LUND, Sweden, Dec. 28, 2020 /PRNewswire/ -- Alligator
Bioscience (Nasdaq Stockholm: ATORX) today announced that
it has submitted a CTA (Clinical Trial Authorization) application
to the relevant regulatory authorities to start a Phase II efficacy
study of its wholly-owned CD40 targeting antibody mitazalimab.
The upcoming Phase II study OPTIMIZE-1 is an open-label,
multi-center study assessing the clinical efficacy of mitazalimab
in combination with chemotherapy (mFolfirinox) in patients with
metastatic pancreatic cancer. The OPTIMIZE-1 study will be
performed at several clinics in Europe and encompass up to a total of 66
patients. Inclusion of the first patient is planned during the
first half of 2021 and will begin with a run-in period to determine
the best dose for the combination with chemotherapy.
"The CTA submission is an important milestone for Alligator, as
we are now entering clinical Phase II for the first time. With
best-in-class benchmark data presented for mitazalimab during the
autumn, I believe that OPTIMIZE-1 has great potential to deliver
robust efficacy results in pancreatic cancer", said Per Norlén, CEO
of Alligator Bioscience.
The mitazalimab drug candidate has previously reported positive
clinical data from two Phase I studies, one performed by Alligator,
one performed by Janssen Biotech Inc., displaying a manageable
safety profile as well as early signs of efficacy.
For further information, please contact:
Cecilia Hofvander, Director Investor
Relations & Communications
Phone +46 46 540 82 06
E-mail: cecilia.hofvander@alligatorbioscience.com
The information was submitted for publication, through the
agency of the contact person set out above, at 11:00 a.m. CET
on December 28, 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 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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Alligator Bioscience
submits CTA for the mitazalimab Phase II study
OPTIMIZE-1
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SOURCE Alligator Bioscience