Nordic Nanovector has raised NOK 499 million ($60 million) in an oversubscribed private placement. The cash injection will enable Nanovector to test its CD37-targeting antibody-radionuclide conjugate (ARC) in combination with rituximab, better known as Roche’s cancer powerhouse Rituxan.
Oslo, Norway-based Nanovector regards the combination as a potential second-line treatment for follicular lymphoma, a type of non-Hodgkin lymphoma (NHL). And, with investors quick to snap up shares this week, it now has the financial firepower to put the theory to the test in a phase 2 study.
Nanovector is advancing into phase 2 on the strength of clinical data on its candidate, Betalutin, as a monotherapy and preclinical evidence of its effectiveness in combination with rituximab. The firm presented both sorts of data at the 2016 American Society of Hematology Annual Meeting and Exposition in the days preceding the private placement.
The preclinical combination data suggest Betalutin can increase the uptake of rituximab into NHL tumors and its binding to NHL cells. If that carries through into the clinic and improves outcomes in patients, the combination with rituximab could enable rituximab to secure approval as a second-line treatment.
Third-line use as a monotherapy is the near-term focus. In the latest clinical data update, Betalutin delivered an overall response rate of 63%—and complete response rate of 29%—in the 35 heavily-pretreated NHL patients who were evaluable at the time. And data from the pre-dosed arm appeared to back up Nanovector’s belief this approach can prevent the safety issues that cropped up in an earlier version of the trial.
With the data encouraging Nanovector to advance the candidate into the next stage of development next year, the goal is to file for approval in third-line follicular lymphoma in the first half of 2019.
Nanovector has advanced this far fueled by the NOK 575 million it raised 20 months ago in one of the biggest biotech IPOs on a European exchange in 2015. The ARC specialist disappointed investors six months after the IPO by shunting back a planned regulatory filing for Betalutin from 2017 to 2019, but more assured progress since then has seen it regain the lost value and then some. In Oslo, the stock is up 250% since the IPO.
That stock surge has helped Nanovector put together a financing package that will fund advances on multiple fronts. While working on the Betalutin-Rituxan combo phase 2, Nanovector will also move its 177Lu-conjugated chimeric antibody anti-CD37 ARC into phase 1. Nanovector sees the anti-CD37 ARC as a potential first-line treatment for follicular lymphoma, giving it a pipeline that on paper can meet the needs of patients at multiple stages of disease progression.