Cambridge, Mass.– Clinical-stage oncology company Akamis Bio announced the enrollment of the first patient in its Phase 1b FORTRESS trial, a proof-of-concept study evaluating the company’s next-generation immunotherapy NG-350A in patients with locally advanced rectal cancer (LARC).
The FORTRESS trial (Functional Oncoimmunotherapy Response Trial for Rectal Cancer Enhanced by Systemic Synergy) is a multi-center, open-label, non-randomized Phase 1b study. It aims to evaluate the clinical complete response (cCR) rates when NG-350A is combined with standard-of-care chemoradiotherapy (CRT) in adult patients with LARC who have at least one risk factor for local or distant recurrence.
NG-350A is based on Akamis Bio’s proprietary Tumor-Specific Immuno-Gene Therapy (T-SIGn®) platform and is designed to induce intratumoral expression of a CD40 agonist monoclonal antibody. This mechanism enables targeted immunotherapy in both primary and metastatic tumor sites, delivered via a systemic intravenous route.
“We have previously demonstrated that intravenously administered T-SIGn® therapeutics can reach both primary and metastatic tumor sites to drive local expression of immunotherapeutic payloads,” said Dr. Oliver Rosen, Chief Medical Officer at Akamis Bio.
“The results from earlier clinical studies provide a clear foundation for the FORTRESS trial, where we aim to establish both the safety and efficacy of NG-350A in rectal cancer patients and ultimately improve the current standard of care.”
The FORTRESS study builds on findings from the earlier CEDAR study, which showed that the combination of Akamis Bio’s first-generation immunotherapy with CRT significantly increased complete response rates in LARC patients compared to standard CRT alone. Previous evaluations of NG-350A also demonstrated a favorable safety profile, with no transgene-related or off-target toxicities observed.
With LARC posing a high risk of recurrence even after aggressive treatment, the FORTRESS trial could pave the way for novel immunotherapy-based treatment strategies that not only enhance response rates but potentially reduce the need for invasive surgical procedures.
Akamis Bio continues to develop its T-SIGn® platform for use across a broad range of solid tumors, aiming to transform the way immunotherapeutics are delivered and activated within the tumor microenvironment.
