Akamis Bio has announced encouraging initial findings from its ongoing Phase Ib trial of the oncolytic immunotherapy NG-350A in combination with chemoradiotherapy (CRT) for mismatch repair-proficient (pMMR), locally advanced rectal cancer (LARC) patients.
The single-arm, multi-centre, open-label trial showed a 50% composite response rate among the first ten participants who completed the 12-week treatment, with no serious adverse events or new safety concerns linked to NG-350A.
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It aims to assess whether NG-350A, given along with CRT, can increase composite response rates in pMMR LARC compared to CRT alone.
The study’s main endpoint is the proportion of patients attaining either clinical complete response (cCR) or near clinical complete response (ncCR) at 12 weeks.
A previous investigator-led CEDAR study using EnAd (a precursor to NG-350A) plus CRT in LARC achieved a 50% composite response rate.
The preliminary findings from FORTRESS confirm these results and highlight NG-350A plus CRT’s potential to improve outcomes when compared to CRT by itself.
The trial will enrol 30 adults with pMMR LARC, administering NG-350A plus CRT over 12 weeks.
The investigation will also monitor adverse events, clinical response outcomes, magnetic resonance tumour reduction grading, and circulating tumour DNA (ctDNA) clearance. Recruitment is scheduled to conclude in the second half of 2026.
Akamis Bio CEO Howard Davis said: “We believe these early FORTRESS data provide the first key evidence of clinical proof of concept for NG-350A plus CRT in pMMR LARC. When treated with the current standard of care, patients need to undergo life-altering surgery to remove portions of the rectum.
“We believe that NG-350A plus CRT has the potential to advance the pMMR LARC standard of care, offering more patients access to a non-operative approach to management of their disease, as well as the opportunity for organ preservation – a critically important treatment goal as LARC continues to impact increasingly younger patient populations.”
