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therapeutic monoclonal antibodies. Antigens can act as biochemical signatures or
markers that distinguish a cancer cell from a normal cell, and one person’s cancer
from another’s. The selection of antibodies of interest at ARIUS Research Inc is
based on the ability of the antibody to activate an antigen to selectively produce
cancer cell death. ARIUS holds proprietary and patented technology that allows it
to generate large numbers of functional antibodies at low cost. The core of ARIUS’
technology platform is its high-throughput functional screens, which enable the
Company to rapidly identify and select MAbs that show superior cancer killing abil-
ity. These MAbs, earmarked as potential drug candidates, are reserved for ARIUS’
functional antibody library. The ARIUS approach to antibody development offers
the following advantages:
- The process can produce multiple antibody drug candidates for any solid tumor
cancer type - The antibodies are functional in and of themselves and are drug candidates at the
very outset - Development is more fl exible and less expensive because the antibodies are
derived from patient tumors and do not rely on isolated target antigens that may
have to be in-licensed - The antibodies can be used to discover novel cancer antigens, since they are not
produced against pre-defi ned targets
The developmental tasks remaining are similar to classic antibody development
pathways with the exception of fi nding the target for the newly formed functional
anticancer antibody. Generally, a number of biochemical and proteomic approaches
are taken for the identifi cation of the target antigen. In addition, a number of valida-
tion studies for the antibody are performed including testing for recognition of
human cancer, as well as specifi city studies. The antibodies are studied in animal
models of human cancer to determine its effectiveness in vivo. If the antibodies are
found to be safe and effective then they become candidate for clinical study. ARIUS
has built a library of over 100 functional antibodies, plus attendant protocols and a
database. Three of these are in animal testing phase:
- ARvitamab (ARH460-23) suppresses tumor growth with the following feature:
(a) prevents metastases in human lung cancer models; (b) is compatible with and
additive to cisplatin chemotherapy to improve disease free survival; (c) recog-
nizes a widely distributed tumor-associated antigen; and (d) is non-toxic in ani-
mal models. The putative target antigen for ARvitamab exhibits increased
expression in many cancers including those involving breast, pancreatic, colon
and prostate as well as nonepithelial cancers such as melanoma and lymphoma. - ARH460-16-2 displays cytotoxic activity in vitro against human breast cancer,
colon cancer and melanoma cell lines. More signifi cantly, it showed almost com-
plete suppression of tumor growth in a prophylactic breast cancer xenograft
model while the antibody was being administered. Ongoing research and devel-
opment is aimed at identifying and validating the ARH460-16-2 target, estab-
lishing the safety and specifi city of the antibody and producing a humanized
form of the antibody for human clinical trials.
10 Personalized Therapy of Cancer