Gallium-68 NOTA hGZP

SUDBURY, Mass.--(BUSINESS WIRE)-- CytoSite Bio, a company developing precision imaging products that determine patient response to immuno-oncology therapy today shared new data at the Radiological Society of North American (RSNA) Annual Meeting in Chicago, IL. In an oral presentation titled “Interim analysis of a first-in-human first-in-class phase I study of Granzyme B PET imaging for assessing single agent immune checkpoint inhibition response in melanoma and non-small cell lung cancer,” data showed that CytoSite’s Granzyme B (GzmB) PET imaging using [68Ga-NOTA]-hGZP (CSB-111) was feasible and safe in human subjects. These data come from a Phase I trial assessing the safety and feasibility of GzmB PET imaging in subjects with melanoma and non-small cell lung cancer (NSCLC) receiving KEYTRUDA® (pembrolizumab). “The interim analysis of data in the first eight subjects who underwent imaging from this study clearly demonstrates the promise of Granzyme B PET imaging as a tool to optimize cancer immunotherapy treatment decisions,” said Ryan Sullivan, MD, Associate Professor of Hematology & Oncology at Massachusetts General Hospital and Principal Investigator of the study. “This non-invasive approach has the potential to inform physicians of the efficacy of the immunotherapy within weeks of the first immunotherapy dose rather than waiting for several months and often multiple scans to confirm response or progression, allowing for a rapid change in treatment which could save lives and transform the immune-oncology landscape. I am pleased that these early, promising data are showing how that option could become a reality.” CSB-111, a radiopharmaceutical which identifies Granzyme B released from the NK and T-Cells in the tumor, was shown to have favorable biodistribution and rapid clearance. Interim analysis of the first eight subjects showed that all tolerated the imaging well. As expected, subjects that showed robust uniform uptake above the blood pool in the lesions showed treatment response to ICI with continued disease remission during the 6-month follow-up, while subjects with low-level lesion uptake clearly below the blood pool level had progression on therapy. “The data presented today validate CytoSite’s belief that our work to use PET imaging to detect Granzyme B has the potential to transform outcomes in immuno-oncology,” said Jim Jenson, PhD, Co-founder and CEO of CytoSite. “If approved, our proprietary biomarker and approach to imaging could provide better tools for our oncologists to enable improved outcomes for patients with cancer and rapidly expanding options for new immunotherapies. These data represent a fantastic step toward our ultimate goal, and we look forward reporting results from our Phase 1/2 study upon study completion.” About CytoSite Bio CytoSite Bio is developing precision imaging products that determine patient response to immuno-oncology therapy very early in the treatment cycle. Our products detect active Granzyme B, the primary element responsible for the killing of tumor cells by the immune system. Our products enable individually optimized treatments for patients, and more rapid evaluation of new drugs and drug combinations, using non-invasive, whole-body PET imaging.

INDIANAPOLIS, Nov. 22, 2022 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) with up to 50mCi for radiolabeling is available for use on 100mCi (millicurie) gallium generators, an important development in radioisotope production. High activity generators from Eckert & Ziegler Strahlen- und Medizintechnik AG (EZAG) and IRE ELiT S.A. (the radiopharmaceutical subsidiary of IRE Group), increase activity from 50mCi to 100mCi and will be integral to expanding patient access to gallium-based radiopharmaceuticals as demand for PSMA-PET imaging in the United States continues to grow. This technology increases the number of daily elutions and activity in each elution, enabling hospitals and radiopharmacies to increase the number of daily doses produced, expand their service area and gain greater production efficiency. Dr. Christian Behrenbruch, Group CEO and Managing Director of Telix said, "As the only commercially available kit that can take advantage of high activity generators for up to 50mCi radiolabeling, Illuccix gives hospitals, pharmacies, and physicians added confidence that their dose scheduling needs – and the needs of their patients – can be met today and in the future as the potential of 68Ga PSMA-11 is realized in the diagnostic market. We are pleased to continue our collaborative relationships with IRE ELiT and EZAG to continue to make 68Ga PSMA-11 accessible and convenient to use for customers across the United States." Jay Simon, Managing Director of Eckert and Ziegler North America said, "The high activity GalliaPharm® generator may allow for broader availability and expanded service areas. It is about delivering doses when and where they are needed, whether you're a remotely located clinic, a busy metropolitan hospital or a pharmacy. We are pleased to be working with Telix to harness this innovation to maximize the efficiency for our customers and ultimately, their patients." Jean Bonnet, Head of Sales, Strategy and Marketing at IRE Group said, "While current generator technology is sufficient to meet today's demands, the rollout of the higher activity 100mCi generators are future-proofing the ability to meet demand in a market which is growing exponentially. The use of high activity generators has the potential to increase daily elutions and increase the activity in each elution. When radiolabeled up to 50mCi with Illuccix, the result could potentially provide more flexibilitty in meeting the growing demand for 68Ga radiopharmaceuticals while giving customers the benefit of greater dose scheduling flexibility and efficient production." For more information about Illuccix, visit . 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. Radiation Risks 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. ADVERSE REACTIONS 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%. DRUG INTERACTIONS 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 or call 1-800-FDA-1088. You may also report adverse reactions to Telix by calling 1-844-455-8638 or emailing [email protected]. This information is not complete. Please see full Prescribing Information at About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit and follow Telix on Twitter (@TelixPharma) and LinkedIn. Telix's lead product, gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection, has been approved by the U.S. Food and Drug Administration (FDA),[1] and by the Australian Therapeutic Goods Administration (TGA),[2] and by Health Canada.[3] Telix Media Relations U.S. Mr. Greg Kueterman Email: [email protected] Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Corporate Communications and Investor Relations Email: [email protected] Legal Notices This announcement is intended for a U.S. audience only. This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the ASX or on our website. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to publicly update or revise any forward-looking statements contained in this announcement, whether as a result of new information, future developments or a change in expectations or assumptions. The Telix Pharmaceuticals and the Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. [1] ASX disclosure 20 December 2021. [2] ASX disclosure 2 November 2021. [3] ASX disclosure 14 October 2022. SOURCE Telix Pharmaceuticals Limited