Oct 4, 2023 · Regulatory information

Cantargia: Third party appeals recent EPO decision to maintain granted Cantargia patent

Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) today reported third party filing of a so-called Notice of Appeal concerning one of Cantargia’s granted European patents, EP3293202. The appeal follows a recent opposition where the European Patent Office (EPO) decided to maintain EP3293202. This patent is part of Cantargia’s robust IP portfolio and encompasses a broad range IL1RAP-binding antibodies, including variants of Cantargia’s lead asset nadunolimab (CAN04). The key patent covering nadunolimab has not been subject to oppositions or appeals.

“We have over the years built up a broad, solid patent portfolio and generated strong clinical as well as preclinical results for nadunolimab and CAN10. This appeal confirms the significant commercial opportunities around Cantargia’s assets and strengthens our view that we are on the right track,” said Göran Forsberg, CEO of Cantargia.

Cantargia has extensive patent protection for IL1RAP-targeting antibodies and their use in therapy and diagnostics of cancer, including leukemias and solid tumors. Cantargia’s patent portfolio includes over 100 patents globally, granted in key commercial territories such as the US, Europe, Japan and China. A composition of matter patent for CAN10 has been granted in the US, with additional applications pending in other major territories.

European patent law allows third parties to file oppositions against newly granted patents. The appeal reported today is a common subsequent step to this process, and the specific background is described below:

In late 2021, oppositions were filed by third parties against EP3293202. This patent belongs to the same family as the composition of matter patent for nadunolimab which remained unchallenged. Following oral proceedings held on July 5, 2023, the EPO Opposition Division ruled that EP3293202 would be maintained with a new claim scope, encompassing a broad range of variants of nadunolimab with similar functional and structural properties.

Cantargia today reported that one of the opponents has filed a Notice of Appeal against the EPO Opposition Division’s decision to maintain EP3293202. Following the Notice, the appellant is to submit its detailed Grounds of Appeal within two months. The appeal process has an expected duration of 2-3 years. It should be noted that Cantargia’s other European patents, or similar patents outside Europe, are not affected by this action.

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 main program, the antibody nadunolimab (CAN04), is being studied clinically primarily in combination with chemotherapy with a focus on pancreatic cancer, non-small cell lung cancer and triple-negative breast cancer. Positive interim data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia’s second development program, 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 nadunolimab (CAN04)
The antibody nadunolimab binds strongly to its target IL1RAP and functions by inducing ADCC and blocking IL-1alpha and IL-1beta signaling. Nadunolimab can thereby counteract the IL-1 system which contributes to the immune suppressive tumor microenvironment and development of resistance to chemotherapy. Nadunolimab is investigated in multiple clinical trials; the phase I/IIa trial CANFOUR evaluates nadunolimab in combination with standard chemotherapies in patients with PDAC (gemcitabine/nab-paclitaxel) or NSCLC (platinum-based chemotherapies) (NCT03267316). Positive interim data show durable responses for the combination therapy in 73 PDAC patients, resulting in median iPFS of 7.2 months and median OS of 13.2 months. An even higher median OS of 14.2 months was observed in a subgroup of patients with high tumor levels of IL1RAP. Strong efficacy was also observed in 30 NSCLC patients with median PFS of 7.0 months and a response rate of 53%; even higher responses were observed in non-squamous NSCLC patients. Early efficacy data from the phase Ib/II trial TRIFOUR (NCT05181462) also shows signs of promising efficacy in TNBC with a 50% response rate for nadunolimab combined with carboplatin/gemcitabine. Nadunolimab is also investigated with chemotherapy in the clinical trials CAPAFOUR (NCT04990037) and CESTAFOUR (NCT05116891), and with the checkpoint inhibitor pembrolizumab in the CIRIFOUR trial (NCT04452214).