Unexpectedly catapulted into global fame as a COVID-19 vaccine maker, BioNTech is on the verge of returning to its oncology roots with potentially its first commercial cancer drug. Yet, to Chief Commercial Officer Annemarie Hanekamp, the upcoming launch is less of a standalone milestone than a strategic springboard for a far more critical pipeline product.
Backed by positive phase 2 data and an ongoing confirmatory phase 3 trial, BioNTech is readying its Duality Biologics-partnered antibody-drug conjugate (ADC) trastuzumab pamirtecan (T-Pam) for submission with the FDA for previously treated HER2-expressing endometrial cancer.
If approved, the drug will compete with AstraZeneca and Daiichi Sankyo’s blockbuster HER2 ADC, Enhertu, which boasts a pan-tumor indication. Challenging the market leader, however, is not BioNTech’s end goal for T-Pam.
“This is not about competing head to head with Enhertu and overtaking them,” Hanekamp said in a recent interview with Fierce Pharma. “We’re very realistic, and we know in the oncology space, first-mover advantage matters. They’ve been in the market for a while, it’s an amazing drug, and we don’t claim to be all that differentiated versus Enhertu.”
Instead, Hanekamp views T-Pam as a “strategic launch,” an exercise to “run water through the pipes” and test BioNTech’s commercial infrastructure in oncology.
“We’ve never launched [in oncology] before, and launching is not just building a commercial organization,” she explained. “It’s a mindset. It’s building the muscle across all the functions to become commercial-ready.”
For BioNTech, that operational reset involves rightsizing its manufacturing footprint. By cutting idle capacity in the vaccine space, the company can reallocate resources to its immediate priorities, putting advancing its late-stage pipeline front and center, Hanekamp noted.
The evolution also involves the planned departure of its two researcher founders, CEO Uğur Şahin, M.D., and Chief Medical Officer Özlem Türeci, M.D.
“You see this with all founder-led biotechs that grow into a certain stage that the founders ultimately transition,” Hanekamp observed.
The crown jewel
Ultimately, all the build-out is meant to help polish a crown jewel: pumitamig, a PD-L1xVEGF bispecific antibody partnered with Bristol Myers Squibb.
Years ago, Şahin and Türeci had the foresight to tap into innovations from China before the broader industry caught on. BioNTech first licensed pumitamig from China’s Biotheus in 2023 before fully acquiring the firm the next year. Today, the drug is billed as a potential next-generation immuno-oncology backbone for its new owners, anchored by what is so far the most expansive global phase 3 program in the highly competitive PD-(L)1xVEGF class.
Thanks to BMS’ experience in cancer immunotherapy and the deal's co-commercialization framework, Hanekamp said the alliance is ready to launch pumitamig in the U.S. right away if needed.
“But as BioNTech, it’s our goal to also build that muscle,” she said.
BioNTech and BMS maintain a very flexible partnership, allowing each party to explore combinations independently, Hanekamp noted. While novel combos are not part of the first wave of nine global pivotal trials currently underway for pumitamig, BioNTech is pursuing this strategy for the second wave, which will then require that commercial muscle of its own.
“We’re still all about the novel combinations with the three platforms,” Hanekamp said, pointing to the firm’s targeted therapies like ADCs, immunomodulators and its signature mRNA platform.
Beyond the U.S., BioNTech and BMS have already started commercial planning for pumitamig in Europe, and the partners are “going through the strategic evaluation” to define their blueprint in Japan, according to Hanekamp.
The priority: relationships
Before pumitamig reaches the market, BioNTech could have a second oncology launch in OncoC4-partnered CTLA-4 agent gotistobart. A pivotal readout from the phase 3 Preserve-003 trial in second-line squamous non-small cell lung cancer is expected this year.
Unlike T-Pam, where the launch is “not about the revenues,” gotistobart, if successful, could address an unmet need and add substantial growth to BioNTech’s topline, Hanekamp said.
Gotistobart is poised to bulk up BioNTech’s commercialization muscle, too, ahead of pumitamig’s arrival. Rosetta Lung-01, the first global phase 3 readout expected for pumitamig, is in small cell lung cancer. Meanwhile, the all-important Rosetta Lung-02 trial in first-line NSCLC and Rosetta Breast-01 in triple-negative breast cancer (TNBC) are on track to report results the following year in 2029.
Hanekamp’s commercial team plans to leverage the market footprints of its earlier launches to establish clinical relationships for pumitamig. Specifically, the company sees a major overlap in prescribers who treat endometrial cancer—the planned initial indication for T-Pam—and TNBC. Similarly, the lung cancer specialists BioNTech will engage for gotistobart are the same ones it will need to target for pumitamig.
“For me, there’s one priority, and that’s relationships,” Hanekamp said.
“Once you’re launching out of the gate, you don’t want to have a sales rep needing to build those relationships,” she explained. “If it takes six months to get your first approved meeting with a physician, then you’re six months too late.”
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Of course, any marketing efforts behind pumitamig will have to be based on data. In a bid to accelerate the drug’s regulatory timeline in first-line NSCLC, BioNTech recently tweaked Rosetta Lung-02’s design to make progression-free survival its sole primary endpoint. That means, by the time pumitamig enters that market, it may lack statistically significant data on the key secondary endpoint of overall survival, potentially putting it at a commercial disadvantage.
Hanekamp was involved in making that protocol adjustment, and she said the commercial team is “fully supportive of this approach.”
“Lung cancer is one of the bigger indications. It is important to be part of the first wave,” she said. “We know the timelines for the competition, so we are constantly evaluating, is there an opportunity for us to speed up to bring these drugs to patients earlier, and therefore also be a little bit more competitive?”
If OS is not mature enough to be included in pumitamig’s FDA label—which would bar sales reps from promoting it—Hanekamp argues that a more comprehensive data package will still be available in the public domain once it’s presented at medical meetings.
Even as the commercial infrastructure is meant to lay the groundwork for a much bigger product, Hanekamp stressed that the inaugural team will be right-sized.
“There’s a foundation that I need to build,” the commercial chief said. “Once I have built that capability, then I can scale. Scaling, it’s still effort, but scaling is less complex than to build the capability from scratch.”