Bérénice Framery¹, Karen Dumas¹, André Pèlegrin², Marian Gutowski³, Mats Warmerdam⁵, Alexander Vahrmeijer⁵ and Françoise Cailler¹.

1 SurgiMab S.A.S., Montpellier, France

2 Institut de Recherche en Cancérologie de Montpellier, France

3 Institut du Cancer de Montpellier, France

5 Leiden University Medical Center, Netherlands

Discriminating between malignant and benign tissue remains one of the biggest challenges during oncology surgery. Researchers and surgeons have been working closely together for the last 20 years to develop means of enhanced real-time per-operative tumor visualization, resulting in the development of Fluorescence-Guided Surgery (FGS). In the last decade, development accelerated, with the contribution of several start-ups that have managed to raise sufficient funds to bring molecules into the clinic for various therapeutic applications. Indeed, as tumor-targeted fluorophores are injected to patients prior to surgery, they must follow the same regulatory pathway as any injectable molecule.

While the use of non-targeted dyes may be useful for FGS in certain diseases, specific contrast agents are essential in oncology. However, there are still not many fluorescent probes in the clinic with a clear specificity for tumors. Some teams have tried using therapeutic antibodies as carriers for a fluorochrome but they often lack specificity. In contrast, SurgiMab has developed the first fluorescent probe specific for digestive tumors that has proven both safe and effective in the clinic.

SGM-101 is based on a tumor-specific, anti-carcinoembryonic antigen (CEA) antibody and a NIR emitting fluorochrome. CEA is overexpressed in a wide range of human carcinomas. SGM-101 safety and efficacy have both been demonstrated in several clinical trials and the molecule is currently tested in a pivotal phase III trial in 10 clinical centers, in 4 countries and in several clinical trials for various tumor types.

This talk will describe the main steps of the clinical translation of SGM-101, from an exciting concept first published in 1991 to an industrially produced GMP molecule now used by clinicians in various applications. We will concentrate on the lessons learnt while combining science and business. We will also raise the question of sometimes distinct demands from clinicians and from regulatory agencies and discuss the necessary changes in the field, to adjust to both clinical and commercial reality.

Presenter Biography:
Initially trained as a biotech engineer in the French National Institute for Applied Sciences (INSA), Françoise specialized in cell biology with a Ph.D. at University of Montreal. She then moved into drug development, and later into entrepreneurship. With over 15 years’ experience in the development of targeted molecules and therapeutic antibodies in oncology, she transformed SurgiMAb from an academic project to a developing company with more than €20 million raised from creation. She led SurgiMab’s pipe-line from the initial Fluorescence Guided Surgery concept to successful clinical implementation and set up successful clinical partnerships with KOLs over the world. In 2011 Françoise participated to the sales of Bioréalités, a French biotech specialized in the development of therapeutic antibodies in oncology, to Servier just before creating SurgiMab, where she is now CEO and CSO.

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