Austin, Texas based biotech startup XBiotech Inc. recently commenced an Initial Public Offering (IPO), offering 4,000,000 shares of common stock. The company expects to raise $76 million with the IPO on the week of April 13th, and that the IPO offering price will be between $18 and $20 per share. The XBiotech stock is to be listed on the Nasdaq exchange under the symbol XBIT.
As an “emerging growth company” as defined in the Jumpstart Our Business Startups Act, XBiotech notes that it may elect to comply with certain reduced reporting requirements for its stock prospectus and future filings after this offering.
Founded by Chairman, President and Chief Executive Officer John Simard in 2005, XBiotech is a clinical-stage biopharmaceutical company engaged in discovering and developing proprietary “True Human” monoclonal antibodies for treating a variety of diseases. True Human monoclonal antibodies are those which occur naturally in human beings — as opposed to being derived from animal immunization or otherwise engineered. XBiotech believes that naturally occurring monoclonal antibodies have potential to be safer and more effective than their non-naturally occurring counterparts. While focused on bringing its lead product candidate Xilonix to market, XBiotech have also developed a “True Human” pipeline and manufacturing system.
To support these programs, XBiotech has developed the manufacturing technology to enable production of biological drugs with an unprecedented low cost of goods.
Prior to XBiotech, Mr. Simard was founder and Chief Executive Officer of the therapeutic vaccine developer CTL ImmunoTherapies Corp., headquartered in Los Angeles with over 100 scientists and support staff. Mr. Simard also founded AlleCure Corp., of Valencia, California, a developer of immune-modulating therapies. In 2001, AlleCure and CTL ImmunoTherapies merged to form MannKind Corp., where Mr. Simard served as Corporate Vice President and Member of the Board. Mr. Simard invented the core technologies which form the basis for each of the commercialization programs. Operationally, he has championed an integrated approach to drug development, undertaking R&D, manufacturing and clinical regulatory programs under one roof — which he has used as an effective means to conserve capital and control timelines. Mr. Simard holds a degree in Biochemistry from the University of Saskatchewan and attended graduate studies in Medical Biophysics/Immunology at the University of Toronto, and has numerous patents related to cancer therapy, therapeutic vaccines and therapeutic antibodies, as well as substantial peer-reviewed scientific publications and the textbook “Immune Response Genes.”
The Company operates 46,000 ft 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 took place in September 2014.
XBiotech says its guiding principle is rigorous adherence to the the Hippocratic dictum that medicine “should do no harm” as a cornerstone philosophy as to how they approach drug development. That includes belief that cutting-edge medicine should work in a targeted way to make patients feel better, not worse. XBiotech’s leaders believe this very old principle should continue to shape the future of medicine.
The majority of XBiotech’s research and development efforts to date have been concentrated on developing MABp1 (also known as Xilonix, CA-18C3, CV-18C3, RA-18C3, and T2-18C3), a therapeutic antibody that specifically neutralizes interleukin-1 alpha (IL-1 a ). IL-1 a is a pro-inflammatory protein produced by leukocytes and other cells, where it plays a key role in inflammation. When unchecked, inflammation can contribute to the development and progression of a variety of different diseases, such as cancer, vascular disease, inflammatory skin disease, and diabetes. The company’s clinical studies have shown that blocking IL-1 a with MABp1 may have a beneficial effect in several diseases.
XBiotech has completed a Phase I/II clinical trial for XBiotech’s novel, non-cytotoxic, anti-tumor therapy MABp1 (Xilonix) as a treatment for cancer at the University of Texas MD Anderson Cancer Center in Houston. Results of this study were published in Lancet Oncology in April 2014 in a featured article describing the outcome in 52 advanced cancer patients treated with Xilonix. The so-called true human antibody therapy was reported to have an excellent safety profile, and the report describes comprehensive measures of patient performance during Xilonix therapy. It was reported that overall, patients’ constitutional symptoms improved, including pain and fatigue reduction. A highlight of the report was the finding that almost two-thirds of patients assessed with a new form of X-ray imaging demonstrated physical recovery of lean body mass (another way of referring to muscle mass) and moreover, that these same patients had dramatic improvement in overall survival.
The importance of the article was suggested by the co-publication of a commentary piece written by eminent researcher Dr. Charles Dinarello whose commentary affirms that “The study is a unique contribution because it opens entire new areas in cancer therapeutics. The study also provides a rationale for early use of anti-cytokine therapy in cancer and sets the stage for use of anti-cytokine treatment in combination with kinase inhibitors and antiimmunosuppressive treatments.”
