First in human trial of breakthrough cancer imaging and immunotherapy technology begins at the Royal Adelaide Hospital.

The Central Adelaide Local Health Network (CALHN), AusHealth® and Telix Pharmaceuticals are pleased to announce that the first patient had been dosed in a phase one cancer imaging trial in The Royal Adelaide Hospital.

 APOMABSite

CALHN,AusHealth® and Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’) announced today that the first phase in clinical testing of the APOMAB™ molecular targeting technology has started with dosing of the first patient in The Royal Adelaide Hospital with an imaging product called 89Zr-APOMAB – a vital step towards clinical proof of concept.

The study is a phase one, single-centre, non-randomised, open-labelled, two-arm, single dose trial of chimeric anti-La/SSB antibody (APOMAB™). APOMAB™ is conjugated with a Zirconium-89 label (89Zr-APOMAB™) to make it a theranostic imaging agent using ImmunoPET/CT. 89Zr-APOMAB is being investigated in patients with advanced lung or ovarian cancer. The clinical trial conducted by CALHN is co-funded by AusHealth and Telix.

The target of 89Zr-APOMAB, the La/SSB protein, is specifically expressed by dying or dead cancer cells and the trial aims to test how well the antibodies can trace cancer cells with low-dose radiation.

It will involve eighteen patients in total starting with six patients who are not receiving any treatment for their advanced lung or ovarian cancer, which will be treated with 89Zr-APOMAB. In the second and later part of the study, twelve patients who are to receive their first cycle of platinum-based chemotherapy will subsequently receive also 89Zr-APOMAB.

The objective of the study is to confirm the safety as well as sensitivity and specificity of positron emission tomography (PET) imaging with 89Zr-APOMAB to detect tumour masses in lung and ovarian cancer patients.

Royal Adelaide Hospital Cancer Clinical Trials Unit head professor Michael Brown said that “this first dose in a patient is the culmination of 15 years of preparatory work and gives the prospect that 89Zr-APOMAB might be a clinically useful theranostic imaging agent.”

Inventor

Dr Michael Brown MBBS, Ph.D., FRACP, FRCPA

Consultant Medical Oncologist, Royal Adelaide Hospital

Description

The research behind the APOMAB® technology was led by Professor Brown at the Royal Adelaide Hospital with support from AusHealth® Research (a division of AusHealth®). The technology works by using antibodies to target the La/SSB protein, which is expressed by distressed cancer cells such as those found in patients that have been pre-treated with chemotherapeutic agents. Neighbouring cancer cells are then killed via a mechanism called ‘bystander killing’ that is typically delivered by a toxin or radioactive “warhead”, which in turn has the effect of recruiting the immune system into the cancer-fighting process. As such, APOMAB® has the potential to significantly boost the efficacy of many existing cancer treatments.

About AusHealth®

AusHealth® is a national Profit-for-Purpose company that supports the commercialisation of innovative medical technologies, improving the health of all through three divisions: AusHealth® Research, AusHealth® Work and AusHealth® Hospitals. All profits fund medical research and development of products and services that look to improve the future of medical practice. Since 1985, AusHealth® has helped people with diabetes, joint damage, cardiovascular disease, and cancer; as well as improving burn & scar and foetal health diagnostics. Other commercial success stories by AusHealth® include Mesoblast (ASX:MSB), LBT Innovations (ASX:LBT) and Firefly Health. Visit  www.aushealth.com.au.

About Telix Pharmaceuticals Limited (ASX:TLX)

Telix Pharmaceuticals Limited is a clinical-stage biopharmaceutical company focussed on the development of diagnostic and therapeutic products using Molecularly- Targeted Radiation’ (MTR). Telix is headquartered in Melbourne with international operations in Belgium, Japan and the United States. Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical need in prostate, renal and brain cancer. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com.

Edison Open House: Telix Pharmaceuticals from Core Studio on Vimeo.

Media Contact

John Stedman, National Marketing and Communications Manager AusHealth®
jstedman@aushealth.com.au or Telephone: +61 (0) 417 754 334


1 https://lung-cancer.canceraustralia.gov.au/statistics
2 https://ovarian-cancer.canceraustralia.gov.au/statistics
3 Subject to RAH Human Research Ethics Committee (HREC) approval and TGA Clinical Trial Notification (CTN)

Recent Publications

  • Staudacher et al. The La antigen is over-expressed in lung cancer and is a selective dead cancer cell target for radioimmunotherapy using the La-specific antibody APOMAB® EJNMMI Research 2014, 4:2
  • Al-Ejeh et al. Postchemotherapy and Tumour-Selective Targeting with the La-Specific DAB4 Monoclonal Antibody Relates to Apoptotic Cell Clearance, JNM 2014;55:772-779
  • Staudacher et al. Targeted α-therapy using 227Th-APOMAB® and crossfire anti-tumour effects; preliminary in vivo evaluation, Nucl Med Communications 2014
  • Al-Ejeh et al The La Autoantigen Is a Malignancy-Associated Cell Death Target That Is Induced by DNA-Damaging Drugs, CCR 2007a;13(18 Suppl) September 15, 2007
  • Al-Ejeh et al In vivo Targeting of Dead Tumour Cells in a Murine Tumour Model Using a Monoclonal Antibody Specific for the La Autoantigen CCR 2007b;13(18 Suppl) September 15, 2007