WE PREVENT CANCER DEATHS
WITH OUR MULTI-TARGET CELL AND GENE THERAPY PLATFORM
Cancers impact more than 20 million people each year and cause more than 10 million deaths.
Ovarian Cancer and Peritoneal Carcinomatosis represent a massive unmet medical need and poor prognosis:
BURDEN OF OVARIAN CANCER WORLDWIDE
*Data source: WHO, 2020 data
According to ASCO, an estimated 313,959 people were diagnosed worldwide with ovarian cancer in 2020. The vast majority of these cases were high-grade serious ovarian cancers (HGSC) with reduced survival prognosis. This resulted in an estimated 207,252 people worldwide dying from ovarian cancer. Combined, cancer of the ovaries and peritoneum are the fifth most common cause of cancer-related death in women in the United States.
Peritoneal carcinomatosis is a malignant tumor of the peritoneum, a thin layer of tissue that lines the abdomen. Peritoneal carcinomatosis can originate from nearly any other tumor, most frequently from gastric, intestinal and ovarian cancers. Today, peritoneal carcinomatosis is very difficult to treat and affects hundreds of thousands of patients worldwide.
INTRODUCING AUP-55
our pre-clinical asset for the treatment of OVARIAN CANCER AND PERITONEAL CARCINOMATOSIS
AUREALIS THERAPEUTICS 4-IN-1 PRODUCT AUP-55
We believe that treating deadly cancers requires to tackle multiple biologic targets: (1) activating innate and (2) adaptive immune system, (3) blocking angiogenesis, and ultimately (4) killing cancer cells.
This is exactly what AUP-55, our Oncolytic-Bacteria based Advanced Therapy Medicinal Product (ATMP), actually does.
1. INTERFERON ALPHA
(h-IFN-α)
Anti-proliferative and anti-angiogenic used in multiple cancers, modulating tumor cell growth, differentiation, survival, migration via autocrine and paracrine routes.
2. INTERLEUKIN 15
(h-IL-15)
Pleiotropic common gamma chain cytokine promoting the differentiation and expansion of T cells, B cells and NK cells.
3. BACTERIAL MEMBRANE COMPONENTS (TLR2 AND NOD2)
Surface TLR2 agonist lipoteichoic acid and NOD2 agonist peptidoglycan muropeptide enhancing immune response against cancer cells.
4. BACTERIAL DNA COMPONENT (TLR9)
Intra-cellular TLR9 agonist CpG motif of bacterial DNA driving innate and adaptive immune responses and killing of cancer cells.
Curing deadly cancers requires multi-targeting
In oncology, the therapeutic needs are almost the opposite to wound healing: decrease angiogenesis, reduce proliferation and promote anti-tumor activity through innate and acquired immunity. This requires a different combination of therapeutic proteins.
AUP-55 is built on a non-pathogenic lactic acid bacteria Lactococcus cremoris that is genetically modified to synthetize:
- Human Interferon Alpha (h-IFN- α)
- Human Interleukin 15 (h-IL-15)
- Endogenous Bacterial Factors TLR2, NOD2 and TLR9
Thanks to the unique combination of therapeutic proteins, delivered through intra-tumoral injections, AUP-55 is able to activate the innate immune system, activate the adaptive immune system, block angiogenesis, and have a direct tumor killing effect. All in one product.
SCIENTIFIC PUBLICATIONS ABOUT AUP-55
Aurealis Therapeutics’ abstract titled Effect of multi-targeting bacterial gene therapy on tumour regression and survival in mouse models of ovarian and intraperitoneal cancer was accepted for publication at the Journal of Clinical Oncology, an American Society of Clinical Oncology (ASCO) Journal. Access the abstract.
OUR OUTCOME WITH AUP-55 AND CANCER
PRE-CLINICAL
AUP-55 ENABLES SURVIVAL IN MOUSE OVARIAN CANCER
Aurealis AUP platform shows efficacy in oncology, where we have excellent pre-clinical data. This is an example in advanced ovarian cancer.
Tumor implantation took place at day 0. Treatment started at day 14. After 30 days, all control animals have died from the tumor. But after 80 days, more than 90% of the animals treated with AUP-55 are still alive.
ONCOLOGY | AUP-55
ONCOLOGY | AUP-55
AUP-55 oncology development pipeline
Oncology · AUP-55
Ovarian & peritoneal cancer Pre-clinical
AUP-55 · Ovarian & peritoneal cancer
INN: not yet confirmed
The disease
Ovarian cancer is diagnosed in approximately 314,000 women annually worldwide, with around 207,000 deaths each year. Five-year survival is below 20% for advanced-stage disease, and recurrence following standard chemotherapy remains the central clinical challenge.
