EMD Serono to Release New Pipeline Data at ASCO 2014 from Early-Stage Investigational Compounds in Difficult-to-Treat Cancers

ASCO abstract #: Anti-PD-L1: 3064; c-Met: 2521, TPS4151, TPS8121; tecemotide: TPS3658, TPS7608; TH-302: 8534, 2029; further pipeline: 3551, TPS9107, 5030, 2050, e13552

• Robust pipeline reflects commitment to innovation in oncology and immuno-oncology 
• Data from nine EMD Serono pipeline products across oncology and immuno-oncology to be presented, including anti-PD-L1, c-Met inhibitor and TH-302

ROCKLAND, MA, May 29, 2014 /CNW/ - EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, today announced that new data from nine investigational compounds from the company's oncology and immuno-oncology pipeline will be included at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Chicago, Illinois, U.S., from May 30 to June 3, 2014. These data represent EMD Serono's commitment to research and development in oncology and immuno-oncology, and to improving patient outcomes through internally developed compounds, as well as those acquired and in development with the company's strategic partners.

"We are excited to present the most recent data from our oncology development candidates, including Phase I data on our promising anti-PD-L1 monoclonal antibody - a key milestone which highlights the potential of our immuno-oncology pipeline," said Belén Garijo, President and CEO of the biopharmaceutical division of Merck KGaA, Darmstadt, Germany. "Through the spectrum of our efforts, from discovery through development, we keep the patients at the center of our activities, with the goal of transforming innovative research into differentiated medicines that are tailored to their needs."

EMD Serono's oncology and immuno-oncology pipeline includes more than 22 programs in early- and late-stage development, targeting a variety of difficult-to-treat cancers. Notable data presented at this year's ASCO include preliminary data from the investigational anti-PD-L1 monoclonal antibody (MSB0010718C) and the investigational c-Met inhibitor (MSC2156119J), both in advanced solid malignancies, and TH-302, an investigational hypoxia-activated prodrug, in multiple myeloma and glioblastoma.

Abstracts are currently available on the ASCO website.

Notes to Editors 

Abstracts related to EMD Serono's oncology and immuno-oncology pipeline include:

Anti-PD-L1

Title: Phase I open-label, multiple ascending dose trial of MSB0010718C, an anti-PD-L1 monoclonal antibody, in advanced solid malignancies.
Lead author: CR Heery 
Abstract #: 3064 
Presentation date/time (CDT): Jun 1, 08:00-11:45
Session: General Poster Session: Developmental Therapeutics - Immunotherapy
Room/Details: S Hall A2 (Poster Board: 131)

c-Met inhibitor

Title: Results of the first-in-human phase I trial assessing MSC2156119J (EMD 1214063), an oral selective c-Met inhibitor, in patients (pts) with advanced solid tumors.
Lead author: GS Falchook 
Abstract #: 2521 
Presentation date/time (CDT): Time 1: May 30, 13:00-16:00. Time 2: May 30, 16:30-17:45
Session: Poster Highlights Session: Developmental Therapeutics: Clinical Pharmacology and Experimental Therapeutics
Room/Details: Time 1: E354b Time 2: E Arie Crown Theater (Poster Board: 35)

Title: A multicenter, randomized, phase Ib/II trial of the oral c-Met inhibitor MSC2156119J as monotherapy versus sorafenib in Asian patients with MET-positive (MET+) advanced hepatocellular carcinoma (HCC) and Child-Pugh class A liver function.
Lead author: S Qin
AbstractAb#: TPS4151
Presentation date/time (CDT): May 31, 08:00-11:45
Session: General Poster Session: Gastrointestinal (Noncolorectal) Cancer
Room/Details: S Hall A2 (Poster Board: 234B)

Title: Phase I/II multicenter, randomized, open-label trial of the c-Met inhibitor MSC2156119J and gefitinib versus chemotherapy as second-line treatment in patients with MET-positive (MET+), locally advanced, or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor mutation (EGFRm+) and progression on gefitinib.
Lead author: Y-L Wu
Abstract #: TPS8121 
Presentation date/time (CDT):  May 31, 13:15-17:00
Session: General Poster Session: Lung Cancer - Non-small Cell Metastatic
Room/Details: S Hall A2 (Poster Board: 300B)

Tecemotide

Title: A randomized, double-blind, placebo-controlled, multicenter, binational, phase II trial of immunotherapy with L-BLP25 (tecemotide) in patients with colorectal carcinoma following R0/R1 hepatic metastasectomy. (Investigator-sponsored trial).
Lead author: S Kasper
Abstract #: TPS3658 
Presentation date/time (CDT):  May 31, 08:00-11:45
Session: General Poster Session: Gastrointestinal (Colorectal) Cancer
Room/Details: S Hall A2 (Poster Board: 116A)

Title: START2: Tecemotide in unresectable stage III NSCLC after first-line concurrent chemoradiotherapy.
Lead author: S Ramalingam 
Abstract #: TPS7608 
Presentation date/time (CDT): May 31, 13:15-17:00
Session: General Poster Session: Lung Cancer - Non-small Cell Local-regional/Small Cell/Other Thoracic Cancers
Room/Details: S Hall A2 (Poster Board: 216A)

