STOCKHOLM, November 8, 2021 / PRNewswire / – Cantargia AB today provided an update on the progress in developing a manufacturing process for CAN10 and clinical trial preparations, with minor adjustments to the schedule. The development of a manufacturing process for CAN10 was successful and high yields were obtained in the initial productions. Due to the high demand for COVID-19 vaccines, there is a global shortage of raw materials and consumables needed to manufacture clinical grade substances. Therefore, the start of production of CAN10 for use in clinical trials has been moved from Q4 2021 to Q1 2022. Therefore, the first clinical study for CAN10 is expected to start in Q3 2022.
Cantargia is developing pharmaceutical products based on antibodies against the accessory interleukin-1 receptor protein (IL1RAP). The main CAN04 project (nadunolimab) is in phase IIa of clinical development for the treatment of cancer while Cantargia’s second project, CAN10, is in preclinical development for inflammatory and autoimmune diseases.
Cantargia previously announced that a manufacturing agreement had been signed for CAN10, which would supply the drug product needed to conduct toxicology studies as well as the first clinical study. So far, all activities related to the development of a manufacturing process have been carried out according to plan. This includes the development of cell lines, the manufacture of initial small-scale productions, the adaptation of the manufacturing process to medium-scale production and the development of formulations. In addition, sufficient quantities of CAN10 for toxicological studies have been produced. It is important to note that high yields of the antibody were obtained in the initial productions and that the drug product generated has good stability, suggesting a long shelf life. Thus, several risks associated with the manufacture of the CAN10 have been mitigated.
Globally, the supply of raw materials and consumables necessary for the large-scale manufacture of clinical-grade substances has become limited, in large measure due to the high demand for the production of COVID-19 vaccines. This resulted in minor adjustments to the schedule for the production of CAN10 antibodies for the initial clinical trial. Production of the drug product required for the Phase I clinical study for CAN10 will be completed in the first quarter of 2022 rather than the fourth quarter of 2021 as originally planned. As a result, Cantargia plans to launch the Phase I clinical study for CAN10 in the third quarter of 2022.
âWe are delighted with the progress made in developing a manufacturing process for CAN10 and are delighted to be taking the final steps before clinical trials. Over the next few months, we plan to meet with regulatory authorities to discuss the design of the first clinical trial for CAN10. “ said GÃ¶ran Forsberg, CEO of Cantargia.
For more information, please contact:
GÃ¶ran Forsberg, CEO
Telephone: +46 (0) 46-275 62 60
Email: [email protected]
This is information that Cantargia AB is required to make public in accordance with the EU Market Abuse Regulation. The information was submitted for publication, through the contact person indicated above, at 3:45 p.m. CET on November 8, 2021.
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 IL1RAP protein, implicated in a number of forms of cancer and inflammatory diseases. The main project, the nadunolimab antibody (CAN04), is being studied clinically in combination with chemotherapy or immune therapy with a primary focus on non-small cell lung cancer and pancreatic cancer. Intermediate positive data from the combination with chemotherapy indicate greater efficacy than expected from chemotherapy alone. Cantargia’s second project, the CAN10 antibody, focuses on the treatment of severe autoimmune / inflammatory diseases, initially focusing on systemic sclerosis and myocarditis.
Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at www.cantargia.com.
The CAN10 antibody binds strongly to its IL1RAP target and has a unique ability 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. Therefore, CAN10 will initially focus on two serious diseases: myocarditis and systemic sclerosis. The efficacy of CAN10 has been demonstrated in preclinical in vivo models where a CAN10 surrogate antibody significantly reduced the development of inflammation and fibrosis in a myocarditis model and significantly counteracted deterioration of cardiac function. . CAN10 also inhibited the development of the disease in models of peritonitis, psoriasis and psoriatic arthritis. CAN10 is currently in preclinical development and the first clinical trial is expected to begin in the third quarter of 2022.
About nadunolimab (CAN04)
The CAN04 antibody binds tightly to its IL1RAP target and functions by inducing ADCC and blocking IL-1Î± and IL-1Î² signaling. Thus, CAN04 may counteract the contribution of the IL-1 system to the immunosuppressive tumor microenvironment and the development of resistance to chemotherapy. CAN04 is being studied in several ongoing clinical trials. In the CANFOUR phase I / IIa study, first-line combination therapy is being investigated with standard chemotherapies in patients with PDAC (gemcitabine / nab-paclitaxel) and patients with NSCLC (cisplatin / gemcitabine) (NCT03267316) . Intermediate positive data for combination therapies show durable responses or pseudo-progression in patients with PDAC, resulting in a median iPFS of 7.8 months and a median survival of 12.6 months. Higher efficacy was also observed in patients with NSCLC with a median PFS of 7.2 months. A response rate of 53% was observed in patients with non-squamous NSCLC, with even higher responses in patients previously treated with pembrolizumab. These results show greater efficacy than that expected from chemotherapy alone. CAN04 is also being studied with chemotherapy in the phase I CAPAFOUR study, with the FOLFIRINOX protocol for the first-line treatment of metastatic PDAC (NCT04990037), and in two other clinical studies, CESTAFOUR and TRIFOUR, in other forms of cancer, including biliary tract cancer, colorectal cancer, and triple negative breast cancer. CAN04 is also being evaluated with the immune checkpoint inhibitor pembrolizumab, with or without chemotherapy, in the phase I study CIRIFOUR (NCT04452214).
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