Glenmark Pharmaceuticals announced the decision to launch a Phase 1 trial in solid tumors for its CD38xCD3 bispecific antibody GBR 1342. The decision is driven by recent findings derived from a noninterventional human study utilising a clinically validated CANscript platform. GBR 1342 is based on Glenmark’s proprietary BEAT platform and simultaneously targets CD38 and the CD3 T cell co-receptor. CD38 is an antigen known to be implicated in haematological malignancies as well as some solid tumors. The company intends to file an Investigational New Drug (IND) application for GBR 1342 in solid tumors and initiate a clinical trial in 2019.

"Our work with innovative immunotherapeutics such as T cell re-directing bispecific antibodies necessitates detailed analyses to fully-understand and assess the potential opportunities presented by the candidates in our pipeline," said Kurt Stoeckli, President and Chief Scientific Officer, Glenmark Pharmaceuticals. "We are pleased to report that predictive analytics have generated new insights on response rates which inform further clinical development of GBR 1342 in a variety of solid tumor types, both as monotherapy and in combination therapy."

The decision to expand clinical development of GBR 1342 was based on a recently completed ex vivo translational study in multiple solid tumours utilising the clinically validated CANscript platform, where treatment with GBR 1342 revealed predictive responses in various tumour types.

CANscript is a completely human, autologous human tumor platform that integrates an algorithm–driven strategy to predict clinical responses. Glenmark plans to submit these data, along with findings on the mechanism of action, for presentation at upcoming scientific meetings and publication in a peer-reviewed journal. An ongoing first-in-human, open-label, Phase 1 trial of GBR 1342 in multiple myeloma (NCT03309111), is assessing the safety and tolerability of increasing doses of GBR 1342, and will also evaluate biomarkers, immunogenicity, and additional measures of disease activity.