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interfere with IL-1a. In 2010, the company conducted a small study of MABp1 in trial participants who had various forms of cancer that no longer responded to other treatments, and who also suffered from muscle wasting. The resulting data on survival, fatigue, and body weight suggested that the antibody might act to reduce the wasting syndrome. The FDA allowed the company to go forward with a final-stage clinical trial of MABp1 in people with late stage colorectal cancer and cachexia. Investigators on the study recently enrolled the first patient.
The trial is an ambitious one, recruiting 650 patients with colorectal cancer that has spread. They will be randomly assigned to get the experimental XBiotech drug or the appetite stimulator megestrol acetate, and then followed to see how long they live. The study is also set up to measure cachexia, which has been linked to a higher risk of death among cancer patients. Xbiotech anticipates that the trial will be completed in late 2014. If the study shows the XBiotech drug offers a benefit to patients, the company could be in position to seek FDA clearance to start marketing the product in the U.S.
A number of anti-inflammatory agents have also been tested as a means to reduce cachexia in cancer patients, including infliximab (Remicade), marketed by Janssen Biotech, a division of Johnson & Johnson, and Pfizer’s celecoxib (Celebrex).
Drugmakers are recognizing cachexia treatment as a potentially big market, says Eric Roeland, an investigator on XBiotech’s big study and an assistant clinical professor of gastrointestinal oncology at UC San Diego’s Moores Cancer Center.
“There are not a lot of great tools for it,” he says. Roeland enrolled the first participant in the XBiotech trial and is also an investigator in two other trials. One is sponsored by Eli Lilly, and the other by the private Lugano, Switzerland-based company Helsinn, which has a focus on cancer supportive care.
Each of the three companies is seeking to treat the disease through a different biological mechanism. Helsinn’s trial, in non-small cell lung cancer, is testing anamorelin, a compound designed to maintain the appetite by mediating the effects of the hormone ghrelin. In a pancreatic cancer trial, Eli Lilly is evaluating LY2495655, a monoclonal antibody designed to neutralize the protein myostatin, which acts as a natural brake against the buildup of lean muscle mass.
Roeland says he suspects that a combination of treatments will be needed to control cachexia, and that the control of inflammation will play an important role.
But reimbursement may be the biggest challenge for biologic drugs such as XBiotech’s MABp1, Roeland says. Medicare restricts payments for expensive drugs such as those given by infusion when cancer patients are in hospice care during the later stages of their disease, he says.
XBiotech is trying to minimize its manufacturing costs and eventually build a wide franchise for MABp1.
Trials may follow in cancer types other than colorectal cancer, as well as in non-cancer conditions. XBiotech has announced encouraging results in a series of small proof of concept trials of MABp1 in acne and psoriasis—two skin diseases worsened by the inflammatory response. Early signs were also positive in small trials of the antibody in Type 2 diabetes and in a cardiovascular condition called restenosis, the company says.
In the diabetes trial, investigators tested the experimental drug’s ability to help improve blood sugar control by reducing inflammation in the pancreas. In the cardiovascular trial, MABp1 was used to try to block the inflammation that can come as a side effect of surgeries that open up constricted arteries in the leg through balloon angioplasty and insertion of a metal stent. Inflammation can cause a re-narrowing of the passage through the treated blood vessel—a condition called restenosis.
XBiotech is hoping for a clean safety profile for MABp1. The origin of the bioengineered drug was an antibody produced naturally by a human blood donor, rather than an antibody produced originally by a mouse and then modified, like most engineered antibody drugs. XBiotech maintains that what it calls “True Human” antibodies are less likely to trigger immune system reactions than drugs originating with mouse antibodies that are “humanized” by adding components common in human biomolecules.
XBiotech is thinking ahead about what success would look like. In April of 2012, the company announced plans for a 67,000 square-foot manufacturing complex of five buildings on a 48-acre wooded campus it owns in Austin. Construction will begin when XBiotech can raise the funds for it, Simard says. For now, XBiotech makes its bioengineered drugs in buildings it occupies in the southeast outskirts of Austin.
In the meantime, XBiotech is looking for a partner in a possible venture to use the company’s manufacturing units to make biosimilars—bioengineered drugs that are losing patent protection.
Simard says XBiotech has completed multiple funding rounds, but he declined to say how much money the company has raised to date. “So far it’s all private wealth.’’
The CEO says he has had talks with venture firms, and doesn’t rule out that route. So far, he hasn’t agreed on terms with a VC. “We’re looking to do another private round,” Simard says.
With a number of therapeutic avenues to pursue, XBiotech is also interested in working with other limited partners. “We’ll continue this development in a staged way in each of these indications,” Simard says.
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