FDA Gives Go-Ahead for XBiotech’s Candidate Therapy for Phase I/II Double-blind Placebo Controlled Study in Pancreatic Cancer
Pancreatic cancer is typically identified at an advanced stage and treatment often includes surgery and aggressive chemotherapy. A current approved treatment involves combination chemotherapy including ONIVYDE and 5-fluorouracil, drugs that have significant toxicities and provide only modest response rates. XBiotech’s new drug candidate (XB2001) specifically targets a process potentially involved in the growth and spread of malignant tumors; and the drug also blocks inflammation associated with tissue injury, which may reduce toxicity associated with the chemotherapy and allow these drugs to be better tolerated and more effective.
The Phase I/II clinical study will evaluate XBiotech’s new drug candidate when added to the ONIVYDE/5-FU combination therapy. The clinical study is chaired by Dr.
Several classes of therapeutics are undergoing development for pancreatic cancer, such as new cytotoxic chemotherapy, so called PKIs and immunotherapies. However, each of these treatments approaches are expected to provide, at best, modest improvements in survival and are not expected to replace existing current cytotoxic agents. Thus, significant opportunity exists for new drugs that could synergize with existing cytotoxic agents to reduce treatment and disease-related morbidity, and improve treatment outcomes.
Cytotoxic chemotherapy agents result in systemic toxicity—which is considered a trade-off for potential anti-tumor activity. Toxicity is of acute importance clinically, but consequences of inflammatory responses induced by cytotoxic agents may also have a more profound impact, promoting tumor growth and compromising the efficacy and durability of the therapy itself. Cytotoxic agents upregulate inflammatory pathways, including activation of leukocytes, vascular endothelium and stromal cells of the tumor microenvironment. IL-1a may be a key player in the tumor and treatment related inflammatory pathway.
XBiotech’s new drug XB2001 is a naturally occurring antibody that potently neutralizes IL-1⍺ and is thus a safe and promising approach to block inflammation that occurs with advanced malignancies and chemotherapy. Unchecked, IL-1⍺ can stimulate angiogenesis, enhancing blood and nutrient supply to the tumor; IL-1⍺ may also act to recruit unwanted leukocytes (such as myeloid suppressor cells) into the tumor, that can suppress the ability of the body’s immune system to fight off the tumor; and systemically, IL-1⍺ can mediate metabolic dysfunction, and cause fatigue, anorexia, and anxiety. IL-1⍺ is thus a central player in paraneoplastic inflammation and XBiotech’s new drug therapy holds promise for treating a wide array of cancers.
About True Human™ Therapeutic Antibodies
XBiotech’s True Human™ antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.
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Source: XBiotech Inc.