XBiotech Inc., an Austin, Texas based biotechnology company and the lead developer of True Human™ therapeutic antibodies, announced this week that the positive results from their clinical study at MD Anderson Cancer Center in Houston were to be published in the latest on-line edition of Investigational New Drugs. The study entitled, “Xilonix, a novel true human antibody targeting the inflammatory cytokine interleukin-1 alpha, in non-small cell lung cancer,” was based on a subset of non-small cell lung cancer (NSCLC) patients treated with the XBiotech’s lead antibody, Xilonix and assessed for 24 months using radiographic evidence of tumor response, changes in lean body mass, and quality of life indicators.
- Human Monoclonal Antibody Therapy: uses antibodies that are made in the lab rather than by a person’s own immune system. Once the antibodies are given, they may recruit other parts of the immune system to destroy the targeted antigen, such as a cancer cell.
- Epidermal growth factor receptor (EGFR): exists on the cell surface and is activated by binding of its specific ligands (molecular targets), including epidermal growth factor and transforming growth factor α (TGFα).
The MD Anderson researchers enrolled 16 patients from March 15 2010 to July 30, 2012. The average age of the study population was 58.5 years and 62% were women (n=10/16). Before enrolling in the study the patients previously tried treatment protocols that had all failed. In an attempt at treatment success, these subjects received Xilonix via intravenous (IV) infusion every 3 weeks through four dose levels:
- 25 mg/kg
- 75 mg/kg
- 25 mg/kg
- 75 mg/kg
- and 3.75 mg/kg every 2 weeks in the highest dose level.
Patients were not pre-treated with any steroids or anti-histamines. They could continue on study until disease progression was observed through radiographic or clinical observation, or unless they elected to leave study earlier or toxicities warranted discontinuation.
After a 24 month observation, the results showed a significant difference in median overall survival for patients treated with anti-EGFR therapy of 9.4 months compared to only 4.8 months for non-pretreated patients. Also, radiographic evidence of anti-tumor effect was observed, in addition to improvements in lean body mass and quality of life: self-reported outcomes revealed reductions in pain, fatigue and improvement in appetite.
Lung cancer is the leading cause of death worldwide. The most common type of lung cancer is NSCLC, accounting for upwards of 80% of the known cases. Survival rates for NSCLC range from 49% if caught early at Stage I to 1% at Stage IV. Therefore, advances in treatment modalities are desperately needed to increase patient survival rates.
With the completion of this study and further investigational studies planned, XBiotech hopes to prove that Xilonix, is one of the advanced treatment options NSLC patients and their healthcare providers are anxiously waiting for.
XBiotech is building on a foundation of remarkable new therapies, innovative approaches to commercialization and a commitment to develop treatments for unmet medical needs worldwide.
The Company is a leading developer of biological therapies—including a pipeline of True Human™ antibodies and proven blockbuster biosimilars. To support these programs, XBiotech has developed the manufacturing technology to enable production of biological drugs with an unprecedented low cost of goods.
The Company operates 46,000 ft2 facilities in Austin, Texas. These facilities represent the worldwide headquarters for the Company, housing administrative, R&D, clinical and manufacturing operations. XBiotech USA Inc., XBiotech Japan K.K., XBiotech Swiss AG, and XBiotech Germany GmbH are all 100% owned subsidiaries of the parent company, XBiotech Inc. Canada. To accommodate future commercial demand, XBiotech has purchased 48 acres of land and designed and engineered a commercial manufacturing facility. Ground breaking on this new facility occurred in September 2014.