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Akamis Bio is advancing its lead candidate, NG-350A, an intravenously delivered viral vector-based tumor gene therapy expressing a CD40 agonist monoclonal antibody. Early clinical studies have shown a consistent safety and tolerability profile with promising preliminary evidence of activity. The ongoing FORTRESS Phase 1b study is evaluating the combination of NG‑350A with chemoradiotherapy in patients with locally advanced rectal cancer, aiming to demonstrate proof-of-concept for this approach. Over 200 patients have been treated across monotherapy and combination settings. Initial proof-of-mechanism was published from the FORTITUDE first-in-human dose escalation study.
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