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
"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
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
About Seraph Research Institute
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
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
SOURCE Seraph Research Institute