Argos Obtains Option to License PD1 Checkpoint Inhibitors
February 05 2018 - 4:47PM
- Data showing synergy between PD1
checkpoint inhibition and analogue of Rocapuldencel-T in a
preclinical model of renal carcinoma presented at ASCO-SITC
-
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 that it has entered into an
option agreement with Pharmstandard International, S.A. and Actigen
Limited under which the Company has an option to license a group of
fully human anti-PD1 monoclonal antibodies (PD1 checkpoint
inhibitors) and related technology.
Results of a preclinical study of a murine
analogue of Rocapuldencel-T (Roca-T), the Company’s investigational
dendritic cell therapy for the treatment of metastatic renal cell
carcinoma (mRCC), in various combinations with a murine PD1
monoclonal antibody (anti-mPD1) and sunitinib in a mouse model of
renal cell carcinoma were recently presented at the ASCO-SITC
Clinical Immuno-Oncology Symposium. In this model, murine dendritic
cell precursors were processed in a similar manner to that by which
human monocytes are processed to manufacture Roca-T. Multiple
combination dosing strategies were tested, all of which included
treatment with sunitinib. Anti-mPD1 was tested both with
administration two days following tumor inoculation (therapeutic
administration) and with administration six days prior to tumor
inoculation (prophylactic administration).
The dosing regimen consisting of dendritic cells
followed by anti-mPD1 (therapeutic administration) and sunitinib
showed a substantial synergistic effect, with median overall
survival (mOS) of 67 days. This compared favorably with the regimen
evaluating anti-mPD1 (therapeutic administration) and sunitinib
(mOS of 39 days) and with dendritic cells followed by sunitinib
(mOS of 46 days). Of note, the timing of anti-mPD1 administration
was found to be important, as the regimen consisting of dendritic
cells in combination with anti-mPD1 (prophylactic administration)
and sunitinib showed a mOS of 48 days. Control mice had a mOS of 29
days.
Of note, histologic evaluation in these studies revealed that
murine dendritic cells with similar properties to Roca-T resulted
in recruitment and migration of lymphocytes into the tumor
microenvironment and an increase in CD8+CD28+CD45RA- memory T
cells. An increase in this same type of memory T cell after seven
doses of Roca-T, as measured in blood samples, correlated with
longer survival in the Company’s phase 3 ADAPT clinical trial of
Roca-T in mRCC patients. These findings suggest that the mechanism
of action of the murine analogue of Roca-T in this model is similar
to that of Roca-T in man.
“Data from this study support the rationale for
combining dendritic cell therapy with a PD1 checkpoint inhibitor in
the treatment of renal cell carcinoma,” noted Charles Nicolette,
chief scientific officer, Argos Therapeutics. “These data also
demonstrate the importance of the administration sequence for
active immunotherapy with a murine analogue of Roca-T and a PD1
checkpoint inhibitor, along with sunitinib, and suggest that the
cellular immune response must be initiated and established prior to
administration of anti-mPD1 and sunitinib in order to achieve
synergy in this murine model of mRCC.”
Jeff Abbey, president and chief executive
officer, Argos Therapeutics, added “We are pleased to have secured
an option to license a group of fully human PD1 antibodies from
Pharmstandard and Actigen. Provided sufficient funding is
available, we expect to exercise this option and undertake the
necessary preclinical studies in order to initiate clinical
development of Roca-T in combination with a PD1 antibody.”
Conference Call Logistics
The Company will host a conference call
beginning at 8:30 a.m. Eastern Time on Tuesday, February 6,
2018. To participate by telephone, please dial (855) 433-0930
(Domestic) or (484) 756-4271 (International). The conference ID
number is 8327219. A live and archived audio webcast can be
accessed through the Investors section of the Company's website at
www.argostherapeutics.com. The archived webcast will remain
available on the Company's website for twelve (12) months following
the call.
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 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 will exercise its option under the
Option Agreement or, if it does, whether it will reach
agreement with Pharmstandard and Actigen upon the terms of a
license; 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