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.
Alligator Bioscience (Nasdaq Stockholm: ATORX) today announces that it will receive payments of more than USD 3.5 million under its collaboration agreement with the South Korean company AbClon Inc. (“AbClon”). This is following the exercising of an option by a third party, Shanghai Henlius Biotech, Inc. (“Henlius”), to expand from a regional to a global agreement.
Alligator Bioscience AB (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, today announces that a new bispecific drug candidate, ATOR-1144, has entered preclinical development. ATOR-1144 is a first-in-class bispecific tumor-localized antibody targeting the checkpoint inhibitor CTLA-4 and the co-stimulatory receptor GITR. The bispecific antibody ATOR-1144 is a dual immune activator targeting CTLA-4 and GITR. It works through several pathways, including activation of T cells, depletion of regulatory T cells (Tregs) and activation of NK (natural killer) cells, for enhanced tumor cell killing. Based on its mode of action, ATOR-1144 may be suitable for the treatment of solid tumors as well as hematological cancers.