Gilead’s Pipeline Strategy Takes Shape With $3B Acquisition of Cancer Biotech Tubulis Leave a comment
Gilead Sciences is building out its pipeline through a multi-billion dollar deal to acquire Tubulis, a startup with two targeted therapies in clinical testing. While those therapies are in development for cancer, Tubulis also brings the platform technologies that produced them, which Gilead could apply to indications beyond oncology.
In addition to a $3.15 billion upfront cash payment, Gilead could pay out up to $1.85 billion more if the Tubulis assets achieve milestones, according to financial terms announced Tuesday. The deal continues what has been an active business development strategy. Tubulis represents Gilead’s third M&A announcement this year.
Munich, Germany-based Tubulis specializes in developing antibody drug conjugates (ADCs), a type of cancer therapy made by linking a targeting antibody to a toxic drug payload. ADCs are already represented in the Gilead portfolio by Trodelvy, whose approvals in breast and bladder cancers have made it a blockbuster seller. Trodelvy came from the $21 billion acquisition of Immunomedics in 2020. With its latest deal, Gilead is betting Tubulis can be part of the next generation of ADCs.
Though currently available ADCs enable targeted delivery, sometimes the drug payload is released before the therapy reaches the tumor, causing off-target toxicity. Tubulis’s drugs come from platform technologies that produce ADCs with better stability. A stable ADC is less likely to release its drug payload prematurely, CEO Dominik Schumacher said in a 2024 interview. He added that Tubulis’s technologies also enable the company to develop ADCs with more potent drug payloads. The startup’s technologies are based on research from the Leibniz Research Institute in Berlin and the Ludwig Maximilians University in Munich.
Lead Tubulis program TUB-040 is designed to target NaPi2b. While high expression of this protein by ovarian and lung cancers make it a promising target, others have fallen short in their attempts to drug it. Zymeworks and Mersana Therapeutics are among the biotechs that have stopped work on NaP12b-targeting ADCs.
TUB-040 is currently in Phase 1b/2 testing in platinum-resistant ovarian cancer (PROC) and non-small cell lung cancer (NSCLC). The first interim data from Phase 1/2a testing in ovarian cancer were presented last fall during the European Society for Medical Oncology meeting. In 66 evaluable patients, results showed a 50% overall response rate. TUB-040 was generally well tolerated across all doses and the majority of treatment-related adverse events were classified as Grade 1 or 2. Soon after the conference, Tubulis was able to add new investors to its Series C round of financing, which closed at €344 million (about $401 million) total.
The next ADC in the Tubulis pipeline is TUB-030, which is designed to target 5T4, a protein highly expressed by many cancers but rarely by healthy tissue. Tubulis is assessing this ADC in a basket study spanning 13 types of solid tumors.
Gilead got better acquainted with Tubulis’s ADC technologies and pipeline through a partnership started in 2024. Gilead paid $20 million up front to collaborate on the discovery and development of an ADC for an undisclosed target. The deal granted Gilead the exclusive option to license the program for further development and potential commercialization. In Tuesday’s acquisition announcement, Gilead CEO Daniel O’Day said the collaboration gave his company conviction in Tubulis’s programs and research capabilities.
“Bringing this potential into Gilead would further expand what is already the strongest and most diverse pipeline in our company’s history,” he said.
Virology has been Gilead’s strength, but the company is also prioritizing immunology and oncology as additional areas for growth. In February, Gilead agreed to buy partner Arcellx in a $7.8 billion deal that brings a next-generation multiple myeloma cell therapy currently under FDA review. In March, Gilead agreed to pay about $1.7 billion to buy Ouros Medicines, a startup developing T cell engagers for autoimmune conditions. Both deals include the platform technologies that produced the companies’ respective drug candidates.
While Leerink Partners analyst Daina Graybosch acknowledged the potential of Tubulis’s two clinical-stage assets, her research note highlighted the biotech’s platforms, which she said give Gilead a way to drive future pipeline innovation. A note that Gilead sent to analysts said Tubulis’s next-generation ADC technologies fit with Gilead’s medicinal chemistry capabilities, which could lead to new classes of ADC payloads used in oncology, inflammation, and virology, Graybosch wrote. She added that Gilead’s comments brought to mind Merck’s $9.2 billion acquisition of Cidara. While Cidara’s platform technology produced the influenza-preventing drug that is its lead program, this technology also has applications in cancer. That is the type of novel antiviral drug conjugate program that Leerink believes Gilead aims to apply to virology, specifically for HIV drug R&D.
“This is more than an oncology bolt-on; we see real platform value in application of Tubulis’ ADC technologies to other therapeutic areas, namely virology,” Graybosch said.
Gilead expects to complete the Tubulis acquisition in the current quarter. The company has scheduled a 4:30 pm Eastern conference call Tuesday to discuss the acquisition as well as the recent Arcellx and Ouros deals.
Photo: Justin Sullivan, Getty Images
