Clinical-Stage T-SIGn® Therapeutic Programs

NG-350A

FDA Fast Track
Designation

Transgene Payload:
CD40 agonist mAb

Indication:
pMMR LARC

NG-350A is a clinical-stage, intravenously delivered T-SIGn therapeutic designed to drive intratumoral expression of a secreted CD40 agonist monoclonal antibody (mAb). Intratumoral expression of the CD40 agonist mAb activates antigen-presenting cells (APCs) resident in solid tumors and their draining lymph nodes. Once activated, the 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 and in combination with pembrolizumab 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-specific delivery, replication and transgene expression.

NG-350A is currently being evaluated in combination with chemoradiotherapy in the actively recruiting Phase 1b FORTRESS study (NCT06459869) in mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC) patients. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to NG-350A for the treatment of pMMR LARC.

NG-348

Transgene Payload:
CD80 and anti-CD3 scFv

Indication:
mCRC

NG-348 is a clinical-stage, intravenously delivered T-SIGn therapeutic designed to drive intratumoral expression of two membrane-bound T cell activators: CD80 and anti-CD3 scFv. Expression of membrane-bound CD80 and the anti-CD3 scFv on the surface of tumor cells leads to activation of T cells in the vicinity of the tumor, driving direct tumor cell killing and leading to a potent and durable anti-tumor immune response.

Akamis Bio has evaluated NG-348’s safety, tolerability, and preliminary efficacy as a monotherapy in patients with metastatic or advanced epithelial tumors. In this study, NG-348 demonstrated a consistent safety and tolerability profile, as well as promising preliminary efficacy in a difficult-to-treat metastatic colorectal cancer (mCRC) phenotype.

Our Pipeline

Our pipeline is anchored around one goal—to bring meaningful innovation to patients with colorectal cancers.

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