Patent application for a biomarker gene set for prediction of anti-PD1 efficacy. No conflict of interest here!!!

Predictive Biomarkers for Programmed Death Protein-1 Blockade Immunotherapy

This technology is a diagnostic biomarker gene set for the prediction of anti-Programmed Death Protein-1 (PD-1) blockade immunotherapy efficacy. Immunotherapy is regarded as a valid treatment option for melanoma patients with metastatic disease; however, its long-term efficacy in patients is poor as evidenced by 90% relapse rates in ipilumumab immunotherapy-treated patients. A set of biomarkers that predict patient outcome could influence treatment decisions and lead to a more efficacious and cost-effective tailored cancer therapy. In a retrospective study using our biomarker gene set on metastatic melanoma patient samples receiving PD-1 blocking antibody (BMS-936558) therapy, we show a statistically significant association between biomarker expression and patient response to PD-1 therapy.


COMMERCIAL OPPORTUNITY:
● In 2010, over 68,000 new cases of melanoma were diagnosed in the US. Immunotherapy treatment is recommended for many patients with metastatic disease, although the NCCN recognizes limited knowledge of which patients derive the most benefit from it.
● For example, over 90% of melanoma patients treated with the immunotherapy drug ipilimumab relapse after therapy. If patients were selected for this therapy based on their likelihood of response, insurance payers would save an average of over $115,000/patient on this large group of patients who receive no lasting benefit from the immunotherapy.
● Our biomarker set can be readily measured using standard RT-PCR expression assays on mRNA purified from CD8+ T-cells isolated from patient peripheral blood , making this a minimally invasive diagnostic procedure.
● Anti-PD-1 immunotherapies such as BMS-936558 and BMS 936559 (antibodies in clinical trials for a broad spectrum of cancers) could benefit from patient response prediction to maximize efficacy while reducing cost.

TECHNOLOGY:
This technology is a biomarker gene set where expression levels of a specific gene combination are used to predict clinical response to PD-1 blockade therapy. Primary CD8+ T-cells are isolated from samples of cancer patients’ peripheral blood, and the low expression of CD276 (p=0.0003) and high expression of NKTR (p=0.0263), PTEN (p=0.0232), and GATAD1 (p=0.0258) at baseline are correlated with clinical response to anti-PD-1 therapy. To date, efficacy of clinical response prediction using these biomarkers has been studied retrospectively in 22 melanoma patients (11 clinical responders and 11 clinical non-responders) at Moffitt Cancer Center.

PUBLICATION/PATENT: ● US Provisional Patent Application filed May 9, 2012 for Drs. Jeffrey Weber and Wenshi Wang and Bin Yu

I don't make this stuff up!!!  This is a copy of the patent application.  Just what I always dreamed to be....a "COMMERCIAL OPPORTUNITY" for Moffitt, Weber, Wang and Yu!!!! Not to mention my burning desire to have MY data, create a better methodology for insurance companies to deny care based on a "biomarker"!  Wouldn't want the insurance company to lose any money!!! Awesome! So...Weber, Wang, and Yu?  If you were suddenly forced to walk in any melanoma patient's shoes...you would prefer that, let's say...Blue Cross Blue Shield...would save $115, 000, and thereby deny you treatment, if your "test" showed that you would NOT have a permanent, relapse free response to immunotherapy?  Six months, a year, whatever, is less important than saving those insurance dollars since YOU wouldn't get "lasting benefit"?  AND....you would have this decision based on the gigantic, hugely significant number of 22 patients?  Hmmmmm....  They don't make them like Marie Curie anymore...apparently.  - c