NeoTX Therapeutics, Ltd announced today that it has entered into a clinical collaboration with AstraZeneca Group Plc (NYSE: AZN) global biologics research and development arm, MedImmune, to support Phase 1b/2 studies investigating NeoTX’s naptumomab estafenatox (“naptumomab”) in combination with IMFINZI® (durvalumab). These studies are expected to begin in 2019. Naptumomab is the lead drug in NeoTX’s novel Selective T cell Redirection (“STR”) platform.
Naptumomab’s dual mechanism of action coats the tumor with a target that can be easily identified by T cells and then primes and redirects specific activated T cells that can identify that target, to the tumor.
Durvalumab is a human monoclonal antibody that blocks the immune checkpoint protein, programmed death-ligand (PD-L1), and allows activated T cells to attack tumor cells.
The Phase 1b/2 studies will determine the maximum tolerated dose (MTD) of naptumomab in combination with durvalumab, evaluate the clinical response, safety and tolerability of the combination, as well as test for multiple pharmacodynamic parameters.
Under terms of the agreement, NeoTX and AstraZeneca will collaborate on a non-exclusive basis to evaluate the combination of the two drugs in solid tumors. NeoTX will sponsor the study, while AstraZeneca will supply durvalumab. Up to 195 patients are planned to be enrolled in this multicenter, open-label study.
“We are pleased to work with AstraZeneca addressing the high unmet medical need of patients with tumors for which checkpoint inhibitor therapy has had little success,” said Asher Nathan, NeoTX Therapeutics’ Chief Executive Officer. “The safety profile of naptumomab alone and in combination with interferon has been demonstrated in clinical studies in hundreds of patients with solid tumors. Naptumomab can enhance T cell activation and infiltration in tumors and can remodel the immunosuppressive tumor microenvironment. In preclinical models, naptumomab has a synergistic effect with checkpoint inhibitors which could translate into durable responses in patients.”
NeoTX Therapeutics Ltd. is a clinical-stage biopharmaceutical company dedicated to developing promising therapeutic candidates in the field of immuno-oncology (www.NeoTX.com).
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About Naptumomab Estafenatox:
Naptumomab estafenatox is the lead compound in NeoTX’s STR platform. The STR platform offers unique advantages in the field of T cell redirection. STR compounds induce the activation and expansion of specific T cells outside of the tumor microenvironment and redirect the T cells to attack the tumor cells.
Naptumomab estafenatox was licensed from Active Biotech in 2016.
About Active Biotech:
Active Biotech A.B (NASDAQ Stockholm: ACTI) is a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer.
Durvalumab, a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumor’s immune-evading tactics and inducing an immune response. As part of a broad development program, durvalumab is being investigated as monotherapy and in combination with immuno-oncology, small molecules, and chemotherapies across a range of tumors and stages of disease.
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