News

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.

Ascelia Pharma has presented results of the Phase I study for Oncoral at the European Society for Medical Oncology (ESMO) Annual Congress in Munich, Germany, 19-23 October 2018.

The poster presentation contains data from a dose escalating study in adult patients with solid tumors to assess safety, tolerability and pharmacokinetics of Oncoral, an oral irinotecan formulation, given as single agent. An abstract (# 433P) for the presentation is published online via the EMSO website (https://www.esmo.org/Conferences/ESMO-2018-Congress).

Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, will present preclinical safety data for the drug candidate ATOR-1017 at the 4th CRI-CIMT-EATI-AACR International Cancer lmmunotherapy Conference in New York, USA. The conference is taking place from September 30 – October 3, 2018.

ATOR-1017 is a monoclonal antibody in development for the treatment of metastasizing cancer. It activates the costimulatory receptor 4-1BB and its immunostimulatory function is dependent on cross-linking to Fc-gamma receptors on immune cells.

Orphazyme A/S, a biopharmaceutical company dedicated to developing treatments for patients living with rare diseases, today announced encouraging top-line results for its clinical Phase II/III trial with orally administered arimoclomol for the treatment of patients with Niemann-Pick disease Type C (NPC).

The trial was a multi-center, prospective, double-blinded, placebo-controlled interventional study with a 12-month duration. In total, 50 patients were enrolled in the EU and US. The purpose of the trial was to assess the efficacy and safety of arimoclomol, compared to placebo, in the treatment of NPC, administered in addition to the patient’s standard-of-care. The primary endpoints, 5-domain NPC-CSS and Clinical Global Impression of Improvement (CGI-I), evaluated the treatment difference between the arimoclomol-treated and the placebo group after 12 months of treatment.

Overall, baseline characteristics were well-balanced across treatment arms. Arimoclomol was well-tolerated. The overall incidence of adverse events (AEs) was similar for arimoclomol (85.7%) and placebo (81.3%). Serious AEs occurred less frequently in the arimoclomol group (14.3%) compared to placebo (37.5%). The top-line data demonstrated a 74% reduction in progression on the primary endpoint, corroborated by consistent benefit across sub-populations. Placebo progression rates on the CGI-I were lower than expected impeding the ability to show a positive effect.

VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, today announced the signing of a development and commercialization collaboration agreement with China Medical System Holdings Limited (CMS) (HKSE:0867).

VAXIMM will collaborate with CMS, which will have the full rights in China and other Asian countries (excluding Japan) to VAXIMM’s existing programs, enabling the development and commercialization of VAXIMM’s pipeline of oral cancer immunotherapy candidates in the region. The parties will coordinate and share data from their respective clinical studies. VAXIMM will also receive development and commercial milestones and royalties based on the achievement of sales milestones by CMS. In parallel with the agreement, CMS will make an equity investment in VAXIMM, as part of VAXIMM’s current Series B financing.