Gilead acquisition of Immunomedics : Pharma giant to gain access to breast cancer drug Trodelvy

Gilead acquisition of Immunomedics : US pharma giant Gilead Sciences has signed a $21 billion worth deal to acquire New Jersey-based biopharma company Immunomedics to gain access to the latter’s FDA approved breast cancer drug Trodelvy (sacituzumab govitecan-hziy).

Immunomedics, which has been offered $88 per share in cash by the US pharma giant, is focused on developing antibody-drug conjugates (ADCs) for the treatment of hard-to-treat cancers.

The ADC platform of the Californian biopharma company focuses on using a novel linker that does not need an enzyme for releasing the payload for delivering an active drug inside the tumor cell and the tumor microenvironment, as a result, providing a bystander effect.

Commenting on Gilead acquisition of Immunomedics, Daniel O’Day – Chairman and CEO of Gilead Sciences, said: “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.

“We look forward to welcoming the talented Immunomedics team to Gilead so we can continue to advance this important new medicine for the benefit of patients with cancer worldwide.”

Gilead acquisition of Immunomedics. Image courtesy of skeeze from Pixabay.

Trodelvy is the first ADC to have been approved by the US Food Drug and Administration (FDA) for the treatment of patients having metastatic triple-negative breast cancer. Besides, it is the first anti-Trop-2 ADC to have been approved by the FDA.

Currently, the ADC has an accelerated approval from the FDA in metastatic triple-negative breast cancer (mTNBC) in adult patients who have been subjected to at least two prior therapies for metastatic condition of the disease.

Immunomedics expects to file a supplemental biologics license application (BLA) with the FDA during Q4 2020 for requesting full approval for Trodelvy.

The biopharma company is also looking to pursue an approval for Trodelvy in the European Union by filing a regulatory approval for the anti-Trop-2 ADC in Europe in H1 2021.

In addition to mTNBC, Trodelvy is going through a phase 3 clinical trial in third line HR+/HER2- breast cancer patients and a phase 2 clinical trial in patients with bladder cancer. Besides, the anti-Trop-2 ADC is being probed as a potential treatment for non-small cell lung cancer and other types of solid tumors.

Behzad Aghazadeh – Executive Chairman of Immunomedics, commenting on Gilead acquisition of Immunomedics, said: “We are very pleased that Gilead recognized the value of Trodelvy – both for the important role it has already begun to play for patients with metastatic triple-negative breast cancer and for its potential to help many other patients with cancer in the future.

“We are excited for the opportunities ahead of us as we join with Gilead to advance our shared mission in defeating cancer. By working with Gilead, we have the opportunity to accelerate our progress and improve care for patients in need of new therapies.”

The closing of Gilead acquisition of Immunomedics is anticipated to be wrapped up during Q4 2020.

In June 2020, Gilead Sciences signed a deal to acquire a 49.9% stake in California-based cancer immunotherapy company Pionyr Immunotherapeutics, for a price of $275 million. (Read Gilead Sciences acquisition of Pionyr Immunotherapeutics)