Company to disclose clinical safety and efficacy data for NG-350A in combination with chemoradiotherapy following 12-week active treatment period

Akamis Bio, a clinical-stage oncology company working to advance the standard of care in colorectal cancer, today announced an upcoming poster presentation of initial clinical data from the FORTRESS study of NG-350A, an oncolytic immunotherapy for the treatment of mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC), at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place April 17-22 in San Diego.

The ongoing Phase 1b FORTRESS study (NCT06459869) is assessing the anti-tumor effects of NG-350A plus chemoradiotherapy (CRT) following a 12-week active treatment period to establish whether NG-350A can improve response rates relative to expected outcomes from CRT alone. The trial is enrolling adult patients with pMMR LARC and at least one risk factor for local or distant recurrence.

NG-350A is an intravenously delivered oncolytic immunotherapy designed to drive intratumoral expression of a CD40 agonist monoclonal antibody triggering the activation of antigen-presenting cells (APCs) resident in solid tumors and their draining lymph nodes. Once activated, APCs recruit T cells into the vicinity of the tumor to deliver a potent anti-tumor immune response.

Poster Presentation Details

Title: Phase 1b trial of NG-350A, a CD40 agonist antibody expressing adenoviral vector, in combination with chemoradiotherapy (CRT), in patients with mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC): Initial results from the FORTRESS study
Session Title: Phase II and Phase III Clinical Trials
Date and Time: April 20, 2:00PM – 5:00PM PST
Location: Poster Section 52
Poster Number: 19

About NG-350A
NG-350A is a clinical-stage, intravenously delivered Tumor-Specific Immuno-Gene (T-SIGn^®) therapeutic designed to drive intratumoral expression of a CD40 agonist monoclonal antibody triggering the activation of antigen-presenting cells (APCs) resident in solid tumors and their draining lymph nodes. Once activated, APCs recruit T cells into the vicinity of the tumor to deliver a potent anti-tumor immune response. Akamis Bio has evaluated NG-350A’s safety, tolerability, and preliminary efficacy as a monotherapy (FORTITUDE study) and in combination with pembrolizumab (FORTIFY study) in patients with metastatic or advanced epithelial tumors. Across these studies, NG-350A has demonstrated a consistent safety and tolerability profile, as well as strong evidence of tumor-selective delivery, replication and transgene expression.

About the FORTRESS Study
The Phase 1b FORTRESS study (NCT06459869) is an open-label, single-arm, and multicenter trial of NG-350A in combination with chemoradiotherapy (CRT) in adult patients with mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC) and at least one risk factor for local or distant recurrence or with oligometastatic disease. The FORTRESS study builds upon the Akamis Bio-supported, CEDAR study, which showed a significantly greater response rate in LARC patients treated with a combination of Akamis Bio’s first generation oncolytic immunotherapy and chemoradiotherapy (CRT), relative to expected outcomes using standard-of-care CRT alone. The FORTRESS study is planning to enroll approximately 30 patients aged eighteen and older with histologically confirmed adenocarcinoma of the rectum which is locally advanced (clinical stage II-III based on pelvic MRI). During the 12-week active treatment period, patients will receive NG-350A plus CRT (oral capecitabine plus long-course intensity-modulated radiotherapy). The primary endpoint for the study is the proportion of patients achieving a response (complete clinical response [cCR] or near complete clinical response [ncCR]) at week 12. Key secondary endpoints include the incidence and severity of adverse events, characterization of the anti-tumor effects of NG-350A in combination with CRT (including clinical response outcome and magnetic resonance tumor reduction grade [mrTRG]), and measurement of levels of circulating tumor DNA (ctDNA) clearance. Patients recently diagnosed with pMMR LARC interested in learning more about the FORTRESS trial can visit www.FortressStudy.org.

About Locally Advanced Rectal Cancer (LARC)
Colorectal cancer (CRC) is the second leading cause of cancer-related death in the United States (US), and it has recently emerged as the leading cause of cancer-related death in patients under 50 years of age. There are 159,000 people newly diagnosed with CRC in the US each year, with approximately 30,000 of these people diagnosed specifically with LARC. In patients with LARC, tumors have either grown through muscle and into the outermost layers of the rectum, or in more severe cases, through the wall of the rectum where they may attach to other organs and/or into the lymph nodes. Approximately 95% of LARC patients have mismatch repair-proficient (pMMR) tumors indicating that their tumor cells have a functional DNA repair system.

About Akamis Bio
Headquartered in Cambridge, Massachusetts, Akamis Bio is a clinical-stage oncology company developing systemically administered immunotherapies to treat solid tumors, initially for patients with locally advanced rectal cancer (LARC). Its proprietary Tumor-Specific Immuno-Gene Therapy (T-SIGn^®) platform is designed to deliver novel immunotherapeutic proteins, biomolecules and transgene combinations to treat solid tumors, with its lead clinical-stage program, NG-350A, driving intratumoral expression of a CD40 agonist monoclonal antibody. To learn more, please visit www.akamisbio.com.

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