FDA clears IND for Sutro BCMA ADC, triggering Celgene partnership; Celgene passes on Sutro BCMA bispecific

May 7, 2019

Impact level: Moderate

• Sutro has provided updates on preclinical BCMA ADC and BCMA/CD3 bispecific antibody programs that are part of a Celgene immuno-oncology collaboration formed in 2014.

• FDA has cleared the IND for Sutro’s BCMA ADC.
  • This triggered an automatic assumption of worldwide development and commercialization rights by Celgene as this is the first collaboration program to obtain IND clearance. Sutro will be responsible for manufacturing and certain development services and is entitled to milestone payments and tiered royalties from Celgene.

• Celgene will not retain the option to acquire U.S. clinical development and commercialization rights to the remaining three collaboration programs, which include a BCMA/CD3 bispecific. Celgene will maintain ex-U.S. development and commercialization rights and will owe Sutro milestone payments and tiered royalties if any of the other three programs reach the market.

inThought Analysis

The BCMA ADC is on track to be the third BCMA ADC to enter the clinic, joining GSK’s belantamab mafodotin (GSK2857916) and MedImmune’s MEDI2228.

Celgene is forging ahead with its multiple-shots-on goal strategy in the BCMA space. To date, this includes its own clinical-stage bispecific antibody (CC-93269), obtained via its acquisition of EngMab in 2016, at least three BCMA CAR-Ts, the Sutro-partnered ADC and ex-U.S. rights to the preclinical BCMA/CD3 bispecific as part of the Sutro collaboration. The Bristol/Celgene deal is expected to close in 3Q19.

Given the collaboration structure, it appears that Celgene had no choice but to step up to worldwide rights for the BCMA ADC and so it remains to be seen how much emphasis it will be given. It does, however, introduce an ADC to the Celgene BCMA portfolio.

Source: Sutro 8-K