Multiple clinical trials of magrolimab, the CD47-targeting antibody formerly known as Hu5F9-G4, are now underway or nearing initiation, leading Forty Seven to dial up its spending on studies and supplies of the drug.
In the third quarter, the increased clinical activity manifested in R&D expenses of $27.1m (€24.4m), up 50% on the $18m (€16.2m) Forty Seven spent on advancing its pipeline one year ago.
Forty Seven primarily attributed the jump in expenditure to a $9.2m increase in its outlay on clinical research spending associated with the advance of magrolimab, singling out contract manufacturing costs for studies to support a biologics license application (BLA) as one of the drivers.
The third quarter spending figures reveal the acceleration of a trend seen earlier in the year. In the second quarter, Forty Seven’s R&D spending increased from $13.6m to $18.8m year on year.
This 38% rise stemmed mainly from third-party costs, including contract manufacturing, associated with the clinical progress of magrolimab.
The sharp sequential increase in spending, from $18.8m in the second quarter to $27.1m in the third quarter, comes as Forty Seven continues to enroll patients with untreated, intermediate to very high risk myelodysplastic syndrome.
In addition, the company is talking to regulators about a second study in the indication to support accelerated approval – with the supporting trial due to get underway in the first quarter of 2020.
With Forty Seven aiming to submit a BLA for magrolimab in the indication by the end of 2021, the biotech based in San Francisco, US, is stepping up its chemistry, manufacturing and controls activities to support the planned filing.
In parallel, Forty Seven is preparing to start studying magrolimab in 100 patients with diffuse large B-cell lymphoma early next year, adding to its need for supplies of the anti-CD47 antibody.
The escalation of the clinical development program, and knock-on effect on contract manufacturing spend, has led Forty Seven to strengthen its cash position. Forty Seven raised $86.3m in a stock offering in July of this year.
Added to the $15.7m upfront license payment Forty Seven received from Ono Pharmaceutical, the stock offering led the biotech to end September with $166.7m in ready funds. Forty Seven expects the money to see it through to the first quarter of 2021.