Argos Announces First Dosing of HIV Patient with AGS-004 Derived from the Latent Viral Reservoir
September 06 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 reported that for the first time a
patient in the ongoing Phase 2 HIV eradication trial at the
University of North Carolina (UNC) has been dosed with AGS-004
dendritic cell therapy manufactured utilizing RNA antigens from the
patient’s latent viral reservoir. To the Company’s knowledge, this
is also the first time an HIV patient has received a therapy
utilizing RNA antigens from the patient’s latent viral reservoir in
a clinical trial conducted in the United States.
The latent viral reservoir consists of infected
immune cells in which the HIV virus is dormant and therefore hidden
from attack by the immune system. Largely because of the latent
viral reservoir, currently available agents for the treatment of
HIV, while able to limit the proliferation of the HIV virus, have
not been successful in eradicating the virus and thus curing HIV.
Argos is supporting an investigator-initiated clinical trial
combining AGS-004 with the latency-reversing agent, vorinostat,
under the direction of David Margolis, MD, Professor of Medicine,
Division of Infectious Diseases, and Director of the HIV Cure
Center at the University of North Carolina. The trial is designed
to test the hypothesis that boosting antiviral immunity with
AGS-004, an active immunotherapy that stimulates T cells to attack
HIV-infected cells, combined with a latency reversing drug to
expose the virus in latently infected cells to the immune system,
may enable eradication of the virus.
Four participants currently enrolled in the
trial have received AGS-004 manufactured using RNA antigens derived
from infectious plasma collected from the patient prior to the
initiation of antiretroviral therapy (ART). The most recently
enrolled patient is receiving, and all future patients will
receive, AGS-004 manufactured with RNA antigens amplified directly
from the patient’s own latent viral reservoir, which do not need to
be collected prior to the initiation of ART. Because of the
high rate of mutation of the HIV virus, the isolation of specific
viral antigens from each patient’s own viral reservoir may
facilitate a more focused immune system attack.
“We believe that the new manufacturing process
may allow AGS-004 to generate immune responses that are much better
matched to the viral variants that will emerge during latency
reversal with vorinostat treatment and, therefore, maximize the
opportunity for viral clearance,” noted Charles Nicolette, Chief
Scientific Officer of Argos. “In addition, this approach eliminates
the requirement for eligible patients to have archived infectious
plasma prior to the initiation of anti-retroviral therapy, greatly
expanding the eligible patient population.”
In the ongoing Phase 2 eradication trial,
AGS-004 has continued to be well tolerated to date, consistent with
prior experience, including the Phase 1/2 trial for which
immunogenicity data was recently reported.
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.
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 Phase 2 HIV eradication trial and the use of
RNA antigens from a patient’s latent viral reservoir, 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 June 30, 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.
Investor contact:
Richard Katz, MD, MBA
Chief Financial Officer
Argos Therapeutics, Inc.
919-908-0687
rkatz@argostherapeutics.com
Media Contact:
Adam Daley
Berry & Company Public Relations
212.253.8881
adaley@berrypr.com