Replies to post #234021 on Avid Bioservices Inc (CDMO)

[biopharm]

Exploratory analysis will include the assessment of changes in circulating immune cells and cytokines to better understand the immunotherapeutic mechanism.

Many posts talk about CTC's and overall... circulating tumor cells and I find this letter from the FDA to MSK of interest:

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Sept 25, 2015

Debra J. Rasmussen

Letter of support from the FDA to MSK, Medivation and Janssen...to further investigate CTC's as biomarker in clinical trials re: mRCPC

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..test drugs with multiple different mechanisms of action...
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http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/UCM466099.pdf

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Johnson n Johnson and Veridex - Regulatory Affairs
https://www.linkedin.com/pub/debra-rasmussen/7/729/26a

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Now after reading this letter above (could not copy/paste) the letter goes out to Regulatory Affairs => Rasmussen but its very clear that MSK is part of this collaboration and all parties are looking to make sure the FDA is on board to use CTC's as a biomarker in clinical trials.

I'd say another puzzle piece... because Peregrine Pharmaceuticals Bavi/MOA just may support the use of CTC's as a biomarker and now, MSK is on board for this according to the FDA letter above and all just in time for the Peregrine <> MSK collaboration.


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RARITAN, N.J., (Oct. 1, 2009) – Veridex, LLC announced today that the CellSearch® Circulating Tumor Cell (CTC) Test was honored with the first-ever Prix Galien USA 2009 Award for Best Medical Technology.

The CellSearch® System is the first diagnostic test used to automate the capture and detection of CTCs, tumor cells that have detached from solid tumors and entered the patient’s blood. The CellSearch® System assesses CTCs to determine the prognosis and overall survival of patients with metastatic breast, colorectal or prostate cancer at any time during the course of treatment.

“The CellSearch® System represents an important shift in the management of metastatic breast, colorectal or prostate cancer as an adjunct to standard testing methods that provides a more complete picture of patient prognosis,” said Michael Samoszuk, M.D., Chief Medical Officer, Ortho Clinical Diagnostics. “The Prix Galien recognition further supports the important role CellSearch® technology plays in providing oncologists with an additional tool to help them provide optimum care for their patients.”

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https://www.cellsearchctc.com/veridexs-cellsearch%C2%AE-circulating-tumor-cell-test-wins-prestigious-prix-galien-award-best-medical

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By measuring a patient’s CTC levels over time, clinicians can quickly determine if a particular cancer treatment is working.
close-up photo of a part of the CTC-iChip system

This part of the microfluidic CTC-iChip system sorts cells within a sample by size. Source: Murat Karabacak, Harvard Medical School.

CTCs can also be tested to identify genetic mutations associated with a tumor. Many newer cancer medications are designed to target specific genetic mutations, so they work best for limited types and stages of cancer. CTCs can provide a quick method to help physicians choose the most appropriate targeted therapy for a particular patient.
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http://www.nibib.nih.gov/news-events/newsroom/tiny-technology-enables-improved-detection-circulating-tumor-cells

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In the present study we investigated the prognostic value of Circulating Tumour Cells (CTC) and their utility for therapy monitoring in non-small cell lung cancer (NSCLC). A total of 43 patients newly diagnosed with NSCLC were prospectively enrolled. Blood samples were obtained before the 1st, 2nd and 5th cycles of chemotherapy and analyzed using CellSearch technology. Both CTC and CTC-related objects (not morphological standard or broken epithelial cells) were counted. At baseline 18 (41.9%) patients were positive for intact CTC count and 10 (23.2%) of them had =5 CTC, while CK positive events were found in 79.1% of patients. The group of patients with CTC =5 at baseline presented worse PFS and OS than those with <5 CTC (p = 0.034 and p = 0.008, respectively). Additionally, high levels of total CK positive events were associated with poor prognosis in the group of patients with <5 CTC. Regarding therapy monitoring, patients presenting increased levels of CTC during the treatment demonstrated lower OS and PFS rates. All these data supported the value of CTC as a prognostic biomarker and as a surrogate indicator of chemotherapy effectiveness in advanced NSCLC patients, with the additional value of analyzing other “objects” such as apoptotic CTC or CK fragments to guide the clinical management of these patients.

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