SAN DIEGO, Oct. 21, 2020 /PRNewswire/ -- Kintara
Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the
"Company"), a biopharmaceutical company focused on the development
of new solid tumor cancer therapies, announced today the execution
of an agreement with the Global Coalition for Adaptive Research
(GCAR) for VAL-083's participation in GCAR's Glioblastoma Adaptive
Global Innovative Learning Environment (GBM AGILE) Study.
This study was conceived by an international consortium of major
thought leaders in the glioblastoma (GBM) space and is designed to
more efficiently identify effective therapies for GBM patients.
Since the launch of the study in 2019, GBM AGILE continues to gain
momentum among the GBM medical community and has recently expanded
the number of participating trial sites in the U.S. from 24 to 31
centers. Kintara is currently advancing two ongoing Phase 2
clinical trials in GBM with VAL-083 in adjuvant and recurrent MGMT
unmethylated GBM, and in combination with radiotherapy in
newly-diagnosed MGMT unmethylated GBM. Kintara expects to
provide an update on these Phase 2 studies at the Society of
Neuro-Oncology SNO 2020 Virtual Conference, November 19-21, 2020.
"The consummation of a definitive agreement with GCAR for
VAL-083's participation in GBM AGILE is a significant corporate and
clinical milestone for the Company as it is expected to enable us
to accelerate the facilitation of the final clinical stages and the
regulatory process for our novel therapeutic candidate while
enabling us to maximize financial and operational resources,"
commented Saiid Zarrabian, Kintara's
Chief Executive Officer. "The GCAR opportunity is a more robust,
efficient, and cost-effective clinical trial solution than had we
embarked on this effort independently and it provides multiple
shots on goal via enrollment of three separate GBM patient subtypes
enabled by GCAR's FDA-approved adaptive design protocol."
Under the terms of the agreement, Kintara will supply GCAR with
VAL-083 drug along with funding to support the VAL-083 arm of the
GBM AGILE registrational study. In turn, GCAR will manage all
operational aspects of the study, including site activation and
patient enrollment.
"We are pleased to have reached this major milestone with
Kintara and look forward to including VAL-083 into GBM AGILE in the
very near future. We are delighted to have a total of 31 U.S. sites
already enrolling in GBM AGILE, and expect up to 40 total sites by
the end of 2020 in the U.S. and Canada. We have plans to
expand to Europe in 2021,"
commented Meredith Buxton, GCAR's
Chief Executive Officer. "Having such a high number of sites
simultaneously enrolling upon initiation of the Kintara trial arm
should expedite the rate of patient enrollment."
The GBM AGILE Study is an international effort in
newly-diagnosed and recurrent GBM, utilizing an FDA-approved master
protocol with multiple drugs to be tested simultaneously and over
time against a common control arm. As an approved
registrational study, results from the VAL-083 arm of GBM AGILE
Study are intended to be utilized to file for FDA
approval. This study employs a
cost-efficient, adaptive trial design with a Stage 1 (Phase 2)
learning and adapting phase and a Stage 2 (Phase 3) expansion
and confirmation phase. The totality of the data from the Stage 1
and Stage 2 expansion would be used for the regulatory filing of an
NDA. The effort is led by top-tier key opinion leaders in the GBM
field and has the collective support of an international group of
more than 130 clinicians, researchers, biostatisticians, imagers,
pathologists, leaders from government and industry, and patient
advocates. GCAR functions as the GBM AGILE Study sponsor, and
provides financial support for the program infrastructure, as well
as general trial oversight. Comprising some of the world's
foremost clinical, translational, and basic science investigators,
GCAR strives to support the development of novel treatments to
fight against rare and deadly diseases like GBM where patient
prognosis is poor and treatment options are limited.
ABOUT GLOBAL COALITION FOR ADAPTIVE RESEARCH
GCAR is a 501(c)(3) nonprofit organization, comprised of some of
the world's foremost physicians, clinical researchers and
investigators united in expediting the discovery and development of
cures for patients with rare and deadly diseases. As its first
priority, GCAR is sponsoring 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
study effort include the National Brain Tumor Society, National
Foundation for Cancer Research, and Asian Fund for Cancer
Research. These three nonprofit organizations 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 innovative approach to brain tumor
treatment development.
ABOUT KINTARA
Located in San Diego,
California, Kintara is dedicated to the development of novel
cancer therapies for patients with unmet medical needs.
Kintara is developing two late-stage, Phase 3-ready therapeutics
for clear unmet medical needs with reduced risk development
programs. The two programs are 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 National
Cancer Institute (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.
Kintara is also advancing its 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 to date of 80% complete responses of CMBC
evaluable lesions, and with 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.
Forward-Looking Statements
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995, including statements regarding the status of the
Company's clinical trials and the GBM AGILE Study. Any
forward-looking statements contained herein are based on current
expectations but are subject to a number of risks and
uncertainties. The factors that could cause actual future
results to differ materially from current expectations include, but
are not limited to, risks and uncertainties relating to the impact
of the COVID-19 pandemic on the Company's operations and clinical
trials; the Company's ability to develop, market and sell products
based on its technology; the expected benefits and efficacy of the
Company's products and technology; the availability of substantial
additional funding for the Company to continue its operations and
to conduct research and development, clinical studies and future
product commercialization; and, the Company's business, research,
product development, regulatory approval, marketing and
distribution plans and strategies. These and other factors
are identified and described in more detail in the Company's
filings with the SEC, including the Company's Annual Report on Form
10-K for the year ended June 30,
2020, the Company's Quarterly Reports on Form 10-Q, and the
Company's Current Reports on Form 8-K.
CONTACTS:
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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SOURCE Kintara Therapeutics