On November 12, 2018 Medigene AG (FSE: MDG1, Prime Standard, SDAX) reported that it has entered into an exclusive license agreement with Leiden University Medical Center (LUMC), the Netherlands, for worldwide rights to develop, manufacture, and commercialize an HA-1-specific T cell receptor (TCR) as a targeted immunotherapy for cancer (Press release, MediGene, NOV 12, 2018, View Source [SID1234531209]).
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The TCR specific for the minor histocompatibility antigen HA-1 was developed by LUMC and tested for preliminary safety and tolerability in a Phase I clinical trial involving five patients. HA-1 is a well-characterized antigen expressed in cells of the hematopoietic system, in leukemia and lymphoma cells, as well as expressed in various solid tumors.
Dr Kai Pinkernell, CMO and CDO of Medigene , said: "We are excited to have licensed this HA-1-targeting T cell receptor, which has already undergone early clinical testing, to complement Medigene’s preclinical and clinical development program. Scientists from LUMC and Medigene have had a longstanding shared scientific interest and exchange on HA-1 and we look forward to our future interactions. Our own extensive research and development for the HA-1 antigen confirms the potential of this approach in general and this TCR candidate in particular. Its potential applicability in both liquid and solid tumors makes strategic sense within our growing internal pipeline."
Mirjam H.M. Heemskerk, PhD, Associate Professor of the Department of Hematology at the Leiden University Medical Center , said: "Medigene is an ideal partner to further advance this promising TCR candidate given their deep scientific expertise, broad development work and strong focus on TCRs. We share a common vision of developing T cell receptor therapies to offer seriously ill cancer patients much-needed treatment alternatives."
Under the terms of the agreement, Medigene will receive the exclusive worldwide development and commercialization rights to the HA-1-specific TCR developed by LUMC. In return, LUMC will receive a one-time payment along with certain milestone payments. Upon commercialization, LUMC is eligible for royalties in the low-single digit percentage range. Confidentiality was agreed regarding further financial details.
Terms of the deal do not materially impact Medigene’s financial guidance for the balance of the year 2018.
About HA-1: The HA-1 antigen has been extensively studied by Medigene’s research team. It is a clinically validated T cell target used in stem cell transplantation (SCT). HA-1, as a single nucleotide polymorphism (SNP), is easily detected by a PCR method and shows a well-characterized tissue expression pattern.