FDA Fast Tracks NG-350A for Some With Advanced Rectal Cancer

The U.S. Food and Drug Administration (FDA) has reportedly granted fast track designation to NG-350A for the treatment of patients with mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC).

The development was announced in a news release issued by Akamis Bio, the clinical-stage oncology company behind the drug.

Fast track, the FDA explains on its website, is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need with the intention of getting important new drugs to patients earlier.

“The NG-350A Fast Track designation from FDA is a recognition of the significant unmet need for new therapies to treat locally advanced rectal cancer (LARC),” said Dr. Rosen, chief medical officer at Akamis Bio, in a statement included in the news release. “The global incidence of LARC continues to rise, with a particularly alarming increase of this cancer among younger populations. Patients with mismatch repair-proficient tumors account for approximately 90% of LARC cases, and this population has the greatest need for evolution in the standard of care to include treatments that may enable patients to avoid surgical interventions.”

NG0-350A, according to the news release, is an intravenously delivered oncolytic immunotherapy that is designed to drive intratumoral expression of a CD40 agonist monoclonal antibody, triggering the activation of antigen-presenting cells in solid tumors and their draining lymph nodes. These cells recruit T cells into the vicinity of the tumor to deliver a potent anti-tumor immune response.

NG-350A and the FORTRESS Study

The drug is currently being evaluated in combination with chemoradiotherapy in the phase 1B FORTRESS study, which is currently recruiting patients with pMMR LARC.

The FORTRESS study, according to the news release, is an open-label, single-arm, multicenter trial of NG-350A in combination with chemoradiotherapy among adults with pMMR LARC and at least one risk factor for local or distant recurrence or with oligometastatic disease.

The trial is planning to enroll approximately 30 patients. According to its listing on clinicaltrials.gov, the trial is being conducted at four locations — Ohio State University Comprehensive Cancer Center in Columbus and The University of Texas MD Anderson Cancer Center in Houston, as well as two locations in the United Kingdom, in London and Sutton.

According to the listing, the trial has an estimated primary completion date of Feb. 28, 2026, and an expected study completion date of approximately Jan. 30, 2029.

The company has also evaluated the safety, tolerability and preliminary effectiveness of the drug as a monotherapy in the FORTITUDE study and in combination with Keytruda (pembrolizumab) in the FORTIFY study among patients with metastatic or advanced epithelial tumors, with Akamis Bio noting in the news release that the drug has displayed a consistent safety and tolerability profile along with strong evidence of tumor-selective delivery, replication and transgene expression.

Colorectal Cancer Facts

Colorectal cancer, according to the news release, is the third most common cancer that is diagnosed in both men and women in the United States, with approximately 145,000 people being newly diagnosed very year. Among this population, approximately 45,000 people are diagnosed with colorectal cancer, of which around 60% have locally advanced rectal cancer, which means it has spread to nearby tissues or lymph nodes. Nearly all of these patients, or approximately 90%, have mismatch repair-proficient tumors, which are tumors that have a functional DNA repair system.

References

1. “Akamis Bio Receives FDA Fast Track Designation for NG-350A for the Treatment of Mismatch Repair-Proficient Locally Advanced Rectal Cancer,” news release; https://www.akamisbio.com/items/akamis-bio-receives-fda-fast-track-designation-for-ng-350a
2. “Fast Track,” FDA; https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
3. “NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer (FORTRESS);” https://clinicaltrials.gov/study/NCT06459869#study-overview

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