Cantargia has reported new encouraging results from non-GLP toxicology and pharmacokinetic studies for its anti-inflammatory IL1RAP-binding antibody CAN10.
Results show no toxicologically relevant changes using a new subcutaneous formulation, with high bioavailability and desirable pharmacological half-life, states the company. Further studies using intravenous administration show good safety by repeated dosing at 50 mg/kg. The GLP toxicology studies for CAN10 are scheduled to start Q2 2022, with timelines slightly adjusted to fit with global capacity during the COVID pandemic.
CAN10 is Cantargia’s second major program and extends the reach of Cantargia’s IL1RAP platform beyond oncology to inflammatory and autoimmune disease. The non-GLP toxicology studies reported today demonstrate no abnormal clinical signs and no toxicologically relevant changes. Additionally, a newly developed subcutaneous formulation was shown to have high bioavailability and desirable pharmacological half-life. The subsequent GLP toxicology studies required by drug regulators have been scheduled to start in Q2 2022 and are expected to lead to initiation of the phase I clinical trial for CAN10 early 2023.
“We are excited about the progress in the CAN10 project, which adds novel opportunities in anti-inflammatory sectors to our multiple ongoing phase II developments in oncology with nadunolimab. Cantargia’s proactive counter-measures have limited the impact of COVID-related challenges to the development of CAN10, and we expect to take CAN10 into phase I studies early 2023,” says Göran Forsberg, CEO of Cantargia.
The next step
Previously reported non-GLP toxicology and pharmacokinetic studies have not shown any toxicologically relevant changes of CAN10 administered intravenously as a single dose. New studies confirm the favorable safety of CAN10 following repeated intravenous administration at 50 mg/kg and demonstrate that subcutaneously administered CAN10 has above 90% bioavailability and a pharmacological half-life in line with design criteria. Subcutaneous administration of antibody drugs allows treatment in doctors’ offices or a patient’s home environment rather than in a hospital or infusion center, providing flexibility, convenience and other commercial advantages. Obtaining data on the subcutaneous formulation at this early stage allows for these important findings to be incorporated in the phase I clinical development.
In the next step of CAN10’s development, Cantargia will undertake GLP toxicology studies, an integral part of the process leading to the initiation of clinical trials. The usual high demand for safety studies has been exacerbated by additional demand from developers of COVID-19 vaccines and therapies. Cantargia has successfully secured the complete capacity required for the CAN10 GLP toxicology studies involving both intravenous and subcutaneous administration. The study is planned to start in Q2 2022 and the phase I clinical trial for CAN10 is now expected to start early 2023. In parallel, manufacture of CAN10 drug product, intended for use in clinical study, is ongoing and proceeding as planned.
Photo of Göran Forsberg: Cantargia