In the second half of 2018, the CIMT Regulatory Research Group (RRG) has decided to reconstitute. The group will be led by Dr. Harpreet Singh and Dr. Thomas Hinz co-chairing the CIMT RRG. The three areas CIMT RRG will focus on are
Commenting and contributing to novel regulatory guidance in the field of cancer immunotherapy. As in the past, the RRG will also – where feasible – collaborate with the regulatory research groups of other international societies.
Educating the scientific community of latest regulatory considerations in cancer immunotherapy. At the upcoming CIMT Annual Meeting in May 2019, CIMT RRG will arrange a dedicated Regulatory Session featuring the latest scientific development and regulatory considerations in the field of actively personalized cancer immunotherapy.
Conducting regulatory research focused on one or two major themes of interest to the scientific and regulatory community with a significant large unmet need.
For 2019 and 2020, CIMT RRG will focus on one or two themes. The first chosen focus theme will be considerations to develop pathways to commercialization of actively personalized immunotherapies. This theme is based on the successful work conducted by CIMT RRG five years ago on the concepts of actively personalized vaccines and published in Nature Biotechnology in 2013. Also based on this work, several clinical trials in this field have been successfully conducted and a number of product candidates of this new class are further pursued with the goal to commercialize. Such actively personalized immunotherapies are a completely new treatment paradigm with an unchartered pathway to registration. CIMT RRG will attempt to contribute drafting possible pathways in collaboration with academia, regulators and biopharma companies.
Thursday, May 23, 2019, 10:30 to 13:00 CET
17th CIMT Annual Meeting in Mainz, Germany
Actively Personalized Immunotherapies (by CIMT Regulatory Research Group)
Co-Chairs: Thomas Hinz, Harpreet Singh
10:30 Harpreet Singh: Introduction and Brief Report from CIMT RRG
10:45 Klaus Cichutek, Paul-Ehrlich-Institute: Development and regulation of personalized immunotherapy products
11:15 Wolfgang Wick, University of Heidelberg: Clinical Development of personalized glioma-directed vaccines
11:40 Cassian Yee, MD Anderson Cancer Center: Endogenous T Cell Therapies for Precision Medicine
12:05 Dolores Schendel, Medigene: Matching future needs for world patient populations needing TCR-T therapies with different antigen specificities and HLA restrictions
12:30 Peter Bross, FDA CBER: Regulatory Perspectives
13:00 End of Session
May 8 RRG Session at 2014 CIMT Annual Meeting with John Haanen (Amsterdam, The Netherlands), Carl June (Philadelphia, USA), Matthias Renner (Langen, Germany), Cedrik Britten (Mainz, Germany) and Raj Puri (Bethesda, USA). Carl June, Matthias Renner and Raj Puri have kindly provided their meeting presentations for education purposes. Download the presentations by
"The following presentation by Dr. Raj Puri (FDA CBER OCTGT) at the Annual Meeting in 2014 can be downloaded for education purposes only. It must not be used for any commercial purposes including but not limited to endorsement of any particular product": download
May 16 RRG Session at CIMT Annual Meeting on immunomonitoring and biomarker regulation with Steffen Walter (Tübingen), Eva-Maria Jahn (Langen), Magali Gibou (Illkirch), Jan Müller-Berghaus (Langen) and Ulrich Kalinke (Hanover).
Download the presentations by
Jan Müller Berghaus
Publication on the regulation of the Actively Personalized Vaccine (APVAC) concept in Nature Biotechnology
Britten CM, Singh-Jasuja H, Flamion B, Hoos A, Huber C, Kallen K-J, Khleif SN, Kreiter S, Nielsen M, Rammensee H-G, Sahin U, Hinz T, Kalinke U (2013): The regulatory landscape for actively personalized cancer immunotherapies,
Nature Biotechnology 31 (10), 880-882. doi 10.1038/nbt.2708.
May 25 RRG session at CIMT Annual meeting on actively personalized vaccines with Cedrik Britten (CIMT RRG), Ugur Sahin (Mainz), Samir Khleif (NCI), Peter Bross (FDA CBER), Bruno Flamion (Namur/former Head of EMA SAWP). Download the presentation of Peter Bross: US regulatory considerations for the development of therapeutic cancer vaccines: an FDA reviewer’s perspective
Meeting with EMA Innovation Task Force in Jan 2012 to discuss general, preclinical, pharmaceutical and clinical aspects of Actively Personalized Vaccination (APVAC) download EMA meeting minutes
Comment on EMA Reflection Paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples (jointly with CRI-CIC)
Initiated new major research project: "Individualized Immune Intervention"
RRG session at CIMT Annual Meeting on individualized immune intervention and biomarkers with Bruno Flamion (former Head of Scientific Advice Working Party, EMA)
RRG session at CIMT Annual Meeting: "Regulation – How Translation Can be Successful" with Raj K. Puri (Director Division of Cellular & Gene Therapies, FDA CBER)
Comment on EMA Draft Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
Comment on EMA Concept Paper on the need to revise guideline on the evaluation of anticancer medicinal products in man (jointly with CRI-CIC)
At CIMT 2009, T. Hinz (Section Head Therapeutic Vaccines) from the Paul Ehrlich Institute (Langen, Germany) presented on "Regulatory Environment for Therapeutic Vaccines" as part of the RRG session. You can download the presentation here.
CIMT filed an official comment on the FDA draft "Clinical considerations for Therapeutic Cancer Vaccines". This FDA guidance document discusses considerations common to early and late-phase clinical trials specific for therapeutic cancer vaccines.
RRG filed a comment on the implementation of the "Advanced Therapies" Regulation (EC) No. 1394/2007 during the public consultation period with 198 stakeholders supporting it.
Download the RRG comment.