Allarity Therapeutics, after meeting with the US Food and Drug Administration (FDA), has decided a growth factor receptor drug it licensed from Novartis is no longer commercially viable or in the best interests of its shareholders.
A type C advisory meeting was held between Allarity and the FDA to discuss a development path for dovitinib.
Dovitinib is a growth factor receptor (FGFR), vascular endothelial growth factor receptor (VEGFR) and other receptor tyrosine kinases (RTKs). Allarity had exclusively in-licensed it globally from Novartis, who had completed a phase 3 study in renal cell carcinoma (RCC) in addition to several promising phase 2 studies in breast, liver and endometrial cancer and GIST.
Allarity received feedback from the FDA meeting held during the second quarter of this year where attendees looked at 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 conducting any future phase 3 studies that could enable the submission of a new drug application.
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 and risks, the company has determined that advancing dovitinib as a monotherapy in adults is no longer an option. However, the drug will continue to be externally developed, via the partnership with OncoHeroes Biosciences, as a potential monotherapy for pediatric cancers.
Duncan Moore, 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.
Utilizing current assets
“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.”
Metastatic ovarian cancer
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 the final quarter of this year (2022).
The company says it plans to have trial sites in both the U.S. and Europe. Allarity 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 the last quarter of this year (2022) and the first of next year. All pipeline development activities will continue to utilize drug-specific DRP companion diagnostics to guide patient selection and treatment.
This news follows the company’s announcement that, going forward, it will be mainly focusing on combination therapies as opposed to monotherapies.