Actuate Therapeutics Announces First Patient Enrolled in Phase 2 Clinical Trial of Elraglusib Plus Retifanlimab as Investigational First Line Therapy for Patients With Advanced Pancreatic Cancer
March 01 2022 - 7:55AM
Actuate Therapeutics and The University of Kansas Cancer Center
today announced the enrollment of the first patient on a Phase 2
study of elraglusib (9-ING-41) plus retifanlimab combined with
gemcitabine/nab-paclitaxel for the treatment of patients with
advanced pancreatic cancer in the first-line setting (NCT05239182).
The study will enroll up to 32 evaluable patients in a Simon
two-stage design, with the primary objective of assessing the
disease control rate of the combination regimen.
“The pre-clinical data generated with elraglusib, as a single
agent and in combination with checkpoint inhibitors, along with
clinical data supporting its immunomodulatory activity is
increasingly compelling," said Daniel M. Schmitt, Actuate President
& CEO. “In addition to elraglusib’s established anticancer
activity via direct cytotoxicity and reversal of chemoresistance,
its immunomodulatory actions may be particularly synergistic with
those of anti-PD-1 checkpoint inhibitors. Driven by these
synergistic mechanisms of action, we are very excited to include
this clinical study in our program for patients with pancreatic
cancer and as a template for studies of immunomodulatory
combinations for patients with other refractory cancer types.”
Elraglusib is Actuate’s proprietary small molecule glycogen
synthase kinase-3 beta (GSK-3β) inhibitor which is being developed
for adults and children with advanced refractory cancers.
Retifanlimab, Incyte Corporation’s (NASDAQ:INCY) investigational
intravenous PD-1 inhibitor, is currently under evaluation for
patients with microsatellite instability-high endometrial cancer,
Merkel cell carcinoma, squamous cell carcinoma of the anal canal,
and non-small cell lung cancer.
“We are very excited to launch this first study of elraglusib
combined with retifanlimab as a potentially synergistic
immune-modulatory approach for patients with advanced pancreatic
cancer,” said Anwaar Saeed, MD, study principal investigator. “The
first generation of immune checkpoint (PD-1, PDL-1, CTLA-4)
inhibitors including retifanlimab address a key subset of the
cancer-created blockade of anti-cancer effector cells in our immune
system. We are now beginning to study novel therapies that will
modulate other checkpoints and thus be synergistic with the current
agents – elraglusib is such an agent. We are very focused on
elraglusib in this context as the increasing data on its role as an
immune-modulator, including its ability to stimulate NK/T-cell
anticancer effector functions, has been generated against a
background of it showing meaningful clinical activity in a spectrum
of cancers, particularly advanced pancreatic cancer. I am thus
delighted to open our investigator-initiated study of elraglusib,
retifanlimab and gemcitabine/nab-paclitaxel and am very grateful
for all the support I have received for this initiative.”
“GSK-3β inhibition has been an increasingly important goal in
developmental therapeutics for patients with cancer, pathological
fibrotic conditions, and neuro-degenerative disease over the last
few decades,” said Razelle Kurzrock, Chair of Actuate’s Scientific
Advisory Board. “Elraglusib is the first clinically viable agent
with which we can modulate this target in patients with cancer and
the initial clinical data is very encouraging. Recently we have
gained a very important appreciation for GSK-3β inhibition as a
potential immune-modulatory approach. As the limits of what we can
achieve with first-generation targets have become evident, we are
studying other inhibitory receptor targets, including TIM3, TIGIT
and LAG-3, with data on the latter being particularly encouraging.
GSK-3β inhibition is a means to decrease both PD-1 expression and
LAG-3. The initiation of Dr Saeed’s retifanlimab plus elraglusib in
combination with gemcitabine/nab-paclitaxel study is a milestone
for patients with advanced pancreatic cancer and will guide us in
the design and execution of further studies of these important
novel agents.”
Based on positive data from a prior Phase 2 open-label single
arm study of elraglusib plus gemcitabine/nab-paclitaxel, Actuate
has also initiated an international randomized controlled study of
gemcitabine/nab-paclitaxel versus elraglusib in combination with
gemcitabine/nab-paclitaxel, in patients with advanced pancreatic
cancer in the first-line setting (NCT03678883,
EudraCT#:2018-003739-32). Actuate also recently announced the
initiation of a randomized study of elraglusib plus FOLFIRINOX
alone or with Losartan also for patients with advanced pancreatic
cancer in the first-line setting (NCT05077800).
About Actuate Therapeutics, Inc.Actuate is a
clinical stage pharmaceutical company focused on the development
and commercialization of novel therapeutics for cancers and
inflammatory diseases. For additional information,
please visit the Company’s website at
http://www.actuatetherapeutics.com.
Public Relations Dept.,Actuate Therapeutics, Inc.+1 (847)
986-4190info@actuatetherapeutics.com
Incyte (NASDAQ:INCY)
Historical Stock Chart
From Aug 2024 to Sep 2024
Incyte (NASDAQ:INCY)
Historical Stock Chart
From Sep 2023 to Sep 2024