Argos Reports Immunogenicity Results of AGS-004 in HIV Program
July 26 2017 - 8:00AM
Argos Therapeutics Inc. (NASDAQ:ARGS), an immuno-oncology company
focused on the development and commercialization of individualized
immunotherapies based on the Arcelis® precision immunotherapy
technology platform, today announced immunogenicity data from a
study of AGS-004 dendritic cell therapy in patients treated during
acute HIV infection. These data were recently published in the
Journal of AIDS Research and Human Retroviruses.
The immunogenicity data was generated in a
single arm, open label study in six patients with acute HIV
infection conducted at the University of North Carolina and Duke
University. AGS-004, an autologous cell therapy manufactured using
the Arcelis® precision immunotherapy technology platform, was
produced on an individual basis for each patient. To manufacture
AGS-004, dendritic cells that were obtained through a leukapheresis
were co-electroporated with in vitro transcribed RNA encoding
autologous HIV antigens derived from viremic plasma of patients
taken before commencement of anti-retroviral therapy (ART) and
CD40L, which induces secretion of IL-12, a cytokine necessary to
generate a CD8+ memory T-cell response.
In this study, AGS-004 was administered monthly
to subjects with acute HIV infection suppressed by ART. AGS-004 was
added to ART, and ART treatment was suspended after the immune
response reached a predefined threshold. ART was then re-initiated
based upon an evaluation of certain indicators of viral
rebound. An assessment was made of HIV specific memory T-cell
responses by multi-color flow cytometry following 3 – 4 doses of
AGS-004.
The study achieved its primary endpoint, with
all six patients demonstrating a positive immune response, defined
as a greater than 2-fold increase from baseline in the number of
multi-functional HIV-1 specific effector / memory T-cells.
Because of this positive immune response, all six patients were
able to have ART interrupted, with rebound viremia occurring at a
median of 29 days, following which ART was resumed. Additionally,
the magnitude of the immune response was positively correlated with
longer time to viral rebound following interruption of ART. Viral
rebound after ART interruption is widely attributed to latently
infected cells known as the “viral reservoir” which is
ineffectively targeted by immunotherapy alone. Consistent with
prior clinical studies, AGS-004 was found to be well-tolerated,
with no serious adverse events reported.
The favorable results of this study provide
support for Argos’ ongoing HIV eradication study in which AGS-004
is being administered in combination with vorinostat, a
latency-reversing drug. This study is being conducted at the
University of North Carolina, with planned enrollment of up to 12
patients and with initial data expected in early 2018. Funding for
the development of AGS-004 for the treatment of HIV is being
provided by the National Institutes of Health and the Collaboratory
of Research for AIDS Eradication.
“We are encouraged by the results of this study,
in which AGS-004 generated a targeted immune response against the
HIV virus,” noted Charles Nicolette, PhD, Chief Scientific Officer
of Argos. “This is an important first step in our goal of not
only combating active HIV infection, but also of eliminating the
HIV viral reservoir, which has not yet been achieved with any
currently available agent or combination therapy. We are hopeful
that our strategy of stimulating cells that are latently infected
with the HIV virus with the latency-reversing agent vorinostat will
enable AGS-004-stimulated memory / effector T-cells to identify and
eliminate these latently infected cells, thus potentially
eliminating the HIV viral reservoir.”
About Argos Therapeutics
Argos Therapeutics is an immuno-oncology company
focused on the development and commercialization of individualized
immunotherapies for the treatment of cancer and infectious diseases
using its Arcelis® technology platform. Argos' most advanced
product candidate, Rocapuldencel-T, is being evaluated in the
pivotal ADAPT Phase 3 clinical trial for the treatment of
metastatic renal cell carcinoma (mRCC). In addition,
Rocapuldencel-T is being studied in a Phase 2
investigator-initiated clinical trial as neoadjuvant therapy for
renal cell carcinoma (RCC). Argos is also developing a separate
Arcelis®-based product candidate, AGS-004, for the treatment of
human immunodeficiency virus (HIV), which is currently being
evaluated in combination with vorinostat, a latency-reversing drug,
in an investigator-initiated Phase 2 clinical trial aimed at HIV
eradication in adult patients. Funding for the development of
AGS-004 has been provided by the National Institutes of Health, the
National Institute of Allergy and Infectious Diseases, and the
Collaboratory of Research for AIDS Eradication.
Forward-Looking Statements
Any statements in this press release about
Argos' future expectations, plans and prospects, including
statements about the AGS-004 trial in patients with acute HIV
infections, including the immunogenicity results, and the HIV
eradication study, clinical development of Argos' product
candidates and future expectations and plans and prospects for
Argos and other statements containing the words "believes,"
"anticipates," "estimates," "expects," "intends," "plans,"
"predicts," "projects," "targets," "may," "potential," "will,"
"would," "could," "should," "continue," and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual
results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including whether Argos' cash resources will be sufficient
to fund its continuing operations for the period anticipated;
whether preliminary or interim clinical data will be indicative of
the final data from a clinical trial; whether results obtained in
clinical trials will be indicative of results obtained in future
clinical trials; whether Argos' product candidates will advance
through the clinical trial process on a timely basis; whether the
results of such trials will warrant submission for approval from
the United States Food and Drug Administration or equivalent
foreign regulatory agencies; whether Argos' product candidates
will receive approval from regulatory agencies on a timely basis or
at all; whether, if product candidates obtain approval, they will
be successfully distributed and marketed; whether Argos can
successfully establish commercial manufacturing operations on a
timely basis or at all; and other factors discussed in the "Risk
Factors" section of Argos' Form 10-Q for the quarter ended March
31, 2017, which is on file with the SEC, and in other filings Argos
makes with the SEC from time to time. In addition, the
forward-looking statements included in this press release represent
Argos' views as of the date hereof. Argos anticipates that
subsequent events and developments will cause Argos' views to
change. However, while Argos may elect to update these
forward-looking statements at some point in the future, Argos
specifically disclaims any obligation to do so. These
forward-looking statements should not be relied upon as
representing Argos' views as of any date subsequent to the date
hereof.
Media and investor contact:
Richard Katz, MD, MBA
Chief Financial Officer
Argos Therapeutics, Inc.
919-287-6315
rkatz@argostherapeutics.com