Melbourne (Australia) and Boston, MA (U.S.A.) – June 14, 2022. Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has advanced a partnership with Invicro LLC (Invicro), a global, industry-leading imaging CRO, and part of REALM IDx, Inc., to develop an artificial intelligence (AI) platform to accompany Telix’s PSMA-PET imaging agent, Illuccix® (kit for the preparation of gallium Ga 68 gozetotide) – known as TelixAI™.
TelixAI™ seeks to increase the efficiency and reproducibility of clinicians’ imaging assessments using advanced analysis capabilities with an initial focus on prostate cancer. The platform is designed to do this by automatically separating healthy versus abnormal tracer uptake and then classifies lesions as either visceral (soft tissue) or bone lesions.
Invicro has a depth of experience in AI, machine learning and algorithm development for medical imaging. Its industry leading medical image analyst team consists of over fifty medical image processing scientists. The commercial objective of the development partnership is the submission to the United States Food and Drug Administration (FDA) 510(K) approval for software as a medical device.
A demonstration of the TelixAI™ was presented this week at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting being held in Vancouver, BC from June 11-14.
Telix Chief Scientist, Dr. Michael Wheatcroft said, “We are pleased to be advancing the TelixAI™ platform with Invicro, which aims to further enhance the utility of molecular imaging starting with Illuccix. Our investment in TelixAI™ is expected to extend into multiple applications for Telix’s late-stage imaging assets, including TLX250-CDx, which is currently completing a Phase III pivotal trial in renal cancer imaging.”
CEO of Invicro, Matt Silva, Ph.D., continued, “Invicro is delighted to bring our deep expertise in PET imaging, AI and machine learning and take this collaboration with Telix’s Research and Innovation team into the next stage. We are excited about the possibility of bringing this software to realization with Illuccix and for the potential impact on clinicians’ decision-making and patient outcomes with Telix’s broad theranostic pipeline.”
Headquartered in Needham, MA, Invicro, a part of REALM IDx, was founded in 2008 with the mission of improving the role and function of imaging in translational drug discovery and development across all therapeutic areas. Today, Invicro’s multi-disciplinary team provides solutions to pharmaceutical and biotech companies across all stages of the drug development pipeline (Phase 0-IV), all imaging modalities and all therapeutic areas, including neurology, oncology, and systemic and rare diseases. Invicro’s quantitative biomarker services, advanced analytics and AI tools, and clinical operational services are backed by Invicro’s industry-leading software informatics platforms, VivoQuant® and iPACS®, as well as their pioneering IQ-Analytics Platform, which includes AmyloidIQ, TauIQ and DaTIQ.
Invicro operates out of eight global laboratories, clinics and sites within the United States in Massachusetts, Michigan, California, Connecticut and globally in the United Kingdom, India and Japan. For more information visit www.invicro.com.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.
About Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection)
Telix’s lead product, Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection), also known as 68Ga PSMA-11 injection, has been approved by the U.S. Food and Drug Administration (FDA), and by the Australian Therapeutic Goods Administration (TGA). Telix is also progressing marketing authorisation applications for this investigational candidate in Europe and Canada. Illuccix is currently being investigated for use with Invicro’s AI visual assessment software tool.
INDICATIONS AND USAGE
Illuccix®, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
• with suspected metastasis who are candidates for initial definitive therapy
• with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Risk for Misdiagnosis
Image interpretation errors can occur with gallium Ga 68 gozetotide PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of gallium Ga 68 gozetotide for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of gallium Ga 68 gozetotide for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.
Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and health care workers. Advise patients to hydrate before and after administration and to void frequently after administration.
The safety of gallium Ga 68 gozetotide was evaluated in 960 patients, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). No serious adverse reactions were attributed to gallium Ga 68 gozetotide. The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of < 1%.
Androgen deprivation therapy and other therapies targeting the androgen pathway
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.
You are encouraged to report suspected adverse reactions of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix by calling 1-844-455-8638 or emailing: firstname.lastname@example.org.
Please note this information is not comprehensive. Please see full Prescribing Information at illuccix.com
Invicro Media Contact
REALM IDx Communications Director
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
This announcement has been authorised for release by Dr. Christian Behrenbruch, Managing Director and Group Chief Executive Officer.
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