Short Courses*

SC1: New Directions in Cancer Immunotherapy

Andrea van Elsas, Ph.D., CSO, Aduro

Bruno Gomes, Ph.D., Director, Tumour Immunology, Iteos Therapeutics

Distinct from other paradigms in medical oncology, cancer immunotherapy aims to treat the patient’s immune system. During the past few years a number of different approaches have demonstrated unprecedented clinical responses and long-term benefit in patients diagnosed with several types of malignancy. In addition to T-cell modulation and anti-PD-1 and anti-CTLA-4, additional pathways and therapeutic agents are rapidly being translated to clinical practice alone or in combination approaches. Attend this short course to obtain an overview of:

• Clinically validated approaches
• New emerging targets
• The next generation of products that will improve the outcome for patients
• Advances with small molecules for the treatment of cancer
• Current understanding why some patients are responding to checkpoint inhibitors and others are not. How can we predict efficacy of drugs such as PD-1 in patients?
• Personalised cancer vaccines
• How study of unsuccessful therapeutic vaccines can lead to rationally designed effective therapy
• Rational combinations and why these are necessary
• Outlook for immunotherapy as a treatment for cancer

Speaker Bios

Andrea van Elsas, Ph.D., Chief Scientific Officer, Aduro Biotech Europe

Andrea van Elsas became Chief Scientific Officer of Aduro Biotech Europe in November 2015. He completed his thesis on melanoma antigens and their use in cancer immunotherapy in 1996 (Leiden University Medical Center). A KWF (Dutch Cancer Society) fellowship allowed him to study manipulation of T cell co-stimulation using antibodies blocking CTLA-4 for the treatment of cancer at the University of California in Berkeley, CA. He is a co-inventor on the original patents that formed the basis for the development of ipilimumab. After his academic career, Andrea joined Organon where he was involved in the foundation of the Organon Research Center in Cambridge, MA. Between 2007 – 2009, he served in Cambridge as Head of Oncology Biologics Discovery for Organon and POC team leader for Schering-Plough’s Immune Oncology portfolio. He managed various discovery alliances with biotech and academia in the field of Oncology and he is a co-founder of BioNovion.

Bruno Gomes, Ph.D, Director, Tumour Immunology, Iteos Therapeutics

Bruno Gomes joined iTeos Therapeutics in 2015 and became Director of Tumor Immunology one year later. He was the project leader of the IDO1 inhibitor PF-06840003/EOS200271 who entered phase 1 clinical trial in September 2016. After an education of Doctor in Veterinary Medicine, he completed his PhD in immunology on the identification and characterization of a new signaling pathway in lymphocytes involved in allergic and inflammatory diseases. Then Bruno build a strong expertise in pharmacology, oncology and immuno-oncology as an Oncology Study Director in Sanofi and Research Scientist in Pierre Fabre Pharmaceuticals. Between 2010-2015, he served as Head of in Vivo Oncology in Pierre Fabre Pharmaceuticals. He led various preclinical and translational programs with targeted drugs, kinase inhibitors and onco-immunology drugs.

SC2: CAR T and TCR Manufacturing Challenges to Anticipate and Overcome: Focus on How, Where, and Cost Factors

Ryan McCoy, Eng.D., MEng, Senior Process Development Scientist, Industrialisation Group, Cell and Gene Therapy, Catapult

Dieter Hauwaerts, M.Sc., VP, Operations, Celyad

Cell based immunotherapies are showing immense promise in addressing unmet clinical needs. Chimeric Antigen Receptor (CAR) T cells specifically have found themselves at the forefront of the emerging field with some impressive positive clinical data being published in recent years. The increasing maturity of the field is in turn attracting substantial investment. However, commercial success is certainly not synonymous with positive clinical data and the achievement of marketing authorisation. For cell therapies where the manufacturing cost of goods (CoGs) can be relatively high, it is important to consider this cost early in the development pipeline. The approach, traditionally used by the vast majority of cell therapy developers, has been to allow current process and technology solutions to determine the manufacturing strategy. This superficially quick and low-risk path to production is often not the correct one. Ignoring issues of scalability, automation, raw material supply, intermediate and product stability, grade of clean room, process control or general process robustness/failure rate, will ultimately require them to be addressed later, delaying the clinical programs and potentially reducing the program value.

This short course will illustrate the importance of a cost-based development mantra and significance of considering all stake holders during an end-to-end cell therapy process development program.

• Importance of establishing the production process at an early stage
• Choices regarding where to carry out the manufacture
• Practical details
• How to get the competitive advantage

Speaker Bios

Ryan McCoy, Eng.D., MEng, Senior Process Development Scientist, Industrialisation Group, Cell and Gene Therapy, Catapult

Ryan McCoy has over 10 years’ process development experience in cell therapy and regenerative medicine, working in both industry and academic settings. He completed a MEng in Biochemical Engineering and an EngD in Biochemical Engineering and Bioprocess Leadership at University College London (UCL), before completing a post-doctorate at the Royal College of Surgeons in Ireland (RCSI). He has worked with a broad range of autologous and allogeneic cell therapy types, with particular focus historically on cancer immunotherapies and bone mechanobiology. At Cell and Gene Therapy Catapult his role as a Senior Process Development Scientist sees him utilising a risk-based approach, focusing on innovation and process efficiency, for Cost of Goods reduction and industrialisation of the field.

Dieter Hauwaerts, M.Sc., VP, Operations, Celyad

Dieter joined Celyad in January 2015, and is responsible for all process development, manufacturing, quality and supply chain activities in EU and US. Celyad is a clinical-stage biopharmaceutical company focused on the identification and development of specialized cell based therapies, with product candidates in cardiology (Phase III) and oncology (Phase I).

Prior to joining Celayd, he worked as Director Manufacturing for TiGenix (Belgium) where he was part of the team obtaining first approval of an ATMP in Europe, and headed construction of a state-of-the –art commercial cell therapy facility. Before, he also held various positions in the quality and supply chain organization of Janssen Pharmaceutica (Belgium) and conducted research on microbial genetics at the University of Leuven.

Dieter holds an MSc in chemical engineering from the University of Leuven, Belgium.

*Separate Registration Required