Avid Bioservices Inc (CDMO)

[JamesGMS]

CJ, thanks for posting the SITC information. Your contributions to the greater understanding of the science is greatly appreciated. It's worth restating and highlighting the most salient points.

RESULTS

Pre-treatment (pre-tx) samples were evaluable by qPACC for 62 (32 D+B, 30 D+P) out of the 93 pts who received ICI as next line therapy after the SUNRISE assigned treatment. High pre-tx (>=median) levels correlated with statistically significant OS benefit favoring D+B for the following biomarkers: CD3+ (HR=.37, p=.023), CD4+ (HR=.32, p=.012), CD8+ (HR=.42, p=.036), PD-1 (HR=.33, p=.017), GNLY (HR=0.25, p=.011), FoxP3 (HR=.34, p=.032), naïve CD8+ (HR=.32, p=.034), B-cells (HR=.24, p=.007), MDSC (HR=.33, p=.037) NK56+ (HR=.29, p=.026). Low (<) pre-tx levels of THF correlated with OS favoring D+B (HR=.34, p=.033). No OS difference was observed for pre-tx high or low levels for TH17, CCR6, or CD14+.

CONCLUSIONS

High pre-tx levels (>=median) of circulating immune cells including T cells, B-Cells, MDSCs, NK cells correlated with significant improvement of OS in patients who received D+B then ICI compared to D+P then ICI in the SUNRISE trial.

These results support further investigation of these markers in future bavituximab clinical trials.

RESULTS
In this study, we show that irradiation of B16 melanoma causes an increase in PS expression on the surface of viable tumor and immune infiltrates. We subsequently examined the effects of combining RT with an antibody that targets PS and anti-PD-1. We found that treatment with mch1N11 synergizes with RT to improve anti-tumor activity and overall survival in tumor bearing mice.

In addition, the triple combination of mch1N11, RT and anti-PD-1 treatment displayed even greater anti-tumor and survival benefit. Analysis of the immune response in the tumors of treated animals revealed an increase in M1-like macrophages in the tumors after treatment with RT and mch1N11. In addition, analysis of the systemic immune responses revealed an increase in antigen-specific CD8 T cell infiltration in the tumors as well as increased activation, effector function and differentiation in the triple combination therapy.

CONCLUSIONS
This finding highlights the potential of combining these agents to improve outcome in patients with advanced-stage melanoma and may inform the design of future clinical trials with PS targeting in multiple cancers.

And then a brief - but very important observation from a few days ago posted by North in response to one of my prior posts.

Your quotations hit the high points of current basis for our investment in the PPHM technology. . . . .

Quiet periods abound.

Have a great day.

James