Dose-escalation study to determine maximum tolerated dose ahead of Phase 2 cohort expansion study
Milestone marks initiation of studies in the NeoTX-AstraZeneca collaboration to study Nap in combination with durvalumab
REHOVOT, Israel, Oct. 28, 2019 (GLOBE NEWSWIRE) — NeoTX Therapeutics, Ltd. today announced the dosing of the first patient in its Phase 1b trial of naptumomab estafenatox (Nap) in combination with AstraZeneca’s checkpoint inhibitor IMFINZI® (durvalumab) for the treatment of advanced or metastatic solid tumors. The company aims to establish the maximum tolerated dose in the dose-escalation Phase 1b study before advancing to a cohort expansion study.
“The dosing of the first patient in our Phase 1b trial is a significant milestone for NeoTX, as it is our first clinical-stage molecule developed with our Selective T Cell Redirection (STR) platform,” said Asher Nathan, Ph.D., chief executive officer of NeoTX. “Previous clinical studies have shown Nap to be well-tolerated, and preclinical work conducted by the NeoTX team supports its broad potential in treating advanced and metastatic tumors, especially in combination with checkpoint inhibitors. We’re looking forward to bringing this therapy to patients suffering from advanced cancers that have thus far been unresponsive to therapy with checkpoint inhibitors alone.”
The open-label, multicenter, dose-finding Phase 1b trial (NCT03983954) will enroll patients with previously treated advanced or metastatic tumors. Patients will be treated with a combination of Nap and durvalumab.
About the STR platform
The STR platform leverages the body’s natural antibacterial immune response to selectively expand and redirect T cells to rapidly infiltrate and kill tumor cells, offering 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.
About naptumomab estafenatox (Nap)
Naptumomab estafenatox is the lead compound in NeoTX’s STR platform and is designed to target the 5T4 antigen that is present on many tumors.
Naptumomab estafenatox was licensed from Active Biotech in 2016. Active Biotech AB (publ) is a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer. Please visit www.activebiotech.com for more information.
Durvalumab (IMFINZI®) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses.
Imfinzi is approved for unresectable, Stage III non-small cell lung cancer (NSCLC) in more than 50 countries including the US, in the EU, and Japan based on the Phase III PACIFIC trial. Imfinzi is also approved for previously-treated patients with advanced bladder cancer in 10 countries, including the US.
As part of a broad development program, Imfinzi is also being tested as a monotherapy and in combination with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, small cell lung cancer, bladder cancer, head and neck cancer, liver cancer, cervical cancer, biliary tract cancer and other solid tumors.