First Patient Dosed with A9T-1101 First Product Candidate in Alpha-9 Theranostics Pipeline Initiates Clinical Testing

June 16, 2020, Vancouver, Canada: Alpha-9 Theranostics Inc, a radiopharmaceutical company developing unique technology for imaging and treatment of metastatic cancer, today announced that the first patient in a Phase I/II clinical trial of its neuroendocrine tumour imaging agent A9T-1101 was scanned at BC Cancer, one of Canada’s premier cancer research and treatment centres. The objective of the trial is to determine the utility, biodistribution and safety of A9T-1101. Subject to a positive outcome, A9T-1101 may then be advanced into a larger clinical trial, sufficient to seek regulatory 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 can be manufactured in large batches, with a longer half-life and improved image quality compared to 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 Drs. David Perrin, Professor of Chemistry at the University of British Columbia (UBC) and Drs. Francois Benard 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 for Alpha-9 Theranostics said today; “The start of this clinical trial is a major advance for our Company and potentially for patients and clinicians.

This trial is a critical opportunity to demonstrate the benefits of our unique platform technology in patients. With diagnostic and therapeutic products, A9T-2101 and A9T-2306, targeting solid tumors, also in development, our technology offers the opportunity to change the way in which cancer and in particular metastatic cancer, is diagnosed and treated. Alpha9 has developed a unique platform that is highly differentiated in this space.

About Alpha-9 Theranostics:
Alpha-9 Theranostics is a clinical stage, radiopharmaceutical company based in Vancouver using molecularly targeted radiotherapy 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.

The Company has a second imaging product in advanced development, A9T-2101, for improved imaging of prostate cancer.

Alpha-9’s first therapeutic product, A9T-2306, is a new radiopharmaceutical, in pre-clinical development that targets advanced metastatic prostate cancer. A9T-2306 is being developed with the aim of achieving greater efficacy and an improved safety profile over first-generation products that are currently in clinical trials.

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.

What Is Molecularly Targeted Radiotherapy
Molecularly targeted radiotherapy harnesses ligands, which recognize abnormal proteins associated with specific tumours, to precisely deliver a therapeutic radionuclide directly to a cancer cell with minimal impact on healthy tissue. This offers new hope for cancer patients whose disease has metastasized to vital organs, where surgery is not an option and use of systemic cancer drugs produces intolerable side-effects.

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  regulatory affairs, 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
Web Site : www.alpha9tx.com