Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, announced a collaborative study with Almac’s Diagnostics division for the company’s doxorubicin luteinizing hormone-releasing hormone (LHRH) targeted conjugate compound, AEZS-108, aimed at determining LHRH receptor expression through the development of a companion diagnostic tool. Selection for treatment with AEZS-108 is determined on the basis of LHRH receptor expression, currently measured immunohistochemically. In humans, LHRH receptors are expressed in ovarian, endometrial, breast, bladder, prostate and pancreatic tumours. AEZS-108 is currently in phase 2 trials for advanced LHRH receptor positive ovarian and endometrial cancer.
Juergen Engel, Ph.D., president and CEO of Aeterna Zentaris stated, "We are very pleased with the collaboration with Almac who have proven experience in the development and validation of companion diagnostic tools and potential biomarkers in cancer indications. AEZS-108 is a promising anticancer compound, as demonstrated by the positive final phase 2 results in ovarian cancer expressing LHRH receptors, recently disclosed at the last ASCO meeting. This state of the art companion diagnostic tool will allow us to develop improved methods of selecting the most appropriate patients to be treated with AEZS-108 in order to enhance the efficiency of our clinical trials and help us with the future successful development of AEZS-108 in a number of different LHRH expressing cancers."
President and managing director of Almac Diagnostics, Professor Paul Harkin , said "We are very pleased to collaborate with Aeterna Zentaris on this exciting project. The plan to develop a companion diagnostic for AEZS-108 shows Aeterna Zentaris’s clear commitment to personalized medicine, which will provide this compound with the best opportunity for success."
AEZS-108, a doxorubicin LHRH receptor targeted conjugate, is currently in a Phase 2 trial in advanced ovarian and endometrial cancer. Positive final results in ovarian cancer were disclosed at this year’s American Society of Clinical Oncology (ASCO) meeting, while final results in endometrial cancer are expected by year-end. AEZS-108 has been granted orphan-drug designation by the US Food and Drug Administration and has received a positive opinion for Orphan Medicinal Product designation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency, for the treatment of ovarian cancer.
An Investigational New Drug (IND) in the US is in place for the treatment of bladder cancer.
Additional clinical studies in hormone-resistant prostate cancer and other cancer types are being planned. There may be benefits during the regulatory review process from the medical and scientific logic of this personalized treatment approach to patient selection and possibly have value in reimbursement considerations.
The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and technology (IVRS & Web), to commercial-scale manufacture.