Crown jewel in big Gilead buyout lands breakthrough designation for MDS
Months after Gilead snagged magrolimab in the $4.9 billion buyout of California biotech Forty Seven — the company’s largest acquisition in three years at the time — the anti-CD47 monoclonal antibody is now on an expedited track to approval.
On Tuesday morning, Gilead announced magrolimab’s FDA breakthrough therapy designation for patients with newly-diagnosed myelodysplastic syndrome (MDS). No new MDS treatments have been approved in 14 years, according to the company.
Forty Seven was was founded in 2014 to develop drugs targeting CD47, the “don’t eat me signal” used by cancer cells to avoid the immune system. The biotech brought its first cut of positive data for magrolimab to ASH last fall, which sent its share price soaring as Gilead neared a buyout.
After a few failed offers, Gilead ended up paying $95 a share — a long way from Forty Seven’s dip to $6 a share in October.
The drug’s breakthrough designation was based on a Phase Ib study which showed a 91% objective response rate in intermediate-, high- and very high-risk MDS patients when administered in combination with azacitidine. Forty-two percent of patients experienced complete remission, according to the company.
“The Breakthrough Therapy designation recognizes the potential for magrolimab to help address a significant unmet medical need for people with MDS and underscores the transformative potential of Gilead’s immuno-oncology therapies in development,” Gilead CMO Merdad Parsey said.
A Phase III ENHANCE trial is underway in previously untreated higher risk MDS patients. The drug was also granted fast track designation for the potential treatment of MDS, acute myeloid leukemia (AML), diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma. It has orphan drug designation by the FDA for MDS and AML, and by the EMA for AML.
“We haven’t provided timelines yet in terms of when those might read out,” Mark Chao, Gilead’s VP of oncology clinical research and clinical lead for the magrolimab program, said over the phone. Chao co-founded Forty Seven, then made the jump to Gilead.
At the time, the Forty Seven buyout was the largest acquisition since the $11.9 billion Kite Pharma purchase in 2017. The Forty Seven team won big in the deal — co-founders Irv Weissman and Ravindra Majeti took home $194 million and $123 million respectively, and CEO Mark McCamish earned a $105 million payout.
“You know, one of the reasons that we’re excited about this is … we’ve seen strong activity,” Chao said, citing the Phase Ib efficacy data. “We think that that’s actually pretty beneficial in the sense that azacitidine alone generally has much lower complete remission rates and response rates.”
The drug was well-tolerated, and just 1% of patients discontinued treatment due to an adverse event that was linked to the standard drug, according to Chao.
On Sunday, Gilead announced it struck a deal to buy out ImmunoMedics for $21 billion, which will give it Trodelvy, newly approved for metastatic triple negative breast cancer.