Magazine Article | May 1, 2020

Companies To Watch: argenx

Source: Life Science Leader

By Wayne Koberstein, Executive Editor, Life Science Leader magazine
Follow Me On Twitter @WayneKoberstein

Transatlantic company advances funding and immunological antibodies

SNAPSHOT

Tim Van Hauwermeiren
Argenx is developing new antibody therapeutics for immunological diseases in the neuro-muscular, hematology, oncology, and other areas. Its lead drug, efgartigimod (ARGX-113), which targets the human neonatal Fc receptor FcRn to reduce IgG (immunoglobulin G) autoantibodies, is in Phase 3 trials for myasthenia gravis (MG) and immune thrombocytopenia (ITP), Phase 2 for pemphigus vulgaris (PV), and Phase 2 for a subcutaneous (SC) form of efgartigimod for chronic inflammatory demyelinating polyneuropathy (CIDP) and high-risk myelodysplastic syndromes (MDS). Other key candidates are cusatuzumab (ARGX-110), targeting CD70, in Phase 2 for acute myeloid leukemia (AML), others in early clinical studies with partners, and others in the preclinical and discovery stages.

WHAT’S AT STAKE

Management at the original Belgian startup, argenx, knew the company would need an extraordinary amount of funding for its ambitious drug development plans. Although it had an ideal location for biopharma R&D in the historic home of Janssen near Beerse, Belgium, in 2018 the company turned to another industry hotbed, Boston/Cambridge in the United States, to fully fuel its drug development. There, it set up a second headquarters to draw more entrepreneurial drive, expertise, and financial support.

CEO Tim Van Hauwermeiren says the company’s move to Boston coincided with its shift from a focus on platforms — solving challenges other companies had in antibody production — to developing new antibody drugs in its pipeline. The shift happened for the simple reason that investors demanded it. “When you leave the meeting room with U.S. investors, they say, ‘By the way, do not partner your lead assets. If you do so, we will sell your stock.’ The message to us was, ‘Stop solving the problems of other companies and create your own pipeline. That will create much more shareholder value.’ Ultimately, it also enabled us to transition from private to public funding with an IPO on the Euro exchanges in 2014, which we then used as a stepping-stone to go public on Nasdaq in 2017.”

Those funds were critical in the next stage of the company’s development, from a tiny Belgian startup to a transatlantic organization of 250 people with $1.5 billion in cash on hand. Sixty employees are in Boston and a few more in a Tokyo office anticipating future expansion in Japan. Van Hauwermeiren believes argenx is now on track to become a fully integrated, commercial, and sustainable biotech company. Partnerships continue with several products, but the company’s internal pipeline has grown with additional candidates and indications with immunological targets. “Long-term, the U.S. will be market number one and Japan will be market number two for our lead program in myasthenia gravis.”

U.S. investment has also helped argenx overcome the climate for companies with new drugs in Europe, where local investors prefer lead assets partnered rather than self-developed. Thanks to the Nasdaq listing, Van Hauwermeiren says most of its shares are in the hands of long-term U.S. investors, who have shown patience for building the company.

Every product in the company’s pipeline comes from an academic collaboration, he says. The company aims for products with novel pathways, with the potential for treating orphan or high unmet-need indications where it can participate in the commercialization. It seems evident argenx also puts a great deal of thought and research into planning its clinical trials, with extensive input from all main stakeholders, including patients. In its chosen field of immunological diseases, all with complicated treatment and quality-of-life issues, the company seems wise in pursuing the informed path.


Vital Statistics

Employees: 250
Headquarters: Ghent, Belgium; Boston; Tokyo

Finances
$1.2 B Total raised in Nasdaq IPO and Follow-ons

Investors: T. Rowe Price, Fidelity, Artisan, Baillie Gifford, Wellington, Baker Bros., Redmile, Federated, Bellevue, Avoro BioPharma Ventures

Research Partners:
Janssen global collaboration, licensed ARGX-110
AbbVie - licensed ARGX-115
LEO Pharma, Staten BioScience, AgomAB, academic institutions

Latest Updates
January 2020: Reported positive interim data of Phase 2 proof-of-concept trial of efgartigimod in pemphigus vulgaris patients; supports advancement to Phase 3 second half 2020. Topline Phase 3 results on efgartigimod in myasthenia gravis to be announced mid-year 2020; BLA filing by end of 2020