About Us | XBiotech

history

Our Journey Through Innovation

2005

Founding and Pioneering Vision

John Simard extensively uses natural human antibody immunity for discovery of therapeutic vaccines in previous company.

Rapidly expanding approval of therapeutic antibodies, based on murine or engineered antibodies, evidences natural human immunity is overlooked as source for therapeutic antibodies.

John Simard incorporates XBiotech with $1 million in seed capital in Vancouver, Canada. Application for Intellectual property based on prophetic data for diagnosis, treatment and prevention of vascular disorders using antibodies derived from natural human immunity.

2006

R&D Expansion and Key Discoveries

XBiotech funds R&D laboratories in Copenhagen and Zurich.

John Simard moves to Switzerland to manage R&D projects.

Human antibodies that block inflammation are identified in Danish blood donors and challenge begins to find means to clone.

Company files patents for novel treatments for atherosclerosis and cancer.

2007

Research Intensifies and Global Expansion

Promising animal research results support the potential for targeting inflammation using antibodies against novel target.

Human antibody cloning work in Copenhagen is unsuccessful. New, intensified research is necessary to realise human antibody discovery.

Global search begins for location to build out R&D headquarters. The Company raises $2.5 million from Swiss investors, including Nobel laureate in Medicine, Rolf Zinkernagel.

2008

Strategic Expansion and Facility Buildout

XBiotech USA is incorporated.

Favorable labor and real estate conditions facilitate lease of 40,000 ft warehouse facility in Austin, Texas.

Hiring R&D group, build out of laboratories and simple manufacturing operations begins.

Investor outreach during time in Switzerland leads to W. Thorpe Mckenzie. Mr. Mckenzie creates an investor consortium McBiotech to fund the Company.

$4 million is raised.

2009

Securing Capital and Overcoming Challenges

Agreement with W. Thorpe Mckenzie to fundraise—and succeeds in securing $12 million common stock equity funding.

The R&D and manufacturing programs grow substantially, but significant challenges remain for cloning human antibodies and manufacturing production yields are too low for commercial needs.

2010

Breakthroughs in Manufacturing and Clinical Trials

Crucial invention enables discovery of new therapeutic candidate from human donors.

Manufacturing output increases enough to support clinical trial production.

FDA grants an Investigational New Drug application for a novel antibody for use in cancer therapy.

Collaboration with investigator Dr. Razel Kurzrock pioneering novel cancer therapies is made to start a clinical trial at MD Andersen for advanced cancer.

Novel endpoints, including monitoring of cachexia is used.

XBiotech acquires 48 acres of prime real estate near downtown Austin, Texas.

The Company files new patent applications for treatments for arthritis and cancer.

Mr. Mckenzie and McBiotech provide $23 million investment.

2011

Expansion and New Drug Applications

Investigational new drug applications are filed with the FDA for several indications.

Clinical trials are launched in diabetes, pyoderma gangrenosum and acne.

Mr. Mckenzie and McBiotech continue to contribute funds and company raises $8.5 million.

2012

Expanded Trials and Promising Results

Clinical trials are launched in peripheral vascular disease, and hematological cancers.

Patent applications are filed relating to novel treatments for cachexia, vascular disease and diabetes. Results from M D Anderson study suggest breakthrough treatment for cancer that links therapy to reduction in cachexia and other symptoms while improving outcomes.

The Company raises $7.2 million—Mr. Mckenzie is again a lead investor.

2013

Advancements in Technology and Manufacturing

A new bioreactor technology is engineered and new reactors are constructed.

State-of-the-art technology is acquired to enable development of high producing cells for the production of True Human antibodies.

Manufacturing output is dramatically increased.

Early investor relations in Switzerland pays off, with Swiss investments totaling $12 million.

2014

Preparing for IPO and International Growth

Data in oncology is pointing towards a registration path and Phase 3 study. Unique regulatory opportunities exist in Europe that favor the data and responses seen.

Expanding operations and late-stage studies require more capital. An IPO is contemplated. The requirement for a “crossover” financing round by underwriter’s limits the options.

A new 43,000 ft² headquarter facility is on the drawing board for R&D laboratories, manufacturing and office center. The new facilities are to be located on the company’s 48-acre land just a few miles from its leased buildings.

Investor relations in Switzerland continues to result in funding, with $66 million raised.

Patent applications are filed relating to novel treatments for Staphylococcus Aureus infections.

2015

IPO, Ebola Breakthroughs, and Global Impact

IND filed and study launched for novel treatment for Staphylococcus Aureus.

XBiotech worked with William R. Hambrecht to conduct a Dutch auction, enabling the company to complete a NASDAQ initial public offering.

Approximately $76 million dollars was raised from its existing shareholder base without the need for a “crossover” round.

