First Patient Enrolled in ProstACT TARGET Study

MELBOURNE, Australia, Sept. 26, 2022 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) and GenesisCare, the largest provider of integrated cancer care in Australia, today announce that a first patient has been enrolled in the Phase II ProstACT TARGET study of Telix's prostate cancer antibody therapy candidate TLX591 (¹⁷⁷Lu-DOTA-rosopatamab), in patients experiencing a first recurrence of prostate-specific antigen (PSA) after initial therapy for prostate cancer.

Telix's ProstACT therapeutic program is evaluating the efficacy of the Company's prostate-specific membrane antigen- (PSMA-) targeting lutetium-177 (¹⁷⁷Lu)-labelled therapeutic antibody, TLX591, in various stages of prostate cancer, from first recurrence to advanced metastatic disease. The primary focus of the ProstACT series of studies is to complete the pivotal Phase III ProstACT GLOBAL study in a second-line setting in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing on first-line novel androgen agents.

The TARGET study, a collaboration between Telix and research partner, GenesisCare, is exploring the potential of TLX591 in combination with external radiation in patients at an earlier stage in their prostate cancer, providing direction for future indication expansion. The study, which targets enrolment of 50 patients across multiple Australian sites, enrolled the first patient at GenesisCare's integrated cancer centre at the St John of God Hospital Murdoch campus in Western Australia. The clinical trial is being run through GenesisCare's global Contract Research Organisation and its Australian network of dedicated theranostics centres.

The third concurrent study in the ProstACT program, ProstACT SELECT, is a theranostic (imaging and therapy) Phase I radiogenomics study to demonstrate the utility of Telix's imaging agent Illuccix^® (kit for the preparation of gallium-68 (⁶⁸Ga) Glu-urea-Lys(ahx)-hbed-CC, also known as ⁶⁸Ga-PSMA-11 injection) to select patients for TLX591 therapy given as two doses 14 days apart.

Principal Investigator for the ProstACT TARGET study and GenesisCare Group Medical Director (Theranostics), Professor Nat Lenzo said, "I'm excited to commence this important study that builds on the momentum of ProstACT SELECT. With previous studies having confirmed the preliminary efficacy and safety profile of TLX591, GenesisCare is pleased to partner with Telix to further their therapeutic antibody-based program, which has potential to improve health outcomes for thousands of men living with prostate cancer in Australia and worldwide."

Telix Chief Medical Officer Dr. Colin Hayward added, "Enrolling a first patient in the ProstACT TARGET study is a significant milestone in Telix's overall clinical mission to support men with prostate cancer at every step in their journey with a PSMA antibody approach to targeted radiation therapy. Alongside ProstACT SELECT, this program will add value and clinical insight to Telix's antibody therapy candidate TLX591, as we progress global regulatory submissions for the ProstACT GLOBAL Phase III study. We wish to express our gratitude to Professor Nat Lenzo and his clinical team, as well as the patients who will contribute to the study."

About ProstACT

ProstACT is a series of studies of the investigational product TLX591, the Company's antibody-based, PSMA targeted prostate cancer therapy candidate TLX591 (¹⁷⁷Lu-DOTA-rosopatamab). 

The three studies running concurrently in the program are:  

• ProstACT GLOBAL, a Phase III international, multi-centre, randomised controlled trial (RCT) in patients with PSMA-expressing mCRPC, experiencing disease progression following prior treatment with a novel androgen axis drug. The ProstACT trial will enrol up to 390 patients and incorporates patient selection using ⁶⁸Ga-PSMA imaging with TLX591-CDx (Illuccix). The trial will compare standard of care therapy alone versus standard of care therapy plus TLX591, with a primary endpoint of radiographic progression-free survival (rPFS).

Status: sites in Australia and New Zealand are being prepared to commence patient screening, ahead of initiating global sites.

• ProstACT SELECT, a Phase I radiogenomics study with the goal of comparing ⁶⁸Ga-PSMA (gallium) and ¹⁷⁷Lu-PSMA (lutetium), specifically exploring the biodistribution differences between small molecule and antibody-based targeting. The study is designed to inform optimal patient selection for Telix's antibody-based ¹⁷⁷Lu therapy, with the goal of enabling indication expansion for Telix's PSMA therapeutic portfolio. ProstACT SELECT is a multi-centre study and will enrol up to 50 patients, with a first patient dosed in January 2022.^[1]

Status: first cohort of patients dosed. 

• ProstACT TARGET, a Phase II single arm study in Australia in 50 patients with PSMA-avid^[2] biochemically recurrent oligometastatic (five or less metastases) prostate cancer, in combination with external beam radiation therapy (EBRT). The clinical objectives are delaying disease recurrence and thus deferring the commencement of androgen deprivation therapy (ADT) with the primary endpoint biological progression-free survival (PFS BIO). The study is a collaboration with Telix's strategic partner, GenesisCare. GenesisCare will be enrolling patients at its integrated cancer centres at GenesisCare North Shore, Sydney and GenesisCare at the St John of God  Hospital, Murdoch campus, Perth.

Status: patient enrolment has commenced.

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 www.telixpharma.com 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),^[3] and by the Australian Therapeutic Goods Administration (TGA).^[4] Telix is also progressing marketing authorisation applications for this investigational candidate in Europe^[5] and Canada.^[6]

About GenesisCare

Headquartered in Sydney, Australia, GenesisCare is a global healthcare company and one of the world's largest integrated oncology organisations. The company's purpose is to design care experiences that get the best possible life outcomes. This is grounded in the belief that care should be focused on the individual, not the condition.

GenesisCare is the world's largest provider of radiotherapy – a vital treatment option for cancer patients – and provides patients with access to diagnostics, medical oncology, surgical oncology, radiotherapy, and novel therapies alongside the ability to participate in the latest clinical trials. With a growing research and trials program numbering more than 150 clinical trials, a contract research organisation, and global innovation programs focused on precision medicine and novel therapies, GenesisCare aims to bring new therapies to more patients in need in a more affordable way.

Every year, GenesisCare clinical teams see more than 400,000 people across 440+ locations, including more than 300 locations in the U.S., 40 in Australia, 14 in the UK, and 17 in Spain. A further 30 new centres are also under development. The organisation employs more than 6,000 highly trained physicians, healthcare professionals and support staff across Australia, Europe, and the U.S. For more information, visit www.genesiscare.com

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
Email: kyahn.williamson@telixpharma.com

This announcement has been authorised for release by Dr. Christian Behrenbruch, Managing Director and Group Chief Executive Officer.

Legal Notices

This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). 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.

Logo:  https://mma.prnewswire.com/media/1775408/Telix_Logo.jpg