XB628 / Exelixis, Invenra - LARVOL DELTA

A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=303 | Recruiting | Sponsor: Exelixis | N=75 ➔ 303

Enrollment change • Oncology • Solid Tumor

Preclinical evaluation of XB628: A novel PD-L1 x NKG2A bispecific antibody (AACR 2025) - "XB628 is a first-in-class, bispecific antibody that simultaneously inhibits both adaptive and innate immune checkpoints by engaging PD-L1 and NKG2A, while also recruiting NK cells to tumor cells. XB628 is highly efficacious in tumor cell killing in vitro and in vivo, supporting further clinical development."

Bispecific • Preclinical • Oncology • CD8 • GZMB • HLA-E • IFNG • KLRC1

Anticipated R&D Milestones: Progress of Phase 1 Clinical Programs for XL309, XB010, XB628 and XB371 (Businesswire) - "Exelixis is advancing ongoing phase 1 clinical trials for XL309 (USP1 inhibitor), XB010 (5T4-targeting ADC), XB628 (PD-L1 + NKG2A bispecific) and XB371 (TF-targeting ADC). If phase 1 data are supportive, Exelixis plans to progress these molecules into full development...."

Trial status • Solid Tumor

Advancement of XB628 and XB371 Pipeline Programs into Clinical Development (Businesswire) - "Today, Exelixis provided an update on the recent progress of its early-stage pipeline programs, including XB628 (PD-L1 + NKG2A-targeting bispecific antibody) and XB371 (TF-targeting ADC). In April, Exelixis initiated the phase 1 study of XB628, following the U.S. FDA clearance of its Investigational New Drug (IND) application in March....Additionally, in July, the U.S. FDA cleared Exelixis’ IND application for XB371 and the company plans to initiate the phase 1 study in the coming months."

IND • New P1 trial • Trial status • Solid Tumor

A Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=75 | Recruiting | Sponsor: Exelixis | Not yet recruiting ➔ Recruiting

Enrollment open • Solid Tumor

A Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=75 | Not yet recruiting | Sponsor: Exelixis

New P1 trial • Solid Tumor

Exelixis to Present Positive Preclinical Data Across Its Pipeline Portfolio for Advanced Cancers at AACR 2025 (Businesswire) - "Exelixis will present preclinical data for XL495 and XL309, small molecules that have demonstrated synthetic lethality in the context of certain genetic anomalies frequently found in some tumors. Preclinical data will also be presented for the PD-L1xNKG2A-targeting bispecific antibody XB628 and the tissue factor-targeting antibody-drug conjugate XB371."

Preclinical • Oncology

Exelixis Announces Preliminary Fiscal Year 2024 Financial Results, Provides 2025 Financial Guidance and Outlines Key Priorities and Milestones for 2025 (Businesswire) - "Anticipated Discovery Milestones: Three Potential Investigational New Drug (IND) Applications in 2025. Exelixis anticipates advancing three biotherapeutics programs into clinical development this year, including the XB628 PD-L1-NKG2A bispecific antibody, XB064 ILT-2 monoclonal antibody and XB371 TF-topoisomerase I inhibitor ADC. The company expects to file the IND applications for these compounds in 2025 if preclinical data continue to be supportive. Exelixis plans to present preclinical data from one or more of these programs at a scientific meeting in 2025."

IND • Preclinical • Oncology

Exelixis Announces Preliminary Fiscal Year 2023 Financial Results, Provides 2024 Financial Guidance, and Outlines Key Priorities and Milestones for 2024 (Exelixis Press Release) - "...expects to file IND applications for the XB628 PD-L1-NKG2A bispecific antibody and XL495 small molecule PKMYT1 inhibitor programs in the second half of 2024 if preclinical data continue to be supportive....Exelixis has two DC programs that may be the subjects of IND filings in 2025, including the XB371 TF-Topoisomerase I inhibitor ADC and XB064 ILT-2 monoclonal antibody programs, and the XB033 IL13Ra2-Topoisomerase I inhibitor ADC that may be the subject of an IND filing in 2026. In 2024, the company expects to designate two new programs to DC status, including a small molecule PLK4 inhibitor and an additional ADC."

IND • Oncology

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 Announces Preliminary Fourth Quarter and Full Year 2021 Financial Results, Provides 2022 Financial Guidance, and Outlines Key Priorities and Milestones for 2022 (Businesswire) - "Potential new development candidates:...With respect to biotherapeutics, these include XB010, the first custom ADC generated through the company’s collaboration network, which was designated a development candidate in late 2021 and will enter preclinical development shortly....Additional ADCs advancing through discovery target a range of tumor antigens including AMHR2, ROR1/2, TF and DLL3 and utilize a variety of conjugation technologies and payloads. In addition, Exelixis is advancing two bispecific programs through its Invenra collaboration that combine a PD-L1 targeting arm with either a CD47 targeting arm to block a macrophage checkpoint, or an NKG2A targeting arm to promote NK cell activation in the tumor microenvironment."

Pipeline update • Oncology