Gilead's Oncology Drug Gets Breakthrough Therapy Designation

Gilead Sciences, Inc. GILD announced that the FDA has granted Breakthrough Therapy designation to pipeline candidate, magrolimab, for the treatment of newly-diagnosed myelodysplastic syndrome (MDS).

Magrolimab is a first-in-class, investigational anti-CD47 monoclonal antibody. MDS is a type of cancer caused by poorly formed or dysfunctional blood cells in the bone marrow.

The Breakthrough Therapy designation from the FDA expedites the development and regulatory review of investigational treatments for serious or life-threatening conditions that, based on preliminary clinical evidence, have the potential to substantially improve clinical outcomes compared with available therapy.

The FDA granted Breakthrough Therapy designation to magrolimab based on positive results of an ongoing phase Ib study, which evaluated the drug in combination with Vidaza in previously untreated intermediate, high and very high-risk MDS. Data showed that 91% of evaluable patients treated with magrolimab plus Vidaza achieved an objective response, with 42% achieving a complete remission (CR).

We note that magrolimab is currently being studied in the double-blind, placebo-controlled, randomized phase III ENHANCE study in previously untreated higher-risk MDS. The study will evaluate the safety and efficacy of magrolimab, in combination with Vidaza, as measured by CR and duration of CR.

Magrolimab enjoys Orphan Drug status in the United States for MDS and acute myeloid leukemia (AML) and in Europe for AML.

The candidate was added to Gilead’s pipeline through the acquisition of Forty Seven, Inc.

Gilead has been taking strategic steps to strengthen its oncology pipeline in recent times. The company recently announced that it will acquire oncology company, Immunomedics IMMU, for $88 per share in cash or approximately $21 billion.

Earlier, Gilead also acquired a 49.9% equity interest in Pionyr Immunotherapeutics, Inc., a privately-held company pursuing novel biology in the field of immuno-oncology. Earlier in the month, Gilead announced an agreement with Jounce Therapeutics, Inc. JNCE, a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, to exclusively license its JTX-1811 program.

The massive decline in sales of Gilead’s HCV franchise has propelled it to focus on its HIV franchise, Yescarta and other newer avenues. The rapid adoption of Biktarvy maintains momentum in the HIV space amid stiff competition from the likes of GlaxoSmithKline GSK. However, the company is looking to diversify its portfolio, given the increasing competition in the HIV space.

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