On September 29, 2022 Kling Biotherapeutics, BV, (Kling Bio) a clinical stage biotechnology company focused on developing novel antibody-based therapeutics for cancer and infectious diseases generated through its proprietary discovery platform, reported the dosing of the first patient with KBA1412 in its Phase 1b trial (KBA1412-101, NCT05501821), an open-label, multi-center study evaluating the safety, tolerability, PK/PD, and potential efficacy of KBA1412 in adult patients with advanced solid tumors not responding to standard of care (Press release, Kling Biotherapeutics, SEP 29, 2022, View Source [SID1234621571]).
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KBA1412 is a first in class fully human anti-CD9 antibody based on an antibody produced by circulating B cells in the blood of a cancer survivor. "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 tumors), synergy with PD-1 blockade, and a very favorable preclinical safety profile not seen previously with anti-CD9 antibodies" said Timothy M. Wright, MD, Kling Bio co-founder and interim CEO.
The Phase 1b study will involve dose escalation followed by several expansion cohorts in patients with selected solid tumor types. The expansion cohorts will study KBA1412 alone and in combination with a PD-1 checkpoint inhibitor to further define the dose for future Phase 2 studies and to evaluate secondary endpoints for preliminary assessment of clinical efficacy. "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," said Sohail Ahmed, MD, MBA, Chief Medical Officer at Kling Bio.