RO-7122290

Roche removed schizophrenia candidate ralmitaront from its midphase pipeline. Roche’s vision of developing an oral diabetic retinopathy treatment has taken a hit, with the drugmaker stopping development of vicasinabin after completing phase 2. The CB2 agonist was discarded (PDF) as part of a cull that also saw Roche pull back from its CEAxCD3 bispecific candidate cibisatamab. Vicasinabin, also known as RG7774, entered phase 2 in 2020. Roche pitched the candidate as a potential oral alternative to existing invasive treatments, such as injections into the eye, for a condition that leads to vision loss and blindness in some people with diabetes. However, the clinical trial, which finished in July, failed to persuade Roche to keep investing in the candidate. The action eliminates one of the leading oral contenders in diabetic retinopathy. Ocuphire Pharma has an oral candidate, APX3330, that has cleared phase 2. Bayer, InflammX and Rezolute also have oral, clinical-phase assets. Other companies, notably Boehringer Ingelheim, have swung at the indication and missed.  Roche dropped vicasinabin from its pipeline as part of a third quarter cull that also affected cibisatamab, a bispecific designed to bind to CD3 on T cells and CEA on cancer cells. Multiple companies have zeroed in on CEA as an attractive solid tumor drug target. Roche started a phase 1 trial of an older CEAxCD3 bispecific, RO6958688, in 2014 and followed up by taking cibisatamab into the clinic in 2019. The trial evaluated cibisatamab, also known as RG7802, in combination with Roche’s checkpoint inhibitor Tecentriq in colorectal cancer patients. Now, Roche has removed RG7802 in solid tumors from its phase 1 pipeline. The drugmaker continues to assess RG7802 in combination with RO7122290, a bispecific antibody-like fusion protein that simultaneously targets 4-1BB and FAP, in colorectal cancer.     Asked by Fierce Biotech about the pipeline changes on a conference call with the media this morning, Teresa Graham, CEO of Roche Pharmaceuticals, said: “I think these are both very early-stage assets that currently sit in our research and early development organizations.” “We've seen encouraging early data that would lead us to believe that further study is necessary or warranted,” Graham added. “So I would say stay tuned, and hopefully at an upcoming medical conference we'll have more data that we can share.” Roche also removed the schizophrenia candidate ralmitaront from its midphase pipeline. The company terminated a phase 2 trial of the asset earlier this year after an interim analysis found it was unlikely to meet the primary endpoint. Roche terminated another trial of the molecule last year.