Gilead and Tubulis Enter Into Exclusive Option and License Agreement to Develop ADC Candidate for Select Solid Tumor Target

On December 3, 2024 Gilead Sciences, Inc. (Nasdaq: GILD) and Tubulis reported that they have entered into an exclusive option and license agreement to discover and develop an antibody-drug conjugate (ADC) against a solid tumor target (Press release, Gilead Sciences, DEC 3, 2024, View Source [SID1234648765]).

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Through this agreement, Gilead will gain access to Tubulis’ proprietary Tubutecan and Alco5 platforms. The companies will collaborate to select the best technology to utilize, with Tubulis leading discovery and development efforts to design a topoisomerase I inhibitor-based ADC candidate with superior biophysical properties and stability to address current treatment challenges such as durability and off-target toxicity.

"As we expand our oncology portfolio to address the greatest gaps in care, accessing novel technologies is critical to advancing our pipeline," said Flavius Martin, MD, Executive Vice President, Research, Gilead Sciences. "With Gilead’s ongoing focus on innovating with next-generation therapies and combinations, we are excited to partner with Tubulis to explore a range of solutions that may help increase the therapeutic value of the ADC modality."

"Gilead has established a long track record of developing drugs that provide a significant step-up in therapeutic value, making them a great collaborator for leveraging our technology platforms, in line with our vision of fundamentally changing the ADC landscape," said Dominik Schumacher, PhD, CEO and co-founder of Tubulis. "Tubulis remains primarily focused on driving value through our own clinical development programs while selectively building partnerships with leaders in the industry."

Terms of the Agreement

Under the terms of the agreement, Tubulis will receive an upfront payment of $20 million and, if Gilead exercises its option, a separate option exercise fee of $30 million. In addition, Tubulis will be eligible for development and commercialization milestone payments totaling up to $415 million, plus mid-single to low double-digit tiered royalties on sales of marketed products resulting from the collaboration. Tubulis will lead early-stage research and development activities for the ADC program. If Gilead exercises its option to exclusively license the program, Gilead will be responsible for further development and commercialization activities for all products resulting from the collaboration.

Gilead does not exclude acquired IPR&D expenses from its non-GAAP financial measures. This transaction with Tubulis is expected to reduce Gilead’s GAAP and non-GAAP 2024 EPS by approximately $0.01.