Highlights:
- FDA has granted Enochian an INTERACT meeting for its innovative approach to autologous stem cell transplantation as a potential gene-modified therapy for HIV.
- INTERACT is the first available FDA interaction and is a key step in the process towards an Investigational New Drug (IND) to study first-in-human products leading to potential marketing approval.
LOS ANGELES, Feb. 24, 2020 — Enochian Biosciences, a company focused on genetically modified cellular and immune therapy for infectious diseases and cancer, announces that the FDA has scheduled an Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT) meeting for early June. The meeting is focused on Enochian’s ENOB-HV-01, a novel approach to autologous stem cell transplantation with the potential to increase engraftment of genetically modified cells that are resistant to HIV infection, as a potential cure for HIV.
The FDA’s Center for Biologics Evaluation and Research (CBER) has numerous INTERACT requests and only grants meetings that are deemed appropriate for this early FDA engagement. The INTERACT meetings are a new program at CBER, FDA, as part of their commitment to help accelerate the development and approval of innovative medical products.
About Enochian Biosciences
Enochian BioSciences (formerly DanDrit Biotech USA Inc.) a biopharmaceutical company, focuses on the development and commercialization of novel therapies aimed to change the course of immunotherapy treatments for HIV/AIDS and cancer. The company’s lead candidate ENO-1001 (pre-IND) is a potentially sterilizing cure for HIV/AIDS. ENO-2001 is an HIV vaccine in preclinical stage, and its additional compounds ENO-4001 (phase three asset), ENO-4002, ENO-5001, and ENO-3001 are in discovery stages for prevention relapse in colon cancer patients. Enochian BioSciences is headquartered in Los Angeles, California.
To learn more, visit: www.enochianbio.com