Aurora Bio, Inc. Announces Clinical Data on Lead Program, AUR01, a Novel Systemic Amyloidosis Imaging Tracer, at the Upcoming 61st American Society of Hematology Annual Meeting and Exposition

Analysis of PET images indicated uptake of AUR01 (124I-p5+14) in the heart, kidneys, liver, spleen, pancreas, bone marrow, lung, and adrenal glands of AL patients. Cardiac uptake of the radiotracer was observed in 80% of AL patients and 100% of ATTR patients. Kidney, spleen and liver uptake of AUR01 (124I-p5+14) was observed in 60%, 40%, and 20% of AL patients, respectively. Retention of the radiotracer was also observed in the nerves, kidney, and spleen in patients with ATTR and ALECT2--associated amyloidosis.

NEW YORK--()--Aurora Bio, Inc. www.Aurorabioinc.com today announced 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) annual meeting, to be held December 7 – 10, 2019, in Orlando, FL. Abstract highlights and presentation details are outlined below.

Spencer Guthrie, Chief Executive Officer, stated, “We are looking forward to an exciting ASH 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: https://ash.confex.com/ash/2019/webprogram/Paper128850.html

  • 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

ABOUT AURORA BIO, INC.

Aurora Bio is a clinical stage biopharmaceutical company developing a platform of immunotherapies and an imaging diagnostic for multiple systemic amyloid diseases, including AL, ATTR and ALECT2 amyloidosis. The diagnostic imaging agent is currently in Phase 1 with a planned Ph 3 to potentially initiate in 2020. The company also has 2 pre-clinical stage therapeutic programs being developed for a broad range of systemic amyloid diseases. The immunotherapies consist of a peptide-fusion protein as well as cell therapy utilizing engineered macrophages (CAR-M) to remove amyloid. Currently, there are no approved treatments for 29 out of 30 systemic amyloid diseases While approved therapies in ATTR, and those in development for AL an ATTR, target the pre-cursor protein of individual amyloid diseases, Aurora Bio’s goal is to develop immunotherapies that treat across all systemic amyloid diseases. Aurora Bio, Inc. is based in South San Francisco, CA www.aurorabioinc.com

Cautionary Statement

Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Contacts

Spencer Guthrie
CEO
Aurora Bio, Inc.
Email: spencer@aurorabioinc.com

Contacts

Spencer Guthrie
CEO
Aurora Bio, Inc.
Email: spencer@aurorabioinc.com