NEW PRECLINICAL TRIAL OF AROVELLA’S INKT CELL THERAPY & OnCARlytics PLATFORM

On 26 September 2022 Arovella Therapeutics Ltd, a biotechnology company focused on developing its invariant Natural Killer T (iNKT) cell platform for cancer treatment, reported it collaborate with clinical stage immune-oncology company Imugene Limited (ASX: IMU), using its onCARlytics platform (Press release, Imugene, SEP 26, 2022, View Source [SID1234629026]). This will test Arovella’s CAR19-iNKT (ALA-101) cell therapy with Imugene’s onCARlytics platform to seek and destroy solid tumours. The read out from the preclinical studies performed through the collaboration is expected in H1 2023.

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Arovella’s lead iNKT product, ALA-101, contains a Chimeric Antigen Receptor (CAR) that targets tumour cells producing CD19 on their surface. Typically, CD19 expression is on the cell surface of blood cancers. Imugene’s onCARlytics platform enables solid tumour cancers to express CD19 on their surface, which creates the opportunity to use ALA-101 to seek and destroy the solid tumour cells. Currently, ALA-101 is being developed for CD19-producing blood cancers. Working with Imugene raises the possibility of using ALA-101 to treat solid tumour cancers.

Imugene is evaluating a range of CD19 targeting therapies in combination with onCARlytics of which Arovella’s ALA-101 will be included, allowing Arovella to benchmark its iNKT therapy for the treatment of solid tumours. Initial pre-clinical data from Arovella demonstrates that ALA-101 cells outperform conventional T cells in haematological malignancies that produce CD19 and CD1d. Achieving compelling data in this study would open up a new therapeutic area of potential indications in solid tumours for Arovella’s iNKT cell therapy products.

Solid tumours represent 90% of diagnosed cancer cases1, and as of 2021, the solid tumour market was valued at US$209.61 billion2.

Imugene’s CEO and MD, Leslie Chong, commented, "Our onCARlytics platform opens up the possibility to treat solid tumours with existing CD19 targeting drugs. Solid tumours account for more than 90% of cancers diagnosed, and our technology has the potential to change the outcomes for these patients. We are excited to see how Arovella’s iNKT cell platform and other drugs in our trial perform on the back of our platform. We are delighted to work with another Australian-based biotechnology company focussing on cancer treatment."

Arovella’s CEO and MD, Dr Michael Baker, commented, "We are excited to collaborate with Imugene to evaluate potential of our iNKT product in combination with their onCARlytics product for treatment of solid tumours. Imugene’s onCARlytics is one of the most promising products to be developed for solid tumours. We believe strongly in the unique capability of our iNKT program and look forward to seeing how ALA-101 performs in these models. Arovella is excited by the prospect of expanding its use of its iNKT cell therapy platform to treat solid tumours."

The research partnership is material to Arovella as it includes development of Arovella’s iNKT cell therapy platform licensed from Imperial College London (see ASX announcement dated 18 June 2021) with Arovella’s onCARlytics CD19 oncolytic virus licensed from the City of Hope. The combination has the potential to be a novel approach to treating certain solid tumour cancers.

The research collaboration agreement is effective as of 26 September 2022 and has an initial term of twelve months. The strategic collaboration may be terminated upon completion of the research, or by mutual agreement. Arovella will fund the preclinical studies from its planned research budget, and no further funding is required for the initial research completed through the partnership. Currently each party has full intellectual property (IP) rights (patents) to their individual background technology. In the event new IP is generated from the research collaboration (each a "Combination Invention"), the parties shall discuss in good faith the filing, prosecution, maintenance, enforcement, defense of any patent applications thereto, as well as each party’s right to use, such Combination Invention. After the results from this research agreement are known and can be quantified, the parties will negotiate in good faith (and without obligation) whether to jointly develop or commercialise on the outcomes of the strategic collaboration on commercially reasonable terms.