Software for profiling tumor neo-antigens to empower cancer immunotherapy.

As disclosed previously, during the first half of 2019 OncoImmunity signed a commercial agreement with the personalized vaccine company Flow Pharma and CE-marked its ImmuneoprofilerTM software as an in vitro diagnostic medical device. This growing traction and recognition in the field culminated with OncoImmunity being acquired by the Japanese technology giant NEC Corporation in July 2019. http://www.oncoimmunity.com/news/38-nec-and-oncoimmunity-as-combine-forces-to-use-ai-to.htm. Post the transaction, OncoImmunity will be renamed as NEC OncoImmunity AS and operated from its Oslo headquarters as a fully independent subsidiary with the same management team and employees. NEC OncoImmunity's technology will be used to support NEC's individualized immunotherapy programmes as well as being offered to other biotech and pharma companies on a software-as-a-service basis. Whilst the application of neoantigen-based immunotherapies in the clinic is still in its infancy, it is anticipated that these therapies will produce more efficacious and safer treatments offering real hope to patients with late stage and currently intractable cancers.

CURRENT OUTCOMES & IMPACTS The project has enabled OncoImmunity to build a state-of-the-art software solution called the Immuneoprofiler, which can identify immunogenic neoantigens from NGS data with unparalleled accuracy in a cost effective and clinically actionable time frame. The developments realized during the project have helped OncoImmunity realize the following: Built an international and multidisciplinary development team and established a network of national and international collaborations Built the Immuneoprofiler under a quality management system and got the software CE-marked as an in vitro diagnostic medical device FUTURE OUTCOMES & EFFECTS It is anticipated that the immunotherapy field, empowered by the Immuneoprofiler software, will have a profound and positive impact on the treatment of last stage cancer. Speeding up the development of safer and more efficacious personalized treatments and improving health economics both nationally and internationally.

While scientists have struggled for over a century to harness the power of the immune system to combat cancer, it is only recently that the field has finally come of age. However, despite the fact that immunotherapy is undoubtedly saving lives these therapies only work in a relatively small percentage of patients. Unfortunately the inability to identify responsive patient's up-front poses major challenges for pharmaceutical companies and currently >93% of all cancer immunotherapy drugs fail to make it through the clinical pipeline. Recent studies suggest that neoantigen profiling may offer a solution to this problem as a tumor's neoantigen load has been shown to correlate with a patient's response to immunotherapy. Unfortunately current methods for identifying neoantigens are costly & time consuming. The goal of this project is to develop bioinformatics software that can profile a patient's tumor and identify neoantigens from NGS data in a cost effective and clinically actionable time frame, using specially trained machine-learning algorithms. This disruptive technology could help revolutionize the field: enabling better patient stratification, personalized immune-monitoring, and the identification of optimal neoantigen targets for personalized immunotherapies. The key R&D challenge will be to develop a solution that reliably identifies immunogenic neoantigens and interprets this information within the context of immune escape and the potential for epitope spreading. The software will be developed and tested using clinical data from a trial testing pembrolizumab in sarcoma patients in collaboration with the OUS & Merck The software will be offered on a "software as a service" basis and be accessible in the cloud. We have identified over 600 organizations running over 1000 relevant clinical trials that could benefit from the service. OncoImmunity's estimates suggest the service could generate annual revenue of ~US$25m if the company can capture 3% of the user base