Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) and RefleXion Medical, Inc. ( Hayward, California , U.S.) (RefleXion) today announced the signing of a co-development and commercialisation agreement, to expand the use of Telix’s prostate cancer imaging agent, Illuccix ®.
| MELBOURNE, Australia and INDIANAPOLIS, June 10, 2022 /PRNewswire/ --Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) and RefleXion Medical, Inc. (Hayward, California, U.S.) (RefleXion) today announced the signing of a co-development and commercialisation agreement, to expand the use of Telix’s prostate cancer imaging agent, Illuccix® (kit for preparation of gallium (68Ga) gozetotide) with the RefleXion® biology-guided radiotherapy (BgRT)* platform to guide external-beam radiotherapy in real-time.
BgRT is the first and only cancer treatment designed to integrate PET technology as part of external-beam radiotherapy delivery. It uses PET tracers as biological guides to signal the location of cancer and guide the delivery of radiotherapy to tumors in real-time. BgRT has the potential to offer significant advantages over conventional radiotherapy as it may one day enable treatment of multiple tumors per session for metastatic disease, increase the conformality of radiotherapy delivery, and reduce toxicity to healthy tissue. This approach may facilitate treatment of later stage cancers than is currently practical for hospitals or tolerable by patients. Under the agreement, which builds on an existing strategic collaboration[1] between the companies, Telix and RefleXion will conduct and co-fund a BgRT clinical program using Illuccix as a biological guide, seek regulatory approval and jointly pursue commercialization, initially in the United States. The parties will share in any upside generated if successfully commercialized. The clinical program is expected to commence in 2023. RefleXion is exclusively partnering with Telix for 68Ga PSMA-PET imaging agents for use with BgRT. The agreement also includes the potential to expand the exclusive relationship beyond the U.S., in countries where both Illuccix and BgRT are intending to be commercialised. If approved, Illuccix for BgRT could potentially open a broad new market opportunity for Illuccix as a therapy guidance agent. More than 60,000 men undergo external-beam radiotherapy for prostate cancer every year in the U.S. alone[2]. Illuccix for BgRT would require up to five doses per patient (one for each session of external-beam radiotherapy), potentially expanding the volume of Illuccix used in the U.S. significantly. The scheduling flexibility of Gallium-based compounds such as Illuccix may provide additional advantages for patients and caregivers using BgRT technology. Dr. Christian Behrenbruch, Group CEO of Telix Pharmaceuticals said, “Following a successful evaluation period, we are pleased to expand our relationship with RefleXion and move ahead with a clinical program with the objective of regulatory approval of Illuccix for BgRT. This partnership demonstrates the potential for Illuccix and other molecularly-targeted imaging agents in our pipeline to be used as a tool to both detect the presence of metastatic disease and guide treatment using innovative complementary technologies such as BgRT.” Dr. Thorsten Melcher, Chief Business Officer at RefleXion added, “With PSMA-PET quickly being established as a standard of care in prostate cancer imaging, the clinical program aims to determine whether Telix’s gallium-based tracer can provide a complete and robust signal to guide BgRT to treat all stages of prostate cancer, eventually including metastatic disease. Illuccix offers great accessibility and scheduling flexibility, factors which we believe will be well-suited to the treatment regimen with our BgRT system.” Reflexion has received marketing clearance from the United States Food and Drug Administration (FDA) for its X1 machine that combines high quality computed tomography (CT) imaging with stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS) and intensity modulated radiotherapy (IMRT). About RefleXion Medical RefleXion is a privately-held company developing the first biology-guided radiotherapy system, a significant change in strategy from single tumor therapy to the ability to one day treat multiple tumors in the same treatment session in cancers that have metastasized. Currently, the RefleXion X1 machine is cleared for the delivery of stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS) and intensity modulated radiotherapy (IMRT). The company is also developing BgRT, which incorporates positron-emission tomography (PET) imaging data to enable tumors to continuously signal their location. The BgRT technology will synchronize these data with the linear accelerator to direct radiotherapy to tumors with sub-second latency. For more information, visit www.reflexion.com and follow RefleXion on Twitter (@reflexionmed) and LinkedIn. *The RefleXion® X1 is cleared for SBRT/SRS/IMRT. BgRT is pending regulatory review and is not commercially available. 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),[7] and by the Australian Therapeutic Goods Administration (TGA).[8] Telix is also progressing marketing authorisation applications for this investigational candidate in Europe[9] and Canada.[10] Illuccix is currently being investigated in combination with BgRT treatment. 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:
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 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 via email to pharmacovigilance@telixpharma.com. Please note this information is not comprehensive. Please see full Prescribing Information RefleXion Media Contact: Amy Cook Telix Investor Relations Ms. Kyahn Williamson Legal Notices 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 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. 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 name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).
SOURCE Telix Pharmaceuticals Limited | ||||||||||||
Company Codes: Australia:TLX |
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