Profile: AEterna Zentaris Inc (AEZS.O)
10 Jul 2014
Aeterna Zentaris Inc., incorporated on September 12, 1990, is a late-stage drug development company specialized in oncology and endocrine therapy. The Company’s pipeline encompasses compounds at all stages of development, from drug discovery through to marketed products. The development priorities in oncology are the completion of Phase 3 trials with perifosine in colorectal cancer (CRC) and in multiple myeloma (MM), as well as the further advancement of AEZS-108, for which it has completed a Phase 2 trial in advanced endometrial and advanced ovarian cancer. Its pipeline also encompasses other earlier-stage programs in oncology. AEZS-112, which is an oral anticancer agent, which includes three mechanisms of action (tubulin, topoisomerase II and angiogenesis inhibition) has completed a Phase 1 trial in advanced solid tumors and lymphoma.
As of December 31, 2011, the Company had three wholly owned direct and indirect subsidiaries, Aeterna Zentaris GmbH (AEZS Germany), Zentaris IVF GmbH, a direct wholly owned subsidiary of AEZS Germany, and Aeterna Zentaris, Inc. In addition, several anti-cancer candidates, such as AEZS-120, a live recombinant oral tumor vaccine candidate, as well as its phosphoinositide 3-kinase (PI3K)/Erk inhibitors AEZS-129, AEZS-131, AEZS-132 and their respective follow-up compounds are in preclinical development. The Company’s program in endocrinology, a Phase 3 trial under a Special Protocol Assessment (SPA) obtained from the United States Food and Drug Administration (the FDA) with AEZS-130 as an oral diagnostic test for adult growth hormone deficiency (AGHD), has been completed. AEZS-130 is in a Phase 2A trial for the treatment of cancer cachexia. The Company’s LHRH Antagonists include Cetrorelix and Ozarelix, and its Immunotherapy / Vaccines consists of AEZS-120. Tumor targeting cytotoxic conjugates and cytotoxics consists of AEZS-137 (Disorazol Z) / AEZS-125 (LHRH-Disorazol Z).
The Company’s priorities in oncology are with perifosine, to complete the two Phase 3 trials in CRC and in MM, and to continue its Phase 2 program in multiple cancers, as well as the further advancement of AEZS-108, for which it completed Phase 2 trials in advanced endometrial and advanced ovarian cancer. Perifosine is a oral anticancer treatment that inhibits Akt activation in the PI3K pathway. Perifosine, in combination with chemotherapeutic agents, is in Phase 3 studies for the treatment of metastatic colorectal cancer (mCRC), MM and in Phase 2 studies for the treatment of other cancers. Perifosine as monotherapy is also being explored in chronic lymphocytic leukemia (CLL). Perifosine rights have been licensed to Keryx for North America, to Yakult for Japan, to Handok Pharmaceuticals Co. Ltd. (Handok) for Korea and to Hikma Pharmaceuticals PLC (Hikma) for the Middle East and North Africa (MENA) region.
AEZS-108 represents a new targeting concept in oncology to personalized medicine using a cytotoxic peptide conjugate, which is a hybrid molecule composed of a synthetic peptide carrier and doxorubicin. Phase 2 trials in advanced endometrial cancer and advanced ovarian cancer have been completed. AEZS-108 is also in development in other cancer indications, including refractory bladder and castration-and taxane-resistant prostate cancer. An IND in the United States is in place for the treatment of prostate, bladder and triple-negative breast cancer. The Company owns the worldwide rights to AEZS-108 and also has a collaboration agreement with Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, to develop a companion diagnostic for the immunohistochemical determination of LHRH-receptor expression, for AEZS-108.
In endocrinology, aside from Cetrotide, the Company has completed a Phase 3 trial with AEZS-130, which would be an oral diagnostic test for AGHD. AEZS-130, a ghrelin agonist, is an orally available synthetic small molecule that stimulates the secretion of growth hormone. It completed a Phase 3 trial under a SPA obtained from the FDA. AEZS-130 has been granted orphan-drug designation by the FDA. In addition to the diagnostic indication, it focuses that AEZS-130 has application for the treatment of cachexia, a condition frequently associated with severe chronic diseases, such as cancer, chronic obstructive pulmonary disease and Acquired Immune Deficiency Syndrome (AIDS).
Clinical and Preclinical Programs
The Company is advancing AEZS-112 in Phase 1, an oral anticancer agent which includes three mechanisms of action, (tubulin, topoisomerase II and angiogenesis inhibition), as well as several preclinical programs with development candidates. It also performs targeted drug discovery activities from which it is able to derive preclinical candidates. This drug discovery includes high throughput screening systems and a library of more than 120,000 compounds. As of December 31, 2011, the Company is in a stage in which some of its products and product candidates are being further developed or marketed jointly with strategic partners or with fundings from governmental organizations.
The Company competes with Genentech/Roche, Sanofi, Yakult Honsha, Bristol-Myers Squibb Co., Eli Lilly, Co., Amgen, Bayer HealthCare Pharmaceuticals / Onyx Pharmaceuticals, Inc., Regeneron Pharmaceuticals, Takeda/Janssen, Cilag, Merck & Co., Celgene Corporation, Novartis and Abbott.
AEterna Zentaris Inc
1405 du Parc-Technologique Blvd.
QUEBEC QC G1P 4P5