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Cantargia

Analyytikko

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Nettovaikuttavuus

Muut analyysit
15.10.
2021

Redeye comments on the positive opinion of the Committee for Orphan Medicinal Products concerning an orphan designation of nadunolimab in pancreatic cancer from yesterday. This news follows on the orphan drug designation from the FDA last month.

Tiedotteet
14.10.
2021

Cantargia AB today announced that the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) has issued a positive opinion for orphan designation of nadunolimab (CAN04) for treatment of pancreatic cancer. The European Commission is now expected to grant the orphan designation. This provides a range of incentives in the continued clinical development of CAN04 in pancreatic cancer.

Tiedotteet
30.9.
2021

Cantargia AB holds a large number of granted patents related to IL1RAP as a target for antibody treatment of cancer. One of Cantargia's European patents for treatment of solid tumors, EP 3020730 B1, was opposed by a third party in 2019. Following a hearing at the European Patent Office (EPO), the Opposition Division confirmed the validity of this European patent and rejected the opposition. Cantargia's extensive patent protection for IL1RAP-targeting therapy is thus fully maintained with unchanged claim scope.

Tiedotteet
29.9.
2021

Cantargia AB today announced that the clinical trial application for the phase Ib/II clinical study TRIFOUR has received approval by the regulatory authority and ethics committee in Spain. This study broadens Cantargia's clinical program to include triple negative breast cancer (TNBC) and will investigate nadunolimab (CAN04) in combination with chemotherapy in up to approximately 120 patients with TNBC. The first patient is expected to be enrolled in November 2021.

Muut analyysit
23.9.
2021

Redeye has a positive view of Cantargia's obtaining orphan drug status. It provides some benefits, the most important of which are described in our comment.

Tiedotteet
22.9.
2021

Cantargia AB today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation in the US to nadunolimab (CAN04) for the treatment of pancreatic cancer. This provides access to various incentives in the continued clinical development of nadunolimab in pancreatic cancer.

Tiedotteet
16.9.
2021

Cantargia AB today presented novel interim results in non-small cell lung cancer (NSCLC) patients for nadunolimab (CAN04) in combination with gemcitabine/cisplatin at the ESMO Congress. The data read-out was conducted in August 2021 and the efficacy analysis includes 27 patients. In summary, compared to historical controls, the efficacy was higher than for chemotherapy alone, with an overall response rate (ORR) of 53 % in non-squamous NSCLC. In the total population, ORR was 48% and median progression-free survival (PFS) 7.2 months.

Tiedotteet
13.9.
2021

Cantargia AB today announced the publication of an abstract disclosing novel clinical interim data from the CANFOUR study. The abstract was submitted in May 2021 for the upcoming ESMO Congress starting 16 September, 2021. In 15 non-small cell lung cancer (NSCLC) patients evaluated for efficacy, nadunolimab (CAN04) combined with gemcitabine/cisplatin showed an overall response rate (ORR) of 60%, a median duration of response (DOR) of 6.2 months and a median progression-free survival (PFS) of 8.2 months.

Tiedotteet
10.9.
2021

Cantargia AB today announced approval to start the phase I/II clinical study CESTAFOUR by the regulatory authority and ethics committee in France. This study broadens the clinical development for nadunolimab (CAN04) to include biliary tract cancer (BTC), colorectal cancer (CRC) and late-stage non-small lung cancer (NSCLC) and will evaluate CAN04 in combination with standard of care chemotherapy. The study will be conducted at approximately 20 clinical centers in Europe and will include up to a total of 165 patients.

Tiedotteet
10.9.
2021

Cantargia AB today announced that all planned 40 patients with advanced pancreatic cancer (PDAC) have started therapy in the phase IIa extension cohort in the CANFOUR study. Preliminary data from these patients confirm a good safety profile of nadunolimab (CAN04) combined with gemcitabine/nab-paclitaxel. Presentation of safety and efficacy data for the extension cohort is planned for the first half of 2022. Adding this group to the primary group previously analyzed, more than 70 patients with PDAC have now received CAN04 combined with chemotherapy.

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