Alloplex Biotherapeutics, Inc. (‘Alloplex’) – a private cellular therapeutics company dedicated to developing and commercializing a global first-in-class cellular therapeutic in oncology – today announced that the Human Research Ethics Committee (HREC) in Australia has approved the clinical trial application for the phase 1 trial of its first-generation autologous cell therapy, SUPLEXA, in patients with metastatic solid tumors and hematologic malignancies.

The approval of the highly differentiated, non-engineered therapeutic for clinical trial marks an important milestone for Alloplex.

SUPLEXA is a potential first-in-class, autologous, tumor-agnostic cellular therapy which is manufactured from peripheral blood mononuclear cells using proprietary cell lines which are engineered to stably express specific immunomodulatory proteins. These cell lines, called ENLIST cells, are designed to specifically differentiate and activate a variety of innate and adaptive immune cells to acquire enhanced anti-tumor activity.

A significant body of research over many decades has delineated numerous biological processes involved in cancer initiation and progression, leading to ever more effective and targeted treatments and prevention strategies. These successes notwithstanding, there are still many patients for whom the standards of care are inadequate to control their disease. These are the patients to whom SUPLEXA therapy will be initially directed.

The Australian Phase I basket trial is designed primarily to evaluate the safety and tolerability of SUPLEXA as a single agent. Alloplex will also assess SUPLEXA efficacy outcomes.

“With all key elements now in place, from regulatory, manufacturing, logistics, and clinical management, we are well positioned to initiate our first-in-human clinical trial,” said Dr. Frank Borriello, Scientific Founder and CEO of Alloplex.  “The primary endpoint of the study will define the safety and tolerability of SUPLEXA therapy but we also anticipate that we will get data on the degree of anti-tumor activity.”, he said.

As this in an open label trial, Alloplex will assess patient data in real time and provide updates as they arise during the course of this study.

---

About SUPLEXA

SUPLEXA Therapeutic Cells are a novel autologous cellular therapy intended to treat cancer via a multi-modal anti-tumor mechanism of action/through the activation of multiple immunotherapeutic pathways. The cells are derived from human peripheral white blood cells (PBMC).

Following a short ex vivo activation procedure, the PBMC are differentiated in SUPLEXA cells – which contain a mixed population of cells comprised of NK cells, NK-T cells, CD8 cells, CD56 positive, NK-like T cells and gamma delta T cells. They are cultured ex-vivo and administered by IV

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 clinic-ready 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.

Forward-looking statements

This article contains express or implied forward-looking statements, which are based on current expectations of management. These statements relate to, among other things, our expectations regarding management’s plans, objectives, and strategies. These statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. Alloplex assumes no obligation to update any forward-looking statements appearing in this release, or articles derived therefrom, in the event of changing circumstances or otherwise, and such statements are current only as of the date they are made.