Alloplex presents a patented cell-retraining platform that, by utilizing synergy between key immune pathways, reveals a previously unappreciated dimension of human immunology.
Our lead immuno-oncology candidate, SUPLEXA – a clinically-validated autologous cellular therapy – with compelling clinical results across multiple solid tumor types is Phase 2 trial-ready.
This differentiated, scalable approach to cellular therapy achieved a highly-sought after ‘Top 100’ poster status at SITC 2024.
The clinical Pipeline for developping the SUPLEXA therapeutic platform.
Frank Borriello MD, PhD
Alloplex Biotherapeutics is a privately-owned company pioneering a new era in cancer immunotherapy. Based in Boston, our focus is on developing differentiated cell therapies comprised of highly activated immune cells designed to harness the inherent power of a patient’s own immune system, particularly against solid tumors.
ENLIST training immune cell
SUPLEXA therapeutic cells stand apart from many existing cell therapies. They are reprogrammed using natural signals, and do not require genetic engineered to acquire their anti-tumor activity. This non-engineered lead program bypasses the complexities and potential safety concerns associated with genetic modifications. Nonetheless it can complement CAR or iPSC technologies in both autologous and allogeneic settings.
SUPLEXA is comprised of a diverse population of activated lymphoid immune cells. Notably, the cells are devoid of B and myeloid cell populations. They demonstrate broad killing activity against a broad range of tumor cell types while sparing normal, healthy cells, indicating tumor-specific targeting.
The potential of SUPLEXA is underscored by the successful completion of our first-in-human Phase 1 clinical trial (SUPLEXA-101) in Australia. This study assessed SUPLEXA as a single agent in 35 patients, with various metastatic solid tumors, who had exhausted standard treatment options. All study endpoints were achieved.
The trial established an exceptional safety profile, with no drug-related serious adverse events (SAEs) observed across a wide dose range and over 220 administered doses. No related dose-limiting toxicities (DLTs) or injection site reactions were identified. Opinion leaders have noted that safety is unlikely to be an issue.
Despite treating heavily pre-treated patients as a single agent, the trial showed encouraging signs of clinical activity across multiple challenging solid tumor types. This included complete and partial responses in CRC-dMMR/MSI-H and ccRCC, and long-lasting stable disease in melanoma, lung cancer, and TNBC. Some patients sustained clinical responses for up to two years.
Analyses revealed marked and favorable changes in patient immune profiles, including dramatic decreases in immunosuppressive myeloid cells in the circulation accompanied by increases in activated monocyte numbers, hence supporting an enhanced anti-tumor immune response.
The positive outcomes were recognized when the SUPLEXA trial results were selected among the Top 100 presentations at the SITC 2024 annual meeting, providing significant external validation.
Crucial for accessibility and scalability, our manufacturing process for SUPLEXA therapeutic cells is designed to be simple, robust, and reproducible. It is a defined, GMP-compatible process requiring only standard laboratory equipment, with no genetic engineering steps or feeder cells. The process reliably yields a full course of treatment from a small blood draw within approximately one month.
Building on our compelling clinical validation, Alloplex is actively seeking strategic partnerships with pharmaceutical companies and additional investment to advance Phase 2 clinical testing. We believe the ENLIST platform and SUPLEXA therapeutic cells offer unique opportunities to augment existing cancer therapy programs being developed by other companies and to develop a novel approach to cancer therapy.
The versatile ENLIST platform also holds broad potential for future development, including potential for allogeneic ("off-the-shelf") therapies and integration with other methods like CAR and iPSC-derived approaches with applications in oncology and autoimmunity.
We invite you to delve deeper into the science and opportunity behind Alloplex:
Learn more about the innovative science of the ENLIST platform, the unique mechanisms of action, and the comprehensive clinical data from the SUPLEXA-101 trial.
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The ENLIST Platform Details
SUPLEXA Therapeutic Cells Key Features
Phase 1 Clinical Trial Details
Access Posters, Publications, and Presentations
Discover the compelling investment opportunity presented by our differentiated platform, validated clinical success, robust manufacturing, and strategic vision.
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Key Highlights from the SUPLEXA-101 Trial
SUPLEXA: A Differentiated Cellular Therapy
Robust and Reproducible Manufacturing
Strategic Partnership Opportunities
Review Science and IP Milestones
