Western States Goes East to Advance Immune Modulators
By Jennifer Boggs
Assistant Managing Editor
Just as its name implies, Western States Biopharma-
ceuticals Inc. was formed in early 2009 with discovery and
development work centered in Colorado and Southern
California. But the firm recently turned its eyes east – Far
East, that is - as it sought funding to advance its compounds
aimed at modulating the adaptive immune system.
WSBI had managed to secure some seed capital
and grant money early on, said Michael J. Reilly, co-
founder, president and CEO. But, as a company “born
in the midst of a recession, with VCs focusing on their
own portfolios,” the Aurora, Colo.-based firm found
itself looking elsewhere for much-needed capital.
“People told us all the money was in China and
that we should look there,” Reilly told BioWorld Today.
“So we did, and that led us down an interesting path.”
The firm has been building a presence in China. Co-
founder and chief scientific officer Carl Edwards moved
to a Beijing lab, which is staffed with about 12 people,
and now WSBI is in further collaboration discussions
with institutions in and around Beijing, Reilly said.
WSBI went to China for the equity source –also
attracted to the country’s well-known reputation for
lower drug development costs –“but we’re finding
that the level of talent there is amazing,” he said.
“There’s a lot to be leveraged in China.”
Between six regular employees and a number of
contractors, WSBI has more than 20 people –spread
among its three facilities –all working on the T-cell
cytokine inducing surface molecule (TCISM) technolo-
gy licensed from the University of Colorado, where
co-founder Edwards has served as an associate pro-
fessor in the dermatology department.
Edwards and Reilly previously worked together
on Amgen Inc.’s anti-TNF-alpha franchise prior to the
2002 Immunex Corp. acquisition that brought block-
buster Enbrel (etanercept). After Amgen, Edwards
returned to academia at the university, where he dis-
covered a new way of treating autoimmune diseases
and, perhaps also, inflammatory diseases, Reilly said.
“One of the problems with a number of programs
is that they block individual cytokines, such as TNF-
alpha,” he said. While drugs such as Enbrel, Remicade
(infliximab, Centocor Inc.) and Humira (adalimumab,
Abbott) are efficacious, they also produce several
negative effects such as high infection risk due to
immune suppression. “It was thought a cocktail
approach might be better, blocking two cytokines at
once,” Reilly added, and in those cases, “the efficacy
creeped up, but so did the safety signals. And as long
as we keep using those downstream cytokines, we’re
going to see those safety signals.”
WSBI’s TCISM approach aims to mobilize the adap-
tive part of the immune system, specifically autoreac-
tive T cells, to attack the disease, while leaving the
innate immune system to continue fighting off
pathogens. Blocking those T cells upstream results in
the blocking of downstream cytokines, so com-
pounds can target all usual suspects –TNF-alpha, IL-1
and IFN-gamma –“but only those produced by the
autoreactive T cells,” Reilly said.
The company’s lead candidates currently consist
of murine antibodies, including WSBI-711 , which is
heading into midstage preclinical testing. Reilly esti-
mated the firm is 18 months to two years away from
the clinic. But WSBI’s relationship with the University
of Colorado gives it access to clinical tissues for dis-
eases such as psoriasis and rheumatoid arthritis,
which he said is important given the spotty history of
animal model data in autoimmune diseases.
It’s a tough space –also a crowded one, especially in
RA - “so you need very definitive early studies in order to
convince yourself you have something special,” Reilly
said. So far, early data have been promising. WSBI has
tested its compounds against other therapies, even
going so far as to dump in additional bacteria to make
sure the innate immune system wasn’t impaired by the
therapy. Its drug was able to allow the body to respond
to the bacteria while still addressing the disease, he said.
Testing to date has focused on psoriasis and RA in
predictive models, but Reilly said the company could
look at other diseases, as well. After all, he noted,
“there’s no lack of targets in autoimmune disease.”
