SUDA Pharmaceuticals licenses novel iNKT cell therapy platform from Imperial College London

SUDA Pharmaceuticals Ltd (ASX:SUD) (FRA:E4N) has signed a global, exclusive licence agreement with Imperial College London for a novel invariant Natural Killer T (iNKT) cell therapy platform. The iNKT cell therapy platform is in the preclinical stages and can be used in conjunction with chimeric antigen receptors (CARs) to treat various blood cancers, with the CAR-iNKT cells expected to be suitable for off-the-shelf dosing - as one healthy donor can supply cells to treat many patients. In addition to the licence, the company anticipates raising a minimum of $3 million via an institutional placement to be conducted through Baker Young to support the initial development of the iNKT cell therapy - including hiring key personnel and initiating the manufacturing of critical components to produce the product. “Only ASX-listed CAR-iNKT company” SUDA CEO and managing director Dr Michael Baker said: “Cell therapies have transformed the way we think about cancer treatment. “The iNKT cell therapy platform provides an opportunity to target several cancers using a product that we expect to have superior activity and to be more cost-effective, which should allow the therapy to reach more individuals. “SUDA will be the only ASX-listed CAR-iNKT cell therapy company that is working on this cellular platform and we look forward to progressing the technology into clinical trials.” “Innovative therapies for cancer patients” Imperial College London director of industry partnerships and commercialisation, medicine, Stephanie Morris said: “Imperial College London is delighted to license this technology to SUDA Pharmaceuticals. “We are impressed with the ability of their executive team to push and bring therapies to market expeditiously. “At Imperial, our mission is to deliver world-class, transformative scientific research for societal impact. “We believe SUDA has the vision to offer innovative therapies to cancer patients.” Off-the-shelf advantage The technology developed at Imperial by Professor Anastasios Karadimitris focuses on a specific immune cell type, iNKT cells, and his research group was the first to demonstrate that they are protective against graft versus host disease (GVHD). This provides a critical advantage that the iNKT cell platform may be used off-the-shelf, meaning that the cells can be isolated from a healthy donor, modified to enhance their activity against cancer and stored frozen, ready to be administered to cancer patients as needed. The natural properties of iNKT cells are expected to reduce the complexity of delivering the cell therapy to cancer patients and help to reduce the costs of such an important treatment modality. This has the potential to solve one of the industry’s significant challenges: manufacturing the therapeutic from each individual’s own cells CAR-iNKT cells iNKT cells can be further modified to arm them with a CAR, and CAR-iNKT cells have two ways to recognise, attach to, and destroy cancer cells making them dual targeting. In preclinical studies, CAR-iNKT cells have shown superior activity relative to conventional cell therapies in eradicating cancer cells and extending tumour-free survival. CAR19-iNKT cells are being developed for the treatment of CD19 expressing cancers, including non-Hodgkin’s lymphoma. The technology platform has long patent life, expected to expire in 2038 and has entered national phase in Europe, China, Canada, Australia and the US. Licence agreement terms The terms of the licensing agreement are non-dilutive for SUDA shareholders with no immediate material financial impact on the company as a result of signing the agreement. The licensing payments include an upfront fee, annual maintenance fees and for the first oncology product developed, there are industry standard, non-dilutionary development milestones for initiating Phase 1, Phase 2 and Phase 3 clinical trials and for receipt of regulatory approval of the product in major territories. The licence also includes commercial milestones based on achieving sales targets and a single digit royalty on future sales and sublicensing fees. The licence agreement will expire upon the last to expire patent (or any other relevant patent extension term) or 10 years from commercial launch, whichever is longer, with no associated termination fees.   In addition to the licence agreement, SUDA soon also expects to enter into a collaborative research agreement with Imperial College London, facilitating further research to expand the platform and develop additional intellectual property.