On September 9, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported updated timelines indicating 3-6 months delay for the planned Phase Ib study with ATOR-1015, its tumor-localizing, bispecific CTLA-4 and OX40 antibody developed for treatment of metastatic cancer (Press release, Alligator Bioscience, SEP 9, 2020, View Source [SID1234564803]).
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As previously communicated, preliminary data from the ongoing Phase I study have shown that ATOR-1015 is well tolerated at doses up to 600 mg (about 10 mg/kg), which is believed to be a clinically relevant dose range. At the current dose of 750 mg (~12.5 mg/kg), some grade 3 infusion related reactions have been reported which is expected to result in further dose evaluations.
"While the infusion related reactions will lead to the selection of a Phase Ib dose below 750 mg, we are still considerably higher in dose than our competitors and well within clinically relevant dose levels", commented Per Norlén, CEO at Alligator Bioscience.
The ongoing Phase I dose escalation will be completed during the fourth quarter 2020 as previously communicated. The start of the Phase Ib expansion in malignant melanoma will be pushed into 2021 due to study amendments to adjust for the observed reactions. Recruitment will start as soon as regulatory approval has been obtained.
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 1:40 p.m. CEST on September 9, 2020.
About ATOR-1015
ATOR-1015 is a tumor-localizing, bispecific CTLA-4 and OX40 antibody developed for treatment of metastatic cancer. Promising data from the ongoing ATOR-1015 Phase I clinical trial was presented at ASCO (Free ASCO Whitepaper) in June 2020 and dose escalation continued at the higher dose 750 mg. The next step in the ATOR-1015 clinical development plan is a Phase Ib study for demonstration of single-agent activity.