LUND, Sweden, April 27, 2020 /PRNewswire/ -- Alligator
Bioscience (Nasdaq Stockholm: ATORX), announces that the
company today presents the status of the ongoing Phase I clinical
trial with the bispecific drug candidate ATOR-1015 developed as
tumor-directed therapy for metastatic cancer. The presentation will
take place at the AACR (American Association for Cancer Research)
Annual Meeting, which this year is being held digital for the first
time.
This far, doses of 400 mg (about 6 mg/kg) have been evaluated in
the ongoing study and the current dosing is 600 mg (about 10
mg/kg). 18 patients with varying cancer forms (colon cancer, eye
melanoma, pancreatic cancer, ovarian cancer, gallbladder cancer,
gastric cancer and skin cancer) have been treated and evaluated in
terms of safety. ATOR-1015 has so far been well tolerated.
"We are very proud and happy that our study has been selected
for presentation. The promising results so far demonstrate that
ATOR-1015 can be administered safely. ATOR-1015 has the potential
to be at least as effective as today's available treatment for
these patients, but with significantly fewer side effects," said
Per Norlén, CEO of Alligator Bioscience.
The adverse events in the study were generally mild and
transient, all of grade 1 or 2 (on a scale of 1-5). The most common
adverse events were infusion-related reactions (five patients). No
serious immune-related or dose-limiting adverse events have been
reported.
The presentation with the title "A first-in-human phase 1 study
in patients with advanced and/or refractory solid malignancies to
evaluate the safety of ATOR-1015, a CTLA-4 x OX40 bispecific
antibody" will be held by Charlotte
Russell, Chief Medical Officer at Alligator Bioscience. The
presentation is available through the link below between
9:00 a.m. - 6:00 p.m. EDT
(3 p.m.-12 a.m. CEST) today and will
also be available on the company website
www.alligatorbioscience.com.
https://www.abstractsonline.com/pp8/#!/9045/presentation/10644
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 6:01
a.m. CEST on April 27,
2020.
About the ATOR-1015 Phase I study
The Phase I study with ATOR-1015 is a dose escalation study in
patients with metastatic cancer (NCT03782467). The primary endpoint
of the study is to investigate the safety and tolerability of
ATOR-1015 and to determine the recommended dose for subsequent
Phase II studies. The first patient was dosed in March 2019 and results are expected during the
second half of 2020. Following the establishment of the maximum
tolerable dose or recommended dose for Phase II, further clinical
development of ATOR-1015 is planned, primarily for the treatment of
metastatic skin cancer.
Due to the Covid-19 pandemic, most, but not all, participating
clinics have made a temporary halt in the recruitment of new
patients. Alligator Bioscience is in close dialogue with all
parties in order to resume patient recruitment at full speed as
soon as possible. The company follows the clinics' decisions and
evaluates appropriate measures to minimize any delays. At this
stage, it is too early to estimate whether the slower recruitment
will affect the timeline for 2020 and for the longer term.
About ATOR-1015
ATOR-1015, wholly owned by Alligator, is a bispecific CTLA-4
antibody developed as tumor targeted immunotherapy with increased
capacity for killing regulatory T cells. ATOR-1015 binds to two
different immune receptors - the checkpoint receptor CTLA-4 and the
co-stimulatory receptor OX40. The immune activation is
increased in areas where both target molecules are expressed at
high levels, notably in the tumor microenvironment, which can lead
to reduced side effects.
About Alligator Bioscience
Alligator Bioscience AB is a clinical-stage biotechnology company
developing tumor-directed immuno-oncology antibody drugs.
Alligator's growing 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.
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Alligator Bioscience
presents promising interim Phase I data for its bispecific drug
candidate ATOR-1015 at AACR
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SOURCE Alligator Bioscience