OPTIMAL-PSMA Trial of TLX597-Tx Next Generation RLT Presented at IPCS 2026 Highlighting Therapeutic Potential in Prostate Cancer

• TLX597-Tx is a PSMA^[1]-targeting small molecule radioligand remedy (RLT) candidate, designed to enhance quality-of-life and efficacy in earlier-stage prostate most cancers.
• OPTIMAL-PSMA^[2] preliminary dosimetry knowledge exhibit low salivary gland and kidney uptake, supporting dose intensification.
• Telix is creating two distinct prostate therapeutic packages, tailor-made to illness stage and affected person situation: TLX591-Tx radio antibody-drug conjugate (rADC) in mixtures with commonplace of care (Part 3 in mCRPC^[3]) and TLX597-Tx meant for earlier-stage mHSPC^[4].
• Webcast at this time: Thursday, April 30, at 9:30 a.m. AEST (Wednesday, April 29, at 7:30 p.m. EDT). Register right here: https://s1.c-conf.com/diamondpass/10053985-675tre.html

MELBOURNE, Australia and INDIANAPOLIS, April 30, 2026 /PRNewswire/ — Telix Prescribed drugs Restricted (ASX: TLX, NASDAQ: TLX, “Telix”) at this time pronounces dosimetry outcomes from the randomized Part 2 OPTIMAL-PSMA trial of TLX597-Tx in metastatic castration-resistant prostate most cancers (mCRPC), offered on the 2026 Worldwide Prostate Most cancers Symposium (IPCS 2026) held in Lugano, Switzerland. These findings help TLX597-Tx’s potential to ship a therapy that overcomes quality-of-life challenges that presently restrict the medical utility of current RLTs in earlier-stage metastatic prostate most cancers.

TLX597-Tx (¹⁷⁷Lu-DOTA-HYNIC-panPSMA) is a novel PSMA-targeting small molecule RLT candidate with a extremely favorable dosimetry profile. Considerably diminished radiation publicity to wholesome organs, together with the salivary glands and kidneys^[5], might decrease the incidence of xerostomia (dry mouth) and renal toxicity and help higher tolerability for sufferers. This dosimetry profile mixed with greater tumor uptake in comparison with current PSMA RLTs might ship a wider therapeutic window and allow dose intensification to maximise tumor management whereas preserving affected person quality-of-life.

OPTIMAL-PSMA is an open-label, multi-center, randomized, Part 2 investigator-initiated trial (IIT) led by Professor Louise Emmett at St Vincent’s Hospital in Sydney, Australia. The research is evaluating the protection, dosimetry, and efficacy of an intensified dosing routine of TLX597-Tx in contrast with an ordinary dose schedule in 120 males with superior mCRPC, randomized on a 2:1 foundation. The novel dose-intensification routine delivers greater exercise per cycle (8.5 GBq), delivered on day 1, day 3 and day 15, adopted by 10-weekly dosing for 3 additional cycles. The research goals to substantiate {that a} dose intensified TLX597-Tx routine will maximize the radiation dose to cancerous lesions when they’re most susceptible to break and due to this fact enhance general response to therapy.

Telix believes these dosimetry knowledge help additional analysis of TLX597-Tx in earlier-stage illness and is initiating OPTIMAL-E, a Part 2 research in androgen pathway-sensitive prostate most cancers (mHSPC).

Principal Investigator for OPTIMAL-PSMA, Professor Louise Emmett, commented, “The objective of OPTIMAL-PSMA is to establish a dose routine for TLX597-Tx that results in deeper and longer responses with out growing toxicity for males with metastatic prostate most cancers. We look ahead to beginning the Part 2 OPTIMAL-E trial quickly.”

Dr. David N. Cade, Group Chief Medical Officer at Telix, added, “These encouraging dosimetry outcomes from OPTIMAL-PSMA, mixed with earlier exploratory work^[6], are very promising and spotlight TLX597-Tx’s potential to considerably improve the tumor dose whereas minimizing radiation to delicate organs. For folks residing with earlier-stage metastatic illness, preserving quality-of-life alongside efficient most cancers management is obligatory. These findings help additional research in mHSPC and reinforce Telix’s technique to develop differentiated PSMA-targeting therapies, so clinicians could possibly tailor therapy option to the affected person’s illness stage and particular person situation.”

TLX597-Tx is being developed alongside TLX591-Tx (lutetium-177 (¹⁷⁷Lu) rosopatamab tetraxetan), Telix’s lead antibody-based prostate most cancers remedy candidate, presently the topic of the Part 3 ProstACT International^[7] trial in mCRPC, which is actively dosing sufferers in jurisdictions with regulatory approval and not too long ago reported knowledge from a security and dosimetry lead-in^[8]. TLX591-Tx and TLX597-Tx exhibit complementary modes-of-action, suggesting the potential for distinct functions in mCRPC and mHSPC settings as a part of Telix’s portfolio method to treating prostate most cancers. TLX591-Tx and TLX597-Tx haven’t acquired advertising and marketing authorization in any jurisdiction.

To view the webcast slides, click on right here.

About Telix Prescribed drugs Restricted

Telix is a worldwide biopharmaceutical firm centered on the event and commercialization of radiopharmaceuticals with the objective of addressing important unmet medical want in oncology and uncommon illnesses. Telix is headquartered in Melbourne (Australia) with worldwide operations in the USA, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland) and Japan. Telix is listed on the Australian Securities Change (ASX: TLX) and the Nasdaq International Choose Market (NASDAQ: TLX).

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