TLX592 / Telix - LARVOL DELTA

CUPID (64Cu-TLX592 phase I PK, biodistribution and dosimetry): A proof-of-concept study of TLX592 targeted alpha therapy in prostate cancer. (ASCO 2025) - P1 | " TLX592 blood clearance was more rapid than TLX591 (T½=19.86+1.96, T½=33.65+11.04h, resp.) with similar organ uptake. Preliminary results demonstrate successful proof-of-concept of RADmAb technology, intended for use with therapeutic alpha-emitting radionuclides. Rapid antibody clearance has potential to minimize radiation exposure & augment the safety & tolerability profile of antibody-based therapies. Residence times (mean±SD) MBq.hr.MBq-1."

P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Investor Webinar: Telix Therapeutics Urology Showcase and Expert Forum (GlobeNewswire) - "In this education session, Telix and global key opinion leaders will provide an overview on the development of its therapeutic candidates in prostate and kidney cancers: Neeraj Agarwal, MD...will discuss the ProstACT Global Phase 3 trial of TLX591 (177Lu rosopatamab tetraxetan), Telix’s lead radio antibody-drug conjugate (rADC) therapy candidate in prostate cancer; Eric Jonasch, MD...will discuss the STARLITE studies of TLX250 (177Lu girentuximab) in combination with immunotherapy, in clear cell renal cell carcinoma; Rodney Hicks, MD...will discuss TLX592 (64Cu/225Ac RADmAb) and the role of targeted alpha therapies in the treatment of prostate cancer."

Clinical • Genito-urinary Cancer • Prostate Cancer • Renal Cell Carcinoma

Telix to Showcase Urology Pipeline at Upcoming ASCO Genitourinary Cancers Symposium (ASCO GU 2025) (GlobeNewswire) - "Telix Pharmaceuticals Limited...today announces presentations featuring the Company’s late-stage and next generation therapeutic programs at the upcoming American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU 2025) to be held in San Francisco, CA (US) from 13 – 15 February 2025...'For the first time at a medical congress, preliminary data will be presented from the CUPID study of TLX592, which was successful in demonstrating clinical proof-of-concept of Telix’s alpha therapy candidate for prostate cancer.' ProstACT GLOBAL, the first Phase 3 trial to evaluate Telix’s lead rADC therapy candidate, TLX591...will be highlighted during a ‘Trials In Progress’ presentation. In kidney cancer, Principal Investigators of the STARLITE-1 and -2 investigator-initiated trials will provide an update on design and status of these trials in progress."

P1 data • Trial status • Castration-Resistant Prostate Cancer • Kidney Cancer • Prostate Cancer

CUPID (64Cu-TLX592 phase I PK, biodistribution and dosimetry): A proof-of-concept study of TLX592-targeted alpha therapy in prostate cancer. (ASCO-GU 2025) - P1 | " TLX592 blood clearance was more rapid than TLX591 (T½=19.86+1.96, T½=33.65+11.04h, resp.) with similar organ uptake. Preliminary results demonstrate successful proof-of-concept of RADmAb technology, intended for use with therapeutic alpha-emitting radionuclides. Rapid antibody clearance has potential to minimize radiation exposure & augment the safety & tolerability profile of antibody-based therapies. Residence times (mean±SD) MBq.hr.MBq-1."

P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Telix Completes Proof-of-Concept Study of TLX592 Targeted Alpha Therapy in Prostate Cancer (PRNewswire) - P1 | N=14 | CUPID (NCT04726033) | Sponsor: Telix Pharmaceuticals | "Telix Pharmaceuticals Limited...announces the successful completion of CUPID, a first-in-human Phase I dose escalation study of TLX592 in patients with advanced prostate cancer....The CUPID (64Cu PSMA Imaging and (Bio) Distribution) study is a 3+3 mass dose escalation study with four patient cohorts intended to evaluate the safety, tolerability, pharmacokinetics, biodistribution and radiation dosimetry of TLX592....Preliminary results in 11 evaluable patients enrolled in the study demonstrated accelerated blood kinetics compared to the standard antibody TLX591, while demonstrating similar (favourable) on-target and off-target biodistribution and hepatic clearance. There were no serious adverse events observed in the study. Based on these encouraging results, Telix expects to advance TLX592 into a therapeutic Phase I/II study with 225Ac in the second half of 2024, subject to regulatory approval."

New P1/2 trial • P1 data • Trial completion • Prostate Cancer

64Cu-TLX592 Phase I Safety, PK, Biodistribution and Dosimetry Study (CUPID Study) (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: Telix International Pty Ltd | Recruiting ➔ Completed | Trial completion date: Apr 2023 ➔ Jan 2024 | Trial primary completion date: Apr 2023 ➔ Dec 2023

Trial completion • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

64Cu-TLX592 Phase I Safety, PK, Biodistribution and Dosimetry Study (CUPID Study) (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Telix International Pty Ltd | Trial completion date: Dec 2021 ➔ Apr 2023 | Trial primary completion date: Nov 2021 ➔ Apr 2023

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

First Patient Dosed in CUPID Study of Telix’s Targeted Alpha Therapy Candidate for Prostate Cancer (GlobeNewswire) - "Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) announces today that the first patient has been dosed in its ‘CUPID’ first-in-human Phase I study of the Company’s next generation prostate cancer therapy candidate TLX592 in patients with advanced prostate cancer. The objective of the CUPID (64Cu PSMA Imaging and (Bio)Distribution) study is to evaluate the safety, tolerability, pharmacokinetics, biodistribution and radiation dosimetry of TLX592."

Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer