Cantargia reports encouraging new CAN10 toxicology results and schedules phase I trial for 2023
STOCKHOLM, Feb. 22, 2022 /PRNewswire/ -- Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) today 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. 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," said Göran Forsberg, CEO of Cantargia.
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.
For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
E-mail: goran.forsberg@cantargia.com
This is information that Cantargia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 15.00 CET on 22 February 2022.
About Cantargia
Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. The lead project, the antibody nadunolimab (CAN04), is being studied clinically in combination with chemotherapy or immune therapy in a series of clinical studies – CANFOUR, CIRIFOUR, CAPAFOUR, CESTAFOUR and TRIFOUR – with a primary focus on non-small cell lung cancer and pancreatic cancer. Positive interim data from the combination with chemotherapy indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second project, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases, with initial focus on systemic sclerosis and myocarditis.
Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at www.cantargia.com.
About CAN10
The CAN10 antibody binds strongly to its target IL1RAP and has a unique capability to simultaneously inhibit signaling via IL-1, IL-33 and IL-36. Inhibition of these signals can be of significant value in the treatment of several inflammatory or autoimmune diseases. The initial focus of CAN10 will be on two severe diseases: myocarditis and systemic sclerosis. In a preclinical in vivo model of myocarditis, a CAN10 surrogate antibody significantly reduced the development of inflammation and fibrosis, and significantly counteracted the deterioration of the cardiac function. CAN10 also inhibited disease development in models of systemic sclerosis, peritonitis, psoriasis and psoriatic arthritis. CAN10 is currently in late-stage preclinical development and the first clinical trial is expected to begin in early 2023.
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CAN10 tox PR Eng 220222 Final |
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