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 provided an update on the ADAPT trial, a
randomized, active controlled, open-label, multi-center Phase 3
trial of Rocapuldencel-T in combination with
sunitinib/standard-of-care for the treatment of newly diagnosed
metastatic renal cell carcinoma (mRCC), following a meeting with
the FDA.
As previously reported, the Company has
continued to conduct the ADAPT trial notwithstanding the
recommendation by the Independent Data Monitoring Committee in
February 2017 to terminate the trial for futility. In making this
determination, Argos considered, among other factors, the degree of
maturity of the data set, the mechanism of action of
Rocapuldencel-T, which involves the induction of a long-term memory
immune response, and the IDMC's assessment of the safety profile of
Rocapuldencel-T. Of note, at the time of the IDMC's February
interim analysis, the median duration of follow-up was 20.0 months
and more than half the patients in both treatment groups were still
alive.
The Company submitted information related to its
analysis of the interim data to the FDA and met with the FDA to
discuss the future direction of the ADAPT trial and the
Rocapuldencel-T development program. Participating in the meeting
along with representatives from the Company were Robert Figlin, MD,
Chairman of Hematology Oncology and Professor of Medicine, Cedars
Sinai Medical Center; Nizar Tannir, MD, Professor and Deputy
Chairman, Department of Genitourinary Medical Oncology, MD Anderson
Cancer Center; and Gary Koch, PhD, Professor of Biostatistics,
University of North Carolina.
The FDA agreed with the Company’s plan to
continue the trial in accordance with the current protocol to 290
events, the pre-specified number of events at which the analysis of
overall survival, the primary endpoint, is to be conducted. The
Company believes that 290 events will have occurred by late 2017 or
early 2018. The Company also proposed to submit, and the FDA agreed
to review, a protocol amendment to increase the pre-specified
number of events for the primary analysis of overall survival
beyond 290 events, which the Company believes could enhance its
ability to detect whether Rocapuldencel-T has a delayed treatment
effect. The Company can extend the study past 290 events without
needing to enroll additional patients.
As previously reported, the Company has analyzed
interim data from a predefined subset of patients who demonstrated
an immune response to Rocapuldencel-T at 48 weeks, whose immune
response is consistent with the mechanism of action of the therapy
and correlates with survival, suggesting that the treatment is
biologically active. Analysis of the data from the ADAPT trial,
including immune response data, remains ongoing. The Company
expects to provide further updates on the future direction of the
ADAPT trial and the Rocapuldencel-T program following further
analysis of the data from the trial and further discussions with
the FDA.
“We are pleased to be able to continue the ADAPT
trial,” noted Robert Figlin, MD, principal investigator for the
trial. “We believe that Rocapuldencel-T may offer patients and
their physicians an important new option for the treatment of mRCC,
a disease that remains an area of high unmet medical need. By
amending the protocol to extend the ADAPT trial, we believe we can
potentially increase the likelihood of detecting a treatment
effect, if one exists, given that immunotherapy is expected to
result in a delayed treatment effect. We appreciate the
collaborative efforts of the FDA as we seek to determine the
potential utility of Rocapuldencel-T in the treatment of this
difficult disease.“
“We remain committed to the clinical development
of Rocapuldencel-T, and look forward to providing additional
updates on the ADAPT trial and the Rocapuldencel-T development
program moving forward,” noted Jeff Abbey, CEO of Argos. “We
appreciate the continued commitment of the investigators and
patients in the ADAPT trial as we continue to explore the potential
benefit of this unique therapy.”
About the Arcelis® Technology Platform
Arcelis® 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 single 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 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 an investigator-initiated Phase 2 clinical trial aimed
at HIV eradication in adult patients.
Forward Looking Statements
Any statements in this press release about
Argos' future expectations, plans and prospects, including
statements about the ADAPT trial and the interim data from the
trial, Argos' anticipated discussions with the FDA, 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 periods
anticipated and through completion of the trial; the impact
of the planned analysis of the data and discussions with the
FDA on the development of Rocapuldencel-T; the impact of the
recommendation of the IDMC on the continuation of the ADAPT trial;
whether preliminary or interim clinical data such as the interim
data referenced in this release 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-K for the year ended December
31, 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 and investor contact:
Richard Katz, MD, MBA
Chief Financial Officer
Argos Therapeutics, Inc.
919-908-0687
rkatz@argostherapeutics.com