
After FDA requests a new trial, Allarity drops a cancer drug from solo development
The US-Danish biotech Allarity Therapeutics is having to pivot its pipeline strategy after the FDA forced them to go back to the drawing board for an oncology therapy.
Allarity announced on Tuesday that the board has mandated the biotech to refocus its oncology strategy away from the development of monotherapies and toward the development of “more promising and clinically relevant combination therapies.”
The move also comes after the FDA had an advisory meeting over the Phase III development for dovitinib — a former Novartis candidate, as a therapy for metastatic renal cell carcinoma (mRCC). The FDA indicated the company would need to conduct a new dosing study before any Phase III can move forward. However, conducting a new dosing study would cause further delays and drive up the cost and time of production so the company has chosen to drop it instead.
While Allarity determined that advancing dovitinib is no longer commercially viable, the drug will continue to be externally developed as a potential monotherapy for pediatric cancers.
With its switch to combinations, the board said this can potentially increase the company’s ability to attract additional funding from life science investors, as well as broaden the potential for future partnerships with larger pharmaceutical companies.
But Allarity will also be facing stiff competition in the combination therapies field. Several major pharmas have been racing to get combination therapies out to the public.
For Allarity’s new pipeline, it will start enrollment for Phase Ib/II of a PARP inhibitor with dovitinib, for the treatment of metastatic ovarian cancer by the end of the year. It is not shying away from the mRCC space, as the biotech is also evaluating other potential studies for either stenoparib or dovitinib combined with another oncology therapeutic for its treatment. Allarity’s ongoing Phase II studies of stenoparib, for ovarian cancer on its own, and Ixempra for metastatic breast cancer, will continue through their data readouts.
“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 cancer therapeutic from which they will most likely benefit,” said Allarity’s interim CEO James Cullem.
The move needs to have a positive effect on investors as the company is sitting just above penny stock status and its stock price $ALLR has fallen 89% since December 2021.