Date: 08-May-2020

Nordic Nanovector Receives US Patent Covering Use Of Betalutin To Sensitise B-cell Cancer Cells To CD20 Immunotherapy

Nordic Nanovector ASA announces the grant of a US patent covering the use of Betalutin (177Lu-satetraxetan-lilotomab) for sensitising CD37-positive B-cell cancer cells before treatment with CD20 immunotherapy (such as rituximab/RTX).

The patent strengthens Nordic Nanovector's overall patent estate around the use of Betalutin in combination with other drugs that target antigens presented on the surface of tumour cells in patients with B-cell malignancies, such as Non-Hodgkin's Lymphoma (NHL).

The company believes that the combination of Betalutin and anti-CD20 modalities could represent a novel dual immunotherapy approach for the treatment of NHL patients who are becoming resistant to standard-of-care CD20 therapy. The company is currently investigating the combination of Betalutin and RTX in its ongoing phase 1b (Archer-1) clinical trial in patients with second-line relapsed/refractory follicular lymphoma (a major type of NHL).

The US patent claims are based on the scientific discovery by Nordic Nanovector scientists that use of Betalutin promotes an increase in expression of tumour-specific antigens, such as CD20. In a preclinical mouse model of NHL, the combination of Betalutin and RTX significantly prolonged overall survival compared to treatment with either agent alone, possibly by reversing downregulation of CD20 and resistance to RTX.

Patent No. 10,646,599, which is entitled "Method for upregulating antigen expression," will be active until 2034 with the option of prolonging for five additional years.

Jostein Dahle, chief scientific officer, Nordic Nanovector, commented, "We are pleased that this important patent has been granted in the US, expanding our global patent estate on the use of Betalutin as a potential new treatment for NHL. Patients' whose cancer no longer respond to standard-of-care CD20-targeting therapies have limited options. We have seen promising results from the first cohort in Archer-1 receiving Betalutin plus RTX, in which the combination was well tolerated, and we have seen strong results in the first few patients. The second cohort is being recruited and we expect to be able to evaluate the results later this year."

Betalutin, a novel CD37-targeting antibody-radionuclide-conjugate designed to advance the treatment of non-Hodgkin's lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly US$ 29 billion by 2026. Nordic Nanovector retains global marketing rights to Betalutin and intends to actively participate in the commercialisation of Betalutin in the US and other major markets.