LOS ANGELES

,

June 15, 2021

/PRNewswire/ — (NASDAQ: ENOB) – A promising cure for HIV is moving one step closer to FDA approval. The novel approach to treating HIV in humans using cell therapy, developed by Dr. Serhat Gumrukcu (Dr. Serhat), Director of the Seraph Research Institute (SRI), and his team, will move forward to the first stage of the approval process with the FDA – a Pre-Investigational New Drug (Pre-IND) meeting.

The Pre-IND meeting will grant SRI the opportunity to present an immune-based cell therapy for HIV, to the FDA. A pre-IND meeting is the first official binding interaction with the FDA towards the approval of a drug candidate. The proprietary technology is licensed to Enochian BioSciences. Enochian, co-founded by Dr. Gumrukcu, develops gene-modified cellular and immune therapies for infectious diseases and cancer.

SRI’s innovative cellular therapy could be an important approach to achieving a “functional cure” for HIV, potentially allowing persons with the virus to stop antiviral treatment for extended periods of time.

“We are very excited that the FDA has accepted our pre-IND meeting request,” says Dr. Serhat. “We are hopeful this is the first of many approvals in bringing those living with HIV an alternative treatment to daily antiviral medications.”

The immune-based cell therapy treatment has shown promising results on one patient – a 54-year-old man with human immunodeficiency virus (HIV) who was not able to control the virus under antiretroviral therapy (ART). Under the oversight of an independent Institutional Review Board (IRB), the patient was treated at SRI’s clinical site Seraph Medical using an adoptive cell therapy involving natural killer (NK) and gamma delta T-cells (gdT), collected from a healthy donor. At the 100-day mark, his viral load was below the level of detection (<20 copies/ml). The patient continues to go without antiretroviral medications to this day, and his HIV levels have still remained on or below the minimum detectable level.

“Dr. Gumrukcu has always understood the needs of some of the most marginalized and vulnerable members of our community,” says HIV activist Jack Lorenz who has long served as a senior executive at Equality California, The Los Angeles LGBTQ Center, and now Alliance for Housing and Healing. “We would not be able to provide the kind of care and service we provide without his knowledge, care and support. His promising research is giving our community long awaited hope for a better future.”

The research findings and developments were first presented at the prestigious Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) in May 2021.

About Serhat Gumrukcu, MD, PhD



Dr. Serhat Gumrukcu

is the Executive Director and Director of Translational Research at the Seraph Research Institute, based in

Los Angeles

. His current research on infectious diseases focuses on creating new approaches and mechanisms of actions in antiviral therapies through co-opting virus-specific components of viral replication machinery, on viruses including SARS-CoV-2, HIV, HBV, influenza and Ebola.

About Seraph Research Institute



Seraph Research Institute

is a non-profit research institution, founded by Dr. Gumrukcu, registered with the U.S. Department of Health and Human Services, that works to advance medical science in the areas of unmet need. The organization’s team of leading research scientists and medical experts work to answer the fundamental questions rooted in science – studying disease at every level from molecular to cellular – and physiology, from individual to population-based scales to create novel approaches to help patients with incurable diseases.

About Enochian BioSciences



Enochian BioSciences

, Inc. is a biopharmaceutical company dedicated to identifying, developing, manufacturing, and commercializing gene-modified cell therapy. The company’s gene-modified cell therapy platform can be applied to multiple indications, including HIV/AIDS and Oncology.

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SOURCE Seraph Research Institute