The Financial Times “most Influential European Business Leader of the Last 25 Years” and CEO of Novartis, Dr. Daniel Vasella, joins the board of XBiotech.

Outbreak of deadly Ebola virus in West Africa infects 25,000 people and claims 10,000 lives. Infections reach Texas. Thorpe and Sarah Mckenzie identify African physician that was infected and survived Ebola infection. Company obtains blood donation and develops True Human antibodies that, based on studies performed by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), are shown to neutralize the virus.

XBiotech offers the US government free therapeutic antibody to treat the outbreak in West Africa and elsewhere.

2016

New Headquarters and European Expansion

The Company completes construction of its 43,000 ft2 headquarter facility.

The Company moves 100 employees from its leased premises to its new facilities minimal disruption to operations.

The new facility has clean room facilities to enable commercial production of antibody products.

The Company begins a Phase 3 registration study for colorectal cancer in Europe with close collaboration with the European Medicines Agency.

The study’s lead investigator is in the UK but clinical sites are across Europe.

2017

Setbacks and Resilience in Cancer Trials

Phase III study for colorectal cancer is completed in Europe.

The European Medicines Agency travels to Austin to perform audit on manufacturing facilities in anticipation of marketing approval and XBiotech distribution of its Texas-made product in Europe.

Breakthrough results are presented at the European Society for Medical Oncology World Congress for Gastrointestinal Cancer in Barcelona.

Results based on a novel cancer endpoint were a focal point of the conference.

The clinical study met all the requirements that were agreed upon prior to the study between the Company and the European Medicines Agency, Scientific Advice Working Group. Data submission appeared to be leading to successful registration in Europe for new cancer therapy. However, the two EMA assigned rapporteurs evaluating the application are suddenly removed; new rapporteurs immediately indicate intent to reject registration. Despite appeals, the registration for XBiotech’s colorectal cancer therapy is denied.

2018

Dermatology Breakthroughs and Advancements

Phase II studies are launched with the Company’s bermekimab True human antibody for the treatment of Atopic Dermatitis and Hidradenitis Suppurativa.

Results obtained suggest a breakthrough treatment for atopic dermatitis, with rapid and dramatic resolution of lesions and pain compared to existing therapies.

2019

Partnership and Acquisition by Janssen

Atopic dermatitis findings are presented at the American Academy of Dermatology conference in Washington D.C.

The Company begins discussions with Janssen Pharmaceuticals to acquire the bermekimab antibody used in the atopic dermatitis study.

Bermekimab targets an inflammatory substance that may be an effective therapy in other diseases.

Janssen agrees to allow XBiotech to continue to develop new antibody therapies based on the same target as bermekimab for non-dermatological indications.

XBiotech raises $40 million from Swiss investors.

In December 2019, XBiotech received $750 million in cash and Janssen acquires bermekimab.

2020

Focus on COVID-19 and New Discoveries

Under the terms of the Janssen agreement, XBiotech focuses on discovery of replacement molecules for bermekimab.

Several new True Human antibodies are discovered and the lead candidate Natrunix is quickly identified.

Master and working cell bank for manufacturing Natrunix are established.

XBiotech develops assay to identify individuals with COVID antibodies.

In collaboration with major Texas blood bank BioBridge Global (BBG), XBiotech analyzes blood samples for high levels of COVID antibodies. Subjects identified with high levels of COVID antibodies are used as blood donors to provide treatment for patients hospitalized with COVID infections. As part of the collaboration, BBG provided convalescent blood donations to XBiotech to be used to develop True Human antibody product.

XBiotech succeeds in developing COVID True HumanTM antibody therapeutics.

Engineering and architectural plans are drawn for campus expansion of R&D and administrative space.

Investigational new drug application for Natrunix is submitted with FDA oncology division.

XBiotech purchases $400 million of XBIT shares.

2021

Expanding Trials and Dividend Rewards

First batch of prefilled syringes of Natrunix aseptically filled.

Hutrukin is confirmed as a candidate for neurology and cardiovascular studies.

Hutrukin master and working cell banks for manufacturing are established.

Influenza candidate therapeutics IH201 and IH302 identified and master and working cell banks established for manufacturing.

First batch of Hutrukin drug product successfully filled.

Phase I/II clinical trial for pancreatic cancer is granted approval and study is commenced.

Investigational new drug application is submitted for Natrunix with FDA Rheumatology Division.

Phase I study commences for subcutaneous testing of Natrunix in healthy volunteers.

XBiotech pays out $75 million in dividend to XBIT shareholders.

2022

Expanding Clinical Trials and Safety Data

Natrunix safety and pharmacokinetics trial in healthy volunteers for subcutaneous dosing is completed (conducted as required by the division of rheumatology). Safety and dosing are confirmed.

