Few could accuse XBiotech CEO John Simard of failing to think big.
The Austin, TX-based startup he founded in 2005 is testing a novel biological drug candidate that is aiming to treat the persistent inflammation that makes cancer patients feel so weak in their final months and years.
XBiotech also created a new method to develop its experimental drug, the monoclonal antibody MABp1 (Xilonex), with the aim of eliminating harmful immune system responses to such bioengineered therapies. And, as if that’s not bold enough, the company has plans to build its own manufacturing facility, rather than rely on contract firms, in hopes of dramatically reducing the cost of expensive biologics.
As any startup knows, big goals require substantial funding. XBiotech won’t say how much cash it has raised in its history, or who has invested in it other than wealthy individuals. But it clearly has pulled in more than a few million. The company has a staff of 40 employees, and a lead drug candidate that’s advanced into a 650-patient clinical trial that’s designed to answer whether its drug can help colorectal cancer patients live longer. The trial recently enrolled its first patient, and could yield an answer as soon as 2014.
Simard is a serial entrepreneur who previously founded two companies with venture firm backing—Los Angeles, CA-based vaccine developer CTL ImmunoTherapies and AlleCure of Valencia, CA, which later merged to form MannKind(NASDAQ: [[ticker:MNKD]]) in Valencia, CA. He says his motivation as a first-time entrepreneur was not wealth, but a fascination with “the fundamental biology of T-cells.”
Simard says he was so driven to understand basic biology that he suspended his own graduate school career at the University of Toronto when he was offered a job writing a comprehensive book about immune response genes.
“I read every paper in every subject,” Simard says. “I followed every interesting subject back to its roots, even if it was in the 1800s.”
Simard’s recent dives into the scientific literature led to XBiotech’s current big bet—that a fundamental bodily process forms the common backdrop of many different illnesses that might, therefore, all respond to the same drug. MABp1 targets a molecule that’s part of the inflammatory response, which is triggered either when the body is trying to cope with an acute injury, or when it is grappling with a chronic condition such as Alzheimer’s disease, cancer, or cardiovascular disease.
The inflammation process is useful when it helps heal injured or infected tissues, but the same response can aggravate an illness caused by an underlying, chronic disease, Simard says.
“That chronic inflammation is a cornerstone of tumor growth,” says Simard, who sees inflammation as an opportunity for cancer cells to breach tissue barriers and spread out through the body.
A root cause of these breaches, Simard postulates, is the ability of tumor cells to form complexes with blood platelets—the small, disc-like cells that float close to blood vessel walls and help form clots to prevent injured tissues from bleeding. Tumor cells, when aggregated with platelets, can break through the blood vessel wall to reach body tissues where they can form new metastatic growths, Simard says.
Research indicates that the platelets are coated with an inflammatory cytokine, interleukin-1 alpha or IL-1a. Simard says the inflammatory molecule is a common mediator that enables tumors to spread, and contributes to a cancer-related condition called cachexia, in which muscles throughout the body break down and patients decline into extreme weakness and fatigue.
MABp1, XBiotech’s first drug candidate, is designed to
