Alloplex Biotherapeutics today announced the opening of the third site in its first-in-human clinical trial of SUPLEXA: Southern Oncology Cancer Research Unit ‘SOCRU’.

SUPLEXA therapy is a highly-differentiated, autologous, non-engineered, multi-cellular therapy derived from patient peripheral blood mononuclear cells.

This Phase 1 is a first-in-human, open-label single agent basket study. The primary outcome measure of the trial is to assess the safety, tolerability, and preliminary clinical efficacy of repeated intravenous (IV) infusions of SUPLEXA cells in patients with a variety of measurable metastatic solid tumours and haematologic malignancies. For this initial trial, subjects must meet defined entry criteria and have measurable relapsed or refractory advanced malignancy for which no standard therapy exists

The study (NCT05237206) is now being conducted in two sites in South Australia and one site in Queensland:

• Cancer Research SA (CRSA) with Assoc. Professor Rohit Joshi as the Principal Investigator at St Andrew’s Medical Centre, Adelaide, South Australia
• Southern Oncology Clinical Research Unit (SOCRU) in Adelaide, South Australia, with Dr. Ganessan Kichenadasse as Investigator; and at
• Gallipoli Medical Research Foundation (GMRF), Greenslopes Hospital in Brisbane, Queensland with Dr. Jeffrey Goh as Investigator

Since the in-human trial commenced in April 2022, clinical experience shows that SUPLEXA cells are well tolerated in patients across a wide array of cancer types.

“We are delighted to welcome these prestigious sites to the SUPLEXA-101 first-in-class cellular therapy trial in oncology patients. The cutting-edge individualised therapy has shown a remarkable safety and tolerability profile, enabling us to support treatment of many cancer types,” said Alloplex’s Scientific Founder and CEO, Dr. Frank Borriello. ”We are encouraged by the early signals and look forward to further data from these clinical trial sites” he said.

---

About Alloplex:

Alloplex Biotherapeutics, Inc. is a private-company with headquarters in Boston, USA and a wholly-owned subsidiary, Alloplex Australia Pty. Ltd based in Melbourne, Australia. Alloplex is a clinical stage company focused on developing SUPLEXA; a potential first-in-class autologous, pan-cancer therapy for the treatment of cancer patients. The privately-held company was established in 2016 by Scientific Founder and CEO, Dr. Frank Borriello, MD, PhD on an original concept he developed.

---

About SUPLEXA and The Phase 1 trial:

SUPLEXA Therapeutic Cells are a novel a highly-differentiated PBMC-derived, autologous cellular therapy intended to treat cancer via a multi-modal anti-tumor mechanism of action. Following a short two- week ex vivo activation procedure, the PBMCs are differentiated in SUPLEXA cells – which contain NK, NK-T, CD8 and CD4 positive cells as well as gamma delta T cells. They are administered as three weekly IV infusions.

For the Phase 1 ‘SUPLEXA-101’ trial, enrolling under reference number NCT05237206, subjects must meet defined entry criteria and have measurable relapsed or refractory advanced malignancy for which no standard therapy exists. The primary outcome measure of the trial is to assess safety and tolerability of SUPLEXA in subjects with malignant solid tumours and haematologic malignancies. An Independent Data Monitoring Committee (IDMC) will monitor safety on a regular basis throughout the study.

In January 2022, Australia’s Human Research Ethics Committee ‘HREC’ approved Alloplex’s submission to proceed to in-human trials. In April 2022, Alloplex Biotherapeutics announced the site opening for its first-in-human (FIH) clinical trial of SUPLEXA therapeutic cells at CRSA with Dr. Rohit Joshi as Principal Investigator.

The trial investigators and sites

• Dr. Joshi, Cancer Research SA (CRSA)
  
  A/Prof Rohit Joshi MBBS, MD, is a Medical Oncology Consultant working with GenesisCare (formerly Adelaide Oncology and Haematology) at Calvary Central Districts and St Andrews Hospitals. Rohit is a Fellow of the Royal Australasian College of Physicians (FRACP), Fellow of the American College of Physicians (ACP) and Fellow of the Royal College of Physicians (FRCP). He treats all solid cancer types with major interests in Lung and Breast cancer. He is an Associate Professor at the University of Adelaide and University of South Australia.
  
  Dr S Bishnoi, A/Prof R Joshi, Dr V Kwatra and Dr M Okera are the Directors at Cancer Research SA (CRSA), which is based at St Andrews Hospital. The aim of CRSA is to provide compassionate, state-of-the-art care and ongoing advancements in the prevention, diagnosis, treatment and cure of cancer in the future. It seeks to accomplish this through research, education and clinical practice. www.cancerresearchsa.com.au

• Dr. Goh and Gallipoli Medical Research Foundation (GMRF)
  
  Dr. Jeffrey Goh, MMBS, FRACP is a Senior Staff Medical Oncologist (part-time) at RBWH & TPCH. Also VMO at Greenslopes Private Hospital, Icon Cancer Centre Chermside and Icon Cancer Centre Wesley with main research interests in Gynaecological & Genitourinary Cancers. He is an adjunct Professor at QUT and manages patients with colorectal and pulmonary malignancies.
  
  GMRF’s Clinical Trials Unit provides patients with access to new and emerging medications in an effort to advance medical care for all. The specialist team of scientists and research nurses conduct, manage and coordinate national and international clinical research trials. The team is currently conducting clinical trials in liver disease, respiratory illness and oncology. https://www.gallipoliresearch.com.au/research/clinical-trials-unit/

• Dr. Kichenadasse and SOCRU
  
  Dr. Ganessan Kichenadasse, MBBS, FRACP, PhD is an experienced Oncologist and a Pharmacologist with special interest in the management of variety of cancers such as brain, gynaecological, genitourinary (bladder, kidney, prostate), sarcomas, breast, thyroid cancers, cancer of unknown primary and other rare cancers.
  
  He conducts and designs clinical trials for cancer therapies within the Southern Oncology Clinical Research Unit ‘SOCRU’ with a focus on early phase (first in human) drug trials. He is an active member of several national and international cancer and pharmacology professional associations.
  
  SOCRU is a phase one cancer trials unit located within Flinders Private Hospital, within the Southern Biomedical hub of Adelaide, South Australia. The unit conducts trials using various interventions including cytotoxic, targeted therapies, immunotherapy and oncolytic viral therapies. www.socru.org.au

---

Trademark

References to SUPLEXA, Suplexa, Suplexa therapy and Suplexa therapeutic cells relate to SUPLEXACELLS™ a trademark of Alloplex Biotherapeutics Inc.