At FDA request, pre-clinical studies were performed to establish pharmacodynamic biomarkers for arthritis and human dose levels. Biweekly 400 mg dose established as efficacious dose.

Investigational new drug application in the FDA division of neurology leads to Phase I clinical trial for Hutrukin.

Unmetix pre-IND package submission to the FDA leads to pre-clinical and clinical study design recommendations.

2023

Advancing Therapies and Pre-Clinical Research

Hutrukin safety and pharmacokinetics trial in healthy volunteers completed. Safety and dosing is confirmed.

Phase II study of Natrunix in rheumatoid arthritis trial is initiated.

Hutrukin Phase I study launched and completed. Safety and pharmacodynamics were established.

Patent application filed for treatment of shingles using True Human antibody candidate therapeutic.

Large pre-clinical animal studies required by the FDA are conducted in China through collaboration. Unmetix exhibits expected safety and pharmacokinetics in animal models.

Protocol development is launched for various clinical studies in rheumatology, including ankylosing spondylitis and psoriatic arthritis.

C. difficile therapeutic antibody master and working cell banks for manufacturing are generated.

JC virus antibody screening commences in healthy human blood donors.

2024

Growth and Path to FDA Registration

Phase II Pancreatic Cancer Study is completed. Company begins data analysis and developing registration strategy for FDA.

Phase II clinical study for Rheumatoid Arthritis is completed. Data analysis has been initiated.

Unmetix non-clinical studies completed. IND package preparation in progress.

C difficile therapeutic antibody manufacturing and purification process established. Engineering runs are being conducted.

In vitro assays are being developed to screen JC virus antibody candidates.

Natrunix autoinjector project initiated.

2005

Founding and Pioneering Vision

John Simard extensively uses natural human antibody immunity for discovery of therapeutic vaccines in previous company.

Rapidly expanding approval of therapeutic antibodies, based on murine or engineered antibodies, evidences natural human immunity is overlooked as source for therapeutic antibodies.

2006

R&D Expansion and Key Discoveries

XBiotech funds R&D laboratories in Copenhagen and Zurich.

John Simard moves to Switzerland to manage R&D projects.

Human antibodies that block inflammation are identified in Danish blood donors and challenge begins to find means to clone.

Company files patents for novel treatments for atherosclerosis and cancer.

2007

Research Intensifies and Global Expansion

Promising animal research results support the potential for targeting inflammation using antibodies against novel target.

Human antibody cloning work in Copenhagen is unsuccessful. New, intensified research is necessary to realise human antibody discovery.

Global search begins for location to buildout R&D headquarters. The Company raises $2.5 million from Swiss investors, including Nobel laureate in Medicine, Rolf Zinkernagel.

2008

Strategic Expansion and Facility Buildout

XBiotech USA is incorporated.

Favorable labor and real estate conditions facilitate lease of 40,000 ft warehouse facility in Austin, Texas.

Hiring R&D group, build out of laboratories and simple manufacturing operations begins.

Investor outreach during time in Switzerland leads to W. Thorpe Mckenzie. Mr. Mckenzie creates an investor consortium McBiotech to fund the Company.

$4 million is raised.

2009

Securing Capital and Overcoming Challenges

Agreement with W. Thorpe Mckenzie to fundraise—and succeeds in securing $12 million common stock equity funding.

The R&D and manufacturing programs grow substantially, but significant challenges remain for cloning human antibodies and manufacturing production yields are too low for commercial needs.

2010

Breakthroughs in Manufacturing and Clinical Trials

Crucial invention enables discovery of new therapeutic candidate from human donors.

Manufacturing output increases enough to support clinical trial production.

FDA grants an Investigational New Drug application for a novel antibody for use in cancer therapy.

Collaboration with investigator Dr. Razel Kurzrock pioneering novel cancer therapies is made to start a clinical trial at MD Andersen for advanced cancer.

Novel endpoints, including monitoring of cachexia is used.

XBiotech acquires 48 acres of prime real estate near downtown Austin, Texas.

The Company files new patent applications for treatments for arthritis and cancer.

Mr. Mckenzie and McBiotech provide $23 million investment.

2011

Expansion and New Drug Applications

Investigational new drug applications are filed with the FDA for several indications.

Clinical trials are launched in diabetes, pyoderma gangrenosum and acne.

Mr. Mckenzie and McBiotech continue to contribute funds and company raises $8.5 million.

2012

Expanded Trials and Promising Results

Clinical trials are launched in peripheral vascular disease, and hematological cancers.

The Company raises $7.2 million—Mr. Mckenzie is again a lead investor.

2013

Advancements in Technology and Manufacturing

A new bioreactor technology is engineered and new reactors are constructed.

State-of-the-art technology is acquired to enable development of high producing cells for the production of True Human antibodies.

