On December 13, 2021 Arovella Therapeutics, (ASX: ALA), a biotechnology company focused on developing its invariant Natural Killer T (iNKT) cell therapy platform, reported that it has signed a global, exclusive licence agreement with The University of Texas MD Anderson Cancer Center for the patent rights to a novel mAb developed for cancer treatment (Press release, Arovella Therapeutics, DEC 13, 2021, View Source [SID1234629025]).
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This is the first monoclonal antibody directed against a DKK1 peptide found in complex with HLA-A2 on the surface of cancer cells (DKK1). DKK1 is a target that is found in many cancer types, including blood cancers and solid tumours and 40-50% of the population is HLA-A2 positive, meaning that this technology may be applicable across a wide spectrum of cancers that affect a significant proportion of the population.
Higher levels of DKK1 in cancer patients may serve as a prognostic biomarker for cancers such as Multiple Myeloma, Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Adenocarcinoma (PAAD), and Lung Squamous Cell Carcinoma (LUSC). Higher DKK1 production has been observed in bladder cancer and increased production of DKK1 may assist Non-small Cell Lung Carcinoma (NSCLC) cell invasion and migration. It has also been suggested that increased DKK1 levels may cause resistance to chemotherapy in cancers such as ovarian cancer.
Arovella’s CEO and MD, Dr Michael Baker, commented: "The data that we have seen for the DKK1- CAR is compelling. We see a lot of promise in combining DKK1-CAR with our iNKT cell therapy platform and expect synergistic effects for the treatment of certain cancers. The next steps are to confirm the specificity, safety and proof-of-concept data in animal models before advancing this into manufacturing."
Numerous studies have shown that multiple myeloma cells overproduce DKK1. It is also documented that multiple myeloma cells produce CD1d, which is recognised by invariant Natural Killer T (iNKT) cells, the core of Arovella’s iNKT cell therapy platform. Arovella expects that by combing the DKK1- CAR with its iNKT cell therapy platform, it will lead to a more effective product to treat multiple myeloma and potentially other cancers. To date, the DKK1 mAb has shown promise in treating multiple myeloma when used as a single agent in mouse models. The DKK1-CAR-T successfully eliminates cancer in numerous cancer models, including multiple myeloma, pancreatic cancer, lung cancer and triple negative breast cancer.
More than a decade of work has gone into the production and testing of the DKK1 mAb. Professor Qing Yi, now at Houston Methodist, developed the technology during his time at MD Anderson as a tenured Professor of Medicine. At Houston Methodist, Professor Yi has continued the research, assessing the potential of the DKK1-CAR. Professor Yi was recruited to Houston Methodist in 2018 through a US$6m Cancer Prevention and Research Institute of Texas (CPRIT) award.
Professor Yi commented: "We have been working on the role of DKK1 for more than a decade. To target a range of cancers, we knew we needed to target something unique on the surface of different cancer types. That is why we generated the DKK1-peptide targeting mAb and CAR, because the DKK1 peptide in complex with HLA-A2 is found on many cancers and as expected, we see robust data treating several cancer types."
Key terms of the Licence Agreement
Under the terms of the licence agreement, Arovella has secured the right to use the technology for the treatment of human disease, for which it has agreed to pay MD Anderson license fees, development milestones and single digit royalty payments based on net sales. Upfront fees associated with the license agreement will be funded entirely from existing cash reserves. The licence agreement commences with an effective date of 13 December 2021 and extends to the later of the expiration of applicable patent rights or agreed upon number of years.
Arovella’s role in the oncology market
The Licence Agreement involving the DKK1 mAb adds substantially to Arovella’s existing exposure to the immuno-oncology market. The Company acquired the licence for a novel iNKT cell therapy platform in June 2021 and is developing a CD19 targeting CAR to treat haematological malignancies.
Since acquiring the licence to the iNKT cell therapy platform, Arovella has added new members to its Board of Directors, its Scientific Advisory Board and its management team. Arovella believes that acquiring the licence to another CAR adds substantial value to its iNKT cell therapy platform.