The deal, which is reportedly set to close during Q4 2020, will provide Gilead with Trodelvy (sacituzumab govitecan--hziy), a drug granted accelerated approval in April this year by the US Food and Drug Administration (FDA) for the treatment of adult patients with metastatic triple-negative breast cancer who have received two prior therapies.
“This acquisition represents significant progress in Gilead’s work to build a strong and diverse oncology portfolio.
“Trodelvy is an approved, transformational medicine for a form of cancer that is particularly challenging to treat. We will now continue to explore its potential to treat many other types of cancer, both as a monotherapy and in combination with other treatments,” said Daniel O’Day, chairman and CEO, Gilead Sciences.
Immunomedics is exploring Trodelvy in an additional six indications beyond that current accelerated approval by the US regulator. It is on track to file for regulatory approval for Trodelvy in Europe in the first half of 2021.
Other than Trodelvy, the biotech has IMMU-130 for colorectal cancer and IMMU-140 for the hematological cancers in its pipeline. Both of these drug candidates are at the preclinical stage.
Gilead said it intends to initiate numerous additional mid- and late-stage studies in the near term to determine which patients will benefit from Trodelvy as both a monotherapy or in combination with other products.
The California-based pharma giant further outlined how it will bring commercial, medical, regulatory and manufacturing expertise, which will help rapidly advance Trodelvy through development and reach additional patients.
“Gilead will also bring to Immunomedics an established infrastructure and operations in Europe and Japan to support the launch of Trodelvy in those regions, pending approval. After closing, Gilead will retain global rights to Trodelvy outside of greater China, South Korea and certain Southeast Asian countries," it added.
A ‘new wave’ of ADC therapies
Immunomedics has been working on the development of antibody-drug conjugates (ADCs) since 1982, with the Trodelvy regulatory approval in April this year its first registration.
The therapeutic potential of ADCs and their uptake from the industry has seen several companies establishing partnerships, such as the tie-up between AstraZeneca and Daiichi Sankyo, which was bolstered in July this year, as well as CDMO’s investing in ADC manufacturing capacity. Last summer, Lonza said it was preparing for a ‘new wave’ of ADC therapies.
Expanding oncology portfolio
Meanwhile, Gilead has purchased several other businesses this year in its ambition to expand its oncology portfolio. June saw it acquire a 49.9% equity interest stake in cancer drug developer, Pionyr Immunotherapeutics, for $275m, following on from it paying out US$4.9bn (€4.3bn) for Forty Seven Inc.
Forty Seven’s investigational lead product candidate, magrolimab, is a monoclonal antibody (mAb) in clinical development for the treatment of several cancers, including myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) and diffuse large B-cell lymphoma.