Argos Announces Issuance of Patent Covering the Foundation for Manufacturing its HIV Immunotherapy
February 15 2018 - 8:30AM
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 the issuance of U.S. patent
9,879,053, covering the strain-independent amplification of human
immunodeficiency virus, or HIV, nucleic acid sequences for use in
vaccinations.
The methods described in this patent form the
foundation for the manufacture of AGS-004, Argos’ novel, dendritic
cell-based immunotherapy for HIV. AGS-004 consists of autologous
dendritic cells electroporated with amplified virus RNA and CD40L
RNA that are designed to stimulate T cells to attack HIV-infected
cells. Because HIV has a high mutation rate, viral variants are
different in each patient. The methods described in this patent are
used to amplify RNA encoding the unique viral variants in an
individual from a small amount of blood or infectious plasma from
which the virus can be isolated. This allows the generation of
immunotherapies that are matched to the unique pathogen mutations
in a specific individual, thus facilitating the development of a
customized immunotherapy that may be more effective at controlling
or eliminating the pathogen. The claims in this patent are directed
to AGS-004, methods of manufacturing AGS-004 and methods of
treatment utilizing AGS-004.
AGS-004 is currently being evaluated in an
investigator sponsored Phase 2 clinical trial in combination with
the latency-reversing agent vorinostat under the direction of David
Margolis, M.D., Professor of Medicine, Division of Infectious
Diseases, and Director of the HIV Cure Center at the University of
North Carolina. 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.
The trial is designed to test the hypothesis that boosting
antiviral immunity with AGS-004 combined with a latency reversing
drug to expose the virus in latently infected cells to the immune
system may enable eradication of the virus.
“We believe that our ability to customize the
immune response to patients’ unique viral variants, particularly to
those variants persisting in the latent viral reservoir, offers a
scientifically compelling rationale for this study,” noted Irina
Tcherepanova, Ph.D., vice president of translational medicine,
Argos Therapeutics. Initial data from the ongoing clinical trial is
expected during the second half of 2018.
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). 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 clinical development of Argos' product
candidates, 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 the patents and patent applications
owned or licensed by the Company, such as the patent referred to in
this release, will protect the Company's technology and prevent
others from infringing it; 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 preclinical studies or early 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
September 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, MBAChief
Financial Officer Argos Therapeutics, Inc. 919-287-6315
rkatz@argostherapeutics.com
Media Contact:Adam DaleyBerry & Company
Public Relations212.253.8881adaley@berrypr.com