Jan van de Winkel: Antibody Ascension

Jan van de Winkel, PhD, president and CEO, Genmab

Approaching the decade’s halfway point, many biopharmaceutical organizations are starting to publicly share and promote their so-called “2030 visions.” One of those companies is Genmab, the 25-year-old biotech with Danish roots that is steered today by president and CEO Jan van de Winkel, PhD. The executive also happens to be a co-founder of the therapeutic antibody specialist, which gives him a unique lens to its past and future—and, as often the dynamic in the life sciences, how both connect in plotting pathways for new horizons.

In Genmab’s case, gleaning from a conversation with van de Winkel, it seems the company’s vision for “2030”—the numerals something out of science fiction—is not simply an easy element to weave into marketing campaigns or meeting sound bites. Instead, building on a run of steady momentum for the last decade-plus, the countdown to 2030 could signal a real culmination of sorts in Genmab’s growth and, at times, challenging evolution.

PARTNERING AND PIVOTS

Genmab’s business model has historically centered on product royalties and revenues from antibody drugs for cancer and other diseases it helped develop and then out-licensed. However, with the approval of its first two commercial portfolio treatments in recent years, the company is in the midst of transforming from a purely R&D-focused organization to what van de Winkel calls an “end-to-end integrated company” with a commercial presence in the US, Japan, and potentially the UK and EU. (The company announced a reshuffling of its executive team last month, including the addition of two new C-suite roles: chief technology and chief commercial officers).

At the moment, there are eight approved antibody medicines on the market powered by Genmab’s innovation and four fueled by its bispecific technology. The company also has more than 20 existing partnerships with industry and academic collaborators in the antibody space. Upping the ante further, Genmab, in May, completed the acquisition of ProfoundBio for $1.8 billion, adding a promising pipeline of next-generation antibody-drug conjugates (ADCs) to the mix.

“We hope to bring new medicines to patients by 2030 that can fundamentally transform diseases like cancer,” van de Winkel tells Pharmaceutical Executive regarding the acquisition. “We will hold onto product ownership to basically do the complete product work; we don’t do that at this time, but we could do it by 2030.”

As it charts a new course in commercialization, Genmab doesn’t plan to shed its partnership identity any, particularly with the emergence of digital and artificial intelligence-driven medtech and data and advanced analytics companies, says van de Winkel.

“I think the big advances in the future will come from connecting with others in the innovation ecosystem that you cannot even think of,” adds the Dutch native, who early in his career was a scientist working in immunology research, and would become one of the youngest professors ever at Utrecht University in Utrecht, the Netherlands, a top academic medical center in Europe.

As far as established partnerships with Big Pharma, Genmab is uniquely positioned among publicly traded biotechs. Based in Copenhagen, Denmark, and with operations in the Netherlands, the US, and Japan, the organization (with close to 2,500 employees) may be the largest company focused solely on antibody drugs—an active area today for dealmaking with the influx of next-generation modalities for ADCs especially.

Genmab has co-commercialization arrangements for its two marketed products, Epkinly (epcoritamab) and Tivdak (tisotumab vedotin), with AbbVie and Pfizer (via its 2023 acquisition of Seagen), respectively. Epkinly is a blood cancer bispecific antibody while Tivdak is an ADC that targets cervical cancer. Among other notable therapies leveraging Genmab’s innovation include monoclonal antibody Darzalex (daratumumab), made by Johnson & Johnson (Janssen Biotech) for multiple myeloma; Novartis’s Kesimpta (ofatumumab), a drug for multiple sclerosis (MS) originally indicated for chronic lymphocytic leukemia (CLL); and Amgen’s Tepezza (teprotumumab-trbw), via its purchase of Horizon Therapeutics last year, for thyroid eye disease. Genmab also has partnerships on drug programs in development or incorporating its proprietary technology with AbbVie, BioNTech, Janssen Biotech, Novo Nordisk, ADC Therapeutics, Provention Bio, and H. Lundbeck A/S.

“It is super inspirational for a founder of a company that your idea, from 25 years ago, of using your insights in the biology of antibodies to create better medicines is actually becoming true and helping patients,” says van de Winkel. “I think the best is yet to come. ...The market dynamics are changing. Technologies are changing. The regulatory landscape is continuously changing. You have to build all of that into your thinking on how to develop new medicines for the future.”

AN UP AND DOWN ROAD

Future aspirations for the now-quarter-century-old biotech are perhaps made sweeter when considering the difficult period the company endured in the latter part of the 2000s. Amid impacts from the global financial crisis, between 2008 and 2010, Genmab underwent three rounds of restructuring, reportedly cutting almost 70% if its workforce and selling its production assets and outsourcing manufacturing. To help stay afloat, Genmab reduced its royalty share connected to then-GSK drug Arzerra (ofatumumab) for CLL, which Genmab helped develop. In 2014, Novartis acquired a number of GSK’s oncology products, including the pact with Genmab on ofatumumab, today known as Kesimpta and, as mentioned, targeting MS.

“We had to find a path back to growth again,” van de Winkel tells Pharm Exec. “[The financial crisis] made it impossible to go to the stock market and collect our money back, like we had done multiple times before 2008, basically as a biotech company. That actually forced us to refocus only on a few programs and then maximize the potential of those programs.”

van de Winkel helped navigate the Genmab business back to stable footing, first as president of R&D, where he oversaw the restructurings, and then as CEO, which he was appointed to in June 2010. According to van de Winkel, since 2013, the company has sustained profitability year over year. In addition, powered by royalties of the blockbuster Darzalex, first approved in 2015 (sales of the drug by J&J totaled $9.7 billion in 2023), Genmab has reportedly grown its revenue more than five times since 2017.

