In New Direction, Allarity Deems Risk of Monotherapies too High


Allarity Therapeutics is veering away from monotherapy development activities to focus its time and resources on a more promising combination of oncologic therapies. 

The move comes after the board of directors conducted an in-depth evaluation of current assets and decided to refocus the company's oncology pipeline strategy. Factors that led to the decision include the viability of existing opportunities, funding availability, timelines and costs of development and potential clinical, commercial and regulatory risks. 

Along with shifting away from activities for monotherapy products, the company said it plans to bolster its ability to attract funding opportunities from institutional life sciences investors. Allarity also indicated its openness to commercially partnering with larger pharmaceutical companies in the future to maximize its DRP platform technology and assets in the pipeline. 

"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," James G. Cullem, J.D., the interim chief executive officer of Allarity, commented. 

"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," he added. 

Also In the second quarter, Allarity received feedback from the U.S. Food and Drug Administration regarding its planned Phase III clinical development of dovitinib as a monotherapy third-line treatment for metastatic renal cell carcinoma (mRCC). The U.S. Food and Drug Administration advised the company to conduct a new dosing trial for the drug before moving with any Phase III trials that might lead to the submission of a New Drug Application. This meant further delays, increased costs and higher market risks, given the competitiveness of the mRCC space.

Given the situation, Allarity decided to no longer pursue the commercial possibility of using dovitinib as monotherapy in adults. The drug will, however, still be developed externally through a partnership with OncoHeroes Biosciences but, this time, as a single therapy for pediatric cases. 

In its new direction, Allarity will initiate enrollment for its Phase Ib/II trial for stenoparib, a PARP inhibitor combined with dovitinib for the second-line or later treatment of metastatic ovarian cancer. Trial sites will be set up across Europe and the United States. 

Meanwhile, the company's ongoing Phase II studies of stenoparib as a monotherapy for ovarian cancer and Ixempra as a monotherapy for metastatic breast cancer will continue through interim data readouts in the fourth quarter of 2022 and the first quarter of 2023. All pipeline activities will continue to use drug-specific DRP companion diagnostics to screen and treat patients.  

"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," Allarity Board Chairman Dr. Duncan Moore, Ph.D. noted. "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." 

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