- Gilead Sciences and Forty Seven announced that the companies have entered into a definitive agreement pursuant where Gilead will acquire Forty Seven for $4.9 billion
Gilead Sciences and Forty Seven announced that the companies have entered into a definitive agreement pursuant where Gilead will acquire Forty Seven for $95.50 per share in cash as part of a deal valued at $4.9 billion. The deal was unanimously approved by both the Gilead and Forty Seven Boards of Directors and is anticipated to close during the second quarter of 2020 subject to regulatory approvals and other customary closing conditions.
With the addition of Forty Seven’s investigational lead product candidate, magrolimab, the acquisition is going to strengthen Gilead’s immuno-oncology research and development portfolio. Magrolimab is known as a monoclonal antibody in clinical development for the treatment of several cancers for which new and transformative medicines are urgently needed, including myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) and diffuse large B-cell lymphoma (DLBCL).
The investigational therapy targets CD47, which is a “do not eat me” signal that allows cancer cells to avoid destruction thus permitting the patient’s own innate immune system to engulf and eradicate cancer cells. And Forty Seven saw promising results of a Phase 1b study of magrolimab in patients with MDS and AML at the American Society of Hematology meeting in December 2019.
Initially, Forty Seven is studying magrolimab in patients with MDS and AML. And additional studies are ongoing in non-Hodgkin lymphoma (NHL) and solid tumors.
The U.S. Food and Drug Administration (FDA) has granted Magrolimab with Fast Track designation for the treatment of MDS and AML and for the treatment of relapsed or refractory DLBCL and follicular lymphoma (two forms of B-cell NHL).
Magrolimab has also been granted Orphan Drug designation by the FDA for the treatment of MDS and AML and by the European Medicines Agency for the treatment of AML. Over 400 patients have received the compound to date through clinical trials.
A couple of months ago, Forty Seven presented promising results of a Phase 1b trial evaluating magrolimab in combination with azacitidine in untreated patients with higher-risk MDS and untreated patients with AML — who are ineligible for induction chemotherapy. And this has led to the initiation of a potential registrational cohort in MDS. All patients had received a 1 mg/kg priming dose of magrolimab along with intrapatient dose escalation to mitigate on-target anemia. From there, the patients were then treated with full doses of azacitidine and magrolimab maintenance doses of 30 mg/kg weekly.
Based on the data cutoff of November 18, 2019, 62 patients had been treated with the combination in the Phase 1b portion of the trial, including 35 patients with MDS and 27 patients with AML.
And as of the data cutoff, 46 patients were evaluable for response assessment, including 24 patients with untreated higher-risk MDS and 22 patients with untreated AML who were ineligible for induction chemotherapy. For higher-risk MDS, the overall response rate (ORR) was 92% with 12 patients (50%) achieving a complete response (CR), eight patients (33%) achieving a marrow CR and two patients (8%) achieving hematologic improvement. Two patients (8%) had stable disease.
In untreated AML, the ORR was 64%, with nine patients (41%) achieving a CR, three patients (14%) achieving a CR with complete blood count recovery (CRi) and one patient (5%) achieving a morphologic leukemia-free state (MLFS). Seven patients (32%) had stable disease and one patient (5%) had progressive disease. The median time to response among MDS and AML patients treated with the combination was 1.9 months. And the median duration of response and median overall survival have not been reached for either MDS or AML patients with a median follow-up of 6.4 months (range 2 to 14.4 months) for MDS and 8.8 months (range 1.9 to 16.9 months) for AML.
What about the safety data? As of the data cutoff, the combination of magrolimab and azacitidine was well-tolerated without evidence of increased toxicities compared to azacitidine alone. And adverse events (AEs) were consistent with prior clinical experience. No deaths were observed in the first 60 days on combination treatment and only one patient out of 62 (1.6%) discontinued treatment due to a treatment-related AE.
Beyond magrolimab, Forty Seven is preparing to advance 2 additional investigational compounds into clinical testing. And FSI-174, an anti-cKIT antibody, is being developed in combination with magrolimab as a novel and all-antibody conditioning regimen to address the limitations of current stem cell transplantation conditioning regimens. FSI-189, an anti-SIRPα antibody, is being developed for the treatment of cancer as well as certain non-oncology settings, including transplantation conditioning.
As part of the merger agreement, a wholly-owned subsidiary of Gilead will promptly commence a tender offer to acquire all of the outstanding shares of Forty Seven’s common stock at a price of $95.50 per share in cash. And after the successful completion of the tender offer, Gilead will acquire all remaining shares not tendered in the offer through a second step merger at the same price as in the tender offer.
“This agreement builds on Gilead’s presence in immuno-oncology and adds significant potential to our clinical pipeline. Magrolimab complements our existing work in hematology, adding a non-cell therapy program that complements Kite’s pipeline of cell therapies for hematological cancers. With a profile that lends itself to combination therapies, magrolimab could potentially have transformative benefits for a range of tumor types. We are looking forward to working with the highly experienced team at Forty Seven to help patients with some of the most challenging forms of cancer.”
– Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences
“This is an exciting day for patients who may one day benefit from future anti-CD47 therapies and other immuno-oncology treatments based on our research and an exciting time for Forty Seven as this allows us to achieve our vision of helping patients defeat their cancer. We are pleased to join Gilead and believe that by combining our scientific expertise with Gilead’s strength in developing treatments that modify the immune system, we will be able to more rapidly advance our therapies.”
– Mark McCamish, MD, PhD, President and Chief Executive Officer of Forty Seven