Sairopa reports research milestones achieved in partnership with Exelixis, totalling $35 Million from consecutive clinical milestone payments in 2024

Rhea-AI Summary

Sairopa B.V. has achieved a significant milestone in its partnership with Exelixis (NASDAQ: EXEL) regarding ADU-1805, an anti-SIRPα antibody for cancer treatment. The collaboration has generated substantial payments, including a $40 million upfront payment, $35 million for IND clearance, and an additional $35 million in clinical development milestones. The agreement grants Exelixis an exclusive option for worldwide development and commercialization rights following phase 1 clinical studies data review.

ADU-1805 is currently in a first-in-human phase 1 study across the U.S. and Europe, evaluating both monotherapy and combination treatment with pembrolizumab. The partnership combines Exelixis' oncology expertise with Sairopa's immunotherapy capabilities.

Positive

• Received total payments of $110 million from Exelixis to date
• Successfully achieved clinical development milestones
• Ongoing phase 1 trials in multiple countries
• Potential for additional milestone payments through development progression

Negative

• No clinical efficacy data reported yet
• Final licensing agreement with Exelixis still pending phase 1 data review

ROTTERDAM, The Netherlands, Dec. 17, 2024 /PRNewswire/ -- Sairopa B.V., today announced it has achieved a milestone event in its exclusive clinical development and option agreement with Exelixis, Inc. (Nasdaq: EXEL) involving ADU-1805, an innovative anti-SIRPα antibody with the potential to enhance the immune system's ability to combat cancer.

Under the terms of the agreement, Exelixis has an exclusive option to license worldwide development and commercialization rights for ADU-1805 and other anti-SIRPα antibodies following the review of data from Sairopa's phase 1 clinical studies. As part of its collaboration with Exelixis, Sairopa has previously received from Exelixis an upfront payment of $40 million, a $35 million milestone payment upon Investigational New Drug (IND) clearance of ADU-1805 with the U.S. Food and Drug Administration, and $35 million in milestone payments linked to advances within the clinical development of ADU-1805, in monotherapy as well as in combination with a PD-1 inhibitor.

"Today's operational update signifies a step forward in the partnered effort to develop next-generation therapies for cancer patients worldwide," said Gurvinder S. Chahal, Chief Business Officer of Sairopa. "The advances seen within our clinical program are a testament to the diligent work and innovative science behind our partnership with Exelixis, bringing us closer to realizing our mission of modulating the immune system to improve outcomes for cancer patients."

The safety and pharmacokinetics of ADU-1805 are currently being evaluated in a first-in-human, open-label, multicenter, multi-arm phase 1 study. To date, patients have been enrolled across the U.S. and several European countries, with assessments ongoing in both the ADU-1805 monotherapy and the ADU-1805 plus pembrolizumab dose escalation arms.

This collaboration combines Exelixis' proven track record in oncology drug development and commercialization with Sairopa's expertise in generating innovative cancer immunotherapies, setting the stage for potentially transformative treatments in oncology.

About Sairopa

Sairopa B.V. is a clinical-stage company focused on developing innovative treatments for cancer by modulating the patient's immune system. The pipeline features ADU-1604, an anti-CTLA4 antibody with promising safety and efficacy, having recently concluded a phase 1 study for PD-1 relapsed/refractory melanoma. A phase 2 trial with a PD-1 blocking antibody is planned for 2025. Additionally, Sairopa is advancing a SIRPα-PD-L1 bispecific antibody in preclinical development, aiming for an IND filing in 2026. With a portfolio of therapeutic antibodies developed from groundbreaking research and proprietary platforms, Sairopa aims to lead the way in the development of effective cancer immunotherapies. For more information about Sairopa, please visit www.sairopa.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements related to the clinical and therapeutic potential of ADU-1805, ADU-1604 and the SIRPα-PD-L1 bispecific antibody, along with   Sairopa's future plans and potential for clinical and commercial success. These forward-looking statements are based on the companies' current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties.

Sairopa B.V.
CIC Stationsplein 45

Unit A4.004
3013 AK Rotterdam
The Netherlands

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SOURCE Sairopa B.V.

FAQ

How much has Exelixis (EXEL) paid Sairopa in total for the ADU-1805 partnership?

Exelixis has paid Sairopa a total of $110 million, consisting of a $40 million upfront payment, $35 million for IND clearance, and $35 million in clinical development milestones.

What are the current clinical trial stages for ADU-1805 under the EXEL partnership?

ADU-1805 is currently in a first-in-human, open-label, multicenter, multi-arm phase 1 study, evaluating both monotherapy and combination treatment with pembrolizumab.

What rights does Exelixis (EXEL) have regarding ADU-1805?

Exelixis has an exclusive option to license worldwide development and commercialization rights for ADU-1805 and other anti-SIRPα antibodies after reviewing phase 1 clinical studies data.

What is the mechanism of action for ADU-1805 in Exelixis' (EXEL) pipeline?

ADU-1805 is an anti-SIRPα antibody designed to enhance the immune system's ability to combat cancer.