Roche Discontinues Second Hemophilia A Gene Therapy Candidate Under Spark Amid Shift in Hematologic Portfolio

Discontinuation of RG6358/SPK-8016:
Roche has removed the second hemophilia A gene therapy candidate, RG6358 or SPK-8016, from its pipeline due to insufficient impact on patients1.

Reason for Discontinuation:
The decision was made because the therapy "simply wasn't having the impact that we thought that it was going to have," according to Roche Pharmaceuticals CEO Teresa Graham1.

Remaining Hemophilia A Gene Therapy:
Roche's hemophilia A gene therapy ambitions now rest on SPK-8011 (dirloctogene samoparvovec), which is currently in a pivotal phase 3 trial1 5.

Background on Acquisition:
Roche acquired Spark Therapeutics in 2019 for approximately $4.8 billion, gaining control over Spark's gene therapy candidates for hemophilia A and B2.

Recent Developments:
This discontinuation follows the earlier removal of another gene therapy candidate and aligns with Roche's strategic shift in its hematologic portfolio, including the recent acquisition of Poseida Therapeutics for allogeneic CAR-T cell therapies3 5.