Biogen announced it was exercising its option to participate in Genentech’s development of mosunetuzumab under a long-standing collaboration for antibodies targeting CD20.
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Biogen is backing Genentech on developing a bispecific antibody aimed at B-cell non-Hodgkin’s lymphoma. This morning, Biogen announced it was exercising its option to participate in Genentech’s development of mosunetuzumab under a long-standing collaboration for antibodies targeting CD20.
Mosunetuzumab is a CD20xCD3 T-cell engaging bispecific antibody being developed for B-cell non-Hodgkin’s lymphoma, including follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). Two years ago, the U.S. Food and Drug Administration awarded Breakthrough Therapy Designation to mosunetuzumab to treat adult patients with relapsed/refractory (R/R) FL who have received at least two prior systemic therapies.
At the American Society of Hematology meeting in December, Genentech presented data from the Phase I/II GO29781 study that showed “mosunetuzumab induces high and durable complete response rates in people with follicular lymphoma who have received two or more prior therapies.” According to the company’s report, data showed the responses last “for at least 18 months in heavily pretreated patients with R/R FL who have received two or more prior therapies.” The Phase I/II data showed a complete response rate of 60%, while the median progression-free survival is 17.9 months.
Based on the data from GO29781, Genentech is expected to submit a Biologics License Application to the U.S. Food and Drug Administration soon. If approved, Biogen said mosunetuzumab has the potential to be a first-in-class CD20xCD3 T-cell engaging bispecific antibody in NHL. Roche, Genentech’s parent company, has already submitted the initial marketing authorization application for mosunetuzumab to the European Medicines Agency.
In addition to B-cell non-Hodgkin’s lymphoma, mosunetuzumab is also being assessed in a Phase Ib study for patients with systemic lupus erythematosus.
The Biogen and Genentech collaboration also led to the approval of Rituxan, an anti-CD20 that has been approved as a first-line maintenance treatment in follicular lymphoma.
Under the terms of the agreement with Genentech, Biogen will make a one-time $30 million payment to the South San Francisco-based company and pay a portion of the expenses incurred in 2021 for the development of mosunetuzumab.
Biogen has joint decision-making rights related to the development and commercialization of mosunetuzumab, while Genentech continues to lead the strategy and implementation of the program.
Biogen will share in the operating profits and losses of mosunetuzumab in the United States in the low to mid 30% range. The company will also be eligible to receive low single-digit royalties on sales outside the United States.
