First Patient Dosed in Study of Targeted Alpha Therapy Candidate for Bladder Cancer

Melbourne (Australia) and Nantes (France) – 21 December 2021. Telix announces that a first patient has been dosed in the ‘PERTINENCEPhase I study of TLX250-CDx in patients with non-muscle-invasive bladder cancer

Telix and Nantes-based ATONCO S.A.S. are pleased to announce that a first patient has been dosed in a Phase I study of TLX250-CDx in patients with non-muscle-invasive bladder cancer (NMIBC) at the Institut de Cancérologie de l’Ouest (ICO) in St Herblain, France.

The objective of ‘PERTINENCE’ an investigator-led open-label, proof of concept study, is to evaluate safety, biodistribution and dosing properties of TLX250-CDx (89Zr-DFO-girentuximab) in patients with NMIBC. The PERTINENCE study builds on the Telix and ATONCO licence and development agreement announced in December 2019, and will be led by Dr. Caroline Rousseau at ICO. It will recruit 6 patients over 12 months, with a successful outcome leading to therapeutic studies with astatine-211 (211At) for targeted alpha therapy (TAT). TLX250-CDx (girentuximab) targets carbonic anhydrase IX (CA9), a receptor that is overexpressed in many solid tumours, including urologic malignancies. 

The study is aligned with Telix’s focus on the development of alpha therapy in future pipeline expansion and its strategy to pursue additional indications for the CA9 target, a core pipeline asset, which is currently being evaluated in clear cell renal cell carcinoma (ccRCC) in the company’s Phase III imaging study (ZIRCON) and Phase II therapeutic studies (STARLITE 1 and 2). 

PERTINENCE is the third in a comprehensive series of studies investigating CA9 as a target for molecularly-targeted radiation (MTR) in other tumour types as well as providing a pathway to evaluate TLX250 with an alpha emitting isotope for the first time in humans.   

Alpha emitters have the potential to deliver very high amounts of energy to cancer tissue whilst the short path length can decrease the risk of damage to surrounding healthy cells, increasing the selectivity and potency of the radiation treatment. Alpha emitters have the potential to be complementary to beta-emitters in different stages of disease.  

The two other studies evaluating CA9 (ZiP-UP and OPALESCENCE) have been initiated for urothelial carcinoma or bladder cancer, and triple negative breast cancer, respectively, with other collaborative studies in development for ovarian, colorectal, head and neck, lung, and pancreatic cancers. 

Principal Investigator for the PERTINENCE study, sponsored by ICO, Dr. Caroline Rousseau said, CA9 is a very interesting target that is highly expressed in many hypoxic solid tumors. This study builds on the clinical work we are already doing with CA9 in the OPALESCENCE study and will help us generate a better understanding of the imaging properties of TLX250-CDx in NMIBC as a precursor to studying the role of girentuximab as a therapy with an alpha emitting radioisotope.”  

ATONCO CEO, Sylvain Fanier continued, “We are excited to extend our partnership with Telix, one of the most respected companies in nuclear medicine, and to develop an innovative MTR solution with our local academic and industry partners in Nantes, to improve therapeutic options for patients suffering from NMIBC.” 

Telix Chief Medical Officer, Dr. Colin Hayward added, “We are pleased to further our collaboration with ATONCO to explore girentuximab as a base for therapy with the alpha-emitting radioisotope astatine-211 (211At) as well as extending and accelerating development options to numerous cancer types where there is unmet medical need. We would like to express our gratitude to Dr. Caroline Rousseau and her clinical team at ICO, as well as the patients that will contribute to this ground breaking study.” 

To read Telix’s ASX disclosure please click here.

To return to Telix’s homepage please click here.

More Articles

Corporate Spotlight

Telix Collaborates with Olivia Newton-John Cancer Research Institute on Brain Cancer Imaging Study

Melbourne (Australia) – 22 December 2021. Telix enters a clinical data access agreement with the Olivia Newton-John Cancer Research Institute...

ASX News

First Patient Dosed in Study of Targeted Alpha Therapy Candidate for Bladder Cancer

Melbourne (Australia) and Nantes (France) – 21 December 2021. Telix announces that a first patient has been dosed in the...

ASX News

FDA Approves Telix’s Prostate Cancer Imaging Product, Illuccix®

Melbourne (Australia) and Indianapolis, IN (U.S.A.) – 20 December 2021. Telix announces the FDA has approved Illuccix®, Telix’s lead prostate...

Corporate Spotlight

TRALA Study of TLX66 in AL-Amyloidosis Presented at ASH 2021

15 December 2021 – Clinical Spotlight | TRALA Study of TLX66 for Autologous Stem Cell Transplantation in AL-Amyloidosis Presented at American Society of...

ASX News

Telix and NUCLIBER Sign Distribution Agreement for Prostate Cancer Imaging in Spain

Melbourne (Australia) and Madrid (Spain) – 8 December 2021. Telix announces agreement with NUCLIBER S.A. for the distribution of Telix’s prostate cancer investigational imaging product,...

