Gilead Sciences has licensed a bispecific antibody from Macrogenics, an investigational oncology company, for the treatment of CD123-positive hematologic malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). re-entered the field of
Under the terms, Gilead has made an upfront payment of $60 million to secure rights to MGD024. MGD024 is bispecific in early clinical trials and was promoted to pole position in his CD123xCD3 pipeline at Macrogenics earlier this year.runner Flotetuzumabreached Phase 2.
MGD024 is designed to reduce cytokine release syndrome (CRS), a potentially life-threatening toxicity, with increased anti-tumor activity and a longer half-life, resulting in less frequent dosing.
The profile “may lead to more patient-friendly dosing and improved clinical outcomes for people with AML and MDS,” said Bill Grossman, Gilead’s Head of Oncology Clinical Development.
In addition to the contract fee, there is an additional $1.7 billion offer if MGD024 is brought to market in multiple indications, with tiered royalties on sales. Meanwhile, the deal also gives Gilead options for two of his other undisclosed bispecifics, like MGD024, emerging from his DART bispecific discovery platform at MacroGenics.
The cash injection comes as Macrogenics is in the midst of a restructuring, cutting headcount by 15%, closing two facilities and scaling back its R&D program to reduce cash burn.
The revision states that Biotechnology has published three pivotal trial results: interim data from the Phase 2 portion of the antibody-drug conjugate (ADC) MGC018 in prostate cancer, and Phase 1 dose expansion of the PD-1xCTLA4 bispecific rorigerlimab. It was designed to reserve resources for serving intermediate data from , and a phase 1 dose escalation study of MGD024 in patients with acute myeloid leukemia (AML).
MacoGenics already has one product on the market – the HER2-targeted breast cancer drug Margenza (margetuximab) – but clinical trials have failed to replicate improved efficacy over the HER2 potent trastuzumab in confirmatory studies. New clinical results impede its growth Sophia study reported last year.
With sales of $4.7 million in the second quarter of this year, MacroGenics posted a net loss of approximately $41 million and closed the quarter with a cash reserve of $138 million.
However, if teplizumab for type 1 diabetes is approved in the US, it could result in an additional $60 million payment from Provention Bio in the fourth quarter, in addition to Gilead’s fees.
For Gilead, the deal doubles down on its strategy of deriving at least one-third of its revenue from oncology drugs in 2030 and continues its diversification from its traditional infectious disease focus.