LONDON—It’s been a big year for Genmab. While celebrating its 25th anniversary, the cancer-focused biopharma hasn’t rested on its laurels—securing another approval for the AbbVie-partnered Epkinly, scoring its first M&A win and slowly moving from a partner-based to an asset owner-focused model.
The Copenhagen and Nasdaq dual-listed company made its name with the Johnson & Johnson-partnered multiple myeloma blockbuster Darzalex. But this year’s moves to become more independent have been part of a strategy years in the making, Genmab’s CFO Anthony Pagano told Fierce Biotech on the sidelines of the Jefferies London Healthcare Conference on Nov. 19.
The company has transitioned “from a royalty model to a 50/50 kind of co-co model, to now something that’s approaching a much more 100% own[ership] model,” Pagano said. “We've been making very, very steady progress against that.”
The CFO traces that journey back to the U.S. approval of the antibody-drug conjugate (ADC) Tivdak in 2021, which Genmab was able to co-commercialize with Seagen, now part of Pfizer. Genmab continued this strategy with the approval of Epkinly for lymphoma last year, where as well as co-promoting and co-commercializing the anti-CD20 bispecific, Genmab is also booking net sales in its two priority markets of the U.S. and Japan.
“Some people might just think that's sort of an accounting consequence,” Pagano said. “No, actually in order to book sales, you need to have a lot more substance in your commercialization efforts. And for Genmab, it obviously starts with co-promoting the field force. It also then includes things like distribution, market access and patient services.”
The plans to bolster commercialization resources for Epkinly resulted in news this year that Genmab will expand its U.S. headquarters and add 300 new jobs. Pagano said that Genmab is thinking beyond the “initial opportunity” for Epkinly as a later-line treatment for the 5,000 patients in the U.S. with follicular lymphoma and diffuse large B-cell lymphoma. Instead, the company’s plans have been based on additional indications beyond Epkinly as well as potential new drugs that are currently in late-stage development.
“What we were able to do is leverage that strategy, that vision, that ambition, to attract top talent,” he explained.
The potential new drugs coming down the pipeline include acasunlimab, a PD-L1x4-1BB bispecific antibody that Genmab had been working on with BioNTech until the German biotech decided this year to discontinue the program.
Pagano said Genmab, which had already been eyeing a phase 3 trial for the candidate in second-line lung cancer before the year’s end, is “very happy to move forward with that investment on our own.”
In fact, BioNTech’s decision actually “fits with the strategy of becoming more fully integrated and owning 100%” of Genmab’s future drugs, Pagano added.
There’s also rinatabart sesutecan (Rina-S), an ADC at the center of Genmab’s $1.8 billion cash acquisition of ProfoundBio in April. The transition to a full ownership model means that unlike Tivdak and Epkinly—for which the commercial manufacturing is done by Pfizer and AbbVie, respectively—manufacturing for Rina-S and acasunlimab will be conducted by third-party CDMOs. Ultimately, though, “Genmab is going to be 100% responsible for that global supply chain," Pagano said.
The ProfoundBio buy marked Genmab’s first major acquisition in its 25-year history. Now that the company has a taste for big M&A deals, can we expect to see a second in the near future?
“If we find the right opportunity, we will not shy away from exploring that from an M&A perspective, but it would have to make a lot of strategic sense,” Pagano said.
“From an overall investment profile, we'll be looking for something that has similar characteristics to Rina-S,” he explained. “Is it somewhere where we can look at the modality—meaning antibodies—and/or the therapeutic area. In the case of Rina-S, we were able to leverage what we're doing in the gynecological oncology space with Tivdak and apply that.”
Rina-S was also phase 3-ready when Genmab bought the company, meaning “there wasn't a lot of incremental investment or time that we had to sort of go through prior to starting the first phase 3 trial," the executive noted.
Genmab’s later-stage pipeline is solely focused on oncology but keen observers will have noted that a collaboration with argenx last year referred to finding a preclinical target in immunology as well as in cancer. Could Genmab become the latest oncology biotech to branch into autoimmune disease?
“We made a conscious decision about a year and a half ago to really think about and move into a therapeutic area outside of oncology—namely I&I,” Pagano explained.
This involved the dual focus of the argenx partnership, but it’s also led Genmab to start to evaluate whether either its ADC or C3-based T-cell engaging bispecific antibody programs could be applied to autoimmune diseases.
“That could fit very nicely with our acquisition of ProfoundBio coming through with a set of linker technologies and ADCs on top of it,” he explained. “So it’s an area that we are looking at, but the priority is still oncology.”