Leading national Phase I program

Icon operates Australia’s largest private Phase I clinical trials program which saw 52% growth with the addition of Ashford Cancer Centre Research (ACCR) based at the Tennyson Centre in Adelaide, South Australia.

Icon’s Phase I trials are led by internationally recognised clinicians, A/Prof Jim Coward (South Brisbane, Qld) and Dr Gonzalo Tapia Rico ( Adelaide (Tennyson) and Windsor Gardens, SA) who treat a broad range of solid tumour malignancies and continue to amplify our impact and operate unparalleled, stable and growing private Phase I units.

The group continues to expand the Phase I portfolio, contributing 38% of the annual accrual across participating early phase locations at Queensland sites - South Brisbane, Southport, Wesley, Chermside and South Australia’s Australia’s centres at Adelaide (Tennyson) and Windsor Gardens. This portfolio continues to thrive, with Icon’s ongoing relationships with sponsors including, but not limited to; AbbVie, Akesobio, Atridia, BeiGene and CStone. Notably 35 participants, one third of the annual accrual to Phase I trials, were from five Akesobio trials conducted across both the Icon Cancer Centre Adelaide (Tennyson) and Icon Cancer Centre South Brisbane clinics.

A/PROF JIM COWARD

BSc (Hons), MBBS, PhD, MRCP (UK), FRACP Medical Oncologist, Icon Phase I Lead, Chair of Medical Oncology Research Committee

With more than 20 years of clinical oncology experience, A/Prof Coward is heavily invested in providing cuttingedge medicines through a growing Phase I portfolio. In 2006, he was appointed as an MRC clinical fellow at Barts Cancer Institute, London, where his research on the effects of immunotherapy in advanced ovarian cancer successfully translated to a clinical trial in patients with platinum resistant disease. A/Prof Coward was recently appointed as a member of the IQVIA advisory board committee.

DR GONZALO TAPIA RICO

MBBS, PhD, FRACP Medical Oncologist, Phase I Clinician – South Australia

Dr Tapia Rico maintains a strong interest in clinical trials and research in both his private practice and roles as Clinical Senior Lecturer at the University of Adelaide and Clinical Director of Education at Icon Cancer Centre Adelaide. He received his PhD in 2013 for research exploring alternative classifications of molecular subtypes in breast cancer. He holds several affiliations and memberships, including with the Australasian Gastro-Intestinal Trials Group (AGITG), European Society of Medical Oncology (ESMO) and Spanish Group of Breast Cancer Research (GEICAM).

HIGHLIGHTS AT SOUTH BRISBANE

• Plenary for Phase I Cantrixil (TRX-E-002-01) study:

Principal Investigator, A/Prof Jim Coward

- Published in Cancers and presented at the American

Association for Cancer Research (AACR) conference, the study was found to prolong survival in advanced ovarian cancer by inducing ovarian cancer stem cells’ death and making the cells more sensitive to standard chemotherapy

- A/Prof Coward to lead follow-up Phase II trial which aims to identify biomarkers on hidden stem cells and advance the development of new therapies targeting cancer stem cells treatments

• Open for recruitment Phase I trial - AK105-101: A

Phase IA/IB Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety,

Pharmacokinetics, and Antitumor Activity of AK105 in Subjects With Advanced Solid Tumors. Principal

Investigator: A/Prof Jim Coward

• In 2021, Icon recruited 105 participants to Phase I clinical trials, contributing 38% of the annual clinical trials accrual across early phase trial locations. The Icon Cancer Centre sites involved in Phase I trials are Icon Cancer Centre Adelaide (Tennyson), Icon Cancer Centre South Brisbane and Icon Cancer Centre Windsor Gardens with the breakdown as follows:

+ Icon Cancer Centre Adelaide (Tennyson) — 44 42%

+ Icon Cancer Centre South Brisbane — 37 35%

+ Icon Cancer Centre Windsor Gardens — 15 14%

+ Icon Cancer Centre Southport — 6 5%

+ Icon Cancer Centre Wesley — 2 2%

+ Icon Cancer Centre Chermside — 1 1%

• South Brisbane Clinical Research Coordinator Team

Lead, Stephanie Airey was a finalist in Icon Group’s

Annual Awards. Nominated by her peers, this prestigious recognition highlights Stephanie’s significant contribution to Icon’s Phase I program and the success of the group’s research capabilities, including guidance through the 2021 TGA Good Clinical Practice (GCP) inspection

“Survival outcomes in ovarian cancer are poor, and sadly most patients with ovarian cancer will die with chemotherapy resistant disease. Recent evidence suggests this may reflect the existence of ovarian cancer stem cells that remain dormant and resistant to existing treatment like chemotherapy. Our research has been investigating these stem cells and targeting these could provide the majority of women who are living with ovarian cancer hope of long-term survival.”

A/PROF JIM COWARD

BSc (Hons), MBBS, PhD, MRCP (UK), FRACP Medical Oncologist

HIGHLIGHTS AT ADELAIDE

South Australia’s Phase I unit is supported by a fullservice research program offering trials across Phase I – IV and operated by a dedicated research team, led by Adelaide Director of Research, A/Prof Dusan Kotasek and Clinical Research Business Manager, Sue Yeend. Adelaide added 20 new studies to Icon’s trial portfolio focusing on a wide range of cancer indications to improve access to emerging treatments.

• Early 2021 saw the opening of the fully equipped research unit at Icon Cancer Centre Windsor Gardens, with the first trial patient recruited at the centre in

February

• Opened seven new trials at Windsor Gardens, with 16% of Icon Adelaide patients recruited at Windsor Gardens • Recruited 112 trial participants and identified 214 patients as potential trial participants across Icon

Adelaide centres

• Icon Cancer Centre Adelaide (Tennyson) was the first in the world to dose a patient on theFIH AK127-101 study:

A Study to Evaluate the Safety, Pharmacokinetics, and

Antitumor Activity of AK127 in Combination With AK104 in Advanced and Metastatic Solid Tumours

• Opened the EARLI-001 diagnostic study involving a radically new technique, forcing cancer cells to produce synthetic biomarkers not found in the human body which are then highly detectable and localisable in a

PET scanner