News

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.

Anergis, a company developing proprietary ultra-fast Allergy Immunotherapy (AIT), announced today that the Company has successfully completed the mice proof-of-concept study of the second-generation COP allergy vaccines based on its research collaboration with Mymetics SA, a leader in the research and development of virosome-based vaccines. The Company plans to raise new financing to return to clinical trials in allergic patients as soon as possible.

The mice proof-of-concept immunogenicity study evaluated the effects of the Bet v 1 COPs (the birch pollen allergy proprietary peptides) using the five subcutaneous injection schedule used in clinical trials with Anergis’ first-generation product candidate AllerT. The development of AllerT (Bet v 1 COPs plus aluminum hydroxide) was discontinued by Anergis in 2017 following completion of a Phase 2 clinical trial showing evidence of sensitization to the peptides and a 7% reduction in seasonal allergy symptoms vs. placebo (p=0.0047).

Alligator Bioscience AB (Nasdaq Stockholm:ATORX) today announces that regulatory approvals have been obtained for the first clinical study of ATOR-1015 and patient recruitment can now be initiated. ATOR-1015 is a whollyowned drug candidate developed for tumor-directed immunotherapy. The phase I study is a first-in-human dose-escalation study in up to 53 patients with
advanced solid tumor disease at five different clinics across Sweden and Denmark. The primary aim of the study will be to investigate the safety and tolerability of the drug and to identify the recommended dose for subsequent Phase II studies.

Orphazyme A/S, a biopharmaceutical company dedicated to developing treatments for patients living with rare diseases, today announced that the Company expects to announce the results of the full data set for the clinical Phase II/III trial in NPC in Q1 2019.

On September 28, 2018, Orphazyme announced top-line data showing a treatment benefit in favor of arimoclomol, even if statistical significance was not reached. A subsequent evaluation of the data has motivated a further thorough data review and Orphazyme has initiated a data verification process that will be performed before completing the final statistical analysis of the trial.

Thomas Blaettler, Chief Medical Officer, said, “In this pivotal trial every single data point counts, which has led us to conduct our analysis at the highest level of granularity.”

The comprehensive data verification process is on-going and we expect to communicate the results of the full data set in Q1 2019, instead of in Q4 2018 as previously communicated.

This company announcement does not impact the 2018 financial guidance published in the Annual Report 2017 on March 15, 2018.