ASX News

Illuccix® Granted Use Authorisation for Prostate Cancer Imaging in Brazil

Melbourne (Australia) and Porto Alegre (Brazil) – 1 December 2021. The Brazilian Health Regulatory Agency has granted an exceptional authorisation...

Corporate Spotlight

First Telix and Duchembio Joint Symposium – Emergence of PSMA-PET Imaging in South Korea

22 November 2021 – Clinical Spotlight | Telix and Duchembio announce a joint symposium on 68Ga-PSMA-PET imaging in Korea

Corporate Spotlight

NOBLE Study Brings Advanced Prostate Imaging to Rural Australia – First Patient Dosed

Melbourne (Australia) – 15 November 2021. The first Australian patient has been dosed in the international NOBLE Registry, a study aimed at improving access to state-of-the-art prostate...

Corporate Spotlight

ZIRCON Presentation at International Kidney Cancer Symposium 2021

8 November 2021 – Corporate Spotlight | Telix presents Phase III ZIRCON trial at the International Kidney Cancer Symposium 2021

ASX News

Australian TGA Approves Illuccix® for Prostate Cancer Imaging

Melbourne (Australia) – 02 November 2021. Australian Therapeutic Goods Administration has approved Illuccix® for the diagnostic imaging of men with prostate...

Corporate Spotlight

Telix Japan – Upcoming Events in November

22 October 2021 | Corporate Spotlight | Telix Japan Upcoming Events in November

ASX News

Activities Report and Appendix 4C for September 2021 Quarter

Melbourne (Australia) – 21 October 2021. Telix provides its Appendix 4C and accompanying Activities Report for the quarter ended 30 September 2021.

ASX News

IPAX-1 Late Breaking Oral Presentation at the Congress of Neurological Surgeons (CNS) Meeting

Melbourne (Australia) and Indianapolis (U.S.A.) – 20 October 2021. Telix presented the IPAX-1 study of TLX101 in glioblastoma at the...

Corporate Spotlight

Telix Satellite Symposium at European Association of Nuclear Medicine Annual Congress 2021

15 October 2021 – Clinical Spotlight | Telix Satellite Symposium at the European Association of Nuclear Medicine 2021 Virtual Conference.

Corporate Spotlight

First Patient Dosed in Phase II Study of TLX250-CDx in Triple-Negative Breast Cancer

Potential Indication Expansion for Telix’s Core Kidney Cancer Theranostic Program Melbourne (Australia) and Liège (Belgium) – 5 October 2021. Telix announces...

Corporate Spotlight

Telix Establishes Commercial Hub in Geneva, Switzerland

Melbourne (Australia) and Geneva (Switzerland) – 4 October 2021. Telix announces that it has established a new commercial hub in...

Corporate Spotlight

Second Industry Body Updates Guidance for Use of PSMA PET Imaging

Melbourne (Australia) and Indianapolis, IN (U.S.A.) – 21 September 2021. Telix welcomes SNMMI updated Appropriate Use Criteria for PSMA PET...

Corporate Spotlight

Telix at AdMeTech Summit on Precision Diagnosis and Treatment of Prostate Cancer

16 September 2021 – Clinical Spotlight | Telix to support and participate in AdMeTech 5th Global Summit on Precision Diagnosis...

ASX News

NCCN Guidelines Updated to Include PSMA-PET Imaging

Melbourne (Australia) and Indianapolis, IN (U.S.A.) – 14 September 2021. Telix welcomes the updated NCCN Guidelines® for prostate cancer, which includes...

ASX News

FDA Approves Phase II Kidney Cancer Therapy Study

Melbourne (Australia) and Indianapolis, IN (U.S.A.) – 14 September 2021. Telix announces the FDA has accepted the IND Application to...

ASX News

Telix and Radius Sign Italian Distribution Agreement for Prostate Cancer Imaging

Melbourne (Australia) and Bologna (Italy) – 13 September 2021. Telix enters a commercial distribution agreement with Radius for Telix’s prostate...

ASX News

Japanese Prostate Cancer Imaging Study Completes Enrolment

Melbourne (Australia) and Kyoto (Japan) – 9 September 2021. Telix has completed a Phase I clinical trial of TLX591-CDx for...

ASX News

Telix to Collaborate with Kettering Health on Diagnostic PSMA Imaging & Targeting Theranostics

Melbourne (Australia), Indianapolis (IN, U.S.A.), and Kettering (OH, U.S.A.) – 7 September 2021. Telix announces collaboration with Kettering Health on...

ASX News

Telix and Lightpoint Medical to Collaborate on Radioguided Surgery

Melbourne (Australia) – 23 August 2021. Telix announces collaboration with Lightpoint Medical to explore molecularly targeted radiation and Lightpoint SENSEI®...

