ADU-1805 / Exelixis, Sairopa - LARVOL DELTA

Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: Sairopa B.V. | N=90 ➔ 130 | Trial completion date: Dec 2025 ➔ Jul 2027 | Trial primary completion date: Dec 2025 ➔ May 2027

Enrollment change • Trial completion date • Trial primary completion date • Colorectal Cancer • Endometrial Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Sairopa reports research milestones achieved in partnership with Exelixis, totalling $35 Million from consecutive clinical milestone payments in 2024 (PRNewswire) - "Sairopa B.V., today announced it has achieved a milestone event in its exclusive clinical development and option agreement with Exelixis, Inc...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."

Licensing / partnership • Solid Tumor

Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: Sairopa B.V. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=90 | Not yet recruiting | Sponsor: Sairopa B.V.

Metastases • New P1 trial • Oncology • Solid Tumor

Exelixis Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update (Businesswire) - "acceleration of the XB002 clinical program into full development by year-end; advancement of the XL102 QUARTZ-101 phase 1 study into the tumor-specific cohort-expansion stage and in planned combination cohorts; in collaboration with partner Cybrexa, progression of phase 1 clinical study for CBX-12, including dose-expansion cohorts; expected IND filing for ADU-1805 in the first quarter of 2023 by partner Sairopa; advancement of DCs XB010, XB014 and XB628 toward IND filings."

Clinical • Clinical protocol • IND • New P1 trial • Oncology • Solid Tumor

Exelixis and Sairopa Announce US FDA Clears Investigational New Drug Application for ADU-1805 in Patients with Advanced Solid Tumors (Businesswire) - "Exelixis...and Sairopa B.V....announced that the U.S. Food and Drug Administration (FDA) has cleared Sairopa’s Investigational New Drug (IND) Application to evaluate the safety and pharmacokinetics of ADU-1805 in adults with advanced solid tumors. As a monoclonal antibody active against all human alleles of SIRPα, ADU-1805 has the potential to address a broader patient population than other SIRPα-directed therapies....This IND clearance triggers a $35 million milestone payment to Sairopa which will be paid in the first quarter of 2023....Phase 1 study of ADU-1805 as a single agent and in a combination regimen in advanced solid tumors expected to begin second quarter of this year."

Financing • IND • New P1 trial • Oncology • Solid Tumor

Exelixis Announces Preliminary Fourth Quarter and Full Year 2022 Financial Results, Provides 2023 Financial Guidance, and Outlines Key Priorities and Milestones for 2023 (Businesswire) - "In the first quarter of 2023, Exelixis expects its partner Sairopa to file an IND for ADU-1805, a potential best-in-class monoclonal antibody targeting SIRPα to block the SIRPα–CD47 checkpoint....In 2023, Exelixis plans to advance XB010, the first custom ADC generated through the company’s biotherapeutics network of collaborations, and XB014, the company’s first bispecific antibody designated as a DC in August 2022, through preclinical development and IND-enabling studies, toward potential IND filings in early 2024.... Exelixis announced it has designated XB628 as its latest DC and plans to advance the program through preclinical development in 2023, toward a potential IND filing in 2024."

IND • Oncology • Solid Tumor

Exelixis and Sairopa Establish Exclusive Clinical Development Collaboration and Option Agreement to Develop ADU-1805, a Potentially Best-in-Class Monoclonal Antibody Targeting SIRPα (Businesswire) - "Exelixis, Inc...and Sairopa B.V. (Sairopa) today announced that the companies have entered into an exclusive clinical development and option agreement for ADU-1805, a potentially best-in-class monoclonal antibody that targets SIRPα...Under the terms of the agreement, Exelixis will make an upfront payment to Sairopa of $40 million and an additional $70 million in near-term milestones for an option to obtain an exclusive, worldwide license to develop and commercialize ADU-1805 and other anti-SIRPα antibodies, and for certain expenses to be incurred by Sairopa in conducting prespecified phase 1 clinical studies of ADU-1805 during the option period. Sairopa is eligible to receive additional success-based development milestone payments during the option period. Following the completion of the prespecified clinical studies, Exelixis has the right to exercise its option for an option exercise fee of $225 million...Exelixis’ plans to file an IND for ADU-1805 in the first quarter of 2023..."

IND • Licensing / partnership • Oncology • Solid Tumor

Exelixis and Sairopa Establish Exclusive Clinical Development Collaboration and Option Agreement to Develop ADU-1805, a Potentially Best-in-Class Monoclonal Antibody Targeting SIRPα (Businesswire) - "Exelixis...announced that the companies have entered into an exclusive clinical development and option agreement for ADU-1805, a potentially best-in-class monoclonal antibody that targets SIRPα. SIRPα expressed on myeloid cells interacts with CD47 present on the surface of cancer cells and blocks the ability of macrophages to clear tumor cells via phagocytosis and inhibits tumor antigen presentation to T-cells."

Licensing / partnership • Oncology

Functional characterization of the selective pan-allele anti-SIRPα antibody ADU-1805 that blocks the SIRPα-CD47 innate immune checkpoint. (PubMed, J Immunother Cancer) - "Blocking the SIRPα-CD47 interaction via SIRPα, while similarly efficacious in vitro, differentiates ADU-1805 from CD47-targeting agents with respect to safety and absence of inhibition of T-cell activation. The data presented herein support further advancement of ADU-1805 towards clinical development."

IO Biomarker • Journal • Burkitt Lymphoma • Hematological Disorders • Hematological Malignancies • Immune Modulation • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia