LUND, Sweden, Aug. 25, 2020 /PRNewswire/ -- Alligator
Bioscience (Nasdaq Stockholm: ATORX) will give status updates
and details on the recent clinical development plans for the
clinical drug candidates mitazalimab, ATOR-1015 and ATOR-1017 on a
virtual R&D Day on August 27.
"These clinical plans provide an excellent opportunity for
Alligator to have two or even three competitive cancer therapeutics
in clinical efficacy studies by the end of 2021", commented Per
Norlén, CEO of Alligator Bioscience.
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.
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 inclusion of the first patient H1
2021.
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.
ATOR-1015, wholly owned by Alligator, is a
tumor-localizing, bispecific CTLA-4 and OX40 antibody developed for
treatment of metastatic cancer. The first indication will be skin
cancer (malignant melanoma) where the target molecule CTLA-4 has
been proven effective but associated with significant toxicity.
Promising data from the ongoing ATOR-1015 Phase I clinical trial
was presented in June 2020 and dose
escalation has continued at high doses. The positive tolerability
profile of ATOR-1015 has led to the frontloading of a Phase Ib
study for demonstration of single-agent activity. This allows for
an efficacy readout as early as H2 2021 in malignant melanoma. This
could significantly increase the value of the concept and will be
followed by a Phase II combination study with anti-PD-1.
The interim data include doses up to 600 mg (about 10 mg/kg) and
show that ATOR-1015 is well tolerated, thus supporting for the
concept. Dose-escalation is currently at 750 mg (12.5 mg/kg).
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.
ATOR-1017 is Alligator's wholly owned 4-1BB antibody
in clinical Phase I development for the treatment of metastatic
cancer. ATOR-1017 activates 4-1BB receptors on T cells which
increases the ability of the immune system to detect and kill tumor
cells. ATOR-1017 has a unique profile which creates an opportunity
for a strong and tumor-directed immune activation that can
increase efficacy and reduce side effects for the patient.
The ongoing Phase I study is a dose escalation study in patients
with advanced cancer. The study is conducted at three different
clinics in Sweden and is planned
to include up to 50 patients. The objectives of the study are to
assess the safety and tolerability of ATOR-1017, to determine the
recommended dose for the subsequent Phase II studies, but also to
assess initial signs of efficacy.
A more detailed invitation to the R&D Day on August 27 will be distributed shortly.
For further information, please contact:
Cecilia Hofvander, Director
Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: cecilia.hofvander@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 11:00
a.m. CEST on August 25,
2020.
About Alligator Bioscience
Alligator Bioscience AB is a clinical-stage biotechnology
company developing tumor-directed immuno-oncology antibody drugs.
Alligator's pipeline includes six 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 the clinical project portfolio at Virtual R&D Day
August 27, 2020
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