How AUP-55 works in ovarian and peritoneal cancer
AUP-55 is an oncolytic-bacteria-based ATMP built on the same engineered Lactococcus cremoris platform as AUP-16, configured in fight-mode. Administered by intratumoral injection, it simultaneously activates innate and adaptive immune responses to attack and kill tumour cells across multiple mechanisms.
Pre-clinical evidence
In ovarian cancer mouse models, AUP-55 produced 90% survival versus 0% in untreated controls, with significantly reduced tumour load. Pre-clinical data were presented at the ASCO Annual Meeting, June 2023.
Bladder cancer Pre-clinical
AUP-55 · Bladder cancer
INN: not yet confirmed
The disease
Bladder cancer is among the ten most common cancers globally. Non-muscle-invasive bladder cancer carries high recurrence rates, and patients with BCG-unresponsive disease face limited effective treatment options.
How AUP-55 works in bladder cancer
AUP-55 is an oncolytic-bacteria-based ATMP on the engineered Lactococcus cremoris platform in fight-mode. Its combination of direct tumour killing and local immune activation makes it relevant to bladder cancer, where local delivery can engage the immune system without the toxicity profile of systemic therapy.
Development status
AUP-55 in bladder cancer is at pre-clinical stage.
Recurrent melanoma Pre-clinical
AUP-55 · Recurrent melanoma
INN: not yet confirmed
The disease
Recurrent melanoma remains difficult to treat despite advances in checkpoint inhibition. Patients who relapse after immunotherapy have limited subsequent options, and resistance to systemic therapy is a defining clinical challenge.
How AUP-55 works in recurrent melanoma
AUP-55 delivers multiple immune-activating components simultaneously by intratumoral injection, aiming to re-engage the immune response in tumours that have become resistant to systemic therapy. Local delivery avoids the systemic toxicity associated with conventional immunotherapy.
Development status
AUP-55 in recurrent melanoma is at pre-clinical stage.
| Modality | Product | Discovery | In vivo POC | GLP, S&T, CMC | IND/CTA | Phase 1 | Phase 2 | Phase 3 | NDA/MAA |
|---|
Frequently Asked Questions
01. What is AUP-55, and how does it treat ovarian cancer and peritoneal carcinomatosis?
AUP-55 is Aurealis Therapeutics’ lead preclinical oncology candidate — a genetically engineered strain of the non-pathogenic lactic acid bacterium Lactococcus cremoris, developed as an oncolytic-bacteria-based Advanced Therapy Medicinal Product (ATMP). Administered by intratumoral injection, AUP-55 is engineered to express and secrete multiple human therapeutic proteins directly within the tumor microenvironment. Rather than acting on a single target, it is designed to engage four antitumor mechanisms at once — activating innate immunity, activating adaptive immunity, inhibiting angiogenesis, and directly killing tumor cells — from a single product. This multi-targeting approach is intended to address the multifactorial biology of advanced ovarian cancer and peritoneal carcinomatosis, and extends Aurealis’ cell and gene therapy platform from chronic wounds into oncology.
02. What preclinical data supports AUP-55 in cancer?
In preclinical mouse models of ovarian and intraperitoneal cancer, AUP-55 produced tumor regression, prolonged survival, and was well tolerated, as reported in an abstract presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology. These results demonstrate that Aurealis’ multi-target platform can be reconfigured from wound healing to oncology while retaining its multi-targeting design. They support the continued preclinical development of AUP-55 toward first-in-human studies.
03. How is AUP-55 different from oncolytic virus immunotherapies?
Unlike oncolytic viruses, AUP-55 uses a genetically engineered, non-pathogenic lactic acid bacterium (Lactococcus cremoris) as its therapeutic vector — an organism with a strong safety profile and no endotoxins. This bacterial platform is produced by standard fermentation, giving it far greater scalability and a lower cost of goods (COGS) than conventional viral or cell-based cancer immunotherapies. It also delivers several therapeutic proteins and immune-activating signals from one product, whereas most oncolytic agents act through a narrower mechanism. Together, these features position AUP-55 as a scalable, multi-target immunotherapy for hard-to-treat solid tumors.
Ref.
Tavares LM, de Jesus LCL, da Silva TF, et al. Novel strategies for efficient production and delivery of live biotherapeutics and biotechnological uses of Lactococcus lactis: the lactic acid bacterium model. Front Bioeng Biotechnol. 2020;8:517166. doi:10.3389/fbioe.2020.517166