XBiotech received a fast track designation from the Food and Drug Administration (“FDA”) in October 2012 to develop Xilonix™ as a treatment in the setting of metastatic colorectal cancer. The purpose of the fast track designation is to aid in the development, and expedite the review, of drugs that have the potential to treat a serious or life-threatening disease. Currently the company has have two Phase III studies underway — one launched in the United States for advanced refractory colorectal cancer and another in Europe for symptomatic colorectal cancer. If these trials are successful, XBiotech will seek marketing approvals for MABp1 (Xilonix) in Europe and/or in the United States.
Assuming such marketing approvals are obtained, XBiotech would distribute and sell this product through its own direct sales force or with a commercial partner.
They are also investigating MABp1 in clinical trials for other indications including treatment of vascular disease, Type 2 diabetes, acne and psoriasis. In a randomized Phase II study involving 43 patients, XBiotech evaluated MABp1 for its ability to reduce adverse events after balloon angioplasty, atherectomy or stent placement in patients undergoing revascularization procedures for blockage of the superficial femoral artery (SFA), a major artery in the leg. While the study did not involve a large enough patient population to provide a statistically significant outcome, the company believes that the study’s results may show a trend towards the reduction of restenosis and reduced incidence of Major Adverse Cardiovascular Events (“MACE”) in treated patients compared to the control group.
In a Phase II pilot study completed in 2012, XBiotech tested MABp1 in patients with Type 2 diabetes. A treatment-related decline in HbA1c, and increased serum levels of pro-insulin and C-peptide (indicators of improved glucose control and pancreas function, respectively) were observed. The company also conducted two Phase II pilot studies in skin disease, evaluating potential benefit of MABp1 in subjects with (1) moderate to severe plaque psoriasis and (2) moderate to severe acne vulgaris. The psoriasis study revealed rapid improvements in the Psoriasis Area and Severity Index (PASI), with patients having a median of 43 percent improvement within 35 days. In the acne study, treated patients exhibited a continual improvement in lesions over the course of therapy, with up to 42 percent reduction in eight weeks; and interestingly, these patients had a statistically significant improvement in anxiety, as measured by the Hospital Anxiety and Depression Scale (HADS). XBiotech’s researchers continue to analyze these clinical results, and to prioritize further clinical initiatives for MABp1 in oncology, SFA, diabetes, psoriasis and acne.
XBiotech has also recently filed an Investigational New Drug Application (IND) for a Phase I/II randomized clinical study to assess our True Human antibody therapy for the treatment of serious infections due to Staphylococcus aureus. This product candidate was identified from an individual that harbored a natural antibody capable of neutralizing S. aureus, including drug-resistant strains of the bacteria. The study is currently on clinical hold while, at the request of the FDA, we complete an animal toxicology study. XBiotech expects to complete the animal study during Q4 2015.
More recently, the company has begun using its True Human antibody technology to commence development a therapy for Ebola virus infection. They have recently received blood donations from Ebola-recovered patients which they have now confirmed contain high levels of anti-Ebola antibodies. A product candidate derived from these donations is expected to go into animal studies in 2015.
XBiotech’s True Human antibody therapeutics are developed in-house using the company’s proprietary discovery platform. Identifying True Human antibodies useful for therapeutics may involve screening thousands of blood donors. To distinguish the clinically relevant antibodies from irrelevant background antibody molecules in donor bloods, company researchers use XBiotech’s Super High Stringency Antibody Mining (SHSAM) technology. After antibodies are identified through an in-house discovery platform, a complex process to identify the genes responsible for producing the native antibody is undertaken. Once the nucleic acid sequence is isolated, company scientists are able to clone these genes into production cells. All patents and other intellectual property relating to both the composition of matter and methods of use of True Human antibodies were developed internally at Biotech, and the manufacture of these antibodies includes using a proprietary expression system licensed from Lonza Sales AG. The other components of the company’s manufacturing system — some proprietary and some non-proprietary — were all developed internally.
A key aspect of XBiotech’s manufacturing system involves use of simple disposable bioreactor technology. The company’s manufacturing operation is currently located within its 46,000 square foot facility at Austin, and to accommodate anticipated larger-scale commercial manufacturing needs, they have purchased 48 acres of industrial-zoned property located five miles from Austin’s central business district. In September 2014, ground-breaking on a new manufacturing facility on this property commenced , with construction estimated to be complete by late 2015, XBiotech expects to begin operating in the new facility, which will be capable of producing several hundred thousand doses of antibody annually, in early 2016.
For more information, visit:
Full details on the XBiotech IPO can be found at: