LUND, Sweden, June 4, 2021 /PRNewswire/ -- Alligator
Bioscience (Nasdaq Stockholm: ATORX) today presents novel
supportive data from the ongoing Phase I clinical trial with the
4-1BB (CD137) drug candidate ATOR-1017 developed as tumor-directed
therapy for metastatic cancer. The results, presented in a poster
presentation at the 2021 ASCO Annual Meeting, validate 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.
"ATOR-1017 is the first of the second generation monospecific
4-1BB antibodies to report proof of mechanism by showing increase
in number of activated T cells in the circulation. Safety data show
that ATOR-1017 is safe and well tolerable at doses up to 200 mg and
no dose limiting toxicity has occurred. We are encouraged by these
data validating the potential of ATOR-1017. and we are
now focused on completing the study and determining the dose
for the subsequent Phase II program," said Søren Bregenholt,
CEO of Alligator Bioscience.
The Phase I study with ATOR-1017 is a dose escalation study in
patients with advanced solid cancer (NCT04144842). The primary
endpoint 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 first patient was dosed in December 2019. As of data cut-off March 31, 2021, a total of 13 patients with
varying advanced solid malignancies had been included. 4 patients
(31%) remained on treatment, 3 (23%) of whom had confirmed stable
disease for a period of 3.5-12.5 months.
The results from the evaluation of doses up to and including 200
mg demonstrate that ATOR-1017 has an encouraging safety profile as
the drug related adverse events in the study have generally been
mild and transient. No dose-limiting toxicity or severe
immune-related adverse events have been reported. The results
further demonstrate that ATOR-1017 exhibits a favorable
pharmacokinetic profile with linear elimination and no
accumulation. Activation of T cells in the circulation was observed
across therapeutic dose levels of ATOR-1017 demonstrating
biological activity and proof of mechanism.
The ASCO poster presentation with the title "A first-in-human,
multicenter, open-label, phase 1 study of ATOR-1017, a 4-1BB
antibody, in patients with advanced solid malignancies" will be
available at 03.00 p.m. CEST today,
June 4, on the company website
http://www.alligatorbioscience.com.
For further information, please contact:
Søren Bregenholt, CEO
E-mail: sbr@alligatorbioscience.com
Phone: +46 46-540 82 00
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 08:00 a.m. CEST on June 4,
2021.
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 immunotherapy: 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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