17 October 2022 - - US-based biopharmaceutical companies Gilead Sciences, Inc. (NASDAQ: GILD) and MacroGenics (NASDAQ: MGNX) have inked an exclusive option and collaboration agreement to develop MGD024, an investigational, bispecific antibody that binds CD123 and CD3 using MacroGenics' DART platform, and two additional bispecific research programmes, the companies said.

The collaboration agreement grants Gilead the option to license MGD024, a potential treatment for certain blood cancers, including acute myeloid leukemia and myelodysplastic syndromes.

A leader in the bispecific antibody space, MacroGenics has extensive experience applying its proprietary DART platform to develop novel therapeutics.

MGD024 is a next-generation, bispecific that incorporates a CD3 component that is designed to minimize cytokine-release syndrome, a potentially life-threatening toxicity, while increasing the magnitude of antitumor activity with a longer half-life to permit intermittent dosing.

MacroGenics will be responsible for the ongoing Phase 1 study for MGD024 during which Gilead may elect to exercise its option to license the program at predefined decision points.

The Phase 1 study will include a dose escalation segment and an expansion segment that is intended to evaluate MGD024 as monotherapy and in combination with other therapies across multiple indications.

As part of the agreement, Gilead will pay MacroGenics an upfront payment of USD 60m and MacroGenics will be eligible to receive up to USD 1.7bn in target nomination, option fees, and development, regulatory and commercial milestones.

MacroGenics will also be eligible to receive tiered, double-digit royalties on worldwide net sales of MGD024 and a flat royalty on worldwide net sales of products under the two research programs.

Beginning in the first quarter of 2022, consistent with recent industry communications from the US Securities and Exchange Commission, Gilead no longer excludes acquired IPR and D expenses from its non-GAAP financial measures and expects the transaction with MacroGenics to reduce Gilead's GAAP and non-GAAP 2022 EPS by approximately USD 0.04.

MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer.

The company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains.

Gilead Sciencesis advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.