Cellthera Presents Preclinical Data at SITC Using Argos’ Individualized Immunotherapy
November 18 2016 - 8:00AM
Argos Therapeutics Inc. (Nasdaq:ARGS) (“Argos”), an immuno-oncology
company focused on the development and commercialization of
individualized immunotherapies based on the
Arcelis® technology platform, and its partner
Cellthera Pharm (“Cellthera”), a subsidiary of Pharmstandard
focused on personalized therapeutics, today announced the
presentation of data on a murine (“mouse”) model developed by
Cellthera to determine functional activity of a therapy modeled
after Argos’ AGS-003 individualized immunotherapy. The data were
presented at the Society for Immunotherapy of Cancer (SITC) 31st
Annual Meeting, which was held November 11-13 in National Harbor,
Maryland.
The data presented demonstrated the favorable effects of the
AGS-003-like therapy as a single agent and in combination with
sunitinib and a PD-1 checkpoint inhibitor in a murine model of
renal cell carcinoma (RCC). “Our model provides some exciting
survival data using an AGS-003-like therapy in a murine kidney
cancer model that has proven useful in exploring combinations with
other agents in a relevant preclinical setting,” said Dr. Alexander
Shuster, chairman of Cellthera. In this experiment the agents
were administered alone or together 7 days prior to the inoculation
of tumor cells and then each group was followed for tumor reduction
and survival. Dr. Shuster continued, “The prophylactic mouse
data show the superiority of the AGS-003-like therapy as a single
agent versus control in both survival and enhanced control of tumor
growth. Furthermore, the AGS-003-like therapy when
combined with sunitinib or a PD-1 checkpoint inhibitor outperformed
each agent alone, and the combination of all three therapies
demonstrated the strongest survival advantage.”
Argos is currently evaluating AGS-003 in
combination with standard of care agents in the pivotal
ADAPT Phase 3 clinical trial for the treatment of
metastatic renal cell carcinoma (mRCC). Enrollment in this
462-patient study was initiated in February 2013 and completed in
July 2015. The Independent Data Monitoring Committee (IDMC) for
this study most recently recommended continuation of the study
following a meeting in June 2016, with the next IDMC meeting
planned for February 2017. In addition, AGS-003 is
being studied in Phase 2 investigator-initiated
clinical trials as neoadjuvant therapy for RCC and for the
treatment of non-small cell lung cancer (NSCLC).
“These mouse data support the expectation of enhanced clinical
benefit for the combination of AGS-003 with checkpoint inhibitors
and, importantly, also show that amplified total tumor RNA is
essential to the anti-tumor activity of Arcelis-derived dendritic
cells,” noted Dr. Charles Nicolette, chief scientific officer and
vice president of research and development at Argos. “Additionally,
the observation in mice that the AGS-003-like therapy and sunitinib
are each active separately and lead to improved control of tumor
growth when combined bodes well for our ongoing Phase 3 ADAPT trial
in advanced renal cell carcinoma where AGS-003 is initially being
combined with sunitinib.”
A copy of this and other Argos-related publications can be found
at: http://www.argostherapeutics.com/key-publications/
About the Arcelis® Technology
PlatformArcelis® is a precision
immunotherapy technology that captures both mutated and variant
antigens that are specific to each patient’s individual disease. It
is designed to overcome immunosuppression by producing a
specifically targeted, durable memory T-cell response without
adjuvants that may be associated with toxicity. The technology is
potentially applicable to the treatment of a wide range of
different cancers and infectious diseases and is designed to
overcome many of the manufacturing and commercialization challenges
that have impeded other personalized immunotherapies. The
Arcelis® process uses only a small disease sample
or biopsy as the source of disease-specific antigens and the
patient’s own dendritic cells, which are optimized from cells
collected by a leukapheresis procedure. The proprietary process
uses RNA isolated from the patient's disease sample to program
dendritic cells to target disease-specific antigens. These
activated, antigen-loaded dendritic cells are then formulated with
the patient’s plasma and administered via intradermal injection as
an individualized immunotherapy.
About Argos TherapeuticsArgos 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, AGS-003, is being evaluated in
the pivotal ADAPT Phase 3 clinical trial for the
treatment of mRCC. In addition, AGS-003 is being
studied in Phase 2 investigator-initiated clinical
trials as neoadjuvant therapy for RCC and for the treatment of
NSCLC. 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
an investigator-initiated clinical trial aimed at HIV eradication
in adult patients.
Forward Looking StatementsAny statements in
this press release about Argos’ future expectations, plans and
prospects, including statements about the expected and potential
future closings of the private placement, Argos’ financial
prospects, anticipated use of proceeds, future operations and
sufficiency of funds for future operations, clinical development of
Argos’ product candidates, expectations regarding future clinical
trials 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 periods anticipated;
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; and other factors discussed
in the "Risk Factors" section of Argos’ Form 10-Q for the quarter
ended June 30, 2016, 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 contact:
Adam Daley
Berry & Company Public Relations
212-253-8881
adaley@berrypr.com
Investor contact:
John Menditto
Argos Therapeutics, Inc.
919-908-0687
jmenditto@argostherapeutics.com