TH-302

Title: Preliminary safety and efficacy of TH-302, an investigational hypoxia-targeted drug, and dexamethasone (dex) in patients (pts) with relapsed/refractory multiple myeloma (RR MM).
Lead author: J Laubach 
Abstract #: 8534 
Presentation date/time (CDT): Time 1: May 30, 13:00-16:00. Time 2: May 30, 16:30-17:45.
Session: Poster Highlights Session: Lymphoma and Plasma Cell Disorders
Room/ Details: Time 1: S405. Time 2: S406 (Poster Board: 14)

Title: Phase 1/2 study of investigational hypoxia-targeted drug, TH-302, and bevacizumab (bev) in recurrent glioblastoma (GBM) following bev failure.
(Investigator-sponsored trial).
Lead author: AJ Brenner
Abstract #: 2029 
Presentation date/time (CDT): Time 1: May 30, 13:00-16:00. Time 2: May 30, 16:30-17:45.
Session: Poster Highlights Session: Central Nervous System Tumors
Room/Details: Time: 1 E354b. Time 2: E450 (Poster Board: 20)

Additional Pipeline Projects: Oncology and Immuno-Oncology

Title: Phase 1 study of biweekly (Q2W) anti-EGFR monoclonal antibody (mAb) mixture Sym004 in patients (pts) with metastatic colorectal cancer (mCRC) resistant to previous anti-EGFR treatment.
Lead author:  G Argilés 
Abstract #: 3551 
Presentation date/time (CDT): May 31, 08:00-11:45
Session: General Poster Session: GI (Colorectal) Cancer   
Room/ Details: S Hall A2 (Poster Board: 14)

Title: Targeted modified IL-2 (NHS-IL2, MSB0010445) combined with stereotactic body radiation in advanced melanoma patients after progression on ipilimumab: Assessment of safety, clinical, and biologic activity in a phase 2a study.
Lead author:  H Kaufman 
Abstract #: TPS9107 
Presentation date/time (CDT): May 31, 08:00-11:45
Session: General Poster Session: Melanoma/Skin Cancers
Room/Details: S Hall A2 (Poster Board: 308B)

Title: Primary outcomes of the placebo-controlled phase 2 study PERSEUS (NCT01360840) investigating two dose regimens of abituzumab (DI17E6, EMD 525797) in the treatment of chemotherapy-naive patients (pts) with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC).
Lead author: M Hussain
Abstract #: 5030 
Presentation date/time (CDT): May 31, 13:15-16:15
Session: Poster Highlights Session: Genitourinary (Prostate) Cancer
Room/Details: E354b (Poster Board: 45)

Title: Radiotherapy (RT), temozolomide (TMZ), procarbazine (PCB), and the integrin inhibitor cilengitide in patients (pts) with glioblastoma (GBM) without methylation of the MGMT gene promoter (ExCentric): Results of an Australian phase II clinical trial.
Lead author: M Khasraw 
Abstract #: 2050 
Presentation date/time (CDT): May 31, 13:15-17:00
Session: General Poster Session: Central Nervous System Tumors.
Room/Details: S Hall A2 (Poster Board: 15)

Title: Absolute bioavailability, mass balance, elimination route, and metabolite profile of the selective oral MEK1/2 inhibitor pimasertib in cancer patients.
Lead author:  G Massimini 
Abstract #: e13552 
Presentation date/time (CDT):  Abstract only

Tecemotide, TH-302 and all early-stage products are currently under clinical investigation and have not been approved for use in the U.S., Europe, Canada, or elsewhere. All investigational products have not yet been proven to be either safe or effective and any claims of safety and effectiveness can be made only after regulatory review of the data and approval of the labeled claims.

About EMD Serono, Inc.  

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, is a specialized biopharmaceutical company dedicated to developing therapies with groundbreaking potential. The company has strong market positions in neurology, endocrinology and in reproductive health. In addition, EMD Serono has an enduring commitment to solve the unsolvable, with state-of-the-art science dedicated to developing new therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology. With a long-standing history of industry expertise and a dedication to shape the future of healthcare, the company's US footprint continues to grow, with approximately 1,000 employees around the country and fully integrated commercial, clinical and research operations in the company's home state of Massachusetts.

For more information, please visit http://www.emdserono.com.

About Merck KGaA, Darmstadt, Germany  

Merck KGaA of Darmstadt, Germany, is a leading company for innovative and top-quality high-tech products in the pharmaceutical and chemical sectors. Its subsidiaries in Canada and the United States operate under the umbrella brand EMD. Around 38,000 employees work in 66 countries to improve the quality of life for patients, to further the success of customers and to help meet global challenges. The company generated total revenues of €11.1 billion in 2013 with its four divisions: Biopharmaceuticals, Consumer Health, Performance Materials and Life Science Tools. Merck KGaA of Darmstadt, Germany is the world's oldest pharmaceutical and chemical company - since 1668, the name has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70 percent interest, the founding family remains the majority owner of the company to this day.

SOURCE: EMD Serono

Erin-Marie Beals, Phone [phone]