Nordic Nanovector has increased the amount it is aiming to raise in its upcoming IPO by 25%. The cash will allow Nordic Nanovector to accelerate clinical development of the antibody-radio-conjugate Betalutin in its secondary indication, diffuse large B-cell lymphoma (DLBCL).
Oslo, Norway-based Nordic Nanovector expected work toward a targeted 2017 regulatory filing for Betalutin in follicular lymphoma (FL) would swallow up most of the money raised in the IPO. But with the biotech now aiming to pull in NOK 500 million ($60 million)--and tightening its price range to NOK 31 to NOK 32 per share in response to strong demand--it has the financial flexibility to go after other indications sooner. If everything goes to plan, Nordic Nanovector will have enough money to fully fund Phase I and II trials of Betalutin in DLBCL.
Nordic Nanovector has a two-track development strategy for Betalutin in DLBCL, with the drug being developed simultaneously as a conditioning regimen--which are given before a patient receives blood stem cells--and as a second line treatment for people who are unable to receive such transplants. Phase I trials in both indications are due to start later this year, soon after which Nordic Nanovector will start preparing for midstage studies. The Phase II two-arm conditioning regimen study and single-arm second line trial are both expected to enrol up to 90 patients and wrap up in 2018.
By then, Nordic Nanovector hopes to already have one approval to its name. The company thinks the Phase II trial in FL that is due to start in the coming months will be sufficient to snag Betalutin a FDA nod as a third-line treatment. At this stage though, Nordic Nanovector is yet to decide on an optimal dose. The Phase II trial will split 45 patients across three different doses. Once Nordic Nanovector has assessed which dosage looks most effective, it will start enrolling up to 105 patients in that regimen and drop the other two arms. A Phase III trial as a second-line treatment is planned for 2017.
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