XB371 / Exelixis - LARVOL DELTA

Progress of Early-stage Pipeline Programs (Businesswire) - "In August, Exelixis initiated the phase 1 study of XB371, the company’s next-generation tissue factor-targeting antibody-drug conjugate (TF-targeting ADC) program, following U.S. FDA clearance of its Investigational New Drug application in July."

Trial status • Solid Tumor

A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Exelixis

New P1 trial • 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

Preclinical characterization of XB371, a novel anti-tissue factor antibody-drug conjugate (AACR 2025) - "XB371 demonstrated in vitro cytotoxicity, bystander, and ICD activity, and in vivo efficacy across multiple xenograft cell lines and PDX models. Taken together, these preclinical results support further development of XB371; IND-enabling studies are ongoing."

Preclinical • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HMGB1

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