Manufacturing output is dramatically increased.

Early investor relations in Switzerland pays off, with Swiss investments totaling $12 million.

2014

Preparing for IPO and International Growth

Data in oncology is pointing towards a registration path and Phase 3 study. Unique regulatory opportunities exist in Europe that favor the data and responses seen.

Expanding operations and late-stage studies require more capital. An IPO is contemplated. The requirement for a “crossover” financing round by underwriter’s limits the options.

Investor relations in Switzerland continues to result in funding, with $66 million raised.

Patent applications are filed relating to novel treatments for Staphylococcus Aureus infections.

2015

IPO, Ebola Breakthroughs, and Global Impact

IND filed and study launched for novel treatment for Staphylococcus Aureus.

XBiotech worked with William R. Hambrecht to conduct a Dutch auction, enabling the company to complete a NASDAQ initial public offering.

Approximately $76 million dollars was raised from its existing shareholder base without the need for a “crossover” round.

The Financial Times “most Influential European Business Leader of the Last 25 Years” and CEO of Novartis, Dr. Daniel Vasella, joins the board of XBiotech.

XBiotech offers the US government free therapeutic antibody to treat the outbreak in West Africa and elsewhere.

2016

New Headquarters and European Expansion

The Company completes construction of its 43,000 ft2 headquarter facility.

The Company moves 100 employees from its leased premises to it new facilities minimal disruption to operations.

The new facility has clean room facilities to enable commercial production of antibody products.

The Company begins a Phase 3 registration study for colorectal cancer in Europe with close collaboration with the European Medicines Agency.

The study’s lead investigator is in the UK but clinical sites are across Europe.

2017

Setbacks and Resilience in Cancer Trials

Phase III study for colorectal cancer is completed in Europe.

The European Medicines Agency travels to Austin to perform audit on manufacturing facilities in anticipation of marketing approval and XBiotech distribution of its Texas-made product in Europe.

Breakthrough results are presented at the European Society for Medical Oncology World Congress for Gastrointestinal Cancer in Barcelona.

Results based on a novel cancer endpoint were a focal point of the conference.

2018

Dermatology Breakthroughs and Advancements

Phase II studies are launched with the Company’s bermekimab True human antibody for the treatment of Atopic Dermatitis and Hidradenitis Suppurativa.

Results obtained suggest a breakthrough treatment for atopic dermatitis, with rapid and dramatic resolution of lesions and pain compared to existing therapies.

2019

Partnership and Acquisition by Janssen

Atopic dermatitis findings are presented at the American Academy of Dermatology conference in Washington D.C.

The Company begins discussions with Janssen Pharmaceuticals to acquire the bermekimab antibody used in the atopic dermatitis study.

Bermekimab targets an inflammatory substance that may be an effective therapy in other diseases.

Janssen agrees to allow XBiotech to continue to develop new antibody therapies based on the same target as bermekimab for non-dermatological indications.

XBiotech raises $40 million from Swiss investors.

In December 2019, XBiotech receives $750 million in cash and Janssen acquires bermekimab.

2020

Focus on COVID-19 and New Discoveries

Under the terms of the Janssen agreement, XBiotech focuses on discovery of replacement molecules for bermekimab.

Several new True Human antibodies are discovered and the lead candidate Natrunix is quickly identified.

Master and working cell bank for manufacturing Natrunix are established.

XBiotech develops assay to identify individuals with COVID antibodies.

XBiotech succeeds in developing COVID True HumanTM antibody therapeutics.

Engineering and architectural plans are drawn for campus expansion of R&D and administrative space.

Investigational new drug application for Natrunix is submitted with FDA oncology division.

XBiotech purchases $400 million of XBIT shares.

2021

Expanding Trials and Dividend Rewards

First batch of prefilled syringes of Natrunix aseptically filled.

Hutrukin is confirmed as a candidate for neurology and cardiovascular studies.

Hutrukin master and working cell banks for manufacturing are established.

Influenza candidate therapeutics IH201 and IH302 identified and master and working cell banks established for manufacturing.

First batch of Hutrukin drug product successfully filled.

Phase I/II clinical trial for pancreatic cancer is granted approval and study is commenced.

Investigational new drug application is submitted for Natrunix with FDA Rheumatology Division.

Phase I study commences for subcutaneous testing of Natrunix in healthy volunteers.

XBiotech pays out $75 million in dividend to XBIT shareholders.

2022

Expanding Clinical Trials and Safety Data

Natrunix safety and pharmacokinetics trial in healthy volunteers for subcutaneous dosing is completed (conducted as required by the division of rheumatology). Safety and dosing are confirmed.

At FDA request, pre-clinical studies performed to establish pharmacodynamic biomarkers for arthritis and human dose levels. Biweekly 400 mg dose established as efficacious dose.