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OCTOBER 2017    A Monthly Review of Articles of Interest for the Clinical Community

<This Month's Clinical Focus: BREAST CANCER>

 

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First Patient Treated With Immuno-oncology Antibody CAN04


The first patient has formally completed the safety evaluation period.

Cantargia AB ("Cantargia") announced that the first patient in the CANFOUR clinical trial has received three cycles of treatment with the antibody CAN04. Thereby, the first patient has formally completed the safety evaluation period according to the clinical protocol. Two additional patients have received therapy with CAN04. No serious adverse events have been recorded. The ongoing clinical trial is a combined dose escalation/dose expansion phase I/IIa trial carried out in patients with non-small cell lung cancer, pancreatic cancer, colorectal cancer or triple negative breast cancer. The CAN04 antibody is targeted against IL1RAP, found in a number of cancer forms.

 

The first sites in the phase I/IIa clinical trial CANFOUR have been initiated and patient recruitment is ongoing. According to the protocol, patients are recruited in groups of three. Following the start of patient recruitment, all three patients in the first group has now each been given at least two infusions of CAN04.The first patient has completed three infusions and has been followed through a safety evaluation period of 21 days. No serious adverse events have been noted and once all three patients have received three infusions and have completed their 21-day safety evaluation period, the next dose group can be recruited
 

doctor-explaining-to-a-woman_1139-466 by javi-indy FREEPIK Free Lic CC0
 

In the CANFOUR trial, treatment using Cantargia's proprietary antibody CAN04, directed towards the molecular target IL1RAP, is investigated in patients with cancer. CAN04 works through a dual immuno-oncology mode of action and stimulates immune cells to eradicate tumor cells as well as counteracts tumor inflammation by blocking interleukin-1 signalling. The indications studied in this trial are non-small cell lung cancer, pancreatic cancer, colorectal cancer and triple negative breast cancer. The relevance of targeting IL1RAP has been documented in all these diseases. The primary endpoint for the trial is safety. Other endpoints include pharmacokinetics, efficacy and biomarkers.

The first part of the trial is a dose escalation phase, investigating repeated infusions of CAN04 at different dose levels in order to identify the dose to be used in phase II. The results from this part are expected during summer 2018. After data analysis, the second part is planned to further investigate CAN04 as monotherapy treatment in approximately 20 patients with non-small cell lung cancer or pancreatic cancer, as well as a combination therapy arm investigating CAN04 with standard therapy in one of these forms of cancer. The exact choice of indication and combination therapy will be decided after completion of the first part. The trial is conducted at highly regarded and well experienced sites in Denmark, Norway, Belgium and the Netherlands. Trial information can be found on www.clinicaltrials.govhttps://www.clinicaltrials.gov/ct2/show/NCT03267316


SOURCE: Displayed with permission from PR Newswire


Liquid Biopsy Test Identifies Androgen Receptor Protein Expression in Circulating Tumor Cells in Women with MBC

 

Epic Sciences along with researchers at the MD Anderson Cancer Center (MDA) have recently published their findings...

Epic Sciences along with researchers at the MD Anderson Cancer Center (MDA) have recently published their findings on androgen receptor (AR) protein expression in circulating tumor cells (CTCs) in patients with metastatic breast cancer in PLOS One.  The publication, the most comprehensive today in characterizing the AR protein in CTCs of patients with breast cancer, identifies subclonal heterogeneity of AR protein. 

In recent clinical trials, AR signaling inhibitors, Zytiga® and Xtandi®, approved in metastatic prostate cancer, have demonstrated potential benefits in a portion of women with metastatic breast cancer.  However, current tools to identify patients who may benefit from AR signaling inhibitors are invasive and suffer from accuracy errors in predicting patient response.

 

doctor-working-with-a-virtual-screen_1134-639 by Creative Art FREEPIK Free Lic CC0
 

In addition to profiling CTCs for AR, estrogen receptor and HER2 biomarkers were also characterized.  Protein biomarker heterogeneity was observed in many patients.  To support the hypothesis of tumor heterogeneity, single cell genomic profiling identified genomic heterogeneity associated with the protein heterogeneity which has been identified as a resistance marker in cancer. 

"Subclonal AR protein expression could both identify patients who may resist targeted therapy and at the same time, explain partial response to AR signaling inhibition," said Ryan Dittamore, chief of medical innovation at Epic Sciences and co-author on the study.  "With our academic and biopharma partners, we are expanding our understanding of tumor heterogeneity in metastatic breast cancer to improve tools for patient selection to improve patient survival."

 

This study, led by Naoto T. Ueno, M.D., Ph.D., executive director at The University of Texas MDA Morgan Welch Inflammatory Breast Cancer Research Program and Clinic, utilized Epic Sciences non-biased enrichment free platform to characterize CTCs in blood samples.  The Epic Sciences platform is currently utilized in more than 175 clinical studies in 12 different cancers. 

Further information is available on the Company's website: www.epicsciences.com


SOURCE: Displayed with permission from PR Newswire


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