LUND, Sweden, Sept. 9, 2020 /PRNewswire/ -- Alligator
Bioscience (Nasdaq Stockholm: ATORX) announced today
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.
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.
For further information, please contact:
Cecilia Hofvander, Director
Investor Relations & Communications
Phone: +46 46 540 82 06
E-mail: cecilia.hofvander@alligatorbioscience.com
Per Norlén, Chief Executive Officer
Phone: +46 540 82 00
E-mail: per.norlen@alligatorbioscience.com
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 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.
About Alligator Bioscience
Alligator Bioscience AB is a clinical-stage biotechnology
company developing tumor-directed immuno-oncology antibody drugs.
Alligator's pipeline includes five lead clinical and preclinical
drug candidates: Mitazalimab, ATOR-1015, ATOR-1017, ALG.APV-527
(co-developed with Aptevo Therapeutics Inc.) and AC101 (in clinical
development by Shanghai Henlius Biotech Inc.). 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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Alligator Bioscience
presents an update regarding the Phase I study with the drug
candidate ATOR-1015
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