NLS Drug development

The company has announced that the first patient has been enrolled in the fimaChem RELEASE study with registration intent in inoperable bile duct cancer patients. The pivotal RELEASE study has the potential of accelerated/conditional marketing approval as a first-line treatment given the rare disease status and high unmet medical need in this patient population, which […]

The company has submitted clinical trial authorization (CTA) application to initiate a Phase I study of its fully owned 4-1BB antibody ATOR-1017 for the treatment of metastasizing cancer. ATOR-1017 is an immunostimulatory IgG4 antibody that activates tumor-specific T cells and NK cells through the costimulatory receptor 4-1BB. T cells and NK cells have the capacity […]

The company has announced the publication of the first data from two parallel Phase l/lla clinical trials of its lead product candidate BI-1206 as single agent and/or in combination with rituximab, currently being conducting in the UK and the US/EU respectively. In the UK trial, 10 patients have received single agent therapy with up to […]

Data from the company’s Phase 1/2 O-12-M1 clinical study of lead candidate melflufen demonstrate that melflufen may offer positive disease stabilization and favorable time to next treatment (TTNT) outcomes in heavily-pretreated patients with relapsed/refractory multiple myeloma (RRMM). Overall conclusions from the data presented include: Melflufen plus dexamethasone treatment results in disease stabilization in 76% of RRMM […]

The company has entered a non-binding term-sheet with STADA Arzneimittel for cooperation regarding sales and marketing of Spherotide for Europe, and furthermore, the company updates on its plans to take the product into a phase III study in endometriosis patients. Non-binding term-sheet with STADA The company´s non-binding term-sheet with STADA consists of an agreement to […]

The company has completed treatment of 25% of patients in the STAR trial of its medical device, SiPore15, and is well on track to finalize results by Q4 of this year. The company also reports that treatment compliance is good and the safety profile continues to look positive. STAR trial STAR aims to demonstrate that […]