Servier announces that its partner MacroGenics has initiated the first Phase 1 Study for MGD006/ S80880 for the Treatment of Acute Myeloid Leukemia

18/07/2014

MGD006 /S80880 Represents the First DART® Molecule to Enter the Clinic

Suresnes,  July 16th, 2014 – MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and identifying innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune disease, and with which Servier has partnered for the development of several compounds in the field of oncology, announced on June 19th that a first patient received drug in a Phase 1 study of MGD006/S80880 in relapsed or refractory acute myeloid leukemia (AML). 

MGD006/S80880 is a humanized, Dual-Affinity Re-Targeting (DART®) bispecific antibody-based molecule that binds to both CD123 and CD3, antigens expressed on leukemic cells and T lymphocytes, respectively.  This study marks the first clinical trial of a DART product candidate. 

 “The initiation of this Phase 1 study marks a significant milestone as the first of MacroGenics’ portfolio of DART molecules, MGD006/S80880, enters the clinic,” said Scott Koenig, MD, PhD, President and CEO of MacroGenics. “MGD006/S80880 has demonstrated great promise as a T cell-redirected cancer immunotherapy in preclinical studies. We will see whether these studies translate into clinical trial results indicative of clinical improvement for patients with AML, a disease for which standard therapies have advanced little in the last thirty years.”

MacroGenics has development and commercialization rights to MGD006 in the US, Canada, Mexico, Japan, South Korea, and India; Servier has rights to MGD006 (S80880) in all other countries.

Dr Jean-Pierre Abastado, Head of Oncology R&D division at Servier declared: “We are very enthusiastic about the initiation of this study in which we will explore MGD006/S80880's ability to redirect T cells against CD123-positive leukemic blasts in patients with relapsed or refractory AML,” and in addition he stressed that “the development of new immune-based therapies from MacroGenics’ DART platform not only reinforces, but also diversifies Servier’s R&D oncology portfolio.”

About the Study

The Phase 1 dose-escalation study is designed to assess the safety and tolerability of MGD006/S80880 in patients with relapsed or refractory AML. The study will enroll up to 58 patients across multiple sites in the US  The study has been initiated at Washington University School of Medicine in St Louis with John Di Persio, MD, PhD serving as the lead investigator.  In addition to the primary safety endpoint, secondary endpoints of pharmacokinetics and activity will be evaluated, as will a number of translational endpoints examining the immunobiology of MGD006.

About MGD006/S80880

MGD006/S80880 is a humanized DART molecule that recognizes both CD123 and CD3.  The molecule was designed to redirect T cells via their CD3 component to kill CD123-expressing cells, as shown pre-clinically.  CD123, the Interleukin-3 receptor alpha chain, has been reported to be overexpressed on malignant cells in a wide range of hematological malignancies including AML and myelodysplastic syndrome (MDS).  AML and MDS are thought to arise in and be perpetuated by a small population of leukemic stem cells (LSCs) that generally resist conventional chemotherapeutic agents. LSCs are characterized by high levels of CD123 expression, which is low or absent in the corresponding hematopoietic progenitors and stem cell populations in normal human bone marrow.

About the DART Platform

MacroGenics’ DART platform enables the targeting of multiple antigens or cells by using a single molecule with dual antibody-like binding regions. The Company has created over 100 DART molecules, which have been designed for evaluation in the potential treatment of cancer, autoimmune disorders and infectious disease. These DARTs can be tailored for either short or prolonged pharmacokinetics and have demonstrated good stability and manufacturability. The Company expects to advance multiple additional DART molecules into clinical development in 2014 and 2015 and beyond.

About MacroGenics, Inc.

MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases. The Company generates its pipeline of product candidates from its proprietary suite of next-generation antibody technology platforms, which it believes improve the performance of monoclonal antibodies and antibody-derived molecules. The Company creates both differentiated molecules that are directed to novel cancer targets, as well as "bio-betters," which are drugs designed to improve upon marketed medicines. The combination of MacroGenics' technology platforms and antibody engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies.  www.macrogenics.com

About Servier

Founded in 1954, Servier is an independent French pharmaceutical research company. Its development is based on the continuous pursuit of innovation in the therapeutic areas of cardiovascular, metabolic, neurologic, psychiatric, and bone and joint diseases, as well as cancer.

In 2013, the company recorded a turnover of 4.2 billion euros.

91% of Servier drugs are consumed outside France.

27% of turnover from Servier drugs is reinvested in Research and Development

in 2013. With a strong international presence in 140 countries, Servier employs more than 21 000 people worldwide. The Servier Group contributed 35% to the 2013 French trade surplus in the pharmaceuticals sector.

CONTACT:

More information is available at: www.servier.com
Servier Communication Department
Tel: +33 1 5572 6037
Email: presse@servier.fr