top of page
GettyImages-690657180.jpg

Clinical Trials

Akamis Bio has a growing pipeline of T-SIGn® therapeutics capable of driving the intratumoral expression of a broad range of therapeutic proteins, as well as immunologically active biomolecules which aim to enable a patient’s immune system to recognize, attack, and clear solid tumors. The Akamis Bio clinical-stage pipeline includes the following programs:

NG-350A (Phase 1) – An intravenously delivered T-SIGn® therapeutic which is capable of driving intratumoral expression of a secreted CD40 agonist monoclonal antibody. NG-350A’s mechanism of action is based on CD40-mediated activation of antigen presenting cells (APCs) resident in a solid tumor and its draining lymph nodes. Once activated, the APCs recruit T-cells into the vicinity of the tumor to deliver a potent anti-tumor immune response. NG-350A has the potential for use in both the monotherapy setting, as well as in combination with other immuno-oncology agents. NG-350A is being investigated in the following clinical studies:

Akamis Therapeutics Virus V2.png
Psioxus 2 Transgene

FORTITUDE
(Phase 1a)

This study is evaluating the safety, tolerability and preliminary efficacy of NG-350A as monotherapy or in combination with checkpoint inhibitors, in patients with metastatic or advanced epithelial tumors.

Akamis Therapeutics Virus V2.png
Psioxus 2 Transgene

FORTIFY
(Phase 1a)

This study is evaluating the safety, tolerability and preliminary efficacy of NG-350A in combination with pembrolizumab in patients with advanced or metastatic epithelial- tumors. 

NG-641 (Phase 1) – An intravenously delivered T-SIGn® therapeutic which is capable of driving intratumoral expression of four transgenes (i.e., a FAP-CD3 bispecific antibody, CXCL-9, CXCL-10 & interferon alpha). NG-641’s mechanism of action is based on the recruitment of T-cells into the vicinity of the solid tumor and triggering of a potent anti-FAP+ cancer associated fibroblast response (i.e., to relieve stromal-mediated immunosuppression), as well as direct anti-tumor immune responses. NG-641 has the potential for use in both the monotherapy setting, as well as in combination with other immuno-oncology agents. NG-641 is being investigated in the following clinical studies:

Akamis Therapeutics Virus V2.png
Psioxus 4 Transgene

STAR
(Phase 1a)

This study is evaluating the safety, tolerability and preliminary efficacy of NG-641  as monotherapy or in combination with checkpoint inhibitors in patients with metastatic or advanced epithelial tumors.

Akamis Therapeutics Virus V2.png
Psioxus 4 Transgene

NEBULA
(Phase 1a)

This study is evaluating the safety, tolerability and preliminary efficacy of NG-641  in combination with nivolumab in patients with metastatic or advanced epithelial tumors.

Akamis Therapeutics Virus V2.png
Psioxus 4 Transgene

MOAT
(Phase 1b)

This study is evaluating the safety and tolerability NG-641 as monotherapy or in combination with pembrolizumab in patients with surgically resectable squamous cell carcinoma of the head and neck. This study will also evaluate treatment outcomes and translational markers to assess viral replication, transgene expression and the remodeling of the tumor microenvironment.

bottom of page