Newsroom

January 06, 2015

Cardio3 BioSciences (C3BS) (Euronext Brussels and Paris: CARD), a leader in the discovery and development of cell therapies, today announced the acquisition of OnCyte, LLC a division of Celdara Medical, and its portfolio of immuno-oncology CAR T cell product candidates. The acquisition marks Cardio3 Biosciences’ entry into the rapidly growing and very promising field of immuno-oncology, positioning the Company at the forefront of the CAR T-Cell space and represents a significant step towards the Company’s strategic objective of developing into a world leader in cell therapy.

Cardio3 BioSciences is acquiring OnCyte for an upfront payment in cash and stock, developmental and sales milestones associated with each of the three products and the allogeneic platform, and tiered royalties on sales. Additionally, Celdara Medical and OnCyte will continue to collaborate under a five year sponsored research agreement.

The Chimeric Antigen Receptor (CAR) technology developed by OnCyte uses human Natural Killer cell (NK cell) receptors which, unlike traditional CAR technologies, have the potential to target a broad range of liquid and solid cancers via a human natural receptor that targets ligands present on most tumor types. The research underlying this technology was originally conducted by Dartmouth College Professor Charles Sentman, and has been published in numerous peer-reviewed publications such as Cancer Research, Journal of Immunology and Blood.

OnCyte’s most advanced autologous CAR T-Cell drug candidate, CM-CS1, uses a specific human Natural Killer cell receptor, NKG2D, that targets tumor antigens expressed in most liquid and solid cancers. CM-CS1 has an active Investigational New Drug (IND) filing with the U.S. Food and Drug Administration (FDA) for a Phase I clinical trial in hematologic malignancies, and the Company plans to begin enrolling patients in Q1 2015. The CM-CS1 Phase I study is expected to be completed in the second quarter of 2016. The Company expects to report interim data from this trial throughout the enrolment period. In addition to CM-CS1, OnCyte has two CAR T-Cell programs targeting other cancer cell ligands in pre-clinical development, as well as an allogeneic T-Cell platform, which enables almost any CAR T-Cell therapy to be made into an “off-the-shelf” product.

Dr. Christian Homsy, CEO of Cardio3 BioSciences, commented: “We are thrilled to add the OnCyte development program and CAR T-Cell platform to our portfolio of world-class assets. Building on the strong foundation of our lead cardiac product, C-Cure®, this acquisition positions us in a second therapeutic area characterized by significant unmet medical need, while allowing us to leverage our leading cell therapy capabilities to drive the development of this potentially game-changing immuno-oncology technology. We look forward to initiating the Phase 1 trial of CM-CS1 and advancing the other OnCyte assets to create value for patients, the medical community and other key Cardio3 BioSciences stakeholders.”

Dr. Jake Reder, Co-founder and Chief Executive Officer of Celdara Medical, added: “We are extremely proud of everything that the OnCyte team has accomplished to date. The product candidates they have developed could have a tremendous impact on the field of oncology, and we believe that Cardio3 BioSciences is the optimal partner to lead the further advancement of this groundbreaking technology. Cardio3 BioSciences possesses the right scientific, manufacturing, and clinical expertise to continue developing these therapies and to realize their full potential.”

Recognized by experts as one of the most exciting fields in the treatment of cancer, immuno-oncology, and more specifically CAR T-Cell therapies, represent an innovative approach to treat cancers by leveraging the body's own immune system.

Research reported in this press release was supported by the National Heart, Lung and Blood Institute (including 5R44HL099217) and the National Cancer Institute (including 1R43CA144133) of the National Institutes of Health (USA). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Further information on CAR T-Cell therapies and OnCyte’s technology platform is available at www.c3bs.com/immuno-oncology