RBI-1000 / Replicate Biosci - LARVOL DELTA

A self-replicating RNA Precision Immunotherapeutic for Overcoming Resistance to Endocrine Therapy in Estrogen Receptor Positive Breast Cancer (ER+BC) (SABCS 2023) - "The immune cell-mediated elimination of clones expressing the acquired resistance mutations is predicted to prolong endocrine control of ER+BC, in an analogous manner to small molecule or monoclonal antibody targeted therapies, but with a more favorable dosing and adverse event profile due to precise immunologic targeting and no DDI. RBI-1000 is anticipated to enter clinical studies in the first half of 2024."

IO biomarker • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CD4 • CD8 • ER • ERBB3 • HER-2 • PI3K

Self-replicating RNA therapeutics for off-the-shelf precision immunotherapy targeting acquired resistance mutations in low TMB tumors (SITC 2023) - "mRNA-4157 is a personalized neoantigen vaccine (Moderna) that, when combined with pembrolizumab, demonstrated prolongation of RFS and DMFS when given as adjuvant therapy for high-risk melanoma following complete resection...Results Replicate Bioscience has developed a precision immunotherapy (PIO), RBI-1000, targeting ARM in ER+ breast cancer...RBI-3000, our EGFRm PIO and second oncology therapeutic, targets the known resistance mutations, and primary mutations that are less responsive to tyrosine kinase inhibitor (TKI) therapy and will be administered in combination with SOC TKIs. The coupling of targeted and PIO therapies is anticipated to better address clinical need in the metastatic setting, with chemotherapy replacing surgical resection to address tumor bulk. Conclusions PIO is a novel approach to cancer immunotherapy that is widely applicable to any cancer with characterized ARM."

IO biomarker • Preclinical • Breast Cancer • Hormone Receptor Breast Cancer • Melanoma • Oncology • Solid Tumor • ER • TMB

Replicate Bioscience to Present Progress on Two srRNA Oncology Programs at Society for Immunotherapy of Cancer 2023 Meeting (PRNewswire) - "Poster presentation describes potential of oncology programs RBI-1000 and RBI-3000 to target known acquired resistance mutations....RBI-1000 leads to tumor control with the elimination of tumor cells expressing ARM in preclinical models....RBI-3000 is an srRNA PIO program targeting acquired resistance to current tyrosine kinase inhibitor standard of care therapy for metastatic EGFRm+ non-small cell lung cancer."

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

A self-replicating RNA precision medicine approach to overcoming resistance to endocrine therapy in ER+BC (AACR 2023) - "RBI-1000 is a candidate using a novel type of self-replicating RNA (srRNA) to generate robust immunity directed against acquired resistance mutations that develop in ER+ breast cancer (ER+ BC) in response to endocrine therapy...Priming of T cells against acquired mutations is also confirmed in human HLA-transgenic mice. The immune cell-mediated elimination of clones expressing the acquired resistance mutations is predicted to prolong endocrine control of ER+BC, in an analogous manner to small molecule or monoclonal antibody targeted therapies, but with a more favorable dosing and adverse event profile due to precise immunologic targeting and no DDI."

IO biomarker • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • CD4 • CD8 • EGFR • ER • ERBB3 • HER-2 • PI3K • ROS1

Replicate Bioscience Presents Preclinical srRNA Data at the American Association for Cancer Research Annual Meeting 2023 (PRNewswire) - "Replicate Bioscience...shared new preclinical data underscoring the strength of Replicate's srRNA platform and its potential for oncology applications at the American Association for Cancer Research (AACR) Annual Meeting 2023....RBI-1000 encodes high frequency, clinically characterized pervasive and predictable acquired resistance mutations found in estrogen-receptor expressing breast cancer, representing about 80% of all ER+ breast cancers....In a mouse model expressing the targeted acquired resistance mutations, RBI-1000 successfully primed CD4+ and CD8+ T cells leading to significant tumor growth inhibition and improved survival at a 100-fold lower dose than linear mRNA approaches in other tumor models."

Preclinical • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Replicate Bioscience Shares New Preclinical srRNA Data at American Association for Cancer Research Annual Meeting 2023 (PRNewswire) - "Replicate Bioscience...announced two poster presentations at the upcoming American Association for Cancer Research (AACR) Annual Meeting, April 14-19 in Orlando, Florida....'We look forward to sharing preclinical results with the AACR community demonstrating the potential of our srRNA technology platform and lead oncology program to substantially improve tumor control in estrogen receptor expressing breast cancers'."

Preclinical • Breast Cancer • Oncology • Solid Tumor