Full Press Release Details
Allarity Therapeutics Doses First Patient in
Phase 1b Clinical Trial Evaluating Dovitinib and Stenoparib Combination in Advanced Solid Tumors
Company anticipates that the combination of
pan-TKI dovitinib and PARP inhibitor stenoparib may generate synergistic anti-cancer activity
Program initiation marks key milestone in Allarity's
clinical strategy shift
towards combination therapies
BOSTON, Mass - March 20, 2023 - Allarity
Therapeutics, Inc. (Nasdaq: ALLR) ("Allarity" or the "Company"), a clinical-stage pharmaceutical company developing
novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, today announced that
it has dosed the first patient in a Phase 1b clinical study evaluating the combination of stenoparib and dovitinib for the treatment of
advanced solid tumors, including ovarian cancer.
Currently, approximately 70 percent of patients
diagnosed with ovarian cancer will experience recurrences.[1]
However, PARP inhibitors have improved the treatment outlook for many patients who have completed initial treatment with surgery and platinum-based
chemotherapy. The strategy underscoring Allarity's combination of dovitinib and stenoparib is to address the unmet need of ovarian
cancer patients, as well as those with other solid tumors, who currently do not benefit from the existing PARP inhibitor treatments.
"Having investigated novel combinations
of anticancer agents, including a PARP inhibitor and an anti-angiogenic therapeutic, we have seen improved efficacy. Combining a PARP
inhibitor with a pan-tyrosine kinase (PTK) inhibitor, we are also anticipating efficacy in homologous recombination proficient tumors"
stated Kathleen N. Moore, MD, MS, Associate Director of Clinical Research, Director of the Oklahoma TSET/Sarah Cannon Phase I Drug Development
Unit, Professor of the Section of Gynecologic Oncology at the Stephenson Cancer Center, and the Principal Investigator for Allarity's
Phase 1b study. "I look forward to working with patients and the clinical team at Allarity to determine if the particular combination
of dovitinib and stenoparib can provide synergistic therapeutic benefits and improve outcomes for patients, including those with ovarian
Source: Ovarian Cancer Research Alliance
Allarity Therapeutics, Inc. I 24 School Street, 2nd Floor I Boston, MA I U.S.A. I NASDAQ: ALLR I www.allarity.com
The two-part, open label multicenter Phase 1b
program will first evaluate the safety and anti-cancer activity, and determine the maximum tolerated dose (MTD), of stenoparib administered
twice a day in participants with advanced solid tumors. The second portion of the study will evaluate safety and anti-cancer activity
and determine the MTD of dovitinib when given in combination with the MTD of stenoparib determined in the first cohort.
The Phase 1b trial is designed with a target enrollment
of up to 36 patients with advanced solid tumors, focusing on specific tumor types that Allarity anticipates will be most responsive to
the drug combination. Researchers will analyze patient tumor samples retrospectively using Allarity's DRP companion
diagnostics for stenoparib and dovitinib. The purpose of this analysis is to further validate the DRP companion diagnostics
in advance of an anticipated DRP -guided Phase 2 trial of the dovitinib and stenoparib combination in second line or later metastatic
ovarian cancer, targeted for H2 2024.
Stenoparib is a small molecule, dual-targeted
inhibitor of Poly ADP-Ribose Polymerases (PARP 1 and 2) and tankyrase 1 and 2. It works by limiting cancer's ability to repair single
stranded DNA breaks within tumors, which in turn makes tumor cells more vulnerable to death (apoptosis). Dovitinib is a pan-tyrosine
kinase inhibitor (pan-TKI), and its mechanisms of action (MOA) works in part to block the formation of new blood vessels that
supply a tumor with nutrients and oxygen (anti-angiogenesis), as well as to alter homologous recombination (HR) proficient to HR
deficient tumors by down-regulation of HR. As these combined MOAs serve to promote cancer cell vulnerability and restrict blood flow necessary
to fuel cancer growth and repair, Allarity believes the combination may cause synthetic lethality, thereby increasing the chances of cancer
cell death and providing synergistic, enhanced anti-tumor activity.
"I am very pleased that we have initiated
our first combination therapy trial, an important milestone in our pipeline strategy focused on identifying unmet needs in which combination
therapies may benefit patients with hard-to-treat cancers," said James G. Cullem, Allarity's Chief Executive Officer.
