LUND, Sweden, Oct. 27, 2020 /PRNewswire/ -- Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced additional positive interim safety data from its ongoing clinical Phase I study of the drug candidate ATOR-1017, its wholly owned 4-1BB antibody in development for the treatment of metastasized cancer.
The Data Review Committee that monitors the safety of the patients in the Phase I study, has cleared a 100 mg dose and approved to start dosing at 200 mg, corresponding to approximately 3.2 mg/kg. The majority of the observed drug related adverse events have been mild or moderate (grade 1 or 2) and there are indications that ATOR-1017 activates the immune system of patients.
"ATOR-1017 is now administered at the dose levels we aimed for when designing the study: we are in fact more than 20 times higher in dose than the benchmark product urelumab. This is an important milestone for the program and for the upcoming Phase II efficacy study. ATOR-1017 was designed to overcome the challenges of the first generation 4-1BB antibodies, in particular severe immune-related adverse events. The emerging safety profile, based on data seen this far, suggests that we have been successful", said Per Norlén, CEO at Alligator Bioscience.
The Phase I study is planned to read out in H1 2021, with a Phase Ib/II efficacy study starting in H2 2021.
For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 2:00 p.m. CET on October 27, 2020.
About Alligator Bioscience
Alligator Bioscience AB is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs. Alligator's pipeline includes the two key assets ATOR-1017 and mitazalimab. Furthermore, there are two partnered assets; ALG.APV-527 in co-development with Aptevo Therapeutics Inc. and AC101 in clinical development by Shanghai Henlius Biotech Inc.). In addition, the company has developed a novel concept for more patient-specific immuno-therapy: Neo-X-Prime. Alligator's shares are listed on Nasdaq Stockholm (ATORX). The Company is headquartered in Lund, Sweden. For more information, please visit www.alligatorbioscience.com.
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The following files are available for download:
Predicted therapeutic range dose levels reached in ATOR-1017 Phase I
SOURCE Alligator Bioscience