Alloplex has developed a differentiated, non-engineered, autologous cellular therapy called SUPLEXA. The cells are derived from a patient's peripheral blood mononuclear cells (PBMCs) and are comprised of highly activated immune cells which exhibit broad in vitro anti-tumor activity.
The ongoing Phase 1 clinical trial (SUPLEXA-101) has now reached a significant milestone. It has not only established a reassuring safety profile with no drug-related serious adverse events, but has also demonstrated single-agent clinical activity in solid tumor patients. We have now observed a complete and a partial response in two end-stage patients with MSI-high colorectal cancer with each patient showing durability beyond 80 weeks (as at May 2024). We have also observed long term stable disease in multiple tumor types extending beyond 70 weeks.
Analyses of patient blood samples further reveal a dramatic pharmacodynamic change in the peripheral myeloid cellular composition of the patient within several weeks of first SUPLEXA dose. These changes are consistent with conditions favoring an anti-tumor immune response.
Further laboratory characterization of SUPLEXA suggests multiple mechanisms of action are at play which complement that of immune checkpoint inhibitor (ICI) therapy.
Alloplex is committed to advancing SUPLEXA cells into Phase 2 and exploring its potential in combination with existing ICI therapies to bring new hope to cancer patients. A pre-IND meeting with the FDA is planned for 3Q2024 with the aim to commence a Phase 2 clinical trial in mid-2025.
The story behind Alloplex
Alloplex is led by its scientific founder and CEO, Dr. Frank Borriello MD, PhD – a Harvard-trained immunologist with over two decades pharmaceutical industry experience where he held positions of increasing responsibility, beginning as an oncology clinical trial medical monitor and later developing a keen interest in Search and Evaluation and expertise in Business Development.
After a long hiatus from basic research, several unrelated elements coalesced to inspire Dr. Borriello to launch Alloplex Biotherapeutics.
The first element provided the scientific underpinning and stemmed from his realization that many immune pathways were reported in the literature to drive some level of anti-tumor benefit but that there was no platform for systematically combining their individual contributions. Furthermore, that the molecular methods existed for expressing an array of immunomodulatory protein ligands which could be used to specifically engage naturally occurring receptors on patient-derived white blood cells and thereby transforming them into tumor killing cells.
The second element provided the motivation and came from the premature loss of his brother, Gaetano Borriello, PhD, an accomplished computer scientist, to colorectal cancer at age 56. The personal loss emphasized the huge unmet medical need still remaining in spite of the significant investment and high level of activity in cancer medicine over many decades.
The third and final element provided the serendipitous catalyst and came in the form of the purchase of the company where Dr. Borriello was employed as Head of Search and Evaluation. This event created a career inflection point and the unexpected opportunity to develop a company dedicated to the singular goal of developing an anti-tumor cellular therapy.
Frank Borriello, Sharron Gargosky & James Lederer
