Full Press Release Details
Allarity Therapeutics Refocuses Oncology Pipeline Strategy Towards Combination Therapies
with ongoing shift in oncology standard-of-care towards combination therapies
focus expected to improve the Company's future funding and commercial prospects
New pipeline strategy
follows Type C meeting held with FDA regarding dovitinib clinical development path for third-line mRCC
Cambridge, MA, U.S.A.
(August 2, 2022) - Allarity Therapeutics, Inc. ("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 its Board of Directors has mandated a refocus of the Company's oncology pipeline strategy away
from development of monotherapies towards development of more promising and clinically relevant combination therapies.
Following a lengthy and
in-depth analysis of current pipeline opportunities, clinical/commercial/ regulatory risks, development costs and timelines, expected
availability of funding, and in consultation with Allarity's senior management, its Scientific Advisory Board (SAB), and external
experts, Allarity's Board of Directors has concluded that refocusing the Company's pipeline to development of combination
therapies will accomplish the following:
The Board's decision
also takes into account feedback that the Company recently received from the U.S. Food and Drug Administration (FDA) from a Type C advisory
meeting held in Q2 2022, regarding a potential Phase 3 clinical development path for dovitinib as a monotherapy third-line treatment for
metastatic renal cell carcinoma (mRCC). As part of that feedback, the FDA has indicated, under its recent Project Optimus guidelines relating
to new optimization of therapeutic dosing, that the Company will likely need to conduct a new dosing study for dovitinib prior to Company
conducting any future Phase 3 studies that could enable the submission of a new NDA. Conducting a new dosing study for dovitinib, if required,
would further delay the initiation and completion of a future Phase 3 study, and increase the cost, time, and market risks of advancing
dovitinib as a monotherapy in the increasingly competitive indication of third-line mRCC. In view of those delays and increased costs/risks,
the Company has determined that advancing dovitinib as a monotherapy in adults is no longer commercially viable or in the best interests
of its shareholders. However, the drug will continue to be externally developed, via the partnership with OncoHeroes Biosciences, as a
potential monotherapy for pediatric cancers.
As part of its new strategic
pipeline focus, the Company has announced it expects to initiate enrollment in a Phase 1b/2 study of its PARP inhibitor, stenoparib, in
combination with its pan-TKI, dovitinib, for the second-line or later treatment of metastatic ovarian cancer by or before Q4 2022. The
Company plans to have trial sites in both the U.S. and Europe. The Company is currently evaluating other potential Phase 1b/2 studies
for either stenoparib or dovitinib combined with another oncology therapeutic, including the mRCC space. Allarity's ongoing Phase
2 studies of stenoparib, as monotherapy for ovarian cancer, and IXEMPRA , as monotherapy for metastatic breast cancer, will continue
through their interim data readouts, now anticipated in Q4 2022 and Q1 2023, respectively. All pipeline development activities will continue
to utilize drug-specific DRP companion diagnostics to guide patient selection and treatment.
Therapeutics, Inc. | 210 Broadway,
MA | U.S.A. | NASDAQ:
ALLR | www.allarity.com
"We are grateful for the clear guidance
from our Board on the best path our Company can take to advance our mission to improve cancer patient care by realizing the promise of
truly personalized medicine," said James G. Cullem, J.D., Interim Chief Executive Officer of Allarity. "New therapeutic
development is recognized as a very challenging endeavor, with constantly shifting regulatory requirements, standard-of-care improvements
as new drugs come to market, and financial and market challenges. It has therefore become increasingly difficult to advance development
of monotherapies in increasingly competitive therapeutic spaces. I am confident that our strategic shift of focus and resources is the
correct path forward for Allarity given the current regulatory and market realities, and will best leverage our DRP companion diagnostics
to match the right patients to the cancer therapeutic from which they will most likely benefit."
Dr. Duncan Moore, Ph.D., Allarity's Board
Chairman, stated: "It is clear to our Board, following lengthy discussions with our management team, SAB, and additional key
opinion leaders, that the current, and future, standard of care in cancer treatment is combination therapies, and that, increasingly,
the field and market opportunities are shifting away from monotherapy approaches. In view of that key shift, and in consideration of many
other market and financial factors, as well as the FDA's new Project Optimus drug dose optimization requirements, we have determined
that Allarity's future pipeline must focus on the development of promising combination therapy approaches utilizing its current
assets together with DRP companion diagnostics. I remain very enthusiastic about the Company's vision, mission, and strategy,
and this strategic refocus towards combination therapies, together with our core DRP technology, will give Allarity the best chance
of success as well as best optimize shareholder return on investment."
About Allarity Therapeutics
Allarity Therapeutics, Inc. (Nasdaq: ALLR) develops
drugs for personalized treatment of cancer guided by its proprietary and highly validated 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 post-Phase 3 pan-tyrosine kinase inhibitor; and IXEMPRA (Ixabepilone), a microtubule inhibitor approved in the
U.S. for the treatment of second-line metastatic breast cancer and 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 in Phase 2 development 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 ApS, an affiliate of Smerud Medical Research International, 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.
About the Drug Response Predictor - DRP Companion
Allarity uses its drug-specific DRP
to select those patients who, by the genetic signature of their cancer, are found to have a high likelihood of responding to the specific
drug. By screening patients before treatment, and only treating those patients with a sufficiently high DRP score, the
therapeutic response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. 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 proven 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 anti-cancer drugs, has been extensively
published in peer reviewed literature.
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Allarity Therapeutics, Inc. |
210 Broadway, #201 | Cambridge, MA | U.S.A. | NASDAQ:
ALLR | www.allarity.com
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 relating to the Company's related
to the expected availability capital to fund its anticipated clinical trials, statements related to advancing dovitinib in combination
with 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, and 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.
Any forward-looking statements in this press release are based on management's current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied
by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that results of a clinical