Alloplex Biotherapeutics announced today the site opening for its first-in-human clinical trial of SUPLEXA. 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 – designed 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.
The study (NCT05237206) is being conducted by Cancer Research SA (CRSA) with A/Prof Rohit Joshi as the Principal Investigator, at St. Andrews Medical Centre (Adelaide, South Australia).
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 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.
“SUPLEXA therapeutic cells display a broad anti-tumour activity and are comprised of cells representative of both the innate and adaptive immune systems. As a multi-cellular therapy, they simultaneously deploy multiple mechanisms of action and yet are comprised entirely of non-engineered, normal activated immune cells which are expected to operate in a physiologic homeostasis range.” said Alloplex’s Scientific Founder and CEO, Dr. Frank Borriello. “The initiation of our first-in-human trial for SUPLEXA cells marks a key milestone for Alloplex that has been over 6 years in the making,” he said.
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 now 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.
The AACR Annual Meeting is the focal point of the cancer research community, where scientists, clinicians, other health care professionals, survivors, patients, and advocates gather to share the latest advances in cancer science and medicine. From population science and prevention; to cancer biology, translational, aSUPLEXA 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 2 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.
A/Prof Rohit Joshi is a Medical Oncology Consultant working with GenesisCare (formerly Adelaide Oncology and Haematology), at Calvary Central Districts and St Andrews Hospitals.
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. www.cancerresearchsa.com.au
References to SUPLEXA, Suplexa, Suplexa therapy and Suplexa therapeutic cells relate to SUPLEXACELLS™ a trademark of Alloplex Biotherapeutics Inc.
Including requests for high res images of Dr. Borriello and A/Prof Rohit Joshi