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:
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.
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:
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.
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.