Alpha-9 Theranostics Announces Successful Completion of Phase I/II Trial with A9T-1101 in patients with Neuroendocrine Tumours Diagnostic Imaging Candidate Confirms Utility of BF3 Technology

October 30th, 2020, Vancouver, Canada: Alpha-9 Theranostics Inc.TM, a radiopharmaceutical company developing unique technology for imaging and treatment of metastatic cancer, today announced the completion of a Phase I/II clinical trial of its neuroendocrine tumour imaging agent A9T-1101 at BC Cancer, one of Canada’s premier cancer research and treatment centres. The outcome of the trial confirmed the utility, biodistribution and safety of A9T-1101.  Alpha-9 now intends to advance A9T-1101 into a larger clinical trial, sufficient to seek approval for market entry.

Neuroendocrine tumours (NETs) arise in neuroendocrine cells, which are cells that release hormones when stimulated by the nervous system.  NETs are most commonly found in the digestive tract, pancreas, liver, and lungs. Treatment is dependent on the location and aggressiveness of the tumour, so imaging plays an important role in determining patient outcomes and informing treatment options. A9T-1101 is a potentially transformative imaging agent in that it can be manufactured in large batches, has a longer half-life and generates improved image quality compared to currently available 68Ga-labeled imaging agents, facilitating regional distribution for improved access to state-of-the-art PET/CT scanning for patients affected by NETs.

About A9T-1101:

A9T-1101 is 18F-AMBF3-TATE, an injectable candidate compound, used in conjunction with PET/CT scan imaging and being developed as an improved imaging agent for the diagnosis and staging of neuroendocrine tumours.  A9T-1101 has been developed based on the collaborative efforts of Dr. David Perrin, Professor of Chemistry at the University of British Columbia (UBC) and Drs. François Bénard and Kuo-Shyan Lin, Professors of Radiology at UBC and scientists at the BC Cancer Research Institute.  A9T-1101 uses a proprietary “boron-tag” (trifluoroborate – BF3) that greatly simplifies the attachment, in high yields, of radioactive Fluorine-18 (18F) to a disease-targeting biomolecule.  Fluorine-18 is the preferred imaging isotope for PET/CT scanning due to superior image quality, but difficulties in attaching it to biomolecules have significantly restricted its use up to now.

Ian McBeath, Chief Executive Officer of Alpha-9 Theranostics said today; “The results of this clinical trial confirm that A9T-1101 is very easy to prepare and administer and can produce superior images of primary and secondary neuroendocrine tumors. The high quality of the images obtained can enable a physician to better determine appropriate treatment options.  This trial has provided important clinical confirmation of the image quality with our novel A9T-1101 product, but also the utility of our unique BF3 platform technology, which will be applied to other targeting molecules to provide a range of faster, easier to use PET tumour imaging products.

About Alpha-9 Theranostics:

Alpha-9 Theranostics is a clinical stage, radiopharmaceutical company based in Vancouver using molecularly targeted radiopharmaceuticals for the improved diagnosis and treatment of metastatic cancer.  The Company is developing new theranostic products based on breakthrough technology developed by the scientific founders and exclusively licensed from the University of British Columbia and BC Cancer. 

In addition to A9T-1101, Alpha-9 is currently also developing A9T-2101 for prostate cancer imaging along with A9T-2306 a unique therapeutic molecule targeting metastatic prostate cancer.  A9T-2306 is being developed to provide greater efficacy and a much-improved safety profile compared to first-generation products currently in development.

The Company is also developing a unique dual-acting theranostic approach, where the same cancer seeking molecule can either be labelled with Fluorine-18 for PET imaging, or with a particle-emitting radioisotope to destroy cancer cells that have metastasized. 

This news release contains certain forward-looking statements.  Actual results may differ materially from the statements made as a result of various factors, including, but not limited to, the inherent risks associated with drug research and development, difficulties or delays in development testing, changes in regulations, lack of therapeutic efficacy, unacceptable side-effects, the dependence on partners, the inability to raise sufficient finance, the appearance of competitors and other risks generally associated with the biopharmaceutical industry.

 For further information contact:

 Ian McBeath, Chief Executive Officer

Alpha-9 Theranostics Inc.

595 Burrard Street, Suite 2600,

Vancouver, B.C.,

Canada, V7X 1L3

Telephone: (1)-778-231-2500

E mail:  imcb@alpha9tx.com

www.alpha9tx.com