Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1359 |
| INN | Rosopatamab tetraxetan 177Lu |
| Status | Clinical |
| Drug code(s) | TLX591, ATL-101, Lu-177-huJ591, Rosopatamab-177Lu-DOTA |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Radioimmunotherapy, RIC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | Lu-177 |
| Discovery method/technology | None |
| Target(s) | PSMA |
| Indications of clinical studies | Prostate cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 02, 2000 |
| Start of Phase 2 | July 02, 2004 |
| Start of Phase 3 | |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Telix Pharmaceuticals Ltd |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06520345 Phase 3 study in Prostate cancer started in July 2024. November 12, 2023 I Telix Pharmaceuticals Limited announces that the first patient has been dosed in the Company's Phase III ProstACT GLOBAL study of its investigational prostate-specific membrane antigen targeting radio-antibody drug conjugate therapy, TLX591 (177Lu-rosopatamab tetraxetan). In the Activities Report and Appendix 4C for March quarter (April 17, 2023) Telix announces "Progression of the prostate cancer therapy program (TLX591): Australian and New Zealand site engagement for recruitment into the ProstACT GLOBAL Phase III study has been a focus for the Company. Regulatory applications are in preparation to expand the study to the U.S. in H2 2023. Enrolment of the ProstACT SELECT study is complete (25 patients) with data to be reported in H2 2023." https://telixpharma.com/news-views/activities-report-and-appendix-4c-for-march-quarter-telix-delivers-its-first-100m-revenue-quarter/ NCT04876651 Phase 3 study in prostate cancer due to start in Jan 2024. May 09, 2021: Telix Pharmaceuticals Limited announces it has been granted Human Research Ethics Committee (HREC) approval and received Clinical Trial Notification (CTN) clearance by the Australian Therapeutic Goods Administration (TGA) to commence a Phase III clinical trial of the Company’s PSMA1 targeted prostate cancer therapy candidate TLX591 (177Lu-DOTA-rosopatamab), in patients with advanced metastatic castrate-resistant prostate cancer (mCRPC). NCT04786847 Phase 1 study of 177Lu-DOTA-TLX591-CHO Safety, Biodistribution and Dosimetry Study (PROSTACT-Rapid) due to start in May 2021 Clinical material expected to be released by late Q3 / early-Q4 2019 for commencement of Ph III by end-2019. Sep 2018: ATLAB Pharma has been acquired by Telix Pharmaceuticals. One reason for acquisition is that "Atlab possesses the rights and materials necessary to develop huJ591, the most widely clinically-studied anti-PSMA antibody. Telix will keep huJ591 as a back-up clinical drug candidate and continue to support several high-value academic collaborations around the use of this antibody that may also be informative to the future development of TLX591, including in non-prostate cancer indication". Telix has built on the Atlab/BZL experience to develop TLX591, an engineered and optimized form of 177Lu-labelled huJ591. No specific information about any clinical studies found as of Oct 2017. Nantes, France , 11 March 2015 – ATLAB Pharma SAS announces that updated biological (PSA and CTCs) and survival data in metastatic castrate resistant prostate cancer (mCRPC) patients treated with ATL101 anti-PSMA radioimmunotherapy as single agent and combined with docetaxel have been presented at ASCO GU 2015 (Orlando, USA, February 26-28, 2015). Phase 1 results reported in Oct 2013. Licensed by ATLAB from BZL Biologics (which has exclusive license from Cornell University); companies are planning on a Phase 2/3 study as per ATLAB communication in July 2013. Recent clinical studies seem to be sponsored by only Cornell. Murine and "deimmunized" huJ591 mAbs (including Lu-177 and ADC versions) were previously evaluated in clinical studies by Millennium and BZL Biologics |
| Full address of company | Level 4, 55 Flemington Road, North Melbourne, VIC, Australia, 3051 Australia Australia https://telixpharma.com/contact/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |