The IND clearance by the FDA paves the way for the Dutch clinical-stage company to assess the safety and pharmacokinetics of the SIRPα inhibitor in the US in a phase 1 clinical trial, while triggering a milestone payment of $35m from Exelixis
Sairopa set to begin phase 1 trial of ADU-1805 in the US after FDA’s clearance of IND application. (Credit: Chokniti Khongchum from Pixabay)
Sairopa has secured approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for ADU-1805 in adults having advanced solid tumours.
The IND clearance by the FDA paves the way for the Dutch clinical-stage company to assess the safety and pharmacokinetics of the drug candidate in the US in a phase 1 trial.
ADU-1805 will be evaluated both as a single agent and in a combination regimen in advanced solid tumours in the early-stage trial, which is anticipated to be launched in Q2 2023.
The monoclonal antibody is claimed to be active against all human alleles of SIRPα. It can potentially address a wider patient population than other SIRPα-directed therapies, said Sairopa.
By inhibiting SIRPα, ADU-1805 can potentially boost the ability of the immune system to attack tumors, said the Dutch firm. Furthermore, the monoclonal antibody is said to have been optimised to preferentially attach to SIRPα compared with other SIRP family members, which could improve its ability of triggering immune cells.
The Dutch pharma company has a clinical development and option agreement in place for ADU-1805 with US-based oncology company Exelixis.
As per the deal signed last November, which is worth over $335m, Exelixis has the option to acquire an exclusive, global license to develop and commercialise the monoclonal antibody and other anti-SIRPα antibodies. This will be after review of data from prespecified phase 1 clinical studies of ADU-1805 which will be carried out by Sairopa during the option period.
Sairopa chief operating officer Laura Lassouw-Polman said: “Given the robust preclinical data generated, we are thrilled that ADU-1805 is now able to advance to the clinic.
“This is an important step forward in our partnership with Exelixis to explore the potential of ADU-1805, advancing our mission to develop therapies that modulate immune system activity to improve outcomes for cancer patients.”
The IND clearance by the FDA enables Sairopa to receive a milestone payment of $35m, which will be paid by Exelixis in Q1 2023.
Exelixis product development and medical affairs executive vice president and chief medical officer Vicki Goodman said: “The clearance of this Investigational New Drug Application for ADU-1805 is an exciting milestone for our expanding biologics pipeline, marking the first of many anticipated advancements we expect this year.
“Based on its best-in-class potential and broad applicability, we look forward to learning more about ADU-1805 from the upcoming phase 1 trial across multiple tumor types, as we continue toward our goal of finding innovative solutions for patients with advanced cancers.”