Nordic Nanovector has further delayed a readout from its pivotal lymphoma trial, pushing a planned regulatory filing out to three years after the initial target. The latest setback marks the end of the line for Luigi Costa, who is stepping down as CEO by “mutual agreement” with the company’s board.
Oslo, Norway-based Nordic Nanovector moved the readout from the phase 2b trial of Betalutin from the second half of 2019 to the first half of 2020 after reassessing recruitment rates. Nordic Nanovector had aimed to start the follicular lymphoma trial last year but is yet to dose a patient.
The delay means Nordic Nanovector now plans to file for approval in 2020, not 2019. In isolation, that is a relatively small slip but it isn’t the first time Nordic Nanovector has failed to hit a timeline. Management delayed the filing by two years in 2015 and investors have grown twitchy in recent months amid doubts about the progress of the phase 2b and a Rituxan combination trial.
Those doubts, the stock slide they caused and the missteps underpinning them have cost Costa his job.
“Nordic Nanovector has recently taken a significant hit to its market valuation and credibility with the Norwegian investment community. As CEO, I have to take full responsibility for this. For the good of the company, its employees and investors, I have therefore decided to step down from my position as I hope it will allow the company to receive the support it deserves,” the ex-CEO said in a statement.
The slow progress under Costa could have implications for the prospects of Betalutin. Last year, Bayer won approval for Aliqopa, a PI3K inhibitor that treats the same third-line follicular lymphoma patients targeted by Betalutin. Nordic Nanovector thinks Betalutin is safer and more effective than Aliqopa. But ceding a three-year headstart to Bayer means Betalutin will face an uphill commercial struggle if it comes to market.
Those considerations and doubts about Nordic Nanovector’s ability to execute have tempered enthusiasm for Betalutin. Early data on the anti-CD37 antibody-radionuclide conjugate enabled the biotech to bounce back from the original, two-year delay to its filing and sent its stock up by as much as 200% over its 2015 IPO price.
In the phase 1/2 trial, single-agent Belatulin triggered objective responses in more than half of follicular lymphoma patients. Around one-quarter of subjects experienced complete responses.
Sentiment has soured this year, though, causing the share price to fall to around the same level as when the company first went public. The slip follows delays to the start of enrollment in the phase 2b, which is assessing third-line use of Betalutin in 130 patients with follicular lymphoma, a form of non-Hodgkin's lymphoma.
Costa is one casualty of the phase 2b delay. The other is Humalutin. Nordic Nanovector had planned to move the candidate into human testing later this year. Now, needed to eek out its cash until the phase 2b readout, Nordic Nanovector has indefinitely postponed the start date.