Efforts to Focus on Pre-Clinical and Clinical Research for up to 16 Early-Stage Programs Across Various Types of Cancer

Multi-Year Agreements Build on Long-Term Partnership in Immuno-Oncology, Including BiTE® Therapies and now CAR T Programs

THOUSAND OAKS, CA and HOUSTON, TX, USA I May 31, 2018 I Amgen (NASDAQ: AMGN) and The University of Texas MD Anderson Cancer Center today announced two multi-year collaboration agreements aimed at accelerating development of a variety of Amgen’s early-stage oncology therapies for patients with leukemia, myelodysplastic syndromes, multiple myeloma, small-cell lung cancer, and other non-lung cancers with small-cell histologies. The agreements combine Amgen therapies nearing clinical development or those that have already begun the process with MD Anderson’s translational medicine capabilities.

The collaborations will focus on Amgen’s bispecific T cell engager (BiTE®), chimeric antigen receptor (CAR) T cell and small molecule programs. Amgen is advancing both types of T cell therapies against different targets and, in some cases, the same target. BiTE® antibody constructs and CAR T cell therapies differ in their approach, though they share the same goal – activating a patient’s immune system to eradicate cancer. BiTE® antibody constructs work by bridging T cells to tumor cells, enabling them to attack tumor cells, while CAR T cell therapies reengineer a patient’s own T cells to recognize tumor-specific antigens, inciting an immune system attack against cancer cells.

“These agreements build on a long history of collaboration between Amgen and MD Anderson, including a number of different efforts which helped to enable the advancement and regulatory approval of Amgen’s first bispecific T cell engager,” said David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen. “We are pleased to work with MD Anderson to accelerate the translation of several of our early-stage oncology programs from the laboratory to the clinic.”

The five-year collaboration will begin with Phase 1 clinical studies for BiTE® antibody constructs and CAR T cell therapies for multiple myeloma and small cell lung cancer. The second agreement spans four years and will study BiTE® antibody constructs, CAR T and small molecule treatments in leukemia and myelodysplastic syndromes. The collaboration includes multi-institutional pre-clinical and clinical trials, some of which will be led by MD Anderson, which may offer the potential for identifying new biomarkers.

“The field of immuno-oncology is rapidly evolving and combining resources from both organizations could be important in answering key scientific questions,” said Patrick Hwu, M.D., division head of Cancer Medicine at MD Anderson. “The collaboration allows MD Anderson to study up to 16 different oncology treatments which we hope will lead to rapid development and advancement of important therapies into clinical practice.”

About BiTE® Technology
Bispecific T cell engager (BiTE®) antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body’s immune system to detect and target malignant cells. The modified antibodies are designed to bridge T cells to tumor cells, using the patient’s own immune system to eradicate cancer. BiTE® antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE® antibody constructs are currently being investigated for their potential to treat a wide variety of cancers.

About CAR T Cell Therapy
CAR T cell therapy is an evolving area of personalized medicine in which a patient’s own T cells (a type of white blood cell) are engineered to recognize tumor-specific antigens and incite an immune system attack against the cancer cells. Amgen is exploring the application of CAR T cell therapy across hematologic and solid tumor malignancies. Amgen and Kite Pharma, a subsidiary of Gilead Sciences Inc., are collaborating on engineering and commercializing CAR T cell therapies.

About Amgen’s Commitment to Oncology
Amgen Oncology is committed to helping patients take on some of the toughest cancers, such as those that have been resistant to drugs, those that progress rapidly through the body and those where limited treatment options exist. Amgen’s supportive care treatments help patients combat certain side effects of strong chemotherapy, and our targeted medicines and immunotherapies focus on more than a dozen different malignancies, ranging from blood cancers to solid tumors. With decades of experience providing therapies for cancer patients, Amgen continues to grow its portfolio of innovative and biosimilar oncology medicines.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

About MD Anderson 
The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world’s most respected centers focused on cancer patient care, research, education and prevention. The institution’s sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 49 comprehensive cancer centers designated by the National Cancer Institute (NCI). MD Anderson is ranked No.1 for cancer care in U.S. News & World Report’s “Best Hospitals” survey. It has ranked as one of the nation’s top two hospitals for cancer care since the survey began in 1990, and has ranked first 13 times in the last 16 years. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).

SOURCE: Amgen