Seattle will also take the responsibility to start the Phase 3 clinical trial of IMMU-132 in patients with metastatic triple-negative breast cancer (TNBC) and submit initial biologics license application (BLA) to the US Food and Drug Administration (FDA) for accelerated approval.
In addition, the deal includes the development of additional indications for IMMU-132, comprising of urothelial cancer (UC), small-cell lung cancer (SCLC) and non-small-cell lung cancer (NSCLC).
The Phase II clinical studies are currently conducting for these indications, along with other solid tumor indications being studied in ongoing clinical trials.
As part of the deal, Immunomedics will secure $250m upfront cash payment, in addition to $50m relating to rights outside the US, Canada and the EU.
The deal also includes the payment of an additional $1.7bn based on the achievement of certain clinical, development, regulatory and sales milestones.
These include an anticipated near-term milestone for acceptance of the BLA by the FDA for TNBC, additional milestones based on regulatory approval of IMMU-132 for TNBC in the US and other territories and future development and regulatory milestones for additional indications beyond TNBC.
Based on certain parameters in the agreement, Immunomedics will also retain the right to elect to co-promote IMMU-132 in the US by participating in 50% of the sales effort.
Subject to expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions, the deal is expected to complete in the first quarter of this year.
Immunomedics president and CEO Cynthia Sullivan said: “We are pleased to enter into this exclusive worldwide licensing agreement with Seattle Genetics to further advance IMMU-132 on behalf of patients with late-stage cancers, who have limited therapeutic options, while delivering significant and compelling near- and long-term value to stockholders.”
Image: Immunomedics has signed an exclusive global licensing agreement with Seattle Genetics for solid tumor therapy candidate, IMMU-132. Photo: courtesy of adamr / FreeDigitalPhotos.net.