AB801 / Arcus Biosci - LARVOL DELTA

Arcus Biosciences Reports Fourth-Quarter and Full-Year 2024 Financial Results and Provides a Pipeline Update (Businesswire) - "Pipeline Highlights:...Early Clinical Programs: Evaluation of AB801, a potent and highly selective small-molecule AXL inhibitor, in the dose-escalation phase of a Phase 1/1b study in patients is ongoing. Arcus anticipates advancing this molecule into expansion cohorts in non-small cell lung cancer (NSCLC) in the second half of 2025."

Trial status • Non Small Cell Lung Cancer

Arcus Biosciences Reports Third-Quarter 2024 Financial Results and Provides a Pipeline Update (Businesswire) - "(i) Upcoming Domvanalimab-Zimberelimab Milestones: Overall survival data from the Phase 2 EDGE-Gastric study, evaluating domvanalimab plus zimberelimab and chemotherapy in upper gastrointestinal (GI) adenocarcinomas, are expected to be presented in 2025....(ii) Early Clinical Programs: Evaluation of AB801, a potent and highly selective small-molecule AXL inhibitor, in the dose-escalation phase of a Phase 1/1b study in patients is ongoing. Arcus anticipates advancing this molecule into expansion cohorts in NSCLC in early 2025."

P2 data • Trial status • Esophageal Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma • Non Small Cell Lung Cancer

AB801, a potent and highly selective clinical stage AXL inhibitor, sensitizes tumors to standard of care therapies (EORTC-NCI-AACR 2024) - P1 | "We also present AB801 pharmacokinetic (PK) and safety profiles in ARC-26.Materials and Human and murine cells were treated with docetaxel or paclitaxel in combination with AB801, and viability and levels of DNA damage were evaluated. AB801 is the most potent and selective AXL inhibitor in clinical development. Pre-clinical data support combinations of AB801 with standard of care therapies. AB801 demonstrated favorable clinical PK and safety in ARC-26."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • GAS6

Arcus Biosciences to Present First Clinical Data from ARC-20 Study at the 2024 EORTC-NCI-AACR Symposium (Businesswire) - "Data from the 100mg expansion cohort of ARC-20, a Phase 1/1b study of casdatifan in clear cell renal cell carcinoma (ccRCC), will be presented in an oral plenary session...Two posters will be presented on the preclinical evaluation and human pharmacokinetics/ pharmacodynamics of casdatifan, respectively, and a third poster will be presented on AB801, Arcus’s AXL inhibitor...Arcus will also host a conference call to discuss the ARC-20 results at 5:00 AM PT / 8:00 AM ET on Thursday, October 24, 2024....These data support a potential best-in-class profile, and we are rapidly advancing a differentiated development program for casdatifan, including the planned initiation of our first Phase 3 study in the first half of 2025."

New P3 trial • P1 data • Preclinical • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Arcus Biosciences Reports Second-Quarter 2024 Financial Results and Provides a Pipeline Update (Businesswire) - "Pipeline Highlights:...(i) Etrumadenant: Biomarker data from...ARC-9...study are expected to be presented at a scientific conference in the second half of 2024;...(ii) Quemliclustat: Initiation of a Phase 3 trial, PRISM-1, of quemliclustat combined with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in pancreatic cancer is expected to begin by early 2025;...(iii) Early Clinical Programs: Dose escalation for AB801, a potent and highly selective small-molecule AXL inhibitor, continues. Arcus anticipates advancing this molecule into expansion cohorts in NSCLC in early 2025."

Biomarker • New P3 trial • P1/2 data • Trial status • Colorectal Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer

Arcus Biosciences Reports Fourth-Quarter and Full-Year 2023 Financial Results and Provides a Pipeline Update (Businesswire) - "Quemliclustat (small-molecule CD73 inhibitor):...Initiation of a Phase 3 trial in pancreatic cancer is expected to begin by early 2025....Early Clinical and Preclinical Programs: Arcus initiated ARC-27, a Phase 1 study of AB801, Arcus’s potent and highly selective AXL inhibitor, in advanced cancer patients and expects to initiate the first expansion cohort in NSCLC in 2025."

New P3 trial • Trial status • Non Small Cell Lung Cancer • Pancreatic Cancer

A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AB801 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Arcus Biosciences, Inc. | Recruiting ➔ Completed

Trial completion • Oncology

ARC-27: A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Arcus Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • MET • NTRK • PD-L1 • RET • ROS1 • STK11

ARC-27: A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: Arcus Biosciences, Inc.

