# NG-350A

Source: https://onco.cc/drugs/ng-350a/  
OnCo record `ng-350a` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

NG-350A is an experimental cancer-killing virus from Akamis Bio, in phase 1 trials for locally advanced rectal cancer.

## Summary

NG-350A is an oncolytic adenovirus (T-SIGn), given into a vein, carrying a transgene from Akamis Bio. A tumour-selective adenovirus that makes infected tumour cells produce and release an antibody that switches on CD40, an immune activating receptor. In the phase 1b FORTRESS study (NCT06459869) it is given with chemoradiotherapy to people with mismatch-repair-proficient locally advanced rectal cancer; the company says the study is fully enrolled and reports an FDA Fast Track designation. Two earlier phase 1 studies in advanced epithelial tumours are completed. Greater China rights were licensed to Xuanzhu Biopharma in 2024. Whether it works in people has not been established.

## Fields

- Kind: Treatment
- Status: phase-1
- Last checked: 2026-11-04
- Also known as: NG350A
- Tags: pipeline; ctgov-ingest
- Code: NG-350A
- Modality: Oncolytic adenovirus (T-SIGn), given into a vein, carrying a transgene
- Mechanism: A tumour-selective adenovirus that makes infected tumour cells produce and release an antibody that switches on CD40, an immune activating receptor.

## Sources

- Akamis Bio pipeline: https://www.akamisbio.com/science-pipeline/pipeline/
- Akamis Bio funding and partnership release, December 2024: https://www.akamisbio.com/news/akamis-bio-announces-60-million-in-funding-linked-to-series-a-prime-financing-and-new-strategic-partnership/
- ClinicalTrials.gov NCT06459869: https://clinicaltrials.gov/study/NCT06459869
- ClinicalTrials.gov NCT03852511: https://clinicaltrials.gov/study/NCT03852511
- ClinicalTrials.gov NCT05165433: https://clinicaltrials.gov/study/NCT05165433

## Connected records

- cancers: [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- targets: [CD40](https://onco.cc/targets/cd40/)
- companies: [Akamis Bio](https://onco.cc/companies/akamis-bio/)
- trials: [First in Human Study of NG-350A (an Oncolytic Adenoviral Vector Which Expresses an Anti-CD40 Antibody)](https://onco.cc/trials/nct03852511/), [NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer](https://onco.cc/trials/nct06459869/), [Study of NG-350A Plus Pembrolizumab in Metastatic or Advanced Epithelial Tumours (FORTIFY)](https://onco.cc/trials/nct05165433/)

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