Gilead Plots ADC Comeback With Potential $415M License Agreement

 

The deal with Tubulis will help Gilead regain its footing in the ADC space following the withdrawal of Trodelvy in bladder cancer and its late-stage fail in NSCLC.

Gilead Sciences on Tuesday put forth $20 million in an exclusive option and license agreement with Tubulis to advance novel antibody-drug conjugate therapies for solid tumors.

Aside from the upfront payment, Gilead is also on the hook for a $30 million option exercise fee if it decides to exclusively license the partnership program. Overall, including development and commercialization milestones, Tubulis will be entitled to up to $415 million, plus mid-single to low-double-digit tiered royalties if a product hits the market.

If Gilead exercises its exclusive licensing option, it will assume full responsibility for all further development and commercialization options for the antibody-drug conjugate (ADC) program.

Flavius Martin, vice president of research at Gilead, said in a statement that the Tubulis partnership will allow it to access “novel technologies” that are “critical to advancing our pipeline,” especially as the pharma works to develop “next-generation therapies and combinations.” Together, Gilead and Tubulis hope to “increase the therapeutic value of the ADC modality.”

The partners are planning to achieve this goal by leveraging Tubulis’ proprietary Tubutecan platform, which uses the biotech’s P5 conjugation technology to produce what it calls ultra-stable ADCs that can optimally deliver their topoisomerase-I payloads to their designated targets, while minimizing unwanted toxicities, according to Tubulis’ website.

In April 2023, Bristol Myers Squibb saw the promise in Tubulis’ platform and paid the biotech $22.75 million upfront—along with the promise of more than $1 billion—to use Tubutecan to develop safer and more effective ADCs. Like Gilead, BMS is looking to target solid tumors with Tubulis’ technology.

In March 2024, Tubulis announced that it had closed its nearly $140 million Series B2 funding round, which will help it advance its own pipeline of ADCs, including the ovarian and lung cancer hopeful TUB-040 and the solid tumor candidate TUB-030.

For Gilead, Tuesday’s partnership represents somewhat of an ADC comeback after a series of stumbles in recent months. In October 2024, the pharma announced that it was pulling Trodelvy from the bladder cancer market after disappointing findings in the confirmatory Phase III TROPiCS-04 trial. Data from that study, unveiled in June 2024, indicated that Trodelvy did not result in significant overall survival (OS) benefits versus a physician’s choice of treatment.

In January 2024, Gilead also announced that Trodelvy failed the Phase III EVOKE-01 study in non-small cell lung cancer. Compared with docetaxel, the ADC did not significantly improve OS in patients with advanced or metastatic disease who had progressed on or after platinum chemotherapy and treatment with a checkpoint inhibitor.

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