EXEL - Exelixis to pay Sairopa $35M milestone as FDA clears cancer drug to enter phase 1 trial
- The U.S. Food and Drug Administration (FDA) cleared Exelixis ( NASDAQ: EXEL ) and Sairopa (Sairopa) drug ADU-1805 to enter human trial to treat adults with advanced solid tumors.
- Sairopa had filed an investigational new drug (IND) application to evaluate the safety and pharmacokinetics of ADU-1805 in adults with advanced solid tumors.
- The companies said that a phase 1 trial of ADU-1805 as a single agent and in a combination regimen in advanced solid tumors is expected to begin in Q2 this year.
- This IND clearance triggers a $35M milestone payment to Sairopa which will be paid in Q1 2023, according to the companies.
- Under a November 2022 agreement, Exelixis has the option to obtain an exclusive, worldwide license to develop and commercialize ADU-1805 and other anti-SIRP? antibodies upon review of data from prespecified phase 1 studies of ADU-1805 to be completed by Sairopa during the option period.
- As per the companies, ADU-1805 is a monoclonal antibody targeting SIRP? to block the SIRP?-CD47 checkpoint.
- EXEL -0.34% to $17.49 premarket Feb. 13
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Exelixis to pay Sairopa $35M milestone as FDA clears cancer drug to enter phase 1 trial