Kazia and Kintara Now Enrolling in GBM
AGILE, Registrational Phase 2-3 Adaptive Platform Trial to Evaluate
Interventions for Patients With Glioblastoma
Kazia’s Paxalisib and Kintara’s VAL-083 to
Be Evaluated Across Multiple International Trial Sites
Kintara’s VAL-083 Will Be the First
Investigational Drug to Also Be Tested in GBM AGILE For MGMT
Methylated Tumors
Global Coalition for Adaptive Research (LOS ANGELES, CA), Kazia
Therapeutics Limited (ASX: KZA, NASDAQ: KZIA, SYDNEY, Australia),
and Kintara Therapeutics, Inc. (NASDAQ: KTRA, SAN DIEGO, CA) -- The
Global Coalition for Adaptive Research (GCAR) in collaboration with
Kazia and Kintara, today announced the activation of Kazia's
paxalisib and Kintara's VAL-083 in GBM AGILE (Glioblastoma Adaptive
Global Innovative Learning Environment). GBM AGILE is a
revolutionary patient-centered, adaptive platform trial for
registration that tests multiple therapies for patients with
newly-diagnosed and recurrent glioblastoma (GBM) – the deadliest
form of brain cancer.
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Kazia's paxalisib and Kintara's VAL-083 are entering the GBM
AGILE trial, which initially opened in July 2019 and has screened
over 370 patients to date.
Kazia’s paxalisib will be enrolling in newly diagnosed
unmethylated (NDUM) and recurrent GBM, and Dr. Ingo Mellinghoff,
Chair of the Department of Neurology at Memorial Sloan Kettering
Cancer Center and Dr. Eudocia Q Lee, Director of Clinical Research
at the Center for Neuro-Oncology at Dana-Farber and an Assistant
Professor of neurology at Harvard Medical School are serving as arm
Principal Investigators for the paxalisib arm.
Kintara’s VAL-083 will be enrolling in NDUM and recurrent GBM,
as well as be the first compound being evaluated for patients with
newly diagnosed methylated MGMT. VAL-083 will be led by arm
Principal Investigators, Dr. John de Groot, Professor, Department
of Neuro-Oncology, MD Anderson Cancer Center, and Dr. James Perry,
Professor of Neurology at the University of Toronto and Sunnybrook
Research Institute.
“GBM AGILE is an innovative clinical trial approach that enables
us to simultaneously and dynamically study the effects of multiple
new drug candidates. With the inclusion of paxalisib and VAL-083
for NDUM and recurrent GBM patients, as well as VAL-083 for the
additional methylated GBM patient group, we are excited to offer
all GBM patients access to these latest therapies,” says Dr. James
Perry. “Both investigational drugs have the potential to support
improved outcomes for GBM patients, who need new treatment
options.”
Dr. Ingo Mellinghoff, who also serves as co-Chair of the GBM
AGILE Arm Identification and Selection Committee, adds, “GBM AGILE
is a transformative effort in our field, designed to provide
glioblastoma patients in many different countries access to the
latest, most personalized therapies and, at the same time,
rigorously evaluate the activity of these therapies in an optimized
learning environment. Paxalisib and VAL-083 are two important steps
in this direction and offer potentially beneficial treatments to
our patients, who deserve new and better options for their
care.”
GBM AGILE is an international, innovative platform trial
designed to more rapidly identify and confirm effective therapies
for patients with glioblastoma through response adaptive
randomization and a seamless phase 2/3 design. The trial, conceived
by over 130 key opinion leaders, is conducted under a master
protocol, allowing multiple therapies or combinations of therapies
from different pharmaceutical partners to be evaluated
simultaneously. With its innovative design and efficient
operational infrastructure, data from GBM AGILE can be used as the
foundation for a new drug application (NDA) and biologics license
application (BLA) submissions and registrations to the FDA and
other health authorities.
The new interventions are opening first at Henry Ford Cancer
Institute in Detroit under Henry Ford site Principal Investigator,
Dr. Tom Mikkelsen, Medical Director, Henry Ford Precision Medicine
Program & Clinical Trials, and will subsequently open at over
30 trial sites across the United States, with additional global
sites in Canada, Europe, and China to follow.
"We were first in the world to enroll a patient in the GBM AGILE
study, which is designed to help us quickly identify the most
effective therapies for patients with glioblastoma," notes Dr. Tom
Mikkelsen. "We are excited about the potentially improved
treatments afforded to our patients in this study with the
additional options of paxalisib and VAL-083."
Kazia’s paxalisib (formerly GDC-0084) is a small molecule
inhibitor of the PI3K / AKT / mTOR pathway. The PI3K pathway
appears to be disordered in more than 85% of cases of glioblastoma,
making this pathway a high-potential target for new glioblastoma
therapies. Paxalisib is a potent inhibitor of the PI3K pathway, and
has been shown to have an anti-tumor effect in animal models of
glioblastoma. Licensed from Genentech in late 2016, paxalisib is
distinguished by its ability to cross the so-called blood-brain
barrier, which prevents many drugs from fully affecting brain
tissue. Seven additional studies are active in other forms of brain
cancer. Paxalisib was granted Orphan Drug Designation for
glioblastoma by the U.S. FDA in February 2018, and Fast Track
Designation for glioblastoma by the U.S. FDA in August 2020. In
addition, paxalisib was granted Rare Pediatric Disease Designation
and Orphan Designation by the U.S. FDA for DIPG in August 2020.
