Alloplex Biotherapeutics is charting a groundbreaking path in cancer treatment with its highly-differentiated, non-engineered cellular therapy platform.
As a privately-owned, Boston-based company founded in 2016, Alloplex offers a truly compelling investment opportunity at the forefront of the booming immuno-oncology and cellular therapy space.
Our proprietary ENLIST immune cell training platform is the foundation for our lead product candidate, SUPLEXA, an autologous cell therapy that has demonstrated exceptional safety and encouraging efficacy in a completed Phase 1 clinical trial.
Alloplex's approach is based on the scientific observation that activating numerous immune pathways can contribute to anti-tumor activity. Recognizing the advantage of consolidating the activity of multiple immune pathways into a single therapeutic, our scientific founder, Dr. Frank Borriello, developed the patented ENLIST platform.
This platform uses specially tailored, engineered cell lines called ENLIST cells, derived from a common tumor cell line, that express multiple immunomodulatory ligands designed to engage natural receptors on patient PBMCs. A simple ex vivo co-incubation process 'trains' these PBMCs, resulting in the creation of SUPLEXA therapeutic cells. This process reveals a previously unappreciated synergy between key immune pathways.
We invite you to delve deeper into the science and opportunity behind Alloplex:
The most significant de-risking event and a key highlight for investors is the successful completion of the first-in-human Phase 1 clinical trial (SUPLEXA-101) in 35 patients with various metastatic solid tumors who had exhausted standard treatment options. This landmark study, conducted in Australia and commenced in 2Q 2022, achieved all study endpoints.
The trial established an exceptional safety profile, with no drug-related serious adverse events (SAEs) observed across a wide dose range (3-20 doses of 2.5 billion cells per patient) and over 220 administered doses. There were no related Dose Limiting Toxicities (DLTs) or injection site reactions identified. Preclinical data suggested the therapy would be well-tolerated and safe, which was borne out in the Phase 1 trial. The pre-trial insights from Opinion leaders universally - who noted that "Safety is unlikely to be an issue" - have been borne out. This safety profile is particularly encouraging compared to some engineered cell therapies.
Despite being a single-agent study in heavily pre-treated patients who had exhausted all standard treatment options, the trial showed encouraging signs of clinical efficacy. This included:
A complete response (CR) and two partial responses (PRs) observed in patients with colorectal cancer with deficient mismatch repair/microsatellite instability-high (CRC-dMMR/MSI-H) and clear cell renal cell carcinoma (ccRCC).
Long-term stable disease extending beyond 70 weeks was seen in multiple tumor types. Six out of ten RCC patients achieved stable disease. These clinical findings are consistent with broad preclinical in vitro activity.
A number of long-lasting stable disease (SD) responses in various tumor types, including melanoma, lung cancer, and triple-negative breast cancer (TNBC).
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.
Analyses of longitudinal patient blood samples revealed marked and favorable changes in immune cell composition, suggesting SUPLEXA promotes an anti-tumor immune environment. Specifically, there were dramatic decreases in myeloid-derived suppressor cells (MDSC) and increases in activated monocytes, indicating changes that strongly favor an enhanced anti-tumor immune response31. Baseline immune cell characteristics showed higher levels of NK cells and lower levels of MDSCs in patients showing clinical benefit.
The positive outcomes from the Phase 1 trial were recognized when the SUPLEXA trial results were selected among the Top 100 presentations at the prestigious SITC 2024 annual meeting. This provides significant external validation from experts in the field. Opinion leaders described the approach as "very elegant" and "as good as it gets", with pre-clinical feedback being universally supportive.
SUPLEXA stands out in the competitive cellular therapy landscape due to its unique characteristics, offering several key benefits relevant to investors:
Generated without any genetic modification, relying on the natural activation of the patient's immune cells through physiological signals. This potentially contributes to the exceptional safety profile and preserves the natural complexity of the immune system. The absence of genetic alterations bypasses potential safety concerns associated with DNA engineering techniques, such as tumorigenic mutations.
Differentiated cell therapy comprised of highly-activated lymphoid cells with unique features. This enables a coordinated attack on tumors from independent directions. This allows for direct tumor lysis, antigen presentation, and amplification of the host anti-tumor response.
Demonstrates broad killing activity against various tumor cells while sparing normal, healthy cells, indicating tumor-specific targeting that appears independent of HLA. This suggests activity possibly against ubiquitous tumor-specific motifs, such as tumor cell stress antigens.
Significantly differs from PBMCs by lacking immunosuppressive cell types such as Tregs and myeloid-derived suppressor cells (MDSC) that might suppress the anti-tumor response.
Exhibits immunomodulatory effects in cancer patients, consistent with improved anti-tumor immune function. They can potentially alter the tumor microenvironment.
PBMCs are collected using a standard isolation procedure from a small, easily-collected sample of the patient's peripheral blood. No further cell selection is required — simply place them in a flask with standard expansion media, and the ENLIST reagents supply all the necessary signals in a fixed ratio to generate SUPLEXA cells.
A crucial factor for scalability, accessibility, and commercial viability, the manufacturing process for SUPLEXA therapeutic cells is designed to be simple, robust, and reproducible.
Building on the compelling outcomes of the Phase 1 trial, Alloplex is actively seeking strategic partnerships with pharmaceutical companies. We believe the ENLIST platform and SUPLEXA offer a unique opportunity to:
The Phase 1 data provides a strong rationale for advancing SUPLEXA in Phase 2 clinical trials. The versatile ENLIST platform also holds broad potential for future development, including potential allogeneic ("off-the-shelf") administration and integration with engineering methods should they prove advantageous. The underlying principle of retraining immunosuppressed immune cells suggests potential applications beyond oncology.
Founded in 2016 by Dr. Frank Borriello, a Harvard-trained immunologist with extensive pharmaceutical industry experience, Alloplex is led by a small and nimble leadership team with broad and complementary skill sets.
Key team members include James Lederer, PhD (CSO) and Sharron Gargosky, PhD (Chief Development Officer), who bring expertise in immunology, pharmaceutical development, clinical/regulatory affairs, and business development. Drs. Borriello and Lederer have presented the science and mechanism of action at key cancer conferences.
Alloplex Biotherapeutics is uniquely positioned to impact the future of cancer therapy. Our clinically validated, non-engineered approach, coupled with a robust platform and manufacturing process, presents a compelling investment opportunity.
We invite potential investors and strategic partners to learn more:
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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
