On November 22, 2019 Aurora Bio, Inc. reported that data for the company’s novel PET radiotracer, AUR01, in development for systemic amyloidosis, has been accepted for presentation at the upcoming 61st American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, to be held December 7 – 10, 2019, in Orlando, FL (Press release, Aurora Biosciences, NOV 22, 2019, View Source [SID1234551622]). Abstract highlights and presentation details are outlined below.

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Spencer Guthrie, Chief Executive Officer, stated, "We are looking forward to an exciting ASH (Free ASH Whitepaper) conference as we present our initial data highlighting the unique ability of AUR01 to detect and potentially monitor whole body amyloid burden in systemic amyloid diseases. The unmet need for early and accurate diagnosis for systemic amyloidosis is significant as many patients are getting diagnosed too late to obtain optimal benefit from treatment. There is currently no approved diagnostic, no agent that can detect whole body amyloid burden and no method for directly measuring change in amyloid pathology in treated patients. We believe this compound has the potential to change the way systemic amyloidosis is diagnosed and monitored and holds great potential to provide for efficient drug development for new targeted therapeutics, including Aurora Bio’s own therapeutic programs."

Abstract Highlights: UPDATED RESULTS TO BE PRESENTED AT CONFERENCE
Poster Presentation: View Source

AUR01, a synthetic peptide radiotracer (124I-p5+14), has been shown in preclinical assays and in SPECT and PET imaging of murine systemic amyloidosis, to bind many forms of amyloid, including AL, ATTR, and ALECT2
No radiotracers approved in the US for non-invasive quantitative measurement of systemic amyloid disease
Ph 1 study Included AL, ATTR and ALECT2 patients with biopsy proven amyloidosis and adequate renal function
The primary endpoint includes safety and dosimetry estimation with a secondary endpoint of efficacy
10 patients have been dosed and evaluated. No serious adverse events of any grade were noted
Retention in the heart, kidneys, liver, spleen, pancreas, bone marrow, lung, and adrenal gland of AL patients
Cardiac uptake of the radiotracer was observed in 80% of AL patients and 100% of ATTR patients
Kidney, spleen and liver retention was observed in 60%, 40%, and 20% of AL patients
Retention of the radiotracer observed in the nerves, spleen and kidney in patients with ATTR and ALECT2
Conclusion: Initial PET/CT image data indicate that 124I-p5+14 can provide quantitative detection of systemic amyloidosis in multiple organ systems and may have general utility in detecting and monitoring amyloid burden in many forms of amyloidosis
Presentation Details

3034 Preliminary Phase 1 Data on the Safety and Efficacy of a Novel PET Radiotracer, 124I-p5+14, for Imaging Systemic Amyloidosis

Program: Oral and Poster Abstracts
Session: 641. CLL: Biology and Pathophysiology, excluding Therapy: Poster II
Sunday, December 8, 2019, 6:00 PM-8:00 PM
Hall B, Level 2 (Orange County Convention Center)
Presenter Jonathan S. Wall, PhD, Head of Cancer and Amyloidosis Theranostics Program, University of Tennessee