Executive summary

In the highly competitive space of oncology research and development, the specific field of cellular therapy and, more generally, immuno-oncology is booming. Today, we are witnessing unprecedented international investment in research designed to improve clinical outcomes in cancer through augmenting the antitumor activity of the patient’s own immune system.

Employing a novel approach to the challenge, Alloplex focused on creating SUPLEXA therapeutic cells, an individualized, non-engineered cellular therapy.

The oncology cellular therapy commercial landscape is currently (2023) comprised exclusively of several approved CAR-T products. Researchers are expanding on this early success by adding additional features to CAR-T cell constructs as well as exploring other cell types to engineer such as NK, γδ-T cells, macrophages, B cells, TILs and iNK cells.

Conversely, SUPLEXA therapeutic cells are comprised of many different cell types of both the innate and adaptive immune systems and each individually known to possess anti-tumor activity. It is an autologous therapy, created from a small amount of the patient’s peripheral blood coincubated with proprietary training cells, known as ENLIST cells.

The company has been undertaking exacting research on its original concept since 2016 when scientific founder Frank Borriello, MD, PhD developed the concept and registered the first patent for proprietary ENLIST cells.

Nonclinical research suggested SUPLEXA therapeutic cells would be well-tolerated and safe and this has now been borne out in the first in human clinical trial.

The first generation GMP manufacturing is well-established and recent improvement in processing have led to a second-generation process resulting in SUPLEXA cells with cytolytic activity in vitro augmented by approximately 10-fold.

The first in human clinical trials, which commenced in 2Q2022, are progressing well and are demonstrating excellent safety and tolerability and encouraging early signals of outcomes.

  • “The SUPLEXA approach has proven to be remarkably robust and versatile, yielding highly efficacious results in all preclinical experiments to date.

    Furthermore, observations from our first-in-human studies have not only extended these preclinical safety and efficacy data but have also revealed an unanticipated immunomodulation beneficial to an anti-tumor response.”

    Frank Borriello, MD, PhD

    Photo of Dr. Frank Borriello MD, PhD

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About Alloplex

General company information

Alloplex is a privately held company with operations in Boston, USA and a wholly owned subsidiary in Melbourne, Australia.

Science and IP Milestones

Corporate and Finance Milestones

Science and IP Milestones
  • July – Dr. Borriello develops concept.
  • ENLISTCELLS trademark registered.
  • SUPLEXACELLS trademark registered.
Corporate and Finance Milestones
  • Alloplex Biotherapeutics Inc. registered.
Science and IP Milestones
  • Initial experiments conducted.
  • Nov – US patent application (15/821,105) filed.
  • Nov – Patent applications filed in Australia, Japan and Korea.
Corporate and Finance Milestones
  • Jan – Dr. Lederer appointed Chief Scientific Officer.
Corporate and Finance Milestones
  • Scientific Advisory Board established.
  • Aug – Dr. Gargosky appointed Chief Development Officer.
Science and IP Milestones
  • Oct – US Application 16/660,442 filed.
  • Nov – First poster presented at SITC.
Corporate and Finance Milestones
  • May – Alloplex Australia Pty Ltd registered.
  • Nov – Dr. Cheever appointed to Scientific Advisory Board.
Science and IP Milestones
  • May – US patent application filed: ‘directed to mesenchymal stem cell lines and uses thereof’.
  • Mid – First Xenograft study completed.
  • Aug – US Patent 10,731,128 issued.
Corporate and Finance Milestones
  • May – Dr. Robinson appointed to Scientific Advisory Board.
Science and IP Milestones
  • Mar – Second Xenograft study completed.
  • Aug – Third Xenograft study plus cytokines completion (est.).
  • Aug – Fourth Xenograft study completion (est.).
  • Robust data of successful SUPLEXA cell production.
  • Robust data from heavily compromised leukaemia blood sample.
Corporate and Finance Milestones
  • Apr – Series A funding round (US$15m) for 1st in-human clinical trial (of SUPLEXA therapeutic cells) commences.
  • Nov – Corporate Board formed. Dr. Sung-Wu Kim and Jared T. Chung appointed as Board Members.
  • Dec – Dr. Goy appointed to Scientific Advisory Board.
Science and IP Milestones
  • 1Q – SUPLEXA cells are Phase 1 development ready.
  • Jan – First in-human clinical trial approved by HREC.
  • Apr – First in-human clinical trial.
Corporate and Finance Milestones
  • Mar – Dr. Brown appointed to Scientific Advisory Board.
  • Nov – Presentation of encouraging safety and tolerability data at SITC2022.
  • Dec – Third trial site ‘SOCRU’ opens
Science and IP Milestones
  • Feb – Series A funding round concludes
  • May – Clinical trial closed to enrolment
Corporate and Finance Milestones
  • Feb – Dr. Andrew Lichtman appointed to Scientific Advisory Board

Science and IP Milestones

Corporate and Finance Milestones

The team

Alloplex was founded by Dr. Borriello, a Harvard-trained immunologist with more than 20 years in the pharmaceutical industry. He has served in diverse roles ranging from clinical development to external innovation assessment and business development.

He heads a small and nimble leadership team at Alloplex whose members bring broad and complementary skill sets that span immunology and analytical science, pharmaceutical development, clinical and regulatory expertise, and business development.

Dr. Borriello is joined by:

  • James Lederer, PhD, serving as CSO. Dr. Lederer who also holds an Associate Professorship of Surgery at the Brigham and Women’s Hospital and Harvard Medical School. He is an expert in the injury induced modulation of the immune system; and
  • Sharron Gargosky, PhD, as Chief Development Officer. Dr. Gargosky has managed international programs from early research phase through the U.S. Food & Drug Administration approval process. She has over 25 years’ experience in global clinical development and operations, medical affairs, regulatory and manufacturing in the field of pharmaceutical and biologic development.

Drs. Borriello and Lederer, the company’s Chief Scientific Officer, have presented at key cancer conferences and meetings on the unique science and mechanism of action of the proprietary ENLIST training cells and the resulting SUPLEXA therapeutic cells.

The concept

Alloplex has developed SUPLEXA therapy; a non-engineered autologous PBMC-derived cellular therapy based on a novel concept that relies on the foundational observation that many known immune pathways possess some degree of anti-tumor activity.

Alloplex Logo

In the process, Alloplex has identified several instances of unexpected synergistic activity in which simultaneous activation of distinct pathways led to a stronger than expected expansion of cells with anti-tumor activity.

These ENLIST training cells serve as a platform that can be varied to engage and activate various PBMC subsets with the near-term objective of enhancing the anti-tumor activity. The resulting activated cells are called SUPLEXA therapeutic cells and are comprised of NK, NKT, γδ-T cells and αβ-T cells of both CD8 and CD4 phenotypes, effectively representing a cross section of both the innate and adaptive immune systems. These cell types have been shown by others to individually possess anti-tumor activity. In contrast, SUPLEXA therapeutic cells lack immunosuppressive cell types such as Tregs and myeloid-derived stromal cells (MDSC) that might suppress the anti-tumor response.

  • The ENLIST cell platform by which SUPLEXA therapeutic cells are generated offers multiple opportunities to broaden the pipeline and generate strategic partnerships.

SUPLEXA cells are broadly cytolytic against a variety of tumor cells but do not target normal naïve or activated immune cells, confirming that the targeting phenomenon is tumor-specific. The emerging hypothesis is that SUPLEXA cells mount a coordinated attack on the tumor through independent orthogonal directions; a cellular therapeutic approach distinct from many others that rely on a single cell type or mechanism for the anti-tumor activity. SUPLEXA cells emerge following a simple co-incubation of ENLIST cells with patient-derived PBMC in the absence of any genetic engineering steps. We believe that, since SUPLEXA cells are activated through naturally-occurring receptors, they are likely to retain normal trafficking patterns and homeostatic mechanisms, suggesting a more efficacious and safe cellular therapy.

IP status

Alloplex’s proprietary ENgineered Leukocyte Immune STimulator cell line concept (ENLISTCELLS™) is protected by a combination of patent and trade secret.

Patent Summary:

1 - Directed to Allogeneic Tumor Vaccines (Group A).

2 - Directed to Allogeneic Tumor Vaccines (Group B).

3 - Directed to Compositions and Methods for In Vitro Activation and Expansion of Serial Killer T Cell Populations and Passive Immunization of a Cancer Patient with Tumor Cell Killing Cells.

Key features of SUPLEXA therapeutic cells

SUPLEXA therapeutic cells are not engineered; they are reprogrammed to recognize and kill tumor cells.

  • Simple and reproducible manufacturing.
  • Successful technical transfer and GMP manufacturing.
  • No genetic engineering.
  • All GMP compatible non-xeno sourced reagents.

Preclinical data:

In all preclinical experiments conducted to date, SUPLEXA cells demonstrated that they are broadly cytolytic against a variety of tumor cells but do not target normal naïve or activated immune cells, suggesting that the antitumor activity is both tumor-specific and HLA-independent.

The hypothesis that emerged during the pre-clinical phase was that SUPLEXA cells mount a coordinated attack on the tumor through independent orthogonal mechanisms consistent with the nature of the various immune cell types involved; hence a cellular therapeutic approach distinct from many others that rely on a single immune cell type or cancer antigen (e.g. CAR-T cell).

The absence of any genetic alterations in SUPLEXA therapy also brought profound functional benefits; such as retention of natural homeostatic mechanisms as well as commercial benefits that derive from a low cost of goods.

Preclinical data included successful SUPLEXA cell production even from heavily-compromised leukemic blood samples.  Please review our ASCO oral presentation and poster.

Preclinical studies suggested that SUPLEXA therapeutic cells could represent a safe and effective therapy across tumor types. Feedback from a number of opinion-leaders at that time was, without exception, supportive of this view.

Clinical data:

Safety assessment

We have observed an excellent safety profile with no drug-related serious adverse events during the in-human clinical trials of SUPLEXA to date (July 2023). Any SAEs were classified as not related to SUPLEXA. The testing protocol, which was perfected over time, and incorporated increased dosing rates, has also unfolded without drug-related SAEs.

Efficacy assessment

Signs of clinical activity in various tumor types are encouraging. These are consistent with broad pre-clinical in vitro activity. Exploratory CyTOF characterization, which has been conducted on all patients, demonstrates improved markers of immune health over initial time points.

Pharmacodynamic monitoring

Longitudinal blood samples from SUPLEXA-treated patients were immuno-profiled in order to identify SUPLEXA-induced changes over time. Analysis of the PBMC composition revealed rapid modulation of the myeloid components characterized by dramatic decreases in the number of myeloid derived suppressor cells combined with complementary increases in the number of activated monocytes. Based on what is known about these cell types, it appears these changes would strongly favor an enhanced anti-tumor immune response.

Manufacturing process

To render this idea commercially viable, we developed a reliable and robust manufacturing process which employs 50mls of patient whole blood, is manufactured under GMP conditions, resulting in multiple SUPLEXA therapeutic doses.

  • Simple

    Manufacturing of SUPLEXA therapeutic cells using ENLIST training cells is a simple, defined process that requires neither additional genetic engineering steps, nor feeder cells. In approximately one month, the manufacturing process reliably provides for a full course of treatment from a simple blood draw.
  • Robust

    All reagents are GMP grade, resulting in a consistent product with routinely high cell yields.
  • Reproducible

    With the requirement for only standard laboratory equipment, manufacturing of SUPLEXA therapeutic cells is more readily reproducible compared with genetically engineered forms of cellular therapy.

Phase 1 clinical trial

A first-in-human (phase 1) clinical trial to assess the safety and tolerability of this novel therapeutic and to provide early evidence of clinical anti-tumor activity is underway.

Alloplex appointed experienced clinical trial partners for this first-in-human clinical trial in Australia. The initial trial site was confirmed and the trial commenced in 2Q, 2022. The third, and final, trial site was confirmed in December 2022.

Trial participant requirements:

  • Cancer patients with measurable disease, irrespective of tumor type, provided that the patient is not concomitantly receiving or under the influence of an immunosuppressive therapy.
  • The design of the open label trial is expected to yield an accruing body of data on both safety and efficacy over a 12–18-month period.

Vision beyond first-generation product

While Alloplex has opted for a variety of theoretical and strategic reasons to make its first-generation product autologous, there is a clear path to making a version of these therapeutic cells suitable for allogeneic administration as an off-the-shelf therapy and even integrating an engineering step, should one prove to be particularly advantageous.

Furthermore, there is significant potential to use SUPLEXA therapeutic cells:

  • as single agent against multiple tumor cells types or
  • in combination with any immune cell sparing therapies.

Market considerations

National expenditures for cancer care worldwide continue to increase. Spending on cancer care in the US surpassed $200 billion1 in 2020.

Cancers are a leading cause of death worldwide, accounting for nearly 10 million deaths, or 1 in 6 deaths, in 20202. Furthermore, the number of new cancer cases per year is expected to rise to 29.5 million and the number of cancer-related deaths to 16.4 million by 20403.

Much of the cellular therapy landscape is focused on CAR-T, NK and CAR-NK, autologous dendritic cells and allogeneic dendritic cell lines, γδ-T cells, macrophages, B cells and TILs (tumor infiltrating lymphocytes).

While some alternative Phase 2-ready cellular approaches have significant patient burdens of surgical procedures, apheresis blood collections, and chemotherapy ablation, SUPLEXA requires less than 50mL of whole blood to manufacture a sufficient number of SUPLEXA therapeutic cells for an entire course of therapy.

1  Mariotto AB, Enewold L, Zhao J, Zeruto CA, Yabroff KR. Medical care costs associated with cancer survivorship in the United States.Cancer Epidemiol Biomarkers Prev. 2020;29(7):1304-1312. doi:10.1158/1055-9965.EPI-19-1534 PubMedGoogle ScholarCrossref Dieleman JL, Cao J, Chapin A, et al. US health care spending by payer and health condition, 1996-2016. JAMA. 2020;323(9):863-884. doi:10.1001/jama.2020.0734
WHO Cancer Factsheet.
The WHO’s International Agency For Research On Cancer.

  • SUPLEXA therapeutic cells is a unique non-engineered cellular therapy that demonstrates high potential to address a significant unmet medical need in a simple, reproducible and robust manner.