In March 2017, LLS began its partnership with Forty Seven to support "A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Rituximab or Rituximab + Chemotherapy in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma" and in July 2019, LLS expanded its partnership by making an equity investment to support "ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination With Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients With Higher Risk Myelodysplastic Syndrome."
LLS funded Stanford University researchers and founders of Forty Seven, Irv Weissman, MD, and Ravi Majeti, MD, PhD, to study seminal work in macrophages. This is a type of immune cell that patrols the body and chews up damaged cells. If a macrophage latches onto a normal cell, a protein known as CD47 sends a “don’t eat me” signal. But lymphoma and leukemia cells are clever and use CD47 to trick the macrophages into ignoring them and letting them grow as cancer. In pre-clinical mice models, Drs. Weissman and Majeti used an antibody to block the “don’t eat me” signal and stimulate the immune system to recognize the cancer cells as invaders. When they added rituximab as an “eat me” signal, the therapy delivered a one-two punch.
Forty Seven is a clinical-stage immuno-oncology company that is developing therapies targeting cancer immune evasion pathways and specific cell targeting approaches based on technology licensed from Stanford University. Forty Seven’s lead program, magrolimab, is a monoclonal antibody against the CD47 receptor, a “don’t eat me” signal that cancer cells commandeer to avoid being ingested by macrophages. Gilead Sciences acquired Forty Seven in April 2020 and continues to develop magrolimab in multiple clinical studies in patients with myelodysplastic syndrome, acute myeloid leukemia, non-Hodgkin lymphoma, and solid tumors.
Magrolimab has been granted the Fast Track designation by the FDA for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). It has also been given the Orphan Drug designation by the FDA and the European Medicines Agency for the treatment of AML.
Gilead is continuing to explore the role of magrolimab and is currently enrolling patients in the following clinical trials:
- A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Rituximab or Rituximab + Chemotherapy in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NCT02953509)
- ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination With Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients With Higher Risk Myelodysplastic Syndrome (NCT04313881)
- Study to Evaluate the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Adults With TP53 Mutant Acute Myeloid Leukemia (ENHANCE-2) (NCT04778397)
For more information about Gilead, visit www.gilead.com.
- December 06, 2020 - announced updated results from the magrolimab Phase 1b trial. Magrolimab is an investigational, potential first-in-class, anti-CD47 monoclonal antibody being studied in previously untreated acute myeloid leukemia (AML) patients who are ineligible for intensive chemotherapy, including patients with TP53-mutant AML. The data were presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.
- September 15, 2020 - announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for magrolimab, a first-in-class, investigational anti-CD47 monoclonal antibody for the treatment of newly diagnosed myelodysplastic syndrome (MDS).
- May 29, 2020 - announced updated results from a single-arm, open-label Phase 1b trial of magrolimab, an investigational anti-CD47 monoclonal antibody, in combination with azacitidine in previously untreated patients with higher-risk myelodysplastic syndrome (MDS) and previously untreated patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy, including patients with TP53-mutant AML, a high unmet need population. Results continue to support the clinical activity of magrolimab and azacitidine. The data were presented during an oral session at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting