CAMBRIDGE, Mass. — Akamis Bio, a clinical-stage oncology company developing treatments for colorectal cancer, has completed enrollment in its Phase 1b FORTRESS study evaluating the experimental immunotherapy NG-350A in patients with locally advanced rectal cancer.
The study enrolled 33 patients with mismatch repair-proficient (pMMR) locally advanced rectal cancer across seven clinical sites in the United States and United Kingdom.
The trial is evaluating the safety and effectiveness of NG-350A in combination with chemoradiotherapy, with topline results expected in the first half of 2027.
Subject to regulatory discussions, Akamis Bio plans to initiate a randomized Phase 2 clinical trial in the second half of 2027.
“Completion of enrollment of the FORTRESS study marks an important milestone as we evaluate the potential of NG-350A plus chemoradiotherapy to advance the standard of care for patients living with mismatch repair proficient locally advanced rectal cancer,” said Oliver Rosen, MD, chief medical officer of Akamis Bio.
Rosen said preliminary findings suggest the combination therapy could improve tumor response rates compared with expected outcomes from chemoradiotherapy alone.
The FORTRESS study is assessing tumor responses following a 12-week treatment period. Its primary endpoint measures the percentage of patients achieving either a complete or near-complete clinical response.
According to the company, the benchmark response rate for chemoradiotherapy alone at 12 weeks is approximately 25 percent.
Preliminary data presented earlier this year at the American Association for Cancer Research Annual Meeting showed a 50 percent composite response rate among the first 10 patients who completed treatment. No serious adverse events or new safety signals related to NG-350A were identified in that initial group.
The U.S. Food and Drug Administration previously granted NG-350A Fast Track designation for the treatment of pMMR locally advanced rectal cancer.
NG-350A is an intravenously administered oncolytic immunotherapy designed to stimulate the body’s immune system to attack tumors. The treatment promotes the production of a CD40 agonist antibody within tumors, activating immune cells that help recruit T cells to target cancer.
Akamis Bio has previously evaluated NG-350A as a standalone therapy in its FORTITUDE study and in combination with pembrolizumab in its FORTIFY study involving patients with advanced or metastatic tumors.
The FORTRESS trial is an open-label, single-arm study involving adults with stage II or III rectal cancer who have risk factors for recurrence or limited metastatic disease.
Participants receive NG-350A alongside standard chemoradiotherapy, including oral capecitabine and radiation treatment.
In addition to tumor response rates, researchers are evaluating adverse events, tumor regression and circulating tumor DNA clearance.
The study builds on earlier research involving Akamis Bio’s first-generation oncolytic immunotherapy, which demonstrated improved tumor responses when combined with chemoradiotherapy compared with expected outcomes from conventional treatment alone.
Akamis Bio said the full FORTRESS results will help guide the next phase of clinical development for NG-350A.
