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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:

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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.

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Akamis Bio 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 metastatic or advanced epithelial- tumors. 

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REVOLUTION
(Phase 1b)

This study is evaluating the safety, tolerability and preliminary efficacy of NG-350A in combination with ipilimumab and gemcitabine/paclitaxel in patients with previously untreated metastatic pancreatic adenocarcinoma. REVOLUTION is being conducted in collaboration with the Parker Institute for Cancer Immunotherapy and the Cancer Research Institute.

Expanded Access Policy

Akamis Bio is committed to developing innovative therapeutics for patients with cancer. Our pipeline of T-SIGn® therapeutics are considered investigational, which means that they have not been approved by regulatory authorities. 

 

Akamis Bio is not currently making any of its investigational therapeutics available on an Expanded Access basis. Patients interested in learning if enrolment in a clinical trial is an option for them should consult with their treating physician.

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