ASX News

Telix Half-Year Results 2021 and Company Update Conference Call

Melbourne (Australia) – 19 August 2021. Telix announces Half-Year Results 2021 and provides shareholder update

ASX News

Telix Expands Prostate Cancer Activity with GenesisCare Collaboration

Melbourne (Australia) – 19 August 2021. Telix releases details of two ancillary studies under the ProstACT program, including a Phase...

ASX News

Telix and Merck to Commence Pan-Cancer Clinical Combination Studies

Melbourne (Australia) – 18 August 2021. Telix announces pan-cancer clinical collaboration with Merck KGaA, Darmstadt, Germany.

ASX News

Two New Studies to Explore Telix Assets in Breast Cancer Theranostics

Melbourne (Australia) – 18 August 2021. Telix announces two new studies to evaluate the potential utility of TLX591-CDx and TLX250-CDx...

ASX News

Telix Progresses Novel Lung and Ovarian Cancer Theranostic APOMAB®

Melbourne and Adelaide (Australia) – 17 August 2021. Telix extends partnership with AusHealth relating to APOMAB®, a novel theranostic being...

ASX News

Telix’s TLX66 in Phase II Academic Study of Pediatric Leukemia

Melbourne (Australia) and London (United Kingdom) – 17 August 2021. Telix announces Phase II academic study of TLX66 in children...

ASX News

Telix H1 2021 Results and Company Update Conference Call

Melbourne (Australia) – 11 August 2021. Telix to hold investor conference call to present H1 2021 financial results and Company...

ASX News

First Patient Dosed in CUPID Study of Telix’s Targeted Alpha Therapy Candidate for Prostate Cancer

Melbourne (Australia) – 5 August 2021. Telix announces the first patient has been dosed in its ‘CUPID’ Phase I study...

Corporate Spotlight

Ms. Helen Hovenga Joins Telix as Chief People Officer

4 August 2021 – Corporate Spotlight | Telix announces the appointment of Ms. Helen Hovenga in the role of Chief...

ASX News

Telix Seneffe Production Facility: Progress Update

Melbourne (Australia) and Seneffe (Belgium) – 30 July 2021. Telix authorised to decommission first of two cyclotrons at Seneffe radiopharmaceutical...

ASX News

Activities Report and Appendix 4C for June 2021 Quarter

Melbourne (Australia) – 22 July 2021. Telix provides its Appendix 4C and accompanying Activities Report for the quarter ended 30 June...

ASX News

ZIRCON Phase 3 Renal Cancer Imaging Study: Progress Update

Melbourne (Australia) – 20 July 2021. Progress update on the ZIRCON Phase 3 study for the imaging of renal cancer...

Corporate Spotlight

Telix Appoints Gabrielle Wermenbol as Chief Financial Officer, EMEA

19 July 2021 – Corporate Spotlight | Gabrielle Wermenbol joins Telix as Chief Financial Officer, Europe, Middle East & Africa...

Corporate Spotlight

Kyahn Williamson Joins Telix to Lead Corporate Communications and Investor Relations

Melbourne (Australia) – 12 July 2021. Telix announces that Ms. Kyahn Williamson has joined the Telix executive leadership team in...

ASX News

First Patient Dosed in Clinical Study of TLX250-CDx in Bladder Cancer

Melbourne (Australia) – 23 June 2021. Telix announces that a first patient has been dosed in a Phase I study...

ASX News

IPAX-1 (TLX101 for Glioblastoma Therapy) Clinical Trial Update

Melbourne (Australia) – 21 June 2021. Telix announces preliminary safety data from the IPAX-1 Ph I/II study, with a follow-on...

ASX News

Telix Update on FDA New Drug Application Review for Illuccix®

Melbourne (Australia) and Indianapolis, IN (U.S.A.) – 17 June 2021. Telix announces participation in a late-cycle meeting with the U.S....

Corporate Spotlight

Telix Pharmaceuticals and Applied Radiology launch TelixU Medical Education Platform Focused on Radiopharmaceutical Research

MELBOURNE, Australia and INDIANAPOLIS 14 June, 2021 – Telix announces the launch of a new educational platform focused on radiopharmaceutical...

Corporate Spotlight

Telix launches “Gallium Wave” Awareness Website

Melbourne (Australia) and Indianapolis (U.S.A.) – 11 June 2021. Telix announces the launch of a new website “Gallium Wave”, as...

Corporate Spotlight

Scott Law joins Telix as SVP Global Manufacturing Operations

11 June 2021 – Corporate Spotlight | Scott Law joins Telix as Senior Vice President Global Manufacturing Operations

ASX News

Telix and ATS Awarded $1.56M ‘Eurostars’ Grant for Alpha Therapy

Liège (Belgium) and Gothenburg (Sweden) – 7 June 2021. Advanced Nuclear Medicine Ingredients S.A, a wholly owned European subsidiary of...