"Given that we own both of these assets, the development of this combination benefits from our existing drug supply and manufacturing
pathways, and, subject to our ability to raise additional capital to support the study, should enable us to efficiently conduct the Phase
1b dosing portion of the study with an anticipated data readout in the first half of 2024." Mr. Cullem further noted, "Our
clinical team, together with Dr. Moore and our Scientific Advisory Board, have smartly designed this Phase 1b study to both identify early
signs of therapeutic benefit in likely-to-respond tumor types, as well as to assess the ability of Allarity's DRP
companion diagnostics for stenoparib and dovitinib to identify responder patients."
Allarity Therapeutics, Inc. I 24 School Street, 2nd Floor I Boston, MA I U.S.A. I NASDAQ: ALLR I www.allarity.com
The initiation of a new combination trial marks
a previously-announced shift in the Company's clinical-stage activities toward development of combination therapies (that are dependent
upon the Company's ability to raise sufficient capital to support these new trials), and reflects the Company's commitment to delivering
innovative treatments that address unmet medical needs and improve patient outcomes.
Allarity holds exclusive, global commercial rights to both dovitinib
About the Drug Response Predictor - DRP Companion
Allarity uses its drug-specific DRP companion
diagnostic to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to
a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high DRP score, Allarity
believes that the therapeutic response rate can be significantly increased. The DRP method builds on the comparison of sensitive
versus resistant human cancer cell lines, including transcriptomic information from cell lines combined with clinical tumor biology filters
and prior clinical trial outcomes. DRP is based on messenger RNA from patient biopsies. The DRP platform has demonstrated
its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in 37 out
of 47 clinical studies that were examined (both retrospective and prospective), including ongoing, prospective Phase 2 trials of stenoparib
and IXEMPRA . The DRP platform, which can be used in all cancer types and is patented for more than 70 anticancer
drugs, has been extensively published in peer reviewed literature.
About Allarity Therapeutics
Allarity Therapeutics, Inc. (Nasdaq: ALLR) develops
drugs for personalized treatment of cancer guided by its proprietary and highly developed companion diagnostic technology, the DRP
platform. The Company has a mature portfolio of three drug candidates: stenoparib, a PARP inhibitor in Phase 2 development for ovarian
cancer; dovitinib, a pan-tyrosine kinase inhibitor previously developed in renal cancer through Phase 3; and IXEMPRA (Ixabepilone),
a microtubule inhibitor approved in the U.S. and marketed by R-PHARM U.S. for the treatment of second-line metastatic breast cancer, which
is currently in Phase 2 development in Europe for the same indication. Additionally, the Company has rights in two secondary assets: 2X-111,
a liposomal formulation of doxorubicin for metastatic breast cancer and/or glioblastoma multiforme (GBM), which is the subject of discussions
for a restructured out-license to Smerud Medical Research International AS; and LiPlaCis , a liposomal formulation of cisplatin and
its accompanying DRP , being developed via a partnership with Chosa Oncology AB for late-stage metastatic breast cancer. The Company
is headquartered in the United States and maintains an R&D facility in Hoersholm, Denmark. For more information, please visit the
Company's website at www.Allarity.com.
Allarity Therapeutics, Inc. I 24 School Street, 2nd Floor I Boston, MA I U.S.A. I NASDAQ: ALLR I www.allarity.com
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Forward-Looking Statements
This press release contains "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide Allarity's
current expectations or forecasts of future events. The words "anticipates," "believe," "continue,"
"could," "estimate," "expect," "intends," "may," "might," "plan,"
"possible," "potential," "predicts," "project," "should," "would"
and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not
forward-looking. These forward-looking statements include, but are not limited to, statements related to the expected availability of
capital to fund its anticipated clinical trials, statements related to advancing dovitinib in combination with stenoparib or another therapeutic
candidate or other approved drug, any statements related to ongoing clinical trials for stenoparib as a monotherapy or in combination
with another therapeutic candidate for the treatment of advanced ovarian cancer, or ongoing clinical trials (in Europe) for IXEMPRA
for the treatment of metastatic breast cancer, statements relating to the effectiveness of the Company's DRP companion
diagnostics platform in predicting whether a particular patient is likely to respond to a specific drug, and statements related to the