Nordic Nanovector pulls the plug on troubled Paradigme trial, moves for restructuring

Signs that Nordic Nanovector’s Paradigme trial was on its last legs were clear last month when the company initiated a comprehensive review after enrollment ground to a halt.

Now, the trial has been taken off life support. The company is discontinuing a phase 2b trial for an anti-CD37 antibody radionuclide conjugate, dubbed Betalutin, to treat patients with refractory follicular lymphoma after completing the review and engaging with regulatory agencies. As a result of axing its lead asset, the company also announced restructuring and cost-cutting measures Wednesday. However, details were slim. A spokesperson said more details would be shared in the company's second-quarter earnings report on August 31.

Nordic initiated a review of the trial after failing to enroll any patients in May, just the latest problem that’s delayed a data readout for years. Dosing in the trial began more than four years ago. In January of this year, citing the impact of the COVID-19 pandemic and the omicron variant, the company delayed the readout from the first half of 2022 to the second half. From January until Wednesday, only three additional patients were enrolled. Since the end of the first quarter, the company has burned through more than $7 million, with a current runway of $27.6 million.

Although Nordic has yet to provide a full look under the hood of the trial, the company says Betalutin has not met expectations. Only a third of patients responded to the treatment with an approximate duration of six months. Thus, the company concluded that “the demonstrated profile is no longer sufficiently competitive to bring Betalutin to the market in the third line relapsed and refractory FL indication, within a timeframe that makes financial and commercial sense.” 

Though in the same breath, the company stressed that Betalutin still could have value and hinted at plans to explore potential partnerships. Nordic will also seek “advice” from the FDA to see if there’s a regulatory path forward for the med in a different patient population. 

Irrespective of these last-ditch efforts, the company will focus on other assets, all of which focus on the CD37 protein. Among the other prospects include Humalutin, a radioimmunotherapy for patients with non-Hodgkin lymphoma and Alpha37, an alpha-emitting radioimmunotherapy being co-developed with OranoMed to treat relapsed/refractory chronic lymphocytic leukemia.