FDA Clearance Announced by Active Biotech and NeoTX

Active Biotech AB and NeoTX announced receiving clearance from the US Food and Drug Administration for its Investigational New Drug application of the tumor-targeted superantigen naptumomab estafenatox (Naptumomab). The Phase IIa open-label trial will be done on 35 patients with checkpoint inhibitor pretreated, advanced or non-small cell lung cancer by evaluating the drug’s combination with the docetaxel.

The primary endpoint is the objective response rate as measured by RECIST 1.1 criteria. The safety, duration of response, progression-free survival, pharmacodynamics, and pharmacokinetics will be evaluated in the trial. The treatment will demonstrate the preliminary safety and anti-tumor activity in the early clinical trial stage for solid tumors. Naptumomab binds genetically engineered bacterial determinants to the surface of the tumor while it activates and expands the tumor-specific immune cells.

Helen Tuvesson, CEO of Active Biotech AB, said, “The FDA clearance of the IND for phase II clinical trial of Naptumomab in non-small cell lung cancer marks a significant step in the continuing development of Naptumomab as well as our collaboration with NeoTX. We are glad to receive the IND clearance and are excited to follow the progress of the development of Naptumomab and the upcoming clinical Phase IIa trial.”

Active Biotech is a biotechnology company that deploys its portfolio of compounds and extensive knowledge base to develop first-class immunomodulatory treatments. They treat specialist oncology and immunology indications with a high unmet medical need. At present, the company holds three projects in its portfolio. Naptumomab is targeted anti-cancer immunotherapy along with NeoTX Therapeutics.