Labvax 3(22)-23 / LabyRx Immuno-Oncology - LARVOL DELTA

Safety and preliminary effects of LabVax 3(22)-23 and GM-CSF, with and without pembrolizumab, in patients with labyrinthin-expressing adenocarcinomas (AACR 2025) - "LabVax and GM-CSF, either alone or in combination with pembro, were well tolerated and elicited detectable humoral and cellular immune effects in heavily pretreated patients with Lab-expressing adenocarcinomas. The study is currently accruing patients for Phase II expansion cohorts."

Clinical • Late-breaking abstract • Oncology • CSF2

Labyrinthin as a potential neoantigen for oncogene-driven and non-oncogene-driven lung adenocarcinomas (SITC 2023) - "RNA sequencing analysis of blood mononuclear cells of two pts enrolled in phase I trial revealed that LabVax 3(22)-23 and adjuvant GM-CSF treatment modulated the activity of immune cells and PD-1 pathway. Conclusions LAB is a promising cancer neoantigen for both oncogene-driven and non-oncogene-driven LUAD, which warrant further study."

IO biomarker • Tumor mutational burden • Tumor-specific neoantigens • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • CSF2 • EGFR • HER-2 • HRAS • KRAS • NRAS • PD-L1 • ROS1 • TMB

A phase 1/2 open label study of LabVax 3(22)-23 and adjuvant GM-CSF alone or in combination with pembrolizumab in subjects with labyrinthin-positive adenocarcinomas (SITC 2023) - "Sargramostim, a recombinant granulocyte macrophage colony-stimulating factor (GM-CSF), is given as an immunostimulator with LabVax 3(22)-23 to boost the antitumor immune response. If ≤2 subjects have a DLT, then the study will proceed to phase 2 expansions of 18 participants in each cohort. In Cohort A, if ≥2 LUAD patients respond, an additional 25 patients will be enrolled."

Clinical • Combination therapy • IO biomarker • P1/2 data • Colon Cancer • Colorectal Adenocarcinoma • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CSF2 • PD-1 • PD-L1

Novel biomarker assays for detecting labyrinthin-positive adenocarcinomas for a phase I/II trial of peptide vaccine LabVax 3(22)-23 alone or in combination with pembrolizumab (SITC 2023) - P1/2 | "Ongoing studies are validating these results with more patients with NGS data. Conclusions We have established IHC and RNA assays to identify patients with LAB-positive adenocarcinomas in the ongoing phase I/II study (UCDCC#296, NCT051013560) evaluating the safety and efficacy of the LAB vaccine in combination with pembrolizumab."

Biomarker • Biomarker assay • Combination therapy • IO biomarker • P1/2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2 • PD-L1 • PGR

A Cancer Vaccine (Labvax 3(22)-23) and GM-CSF Alone or in Combination With Pembrolizumab for the Treatment of Advanced Stage Adenocarcinoma (clinicaltrials.gov) - P1/2 | N=77 | Recruiting | Sponsor: Tianhong Li | Phase classification: P1 ➔ P1/2 | N=10 ➔ 77 | Trial completion date: Sep 2027 ➔ Jan 2030 | Trial primary completion date: Sep 2023 ➔ Jan 2026

Combination therapy • Enrollment change • Metastases • Phase classification • Trial completion date • Trial primary completion date • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • NTRK • ROS1

A first-in-human phase I trial of a novel peptide vaccine LabVax 3(22)-23 and adjuvant GM-CSF sargramostim in patients with refractory labyrinthin-expressing adenocarcinomas. (ASCO 2023) - P1 | "Sponsored by Institutional Funding, UC Davis Comprehensive Cancer Center, LabyRx Immuno-Oncology. LabVax 3(22)-23 and GM-CSF were well tolerated in these heavily pre-treated patients with Lab-expressing, refractory adenocarcinomas. Based on preclinical synergism with pembrolizumab, this dose and injection schedule will be tested in a phase II open label study of LabVax 3(22)-23 and GM-CSF in combination with pembrolizumab in patients with refractory lung adenocarcinomas and adenocarcinomas of all other tumor types. Clinical trial information: NCT051013560."

Clinical • IO biomarker • P1 data • Immunology • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CSF2

A first-in-human, phase I, open-label study of a novel cancer vaccine labvax 3(22)-23 and adjuvant GM-CSF in patients with advanced stage adenocarcinomas. (ASCO 2022) - P1 | "Sargramostim, a recombinant granulocyte macrophage colony-stimulating factor (GM-CSF), is given as an immunostimulator with LabVax 3(22)-23 to boost the antitumor immune response. After completion of study treatment, patients are followed every 3 months for 1 year. Two patients are enrolled at the time of submission."

Clinical • IO biomarker • P1 data • Colon Cancer • Colorectal Adenocarcinoma • Gastrointestinal Cancer • Immunology • Oncology • Solid Tumor • CSF2 • PD-1 • PD-L1