News

Sunstone Life Science Ventures today announced the first closing of its Sunstone Life Science Ventures Fund IV (“Sunstone LSV IV”) at €80 million. The investment strategy of the new fund is a continuation of Sunstone’s successful strategy of investing in novel therapeutics with the potential to improve the quality of patient care and treatment. The typical investments are based on strong science and technology with innovative products addressing unmet medical needs within the framework of an attractive business case.

Orphazyme A/S, a biopharmaceutical company dedicated to developing treatments for patients living with rare diseases, today announced the full data set for its Phase II/III clinical trial of arimoclomol in NPC, a devastating rare genetic disorder. Treatment with arimoclomol adjunct to routine clinical care resulted in a 74% reduction in disease progression (p-value =0.0506) as measured by the primary endpoint, 5-domain NPC Clinical Severity Scale (NPC-CSS). In the predefined subgroup of patients of 4 years and older (44 out of 50 randomized patients in the trial), the treatment difference was statistically significant with a minimal disease progression at month 12 in the arimoclomol-treated group (p-value =0.0219). A highly statistically significant treatment difference was observed in another predefined subgroup analysis, requested by the European Medicines Agency (EMA), that compared arimoclomol to placebo control in patients receiving miglustat as a part of routine clinical care (p-value =0.0071).

Alligator Bioscience (Nasdaq Stockholm: ATORX), announces the launch of a novel concept in bispecific antibody formats, RUBY™. The RUBY concept gives Alligator competitive abilities to generate therapeutic antibodies that are both efficient and highly manufacturable in a shorter time period than what is currently possible.

“The bispecific format RUBY significantly strengthens our existing technology platform. We now have all technologies in-house to generate virtually any future bispecific therapeutic antibody, tailor-made for immuno-oncological applications,” said Per Norlén, CEO of Alligator. “Moreover, the RUBY format allows for superior binding and dramatically shortened development timelines which is a crucial competitive factor”.

VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, today announced that the first patient has been dosed in a Phase I/II trial evaluating VXM01 oral immunotherapy in combination with avelumab*, a human anti-PD-L1 antibody, for the treatment of glioblastoma. The trial is part of a collaboration agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc.

This trial is a multicenter, open-label, Phase I/II trial (EudraCT #: 2017-003076-31) to evaluate the safety and efficacy of VXM01 in combination with avelumab in patients with recurrent glioblastoma. The trial is planned to enroll a total of 30 patients at approximately eight clinical sites in Europe. The primary objective of the study is to evaluate the safety and tolerability of VXM01 in combination with avelumab. Secondary objectives include progression-free survival and overall survival.