MacroGenics' decision to pivot its focus to its asset MGD024 appears to have paid off, with Gilead pledging up to $1.7 billion in biobucks for the phase 1 bispecific antibody.
Gilead will also cough up $60 million upfront for the rights to later license the asset—MGD024—in addition to two other bispecific research programs, the companies announced Monday. MacroGenics will be responsible for phase 1 development, with Gilead having the option to license the program “at predefined decision points.” MacroGenics also stands to get tiered, double-digit royalties on worldwide sales of MGD024, should it reach commercialization.
MGD024 targets both CD123 and CD3 with the aim of invigorating the immune system to kill off CD123-expressing cancer cells. Data presented at the American Society of Hematology annual meeting in December showed that the therapy displayed anti-tumor activity when combined with standard of care treatment, according to MacroGenics.
A touted benefit of the antibody is its ability to reduce cytokine release syndrome (CRS), an inflammatory condition that’s spurred by the immune system overreacting. In this morning's release, Gilead’s SVP of oncology clinical development said the drug’s ability to reduce the side effect is promising.
“We believe MGD024, with its potential to reduce CRS and permit intermittent dosing through a longer half-life, could translate to more patient-friendly dosing and enhanced clinical outcomes for people living with AML and MDS,” said Bill Grossman, M.D., Ph.D.
The deal provides a glimpse into MacroGenics' larger strategy a couple of months after shaving off 15% of its staff and closing two satellite facilities to save cash. The company shifted gears from flotetuzumab, its first-gen bispecific targeting CD123 and CD3, back in February to focus on MGD024. Monday’s deal hedges that bet somewhat while validating the revamped molecule’s promise.
Just in the last few months, a number of biotech’s CD123 plans have stalled, emphasizing the open market should MGD024 find clinical success. In August, Affimed announced that it would be prioritizing ex-U.S. markets with its bispecifics targeting CD3 and CD16A, after regulators declined to greenlight a dose escalation study. The same month, ImmunoGen pushed back the timeline for topline phase 2 data of its antibody-drug conjugate (ADC) by two years, following trial design guidance from regulators. Meanwhile, market woes forced Pyxis to pause the development of its CD123-directed ADC to save cash.
The collective clinical development plans come nearly four years after Stemline Therapeutics nabbed the first FDA approval for a CD123-targeted therapy, aimed at a rare form of blood and bone marrow cancer.