LUND, Sweden, Sept. 4, 2020 /PRNewswire/ -- Alligator
Bioscience (Nasdaq Stockholm: ATORX) announced today
biomarker data from a recently performed clinical Phase I study of
the drug candidate mitazalimab, its wholly owned CD40 antibody in
development primarily for the treatment of pancreatic cancer. The
data will be presented today at the scientific conference PEGS: The
Essential Protein Engineering Summit being held virtually
August 31- September 4, 2020.
"The presented biomarker data confirm the proof of mechanism
and strengthen our belief in mitazalimab as a powerful therapeutic
agent. The observed induction of PD-L1-genes supports that
mitazalimab has a potential to make tumors more responsive to PD-1
therapy. This is a very important factor and provides an
opportunity for a clear path to the market and for adding benefit
to patients," commented Per Norlén, CEO at Alligator
Bioscience.
The study identified a large number of upregulated genes after
treatment with mitazalimab, such as PD-L1, which supports a
clinical development plan for mitazalimab in combination studies
with PD-1 inhibition. Furthermore, it was demonstrated that RNA
sequencing can be successfully used to discover pharmacodynamic
biomarkers following CD40 activation with mitazalimab.
In addition, mitazalimab was found to activate patient-derived
tumor-associated macrophages. This is relevant for the upcoming
OPTIMIZE-1 Phase II study in pancreatic cancer and supports the
mode of action for mitazalimab.
Next step in the development of mitazalimab is the submission of
a Phase II clinical trial application (CTA) which is planned for
December 2020. The study (OPTIMIZE-1)
is an open-label, multi-center trial assessing the clinical
efficacy of mitazalimab in combination with chemotherapy
(mFolfirinox) in patients with metastatic pancreatic cancer. The
OPTIMIZE study will be performed at several clinics in Europe, with planned inclusion of the first
patient H1 2021.
Today at 11:30 a.m. EDT in the
session "Agonist Immunotherapy targets, priming the immune
system with costimulatory agents", Dr Peter Ellmark, PhD, VP Discovery at Alligator
Bioscience will give an oral presentation with the title
"Targeting CD40 to Unleash Dendritic Cells in Immuno-Oncology -
Expanding the Tumor Specific T Cell Repertoire". Dr Ellmark
will also act as panel moderator in the sessions "Advances in
CD137 agonists" and "Agonist immunotherapy targets". For
further information, please
visit https://www.pegsummit.com/Immunotherapy-Targets.
The information was submitted for publication, through the
agency of the contact person set out above, at 08:30 a.m. CEST
on September 4, 2020.
About Mitazalimab
Mitazalimab is Alligator's most advanced immunotherapy candidate
intended for the treatment of different types of cancer. It
activates CD40, a receptor on the dendritic cells which allows the
immune system to selectively attack the cancer.
Clinical data previously communicated from mitazalimab's Phase I
development program demonstrated that mitazalimab is safe and
tolerated at clinically relevant dose levels, with early signs of
clinical activity identified, including a partial response in a
patient with renal cell cancer and prolonged stable disease ≥6
months in 10 patients. There is still one patient in the Phase I
study, now treated with mitazalimab for more than 30 months.
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.
For further information, please contact:
Cecilia Hofvander
Director Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: cecilia.hofvander@alligatorbioscience.com
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Alligator Bioscience
presents positive biomarker data demonstrating proof of mechanism
in mitazalimab clinical Phase I study
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SOURCE Alligator Bioscience