Immune Therapeutics, Inc. d/b/a Biostax Corp. (OTC Pink: IMUN)
(“Biostax”), a hub-and-spoke biotech development engine, announces
the signing of a research collaboration agreement with Immgenuity,
Inc. The joint research will focus on using Immgenuity’s IMTV014
and Biostax’s Lodonal™ and JKB-122 both independently and together
to determine if the immune modulatory effects of Biostax’s drug
therapies combined with Immgenuity’s IMTV014 can achieve remission
with HIV patients.
Under the terms of the agreement, Immgenuity and Biostax will
collaborate to advance the development of novel immunotherapies for
the treatment of HIV and other diseases. The collaboration will
leverage Immgenuity's expertise in developing cutting-edge
technologies for the identification and characterization of immune
cell populations, mechanisms of immune escape, and Biostax's deep
knowledge and experience in using naltrexone as an immune enhancing
and anti-inflammatory agent.
Immgenuity’s IMTVO14 vaccine platform is an immunotherapy,
comprising a genetically modified HIV virus which is unable to
block immune signaling like the natural HIV does. By restoring
immune signaling, IMTVOI4 is expected to restore a normal, viable,
and robust immune response to HIV and likely lead to clearing the
virus even from the sanctuary areas where the virus persists
despite aggressive anti-HIV drug treatment.
“While HIV treatment has advanced dramatically over the past
three decades, people living with HIV still face a lifetime of
therapy and chronic illness,” said Sateesh Apte, MD. “Remission in
HIV remains the ultimate aspiration for both Biostax’s and
Immgenuity’s research and development efforts.”
“Patients are required to be off all anti-viral medications
before Immgenuity’s vaccine platform can be administered and we
expect Biostax’s naltrexone-based drug candidates to work
synergistically during the period when patients stop taking their
anti-viral medications and before the vaccine’s immune response
takes effect, " said Dr. Apte. “This, along with Biostax’s
immune-modulating therapy and our other partnerships and internal
programs, reflects our commitment to finding a therapy that will
achieve remission for HIV and bring about an end to the HIV
epidemic.”
“Based upon existing HIV data surrounding both JKB-122 and
Lodonal™ we believe that by performing combined research we will
generate additional compelling data, that complements our existing
clinical data," said Noreen Griffin, Biostax’s CEO. "We are
delighted to enter into this partnership that will further develop
our product candidates for the treatment of patients with HIV.”
Clinical Program JKB-122 and Lodonal
Biostax will also look to fast track a Phase 2b trial with the
FDA: “Effects of JKB-122 and Lodonal™ on T-Cell Immune Activation
and Inflammation in Non-Responders or who are Failing their CAR-T
therapy with HIV.” The primary end point is to show a decrease in
comorbidities and opportunistic infection and clinical symptoms
such as diarrhea, fatigue, pain, upper respiratory infections, skin
disorders, and confirm changes of T-cell immune activation and
reduction inflammation biomarkers.
Prior clinical trials have shown Lodonal™ and JKB-122 can
modulate the immune system by increasing NK cells, CD4, improve the
CD4/CD8 and reduce opportunistic infection and pain in HIV patients
while reducing inflammation. The success in these trials will
provide evidence for the use of Lodonal™ and/or JKB-122 as part of
combined therapy for remission and immune restoration in HIV
patients.
About Lodonal and JKB-122
Biostax has developed a rapid release oral formulation of the
drug substance “low dose naltrexone”, known as Lodonal™, for use as
an active immunotherapy drug with anti-inflammatory properties.
Lodonal™ is one of the first drugs approved to be taken once-a-day
as an immune system regulator for the management of HIV/AIDS. The
approval by NAFDAC was based on the results of a bridging trial
that resulted in a 44% increase in CD4 Count versus an 11% increase
for standard of care patients.
Unlike “single target” immune suppressors, or drugs that require
a specific cell receptor to act, Lodonal™ and JKB-122’s molecular
structure allows it to be a promiscuous antagonist of various
classes of receptors/proteins (multiple targets), eliciting
multiple complimentary effects. Beyond modulation of the cell cycle
by way of growth factor-like activities downstream of opioid
receptors, clinical trials indicated that it reduces the overall
activation state (metabolic shift) of cells responsive to pathogen
signals, damage signals, or both (drivers of inflammation).
Our recent research shows that Lodonal™ and JKB-122’s molecular
shape allows it to bind to a variety of cellular receptors and
proteins beyond the surface and nuclear opioid receptors. Because
noroxymorphone at low dose can bind surface receptors as well as
diffuse rapidly into the cell and its nucleus, several parallel
mechanisms of action combine.
About Biostax
Biostax is an innovative biopharmaceutical company that acquires
and develops immune restoration pharmaceutical and medical
technology (MedTech) products with a well -defined path to market.
We use a hub-and-spoke business model, where the parent company
(hub) holds a centralized management and administrative team, and
each subsidiary (spoke) operates a specialized development team
focused on individual product pipelines.
Where Biostax has a diversity of product pipelines that will
provide revenue while reducing risk, our goal is to develop new
therapies that provide disease remission by restoring immune
balance for patients with autoimmune, inflammatory, and infectious
diseases without suppressing their immune system. Restoring
homeostasis or balance to the immune system is the first step to a
cure by improving patients' lives in chronic illness caused by
immune dysfunction and inflammation. www.biostaxcorp.com
About Immgenuity, Inc.
Immgenuity, Inc. is a biotechnology company dedicated to
developing innovative immunotherapy solutions to improve the lives
of patients suffering from HIV. The company’s lead product
candidate is IMTV014, a novel immunotherapy for HIV and NeuroAIDS,
which has shown to be safe in preclinical studies. Immgenuity, Inc.
is headquartered in Dover, Delaware and is led by a team of
experienced biotech professionals with deep expertise in infectious
diseases, immunology, virology, and drug development. For more
information, visit https://immgenuity.com
Forward Looking Statement
This press release may contain information about our views of
future expectations, plans and prospects that constitute
forward-looking statements. All forward-looking statements are
based on management’s beliefs, assumptions, and expectations of
Immune’s future economic performance, considering the information
currently available to it. These statements are not statements of
historical fact. Although Immune believes the expectations
reflected in such forward-looking statements are based on
reasonable assumptions, it can give no assurance that its
expectations will be attained. Immune does not undertake any duty
to update any statements contained herein (including any
forward-looking statements), except as required by law. No
assurances can be made that Immune will successfully acquire its
acquisition targets. Forward-looking statements are subject to a
number of factors, risks, and uncertainties, some of which are not
currently known to us, that may cause Immune’s actual results,
performance, or financial condition to be materially different from
the expectations of future results, performance, or financial
position. Actual results may differ materially from the
expectations discussed in forward-looking statements. Factors that
could cause actual results to differ materially from expectations
include general industry considerations, regulatory review and
approval of our prospective products, changes in local or national
economic conditions and other risks set forth in “Risk Factors”
included in our filings with the Securities and Exchange
Commission.
Disclaimer
The information provided in this press release is intended for
general knowledge only and is not a substitute for professional
medical advice or treatment for specific medical conditions. Always
seek the advice of your physician or other qualified health care
provider with any questions you may have regarding a medical
condition. This information is not intended to diagnose, treat,
cure, or prevent any disease.
Biostax Contact:
Noreen M. Griffin
Chief Executive Officer
ir@biostax.net
1-888-391-9355
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