J&J ships another bispecific off to FDA, this time in multiple myeloma

 Johnson & Johnson has shipped off another bispecific to the FDA for a potential approval, this time the multiple myeloma drug teclistamab.

Bispecifics have been getting a lot of buzz—and cash—from the Big Pharma crowd this year, as this class of medicine has the potential to tackle cancer in more than one way. J&J already has bispecific antibody Rybrevant approved for patients with non-small cell lung cancer who have a certain gene mutation.

Now, the healthcare giant’s Janssen pharmaceutical unit is going after the blood cancer multiple myeloma with teclistamab. Specifically, the company is seeking an indication for patients with relapsed or refractory multiple myeloma.

The therapy has shown a solid response rate in early-stage trials in heavily treated patients. In May, ahead of the American Society for Clinical Oncology meeting, J&J said the therapy shrank the tumors in 70% of patients whose cancer got worse despite trying several other treatments. Those data came from from two phase 1 studies in patients who have run out of options, including one that serves as the basis for J&J's FDA submission.

J&J also released some initial phase 2 data from the MajesTEC-1 study earlier this month at the American Society of Hematology meeting. The drug posted an overall response rate of 62% at eight months in patients who had received up to three previous types of treatment.

Multiple myeloma is a difficult to treat, incurable cancer affecting a type of white blood cell in the bone marrow that typically helps create antibodies to fight infection. About 35,000 people will be diagnosed this year, and 12,000 will die from the disease, J&J says.

Teclistamab is described by J&J as an off-the-shelf, T-cell redirecting bispecific antibody that targets both B-cell maturation antigen and CD3 receptors. The drug previously scored a priority medicines designation from the European Medicines Agency and a breakthrough-therapy tag from the FDA. It's in a number of clinical trials alone or in combination with other therapies, including one phase 3 study with Janssen’s approved multiple myeloma med Darzalex.

In October, J&J signed a backloaded deal with F-Star worth $17.5 million upfront and up to $13.5 billion in potential milestones for up to five bispecifics. 

The drug class has garnered a lot of attention this past year, and not just from J&J. Bristol Myers Squibb splashed down $150 million upfront plus another $770 million in potential biobucks to Immatics for a preclinical bispecific targeting solid tumors earlier this month. 

Merck KGaA, Denali Therapeutics, BMS and AbbVie all have deals with F-star as well. 

Amgen, which has had wins and losses in the quest to bring new medicines in the class forward, recently previewed a strategy to find multispecifics, which go beyond the two-pronged attack from a bispecific.

https://www.fiercebiotech.com/biotech/j-j-ships-another-bispecific-off-to-fda-multiple-myeloma