Nordic Nanovector AS
Nordic Nanovector AS, established in 2009, is a privately held company based in Oslo, Norway. Our mission is to develop innovative radioimmunotherapeutics that target difficult to treat cancers using the company’s proprietary nanovector targeting technology. Nordic Nanovector intends to commercialise its product candidates through strategic alliances and partnerships with experienced oncology businesses and by establishing its own sales and marketing capabilities in selected markets.
The company’s lead product candidate, Betalutin™, is a radioimmunotherapeutic that aims to prolong the life expectancy and improve the quality of life of people who suffer from non-Hodgkin Lymphoma (NHL). The product candidate is currently undergoing a Phase I/II clinical trial for treatment of relapsed NHL.
Lymphoma is the name for blood cancers that develop in the lymphatic system. There are two main types of lymphoma; Hodgkin lymphoma and non-Hodgkin Lymphoma (NHL).
Non-Hodgkin Lymphoma is a diverse group of lymphomas distinguished by the characteristics of the cancer cells associated with each disease type. Most people with NHL have a B-cell type of NHL (about 80 to 90 percent). The others have a T-cell type or an NK-cell type of lymphoma. The various forms of NHL can be furthermore classified into slow growing (indolent) and fast growing (aggressive) types of disease.
NHL is the 10th most common cancer with 386 000 new cases reported world-wide in 20121. Approximately 731,277 people were either living with lymphoma or were in remission in 2013. The majority of this group, 558,340, were people with NHL2. There is a substantial mortality rate related to the non-Hodgkin Lymphoma, and NHL is the 11th most common cause of cancer death worldwide. There were more than 199,000 deaths from NHL reported in 20123.
Some patients with aggressive NHL can be cured with existing CD20 based immuno- and chemotherapies. For patients with indolent NHL, treatment may keep the disease in check for many years. Although there has been an improvement in the outcomes for NHL patients due to introduction of new treatments, there is still a high mortality rate and there remains a clear unmet medical need for new therapies.
Radioimmunotherapy (RIT) is a targeted form of radiotherapy in which cytotoxic radionuclides are linked to antibodies in order to allow delivery of said radionuclides directly and specifically to cancer cells (Figure 1). RIT has a mechanism of action that allows for a much greater cytotoxic impact on bulky poorly vascularized tumor masses than is possible with immunotherapies and immunoconjugate therapies. The cross-fire advantage that RIT has, allows for effective treatment of both targeted cancer cells, as well as of adjacent tumor cells which may lack the appropriate antigenic determinants or necessary vascularization to be treated by other therapies.
Figure 1. Illustration of how Betalutin™ attaches itself to the CD37 antigen and delivers a lethal dose of Beta radiation to a lymphoma cell
Nordic Nanovector’s lead product candidate, Betalutin™, is a novel form of therapy currently being developed for use in the treatment of non-Hodgkin Lymphoma. The current standard treatment for NHL consists of a combination of a CD20 based immunotherapy and various chemotherapies. Betalutin™ targets the CD37 antigen on lymphoma cells and, as such, may become a therapeutic option when combinations with CD20 based immunotherapies are no longer effective, or when the patients no longer can tolerate further cycles of chemotherapy.
Betalutin™ consists of the radionuclide Lutetium-177 (Lu-177) which is joined to the B-cell seeking carrier/antibody, HH1. Lu-177 is a beta-particle emitter. Beta particles are electrons with energy and effective radius of tissue penetration suitable for treating lymphomas. The HH1 antibody in BetalutinTM binds to the CD37 antigen of B-cells. The CD37 antigen has previously been tested as a target for high dose RIT with promising results with the 131I-MB-1 radioimmunoconjugate (Press et al., 1989). The HH1 antibody internalizes after the binding of Betalutin™ to the tumor cell, which is beneficial as it results in a prolonged irradiation of the tumor cells by Lu-177 from within (Repetto et al. 2013).
Betalutin™ is currently in clinical development. A Phase I/IIa clinical trial to study the treatment of relapsed CD37 positive non-Hodgkin Lymphoma is currently enrolling patients. The objective ofthe Phase I part of the study is to define the maximum tolerable dose of 177Lu-DOTA-HH1 (Betalutin™), assess safety and toxicity, pharmacokinetics, biodistribution and efficacy. Upon completion of the phase I part of the study, a dose will be selected for the phase II part of the study, which is designed to investigate tumor response rates and progression free survival in NHL patients.