Full Press Release Details
Enochian BioSciences: At the Cutting Edge
"The future of Biotech
is disruptive science from unconventional sources"
To: Shareholders of Enochian BioSciences
From: The Hon. Dr. Mark Dybul
Date: January 24, 2022
The past decades in technology, currencies (e.g., Blockchain
and Cryptocurrency) and other rapidly advancing fields have been driven by disruptive, brilliant creativity combined with exacting
execution regardless of educational pedigree, country of origin or rigid disciplinary boundaries and rules. Biotech lags behind. It
is too often constrained by traditional diplomas, methodologies, and dogmas. Academic scientific inquiry is essential and lays
the foundation for long-term advancement. Biotech is rooted in science but can - and must - focus on disruptive ideas from
any source that can more rapidly help solve major global diseases and save and lift up as many lives as possible. We must loosen the ties
that bind, while preserving the fundamentals of basic scientific progress.
Enochian BioSciences" underlying scientific
ideas are innovative with an elegant simplicity that is often the hallmark of groundbreaking advances. And we are working to push through
systems and barriers to translate those disruptive ideas into potential products that could save many lives.
Enochian BioSciences was founded
on a single idea to potentially cure HIV. In a little more than three years, Enochian has initiated development of two platforms
with potential products from several infectious diseases and cancers that kill millions of people worldwide every year.
In summary, there is the potential for up to four human trials
to begin enrollment in 2022.
The innovative approach tricks viruses to use proteins
need to reproduce to trigger cells to commit suicide - taking the virus down with them. Already, we have demonstrated effectiveness
and reached some key benchmarks:
-A potential cure for Hepatitis
B Virus with promising in vitro and in vivo results; FDA Pre-IND completed with clear path to IND and potential
for human studies to begin enrollment by the end of the year;
-A potential inhaled treatment that
is designed to kill cells harboring virus in nose, mouth and lungs that could both limit illness in the infected person and spread
to others for all variants of SARS-Coronaviruses, including those that cause COVID-19. It could also potentially be
used to prevent infection for 6 months or longer, with promising in vitro and in vivo results; potential for IND and
for human studies to begin enrollment during the Summer of 2022;
-A potential inhaled treatment that is designed
to kill cells harboring virus in the nose, mouth and lungs that could potentially both limit illness in the infected person and spread
to others. It could also potentially be used to prevent infection for 6 months or longer, with promising in vitro data and
potential to be active against any variant of Influenza; potential for IND and for human studies to begin in 2023;
-An inhaled product combining potential treatment and
prophylaxis for SARS-Coronaviruses and Influenza viruses; the vector has been designed;
-A vector for HIV has been developed and will enter testing
It is important to emphasize that this novel platform has shown
promising results across several very different viruses, suggesting the soundness of the underlying science.
Allogeneic Cell Therapy Platform
The human immune system is designed to recognize and
destroy "otherness", including something that does not belong in our healthy cells (e.g., viruses and cancer.) The most powerful
response of the immune system is to cells from another human being (allogeneic.) Several of our technologies take advantage of this otherness
to hyper stimulate a person"s immune response to better attack a chronic infection (e.g., HIV) or solid tumors. IN certain pipelines
(e.g., HIV and Cancer), cells taken from another person are sometimes genetically modified to further boost the immune system to seek
-Two HIV potential cures or therapies that could allow
persons living with HIV (PLWH) to control the virus after stopping costly, daily treatment by hyper stimulating an immune response. With
a one-time treatment with one of the approaches, a single person was able to control HIV for a year - levels lower than he was able
to reach with antiviral medication. He resumed treatment at that time, the final research endpoint of the study. An Investigator Initiated
Pre-IND has been completed. A potential IND and enrollment in human trials could begin this Summer.
-The second HIV approach is in trials in monkeys with preliminary
data potentially in 2022.
-A novel approach to genetically modify allogeneic Dendritic
Cells (DC), which orchestrate the immune system, to hyper-stimulate the immune system has shown promising results in vitro. A case
report has been published of a person with recurrent glioblastoma who is tumor-free two years after receiving a single dose of allogeneic
Natural Killer cells and non-genetically modified DC. Enochian BioSciences" approach could potentially be more potent. In vivo
studies of the approach in pancreatic cancer are beginning in near term. If those experiments are successful, there is the potential
for human trials to begin enrollment in 2022.
Enochian BioSciences" Deep Bench of Leading
Scientists and Collaborators and Advisors
While the ideas behind Enochian
BioSciences" pipeline come from the inventor, Dr. Serhat Gumruk u, the pivotal experiments, in particular the in vivo
studies, are conducted independently by some of the leading scientists and Clinical Research Organizations used by NIH and large pharmaceutical
companies including for FDA approvals.
In addition, Enochian BioSciences has assembled leading basic
science and clinical researchers as members of Scientific Advisory Boards (SAB) for HIV, Hepatitis B Virus and Respiratory Diseases (SARS-Coronavirus
and Influenza). The SAB review, interrogate and provide advice on scientific results, as well as experimental and regulatory plans.
The approach to have leading scientists
and clinical researchers to conduct key experiments and as SAB members is an intentional approach executed by Enochian BioSciences"
management to maximally ensure the integrity and validity of the science.
A full list of scientific collaborators and SAB members can be
Link to Collaborators
Link to HIV SAB Members
Link to HBV SAB Members
Link to Respiratory Diseases SAB Members
Commitment to Transparency
Scientific Presentations
In just more than three years, sufficient scientific
data have been collected to have 8 submissions accepted by review panels for presentation at prestigious conferences including
the Conference on Retroviruses and Opportunistic Infections (CROI), the World Congress of Vaccines, the American Society of Gene and Cell
Therapy (ASGCT) and HEP DART.
Every active pipeline has been presented including details on
the mechanism of action, i.e., the way the potential products work. The underlying science has also driven the interest among leading
scientists and clinical researchers to conduct pivotal studies and participate in SAB.
Link to World Vaccine & Immunotherapy Congress
Link to International Liver Conference 2021 Presentation
Link to CROI 2021 Conference Presentation
Link to ASGCT 2020 Conference-Influenza Presentation
Link to ASGCT 2020 Conference - Syngeneic Mouse Presentation
Link to ASGCT 2020 Conference - In Vitro Chemo Selection
Link to ASGCT 2020 Conference - HBV Presentation
Link to HEP DART 2019 Conference Presentation
Dr. Anahid Jewett, PhD, MPH, Professor and Director
of Tumor Immunology laboratory in the Division of Oral Biology and Medicine, and Wintraub Center for reconstructive biotechnology at UCLA
School of Medicine and Dentistry. She has membership in Johnsson Comprehensive Cancer Center (JCCC) and is a member of UCLA Tumor Immunology
"This exciting clinical finding, as well as many other
directions for therapy which Enochian BioSciences is currently undertaking to develop related approaches, gives hope for the possibility
of effective treatment for pancreatic cancer and other solid tumors in the future." Link to Press Release