“My job [when becoming CEO] was to make the company independent of the stock market,” says van de Winkel. “I did that by engaging in partnerships—giving partners access to our technology base to make medicines of their own. And then creating a royalty and income stream that kept the company in play to find partners that worked on our products.”

Those moves helped lay the groundwork for Genmab’s expansion to co-commercialization and with its acquisition of ProfoundBio, potential 100% product ownership in the future.

“We are building the company up step by step—always staying very close to our focus on antibody medicines and our purpose in helping patients live better lives and get better, differentiated treatments,” says van de Winkel.

To that end, in August, the European Commission granted conditional marketing authorization for epcoritamab, branded as Tepkinly in Europe, as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma after two or more lines of systemic therapy. Created using Genmab’s DuoBody technology, Tepkinly is the first subcutaneous T-cell engaging bispecific antibody approved for this patient population, as well as R/R diffuse large B-cell lymphoma, in the EU.

(ANTI)BODY OF WORK

Today, with new advances and promise abounding—and much attention on what next-generation products may be around the corner—the antibody field has, in a way, come full circle for van de Winkel. As a young scientist studying the biology of antibodies, he remembers well how an interest in figuring out how therapeutic antibodies might work, and translating early learnings to a treatment setting, intensified in him.

“I realized that the injection of antibodies is one of the key reasons that vaccination works so well. You’ve seen it during the [COVID-19] pandemic. Vaccination is still the most impactful medical intervention we know of today,” van de Winkel tells Pharm Exec. “I knew we needed to focus on antibody medicines and create better drugs for different diseases, but cancer was the real logical one—because antibodies tend to have much less side effects than other types of medicines for cancer.”

After a period of time immersed in academia, where he contributed several papers to journals such as Nature and sparked numerous patents with his discoveries, van de Winkel arrived at a professional crossroads. He decided it was time to revaluate his career mission and purpose. Inspired, he says, by the approval of Genentech’s Rituxan (rituximab) in the mid 1990s, becoming the first-ever antibody cleared for treating cancer (initially indicated for non-Hodgkin’s lymphoma), the trained biologist felt a tug at the heart to leave the lab and seek to impact patients more directly.

“I began to realize that what I wanted to do was not stay in academia, but work with biotech to create medicine,” explains van de Winkel. “I reflected on, when I retire, and my grandchildren ask me, ‘granddad, what did you do in your life?’ I really wanted to tell them that I helped create medicines that could help millions of people live better lives. ...From that moment on, I realized clearly that I wanted to work with a team.”

van de Winkel joined the European division of US-based biotech Medarex in late 1996 as scientific director. A little more than two years later, Genmab was founded as a European spin-off of Medarex—and the rest is history. Throughout his journey, the executive credits his natural curiosity and the importance, for leaders, to value “lifelong learning,” in helping guide his path.

“You can always learn,” says van de Winkel. “The world is changing very rapidly. That forces you to think outside the box to come up with new solutions. You pick solutions up from management handbooks, but, before you know it, they’re already outdated.”

COFFEE AS A CATALYST

Blending such principles around curiosity and learning, van de Winkel believes he has contributed to shaping a unique culture at Genmab—inspired, he adds, by the company’s diverse employee makeup, including within his leadership group. According to the executive, its workforce comprises people from more than 75 nationalities across the company. He notes that Genmab aspires for a culture and talent mix that is “extra[not]ordinary,” a word the company coined and has formally branded in its communications and outreach, including on social media, official job boards, and other outlets. The concept, he says, is focused on a shared emphasis of empowering employees to be their authentic selves. The goal, adds van de Winkel, is to create an atmosphere of trust and teamwork, where the “non-conventional approaches” the company encourages employee—at all levels—to take have greater opportunity to thrive and deliver results.

“There’s no place here for people who are only focused on their own future and their own goals,” he stresses. “It’s always based on teamwork. I think that gives us a very special culture.”

As far as creative and strategic ways Genmab attempts to uphold that standard, van de Winkel, again, describes the company’s tactics as perhaps “unusual and a little bit unconventional” compared to other organizations of Genmab’s size. He cites, for example, the “coffee meetings” he hosts biweekly with new employees—typically only five or six people at a time.

“They can basically ask me about anything,” he says. “And what we discuss in that room, stays in that room. That creates a very rapid and very good basis for trust and for connection between the new employees and myself. I keep hearing that most of them have never been with a company where they could have a lunch meeting or coffee with the CEO a month after they started.”

In another example, van de Winkel references the “all-hands meetings” that he conducts with Genmab’s US team in Princeton, NJ, (made up of close to 1,000 employees), as well as teams at its Denmark headquarters, the Genmab R&D Center at Utrecht Science Park in the Netherlands, and the company’s Tokyo site. The Q&A portions of these gatherings always play a prominent role in the proceedings, van de Winkel notes. Thus, efforts to establish a setting and vibe closely tuned to the unique cultural and comfort-level drivers of scientists by location is key to achieving an honest and transparent back and forth, he adds.

“We’ve been doing this for many years and it really works,” says van de Winkel. “We have very low turnover in the company. We are growing rapidly, but there’s also many employees that have been with me for 20 years or so. It’s very much—the Americans use the metaphor of an Italian family. It’s many people hanging together as a very cohesive team. It is a culture that you set together and then scale up to a larger and larger company.”

Having transitioned from the often “individualistic or soloistic” nature of academic work, as van de Winkel describes it, to the collaborative world of biotech and drug development—both internally and externally—the Genmab CEO appreciates the opportunities he’s afforded to impart a little wisdom and perspective to those coming up the ranks today.

“What I always say is follow your passion and stay true to your core purpose,” says van de Winkel. “You can hear that from me at all levels. At early stages in your career, you’re easily distracted, of course, by other priorities or what people ask of you. I think to focus on your North Star is always really important.”