Kling Biotherapeutics has dosed the first subject in its Phase Ib KBA1412-101 clinical trial of antibody KBA1412 in adults with advanced solid tumours unresponsive to standard of care.
The open-label, multicentre trial will assess the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD), and possible efficacy of KBA1412 in these patients.
It will have dose escalation and subsequent expansion cohorts enrolling subjects with selected types of solid tumours.
The expansion cohorts will assess KBA1412 as a single agent and along with a PD-1 checkpoint inhibitor to establish the dosage for further Phase II trials.
These cohorts will also analyse secondary endpoints for the initial analysis of clinical efficacy.
A completely human anti-CD9 antibody, KBA1412 is based on an antibody made by circulating B cells in a cancer survivor’s blood.
Kling Biotherapeutics co-founder and interim CEO Timothy Wright said: “KBA1412 has remarkable properties identified in preclinical studies including efficacy as monotherapy mediated by two anti-cancer mechanisms (cell-mediated cytotoxicity and enhanced immune cell infiltration into tumours), synergy with PD-1 blockade, and a very favourable preclinical safety profile not seen previously with anti-CD9 antibodies.”
The Netherlands-based clinical-stage biotechnology firm has a strong pipeline based on evaluating B cells seen in people with significant responses to cancer and infectious ailments.
The B cell immortalisation platform of Kling aids in the quick functional screening of antibodies and has resulted in detecting several antibodies that act on new epitopes (cancer and infectious diseases), as well as cancer-related antigens with distinct post-translational modifications.
Kling Biotherapeutics chief medical officer Sohail Ahmed said: “This study marks an important milestone for Kling Bio and demonstrates the potential to leverage the ‘human-to-human’ approach from discovery to clinical development for advancing novel cancer treatments.”