Biogen backs late-stage bispecific antibody with $30m

By Rachel Arthur

- Last updated on GMT


Related tags Biogen Genentech Roche

Biogen has exercised its option to participate in the development and commercialization of mosunetuzumab, an investigational T-cell engaging biospecific antibody targeting CD20 and CD3 in development for B-cell non-Hodgkin’s lymphoma and other therapeutic areas.

Biogen will pay a $30m one-time option fee to Genentech, a member of the Roche Group, as part of the companies’ long-standing collaboration on antibodies targeting CD20.

Mosunetuzumab is in late-stage clinical trials with a Biologics License Application (BLA) submission to the FDA planned.

Potential first-in-class antibody

Mosunetuzumab is a CD20xCD3 T-cell engaging bispecific antibody in development for the treatment of people with B-cell non-Hodgkin’s lymphoma (NHL), including follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL).

In June 2020, mosunetuzumab was granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed/refractory (R/R) FL who have received at least two prior systemic therapies.

Genentech plans to complete the BLA submission to the FDA in the ‘near future’ for approval consideration from the GO29781 study investigating mosunetuzumab in patients with R/R FL.

If approved, mosunetuzumab has the potential to be a 'first-in-class' CD20xCD3 T-cell engaging bispecific antibody in NHL, according to Biogen.

In Europe, Roche recently submitted the initial marketing authorization application for mosunetuzumab to the European Medicines Agency (EMA), for patients with NHL. In addition, mosunetuzumab recently began a Phase 1b trial in patients with systemic lupus erythematosus.

Alongside the $30m option fee, Biogen will pay a portion of the mosunetuzumab’s 2021 development expenses. The company will have joint decision-making rights related to development and commercialization of mosunetuzumab and Genentech will continue to lead the strategy and implementation of the program.

Biogen will share in the operating profits and losses of mosunetuzumab in US in the low to mid 30% range and is eligible to receive low single-digit royalties on sales outside the US.

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