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Immunotherapeutics biotech Nordic Nanovector demonstrates progress

Authored by Karl Simpson

Biotechnology IPOs have been hitting the market in significant numbers over the 2013-14 period. In the main, these companies were North American companies. However, this fever has spread across the Atlantic and has arrived on the shores of the European continent. One such company which has recently announced its public listing is Nordic Nanovector. I went to Olso to meet with the CEO, Jan Alfheim, to get his perspective on the future of the company. Alfheim, joined the company in August 2011 and has previous experience in the cancer therapy market, most recently at Clavis Pharma as CBO where he brokered the deal with Clovis Oncology.

For Nordic Nanovector, the summer has bought a couple of important announcements, firstly their lead drug candidate Betalutin™ was granted Orphan Drug Designation by the European Medicines Agency for the treatment of follicular lymphoma. Quickly on the heels of this announcement, the company secured additional funding of NOK 250 million ($40 m) in a pre-IPO private placement among new and existing shareholders. This financing added NOK 45 m ($7,5m) from  Nordic Nanovector’s largest investor HealthCap to the NOK 50m ($8,5 m) original investment Healthcap made in the company in 2013 (secured in two tranches of NOK 25m ($4m)).

Nordic Nanovector is a small innovative cancer therapy drug developer using radio-immunotherapeutics to address B-cell Non-Hodgkin Lymphoma (NHL) as a primary indication. The company was founded by Roy Larsen, Øyvind Bruland and Jostein Dahle; 2 founders of Algeta, another Norwegian company which was recently acquired by Bayer for $2.9bn, meaning Nordic Nanovector’s founders have clearly been there before. The company’s lead product is Betalutin™ , a radionuclide, lutetium-177, conjugated to a tumour seeking murine monoclonal antibody (mAbs), HH1, against CD37 antigen. This can be used for irradiation of malignant metastasized tumours with minimal damage to nearby healthy normal tissue. The product uses a standard linker technology (DOTA chelator) which is commercially available and works very well with lutetium. The antibody is a proprietary antibody developed by the Norwegian Radium Hospital in the 1980s.

Jan Alfheim tells me the company is pursuing ‘accelerated clinical pathways’ to approval based on other examples in the field, although this will be data dependant. The product, Betalutin™, has demonstrated promising early clinical data in Phase I/IIa and has what he describes ‘niche buster’ potential in a diseases area (NHL) with a high unmet medical need.  When discussing the IPO option, Alfheim tells me this opportunity to access capital markets “gives the company strategic options to maximise its unencumbered assets to maximise shareholder value”. These options include “independently commercialising in some markets as well as entering strategic partnering agreements at the right time”. This independent opportunity is particularly open to Nordic Nanovector given the limited patient population of the indication and the resources required to market to these patient volumes.

Alfheim points to Non-Hodgkin Lymphoma as a disease which is projected to be globally worth $7bn by 2017 and which is still very much a high unmet medical need with mortality rate around 50% of the incidence rate of the disease.  “Betalutin has a differentiating advantage over existing therapies, particularly those addressing the CD20 antigen which is most of the current therapeutic options.”

With existing therapies still achieving high prices but patient mortality more than 50%, the opportunity for Betalutin™ to achieve a market share at a comparable price-point makes the economics for Nordic Nanovector very encouraging, especially for shareholders in the company. The company has already conducted some pricing analysis through a consultancy to look at competitive landscape and the pricing corridor for the product, which perhaps points the importance for early stage biotechs to answer these questions over pricing very early

Betalutin™ – A new approach to NHL treatment

The premise for the therapy Betalutin™ which Nordic Nanovector is developing, is to bring to patients a far more targeted medicine. A new form of radio-immunotherapy, the product targets the cell-surface CD37 antigen found on more than 80% of non-Hodgkin lymphomas. The anticipated benefits are therefore; greater efficacy, better patient safety and therefore better quality of life. This single injection medicine would be far less invasive for patients and is tailored to the particulars of the patient’s case.

The company is focused initially on the indolent setting of NHL. Tumour biology and tumour cell transformation (heterogeneity and bulkiness of tumours) in indolent NHL make a single cell kill approach of all tumour cells very difficult to achieve. Immunotherapies such as rutiximab and immunoconjugate therapies uses the single cell approach where the antibodies seek out their antigen targets on the surface of individual cancer cells to elicit a response. If one doesn’t have a homogenous mass of well vasculized cancer cells, it is not possible  to get a complete response in all patients. This is seen with an immunotherapy like rituximab where response rates as a mono-therapy have been reported to be  in a range of 10% -50%  (complete response rate) and 48% – 74% (overall response rate). With Betalutin™, the company is able to achieve a cross-fire effect with its radio-immunotherapy. The antibodies seek the antigen target on the surface of the cancer cell, latch on, and the radioactive isotopes emit a burst of radiation directly to the tumour cell and surrounding tumour cells. It is this systemic radiation treatment which gives it its ‘cross-fire’ effect, as radiation emitted from isotopes is deposited over several cell diameters and even poorly perfused or non-antigen expressing cells within a tumour mass suffer the cytotoxic radiation effect.

Given two of Nordic Nanovector’s founders were involved with successful neighbour Algeta and their lead cancer therapy, Xofigo, you might imagine that the underlying technologies might be quite similar. Not so. Alfheim explains, “Xofigo is focused on metastatic bone cancer and here you need a high energy, short range emitter, so it can attach itself to the cancer cell, kill it and not affect the healthy tissues”. Comparably, he adds “in bulkier diseases like lymphomas which have been shown to be very radio sensitive, you can use a beta emitter which can penetrate farther with lower energy, affecting many more cells with the isotope.” There is a very clear strategy the company’s founders took to pick the right radiation type for the right disease.

Alfheim explained that the preclinical results seen in SCID mice have been incredibly positive as the antibodies bound to CD37 (HH1) are internalised and significantly increase the irradiation of the tumour cells which has resulted in an improved survival. In the first clinical trial the company has also seen some encouraging early results, with patients responding almost immediately.

The company is presently focused on conducting a Phase I/II study in Follicular lymphoma (indolent setting) as well as a Phase II study in aggressive lymphoma. Results of the phase I study will be published later this year.

Nordic Nanovector is a company with an experienced executive team which takes in many notable biotechs, including; Clavis Pharma, Algeta, Invitrogen, Photocure and Neurochem. This experience is further strengthened by a deeply experienced Board including the Algeta experience of the founders mentioned prior. At the time of my meeting with Jan Alfheim, the selection of the exchange on which to list Nordic Nanovector had not been taken by the Board, although on July 7th it listed on the Norwegian OTC system (NOTC) under the symbol of NANO. The company is certainly reaching a very exciting phase of its evolution and Alfheim described his response to seeing the effect of the drug in patients during the dose-finding study as a personal ‘WOW’ moment, so he takes the company forward with great enthusiasm for the potential it might have in treating patients with Non-Hodgkin Lymphoma and other B-cell cancers.

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