MedPath

Vironexis Biotherapeutics Launches with FDA Clearance of IND Application for First-Ever ...

Vironexis launches with $26M seed financing, focusing on AAV-delivered T-cell immunotherapy for safer, more effective cancer treatments. Their TransJoin™ platform supports over 10 product candidates, including VNX-101 for CD19+ acute lymphoblastic leukemia, set for Phase 1/2 trials in Q4 2024.


Highlighted Terms

FDAB-cell lymphomaFDAostersarcomaNationwide Children’s HospitalNationwide Children’s HospitalFDApancreatic cancerbreast cancerMoonshots Capitalpancreatic cancerDrive CapitalFuture VenturesDrive CapitalGP350+ nasopharyngeal cancerVNX-101Nationwide Children’s HospitalMoonshots Capitalmultiple myelomaCapital FactoryVNX-101osteosarcomagastric cancerVironexis BiotherapeuticsB-cell lymphomabreast cancermetastatic HER2+ cancerssystemic lupus erythematosusacute lymphoblastic leukemiaacute lymphoblastic leukemiaDrive Capitalcarcinoma in situHER2+ cancerNovartis Gene TherapiesCD19+ systemic lupus erythematosusneuroblastomaNationwide Children’s HospitalB7H3+ ostersarcomanasopharyngeal cancerVironexis Biotherapeuticsgastric cancerpancreatic canceracute lymphoblastic leukemiaostersarcomaVNX-202Vironexis Biotherapeuticsnon-muscle invasive bladder cancergastric cancerDrive CapitalVNX-101FDAMoonshots CapitalFuture Venturessystemic lupus erythematosusU.S. Food and Drug AdministrationFuture Venturesneuroblastomanasopharyngeal cancerNationwide Children’s HospitalCD19+ acute lymphoblastic leukemiaCD19/20+ B-cell lymphomaacute lymphoblastic leukemiaVNX-101Vironexis Biotherapeuticsbreast cancerVNX-202Ferring PharmaceuticalsBCMA/GPRC5D+ multiple myelomabreast cancernasopharyngeal cancernadofaragene firadenovecHER2+ gastric cancerNationwide Children’s HospitalCapital FactoryVironexis BiotherapeuticsCapital FactoryAveXisALLsystemic lupus erythematosusMoonshots Capitalmultiple myelomaFuture VenturesPSMA+ and MSLN+ pancreatic cancermultiple myelomaneuroblastomaacute lymphoblastic leukemiaGD2+ neuroblastomaNCT06533579Vironexis BiotherapeuticsB-cell lymphomaCapital Factory

Related News

Vironexis Biotherapeutics Launches with FDA Clearance of IND Application for First-Ever ...

Vironexis Biotherapeutics, leveraging its TransJoin™ AAV Gene Therapy Platform, aims to deliver safer, more effective, and long-lasting single-dose cancer treatments. The company has a pipeline of over 10 product candidates for blood-based cancers, solid tumor metastasis prevention, and a cancer vaccine. Vironexis raised $26 million in seed financing and plans to advance its first two oncology programs into clinical trials in Q4 2024 and 2025.

Vironexis Biotherapeutics Launches with FDA Clearance of IND Application for First-Ever ...

Vironexis launches with $26M seed financing, focusing on AAV-delivered T-cell immunotherapy for safer, more effective cancer treatments. Their TransJoin™ platform supports over 10 product candidates, including VNX-101 for CD19+ acute lymphoblastic leukemia, set for Phase 1/2 trials in Q4 2024.

Vironexis Biotherapeutics' AAV Vector-Based Immunotherapy VNX-101 Cleared for US Trial ...

Vironexis Biotherapeutics' VNX-101, an AAV vector-based gene therapy for CD19+ acute lymphoblastic leukemia, received FDA IND clearance for a phase 1/2 trial. VNX-101 aims to express a bispecific T-cell engager in liver cells, targeting cancer cells and T-cells for killing. This marks the first AAV vector-based immunotherapy for cancer in clinical trials, leveraging the TransJoin platform. The therapy aims to improve safety, efficacy, and durability over existing treatments like CAR-T therapy and bispecific antibodies.

Vironexis Exits Stealth with $26M, Approved IND - San Diego Business Journal

Vironexis Biotherapeutics, a biotech firm developing single-dose gene therapies for blood-based cancers, launched with $26 million in seed funding and 10+ candidate products. The company received FDA approval for its VNX-101 gene therapy candidate for CD19+ acute lymphoblastic leukemia and plans to start a Phase 1/2 trial in Q4 2024. Vironexis' gene therapies use proprietary TransJoin technology licensed from Nationwide Children's Hospital, aiming to turn the body into a 'drug manufacturing plant'.

FDA Clears IND of VNX-101 in CD19+ Acute Lymphoblastic Leukemia - Targeted Oncology

The FDA has cleared an IND application for VNX-101, a gene therapy for CD19-positive ALL, marking the first AAV-delivered cancer immunotherapy trial. The phase 1/2 study (NCT06533579) is set to begin in Q4 2024, with primary endpoints focusing on safety and secondary endpoints on efficacy.

Vironexis Biotherapeutics Launches with FDA Clearance of IND Application for First-Ever ...

Vironexis Biotherapeutics launched with $26M seed financing, unveiling its TransJoin™ AAV Gene Therapy Platform for safer, more effective, and long-lasting cancer treatments. The company plans to advance its first two oncology programs into clinical trials in Q4 2024 and 2025, respectively.

© Copyright 2025. All Rights Reserved by MedPath