Combination therapy • Metastases • Monotherapy • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck • ALK • EGFR • MET • NTRK • PD-L1 • RET • ROS1 • STK11

Arcus Biosciences Reports Third Quarter 2023 Financial Results and Provides a Pipeline Update (Businesswire) - "Early Clinical and Preclinical Programs: (i) ARC-25, a Phase 1 trial in cancer patients for AB598, an anti-CD39 antibody, is currently enrolling; (ii) Arcus initiated a Phase 1 study in healthy volunteers of AB801, its potent and highly selective AXL inhibitor, and expects to initiate a Phase 1 study in advanced cancer patients in the first quarter of 2024."

Trial status • Solid Tumor

Inhibition of AXL signaling with AB801 augments anti-tumor immune responses (SITC 2023) - "Conclusions AXL is a promising therapeutic target involving both immunomodulatory and tumor-intrinsic mechanisms. The potent and selective AXL inhibitor AB801 reduces immunosuppression in the TME, enables activation of an anti-tumor immune responses, and renders tumors more susceptible to checkpoint blockade and chemotherapeutic treatment."

Oncology

A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AB801 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Arcus Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology

A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AB801 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Arcus Biosciences, Inc.

New P1 trial • Oncology

Arcus Biosciences Reports Second-Quarter 2023 Financial Results and Provides a Pipeline Update (Businesswire) - "AB521 (HIF-2a inhibitor)...Initial pharmacokinetic (PK), pharmacodynamic (PD) and safety data, along with any preliminary signs of anti-tumor activity from the dose-escalation phase of ARC-20, are expected in late 2023 or early 2024. Efficacy data from the dose-expansion stage of the ARC-20 study are anticipated later in 2024. A Phase 2 study evaluating AB521 in combination with other agents is anticipated to begin in the fourth quarter of 2023....Early Clinical and Preclinical Programs: Arcus initiated ARC-25, a Phase 1 trial in cancer patients for AB598, its anti-CD39 antibody, in the second quarter of 2023. Arcus expects to initiate a Phase 1 study in healthy volunteers of AB801, its potent and highly selective Axl inhibitor, in the third quarter of 2023."

New P2 trial • P1 data • Trial status • Bladder Cancer • Breast Cancer • Cervical Cancer • Clear Cell Renal Cell Carcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Arcus Biosciences Reports First Quarter 2023 Financial Results and Provides a Pipeline Update (Businesswire) - "Pipeline Highlights: Preclinical Programs - (i) The IND for AB598, Arcus’s anti-CD39 antibody, has been cleared by the FDA, and Arcus is on track to initiate a Phase 1 trial in cancer patients in the second quarter of 2023; (ii) Arcus expects to initiate a Phase 1 study for AB801, a potent and highly selective Axl inhibitor, in the second half of 2023. Arcus presented data at the American Association for Cancer Research (AACR) Annual Meeting in April 2023 demonstrating high potency and selectivity of AB801 for Axl over other kinases in multiple assays; the data also showed that AB801 significantly decreased tumor volume and increased survival in mouse tumor models."

IND • New P1 trial • Preclinical • Oncology

AB801 is a highly potent and selective AXL kinase inhibitor that demonstrates significant anti-tumor activity (AACR 2023) - "AXL inhibition is a promising therapeutic mechanism for impairing the growth of tumors resistant to SOC therapeutics. AB801 exhibits improved potency, selectivity, and safety profiles compared to other AXL inhibitors currently advancing into clinical development."

Oncology • AXL • GAS6 • MERTK

Arcus Biosciences Reports Third Quarter 2022 Financial Results and Provides a Pipeline Update (Businesswire) - "Arcus remains on track to initiate a Phase 1 trial in cancer patients for AB598, its anti-CD39 antibody, in the first half of 2023. Arcus expects to initiate a Phase 1 trial in 2023 for its next small molecule program, AB801, a potent and highly selective Axl inhibitor."

Enrollment status • Oncology • Solid Tumor

AB801 is a potent and selective AXL inhibitor that demonstrates significant anti-tumor activity in combination with standard of care therapeutics (AACR-NCI-EORTC 2022) - "AB801 demonstrates significant anti-tumor activity in combination with standard of care therapeutics. Selective AXL inhibition is a promising therapeutic strategy to overcome resistance to therapy."

Combination therapy • IO biomarker • Oncology • GAS6

Discovery and characterization of potent and selective AXL receptor tyrosine kinase inhibitor AB801 (AACR-NCI-EORTC 2022) - "AXL inhibition is a promising therapeutic mechanism for impairing the growth and metastasis of chemotherapy- and immunotherapy-resistant tumors. AB801 exhibits improved potency, selectivity, and safety profiles compared to other AXL inhibitors currently advancing through clinical development."

Oncology • AXL • GAS6 • MERTK