“We are proud to be joining GBM AGILE. This is an important and
innovative effort, utilizing a platform approach and cutting-edge
adaptive design to rapidly identify whether drugs such as paxalisib
can bring benefit to patients with glioblastoma,” said Dr. James
Garner, Chief Executive Officer, Kazia. “There is a profound need
for new therapeutic options in this disease, and GBM AGILE has been
designed to accelerate the process of making new drugs available to
patients and clinicians. We have seen encouraging data with
paxalisib in earlier clinical studies, so we hope that success in
GBM AGILE may pave the way to providing a new treatment in this
disease.”
Kintara’s VAL-083 is a "first-in-class," small molecule
bifunctional alkylating agent that crosses the blood-brain barrier.
VAL-083 is independent of the MGMT resistance mechanism, and has
been assessed in over 40 Phase 1 and Phase 2 clinical trials in
multiple indications sponsored by the U.S. National Cancer
Institute (NCI). Published pre-clinical and clinical data indicate
that VAL-083 has activity against a range of tumor types, including
lung, brain, cervical, ovarian tumors and hematologic (blood)
cancers. VAL-083 has been granted Orphan Drug Designation for GBM
by the FDA and EMA, and has also been granted Orphan Drug
Designations for medulloblastoma and ovarian cancer from the FDA.
In addition, the FDA granted Fast Track Designation for VAL-083 in
recurrent GBM. VAL-083 is approved as a cancer chemotherapeutic in
China for the treatment of chronic myelogenous leukemia and lung
cancer. VAL-083 has not been approved for any indications outside
of China.
“Kintara is pleased to participate in the groundbreaking GBM
AGILE trial, and is excited to be the first investigational drug
selected for newly diagnosed methylated GBM in the study. With
VAL-083 being evaluated in all subtypes, we expect that this study
will generate important insights into VAL-083’s potential to
improve health outcomes for all GBM patients,” said Saiid
Zarrabian, Kintara’s Chief Executive Officer.
About Global Coalition for Adaptive Research (GCAR)
The Global Coalition for Adaptive Research (GCAR) is a 501(c)(3)
nonprofit organization uniting physicians, clinical researchers,
advocacy and philanthropic organizations, biopharma, health
authorities, and other key stakeholders in healthcare to expedite
the discovery and development of treatments for patients with rare
and deadly diseases by serving as sponsor of innovative and complex
trials including master protocols and platform trials. GCAR is the
sponsor of GBM AGILE, an adaptive platform trial for patients with
GBM – the most common and deadliest of malignant primary brain
tumors. Key strategic partners for the GBM AGILE trial effort
include the National Brain Tumor Society, National Foundation for
Cancer Research, and Asian Fund for Cancer Research, three
nonprofit organizations that are working together to provide
philanthropic support as well as assistance in communicating with
patients and families and inviting all others to join in supporting
this innovating approach to brain tumor treatment development.
To learn more about GCAR, visit www.gcaresearch.org and follow
us: @GCAResearch and www.facebook.com/GCAResearch.
About Kazia Therapeutics Limited
Kazia Therapeutics Limited (ASX: KZA, NASDAQ: KZIA) is an
innovative oncology-focused biotechnology company, based in Sydney,
Australia. Our pipeline includes two clinical-stage drug
development candidates, and we are working to develop therapies
across a range of oncology indications.
Our lead program is paxalisib (formerly GDC-0084), a small
molecule inhibitor of the PI3K / AKT / mTOR pathway, which is being
developed to treat glioblastoma, the most common and most
aggressive form of primary brain cancer in adults. Licensed from
Genentech in late 2016, paxalisib entered GBM AGILE, a pivotal
study in glioblastoma, in October 2020. Seven additional studies
are active in various forms of brain cancer. Paxalisib was granted
Orphan Drug Designation for glioblastoma by the U.S. FDA in
February 2018, and Fast Track Designation for glioblastoma by the
U.S. FDA in August 2020. In addition, paxalisib was granted Rare
Pediatric Disease Designation and Orphan Designation by the U.S.
FDA for DIPG in August 2020.
For more information, please visit
www.kaziatherapeutics.com.
About Kintara
Located in San Diego, California, Kintara (Nasdaq: KTRA) is
dedicated to the development of novel cancer therapies for patients
with rare unmet medical needs. Kintara is currently developing two
Phase 3-ready therapeutics, VAL-083 for GBM and REM-001 for
cutaneous metastatic breast cancer (CMBC).
VAL-083 is a "first-in-class," small-molecule chemotherapeutic
with a novel mechanism of action that has demonstrated clinical
activity against a range of cancers, including central nervous
system, ovarian and other solid tumors (e.g. NSCLC, bladder cancer,
head and neck) in U.S. clinical trials sponsored by the NCI. Based
on Kintara's internal research programs and these prior
NCI-sponsored clinical studies, Kintara is currently conducting
clinical trials to support the development and commercialization of
VAL-083 in GBM.
REM-001 is a proprietary, late-stage photodynamic therapy
platform that holds promise as a localized cutaneous, or visceral,
tumor treatment as well as in other potential indications. REM-001
therapy, has been previously studied in four Phase 2/3 clinical
trials in patients with CMBC, who had previously received
chemotherapy and/or failed radiation therapy. With clinical
efficacy of 80% complete responses of evaluable CMBC lesions and an
existing robust safety database of approximately 1,100 patients
across multiple indications, Kintara is advancing the REM-001 CMBC
program to late-stage pivotal testing.
For more information, please visit www.kintara.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20210106005257/en/
Global Coalition for Adaptive Research Rachel
Rosenstein-Sisson Rrosenstein.sisson@gcaresearch.org
Kazia Therapeutics Gabriella Hold
Gabriella.Hold@irdepartment.com.au
Kintara Investors: CORE IR 516-222-2560 ir@coreir.com
Media: Jules Abraham Director of Public Relations CORE IR
917-885-7378 julesa@coreir.com
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