LUND, Sweden, Dec. 16, 2021 /PRNewswire/ -- Alligator
Bioscience (Nasdaq Stockholm: ATORX) today announced an update on
the on-going clinical Phase I trial with the 4-1BB (CD137) drug
candidate ATOR-1017, which is developed as a tumor-directed therapy
for metastatic cancer. The early readout data corroborates previous
data on biomarkers, safety and tolerability, sustaining a safety
profile up to and including a dose of 360 mg with no dose limiting
toxicities reported.
The Phase I study with ATOR-1017 is a first-in-human,
open-label, dose escalation study in patients with advanced solid
cancer (NCT04144842). The primary objective of the study is to
investigate the safety and tolerability of ATOR-1017, and to
determine the recommended dose for subsequent Phase II studies. The
results from the current evaluation shows that ATOR-1017 has an
encouraging safety profile. Again, there was no dose-limiting
toxicity or severe immune-related adverse events. The results
support data from earlier read-outs that ATOR-1017 exhibits a
favorable pharmacokinetic profile. Additionally, it confirms and
extends previous biomarker data demonstrating proof of mechanism of
ATOR-1017, including increased proliferation of circulating T-cells
and dose-dependent increases in soluble 4-1BB, both biomarkers of
T-cell activation. A full data read-out is expected in Q1
2022.
Earlier this year, the Company announced results that validated
the therapeutic potential of ATOR-1017 demonstrating a very
favorable safety profile combined with clear signs of proof of
mechanism, as activation of T cells in the circulation was observed
across active dose levels of ATOR-1017 in a poster presentation at
the 2021 ASCO Annual Meeting (link to press release).
"We are extremely pleased with the confirmatory data as it
strengthens the case for the safety and tolerability as well as
confirming the proof of mechanism of ATOR-1017. We are excited by
this outcome and are working hard on completing this study and
determining the dose for a subsequent Phase II program," said Søren
Bregenholt, CEO of Alligator Bioscience.
For further information, please contact:
Julie Silber, Investor
Relations
Phone: +46 46-540 82 23
E-mail: jur@alligatorbioscience.com
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 mitazalimab, a
CD40 agonist, and ATOR-1017, a 4-1BB agonist. Furthermore,
Alligator is co-developing ALG.APV-527 with Aptevo Therapeutics
Inc., several undisclosed molecules based on its proprietary
technology platform, Neo-X-Prime™, with MacroGenics Inc. and novel
drug candidates based on the RUBY™ bispecific platform with Orion
Corporation. Out licensed programs include AC101, in phase II
development, by Shanghai Henlius Biotech Inc. and an undisclosed
target to Biotheus Inc. Alligator Bioscience's shares are listed on
Nasdaq Stockholm (ATORX) and is headquartered in Lund, Sweden.
For more information, please visit
http://www.alligatorbioscience.com.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/alligator-bioscience/r/alligator-bioscience-announces-trial-update-and-early-readout-for-ator-1017-confirming-biomarker--sa,c3473250
The following files are available for download:
|
https://mb.cision.com/Main/12681/3473250/1510578.pdf
|
ATOR 1017 Update
Press Release ENG FINAL
|