cancer Type Targeted Gene Therapy, Route of Delivery Treatment Outcome Pancreatic Adenocarcinoma, metastatic to lymph node, liver and peritoneum, resistant to gemcitabine and 5FU DeltaRex-G, Intravenous Alive, >10 years, no evidence of disease, no further cancer therapy Osteosarcoma, metastatic to lung, chemotherapy-resistant DeltaRex-G, Intravenous Alive, >10 years, no evidence of disease, no further cancer therapy Malignant peripheral nerve sheath tumor, metastatic to lung, chemotherapy-resistant DeltaRex-G, Intravenous Alive, >10 years, no evidence of active disease, no further cancer therapy Osteosarcoma, metastatic to lung, lymph..."

Phase I-II Study Using Rexin-G, a Tumor-Targeted Retrovector Encoding a Cyclin G1 Inhibitor for Metastatic Carcinoma of Breast: A Ten-Year Follow-Up (ASGCT 2019) - "(1) Rexin-G is uniquely safe, (2) exhibits antitumor activity particularly in patients with pure bone metastases, (3) PET-CT is a more sensitive indicator of early tumor responses to Rexin-G and will be used in planned Phase 2 studies, and (4) enhanced immune cell trafficking in the TME indicates that Rexin-G may be combined with other cancer therapy, including immunotherapy, and in theory, may prove to be a biochemical and/or antigen modulator."

P1/2 data

DeltaRex-G induces 10-year remission in a stage IV pancreatic cancer patient: A cure for pancreatic cancer in 2019? - "P=1/2, N=NA; At higher doses, the median duration of survival was 9.2 months and 33.3% one-year survival. To date, one patient is still alive with no evidence of cancer ten years after the start of DeltaRex-G treatment. Taken together, these data suggest that DeltaRex-G, the first and, so far only, targeted gene delivery system for cancer gene therapy/cancer therapy, is uniquely safe, and exhibits significant antitumor activity, for which the USFDA granted fast track designation."

P1/2 data

A Phase I-II Study Using Rexin-G Tumor-Targeted Retrovector Encoding a Dominant-Negative Cyclin G1 Inhibitor for Advanced Pancreatic Cancer. (PubMed, Mol Ther Oncolytics) - "Herein we report on the safety and antitumor activity of escalating doses of Rexin-G in gemcitabine-refractory pancreatic adenocarcinoma, with one 10-year survivor. To date, one patient is still alive with no evidence of cancer 10 years after the start of Rexin-G treatment. Taken together, these data suggest that Rexin-G, the first targeted gene delivery system, is uniquely safe and exhibits significant antitumor activity, for which the FDA granted fast-track designation."

Journal • P1/2 data