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BIOMARKER:

High inflammation signature scores

3years
[VIRTUAL] Clinical biomarker studies with two fusion-enhanced versions of oncolytic HSV (RP1 and RP2) alone and in combination with nivolumab in cancer patients indicate potent immune activation (AACR 2021)
The tumor inflammation signature score (TIS) was also calculated.Preliminary Phase 1/2 biomarker data from paired tumor biopsies include the following: Immunohistochemistry for CD8 and PD-L1 (n=30) indicated robust and increased infiltration of CD8+ T cells and PD-L1 expression, both after combined treatment with RP1 and nivolumab and after single agent RP2 across different tumor types, and including reversal of T cell exclusion following prior combined treatment with ipilimumab and nivolumab in melanoma. Consistent with the pre-clinical data, preliminary clinical biomarker data indicate substantial increase in CD8 T cell infiltration and PD-L1 expression, as well as increased TIS score in the majority of patients treated with RP2 alone or RP1 and nivolumab combination. Particularly marked effects were seen in some patients with clinical responses which occurred independent of both baseline PD-L1 and prior anti-PD1 therapy status, which suggests potential broad utility of the RP1/2 treatment approach in igniting an anti-tumor immune response. Tumor mutation burden analysis and T cell receptor sequencing are currently underway and further updates of the dataset will be presented.
Combination therapy • Late-breaking abstract • Clinical • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • CD27 (CD27 Molecule) • CSF2 (Colony stimulating factor 2)
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PD-L1 expression • CSF2 expression • CTLA4 expression • High inflammation signature scores
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PD-L1 IHC 28-8 pharmDx
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Opdivo (nivolumab) • Yervoy (ipilimumab) • RP2 • vusolimogene oderparepvec (RP1)