1 * Modalities in use across pipeline and marketed products. Modality refers to the structural template of a therapeutic agent. ‡ Amgen has an additional three biosimilar programs in development which are undisclosed at this time. **Tradename provisionally approved by the United States Food and Drug Administration, This information reflects public disclosures cu rrent as of April 7, 2017. Amgen’s product pipeline will change over time as molecules move through the drug development process, including progressing to market or failing in clinical trials, due to the nature of the development process. This description contains forward-looking statements that involve significant risks and uncertainties, including those discussed in Amgen’s most recent Form 10-K and in Amgen’s periodic reports on Form 10-Q and Form 8-K, and actual results may vary materially. Amgen is pro viding this information as of the date above and does not undertake any obligation to update any forward-looking statements contained in this table as a result of new information, future events or otherwise. © 201 7 Amgen Inc. All rights reserved. 33 pre clinical and clinical targets with STRONG GENETIC SUPPORT The industry’s largest toolkit with 13 MODALITIES* A mix of INNOVATIVE MOLECULES, NEW INDICATIONS, AND BIO SIMILARS A robust and differentiated pipeline, leveraging state-of-the-art science to create medicines for serious illness. Amgen is focused on high-quality candidates that demonstrate large, clinically-relevant effects. Human genetic validation is used whenever possible to enhance the likelihood of success. BIOSIMILARS ‡ ABP 215 (biosimilar bevacizumab) Hematology/ Oncology ABP 494 (biosimilar cetuximab) Hematology/ Oncology ABP 710 (biosimilar infliximab) Inflammation ABP 798 (biosimilar rituximab) Hematology/ Oncology & Inflammation ABP 959 (biosimilar eculizumab) Hematology /Oncology ABP 980 (biosimilar trastuzumab) Hematology/ Oncology PHASE ONE PHASE TWO PHASE THREE AMG 176 Hematology/ Oncology AMG 211 Hematology/ Oncology AMG 224 Hematology/ Oncology AMG 899 Cardiovascular BLINCYTO (blinatumomab) Hematology/ Oncology Erenumab Neuroscience AMG 520 Neuroscience Aranesp (darbepoetin alfa) Hematology/ Oncology BLINCYTO (blinatumomab) Hematology/ Oncology AMG 301 Neuroscience AMG 330 Hematology/ Oncology AMG 420 Hematology/ Oncology Tezepelumab Inflammation Enbrel (etanercept) Inflammation Erenumab Neuroscience **EVENITY TM (romosozumab) Bone Health AMG 557 Inflammation AMG 570 Inflammation AMG 592 Inflammation IMLYGIC (talimogene laherparepvec) Hematology/ Oncology KYPROLIS (carfilzomib) Hematology/ Oncology Omecamtiv mecarbil Cardiovascular AMG 820 Hematology/ Oncology AMG 986 Cardiovascular IMLYGIC (talimogene laherparepvec) Hematology/ Oncology Prolia (denosumab) Bone Health Repatha (evolocumab) Cardiovascular Vectibix (panitumumab) Hematolog y/ Oncology KYPROLIS (carfilzomib) Hematology/ Oncology Oprozomib Hematology/ Oncology XGEVA (denosumab) Hematology/ Oncology 2 * Modalities in use across pipeline and marketed products. Modality refers to the structural template of a therapeutic agent. ‡ Amgen has an additional three biosimilar programs in development which are undisclosed at this time. This information reflects public disclosures current as of April 7, 2017. Amgen’s product pipeline will change over time as molecules move through the drug development process, including progressing to market or failing in clinical trials, due to the nature of the development process. This description contains forward-looking statements that involve significant risks and uncertainties, including those discussed in Amgen’s most re cent Form 10-K and in Amgen’s periodic reports on Form 10-Q and Form 8-K, and actual results may vary materially. Amgen is providing this information as of the date above and does not undertake any obligation to update any forward-looking statements contai ned in this table as a result of new information, future events or otherwise. © 201 7 Amgen Inc. All rights reserved. PHASE ONE Phase 1 clinical trials investigate safety and proper dose ranges of a product candidate in a small number of human subjects. MOLECULE NAME & PRONUNCIATION MODALITY THERAPEUTIC AREA DESCRIPTION AMG 176 Small Molecule Hematology/ Oncology AMG 176 is a small molecule being investigated as a treatment for multiple myeloma. AMG 211 BiTE A ntibody Hematology/ Oncology AMG 211 is an anti-CEA x anti-CD3 (BiTE ) bispecific antibody construct. It is being investigated as a treatment for various cancer types. AMG 211 is being jointly developed in collaboration with MedImmune. AMG 224 Antibody Drug Conjugate Hematology/ Oncology AMG 224 is an antibody drug conjugate being investigated for the treatment of multiple myeloma. AMG 301 Monoclonal Antibody Neuroscience AMG 301 is a human monoclonal antibody that inhibits the type 1 receptor of the pituitary adenylate cyclase-activating polypeptide (PAC1). It is being investigated for migraine prevention. AMG 301 is being jointly developed in collaboration with Novartis. AMG 330 BiTE Antibody Hematology/ Oncology AMG 330 is an anti-CD33 x anti-CD3 (BiTE ) bispecific antibody construct. It is being investigated as a treatment for acute myeloid leukemia. AMG 420 BiTE Antibody Hematology/ Oncology AMG 420 is an anti-BCMA x anti-CD3 (BiTE ) bispecific antibody construct. It is being investigated as a treatment for multiple myeloma. AMG 557 Monoclonal Antibody Inflammation AMG 557 is a human monoclonal antibody that inhibits the action of B7 related protein (B7RP-1). It is being investigated as a treatment for systemic lupus erythematosus. AMG 557 is being jointly developed in collaboration with AstraZeneca. AMG 570 Bispecific Antibody Inflammation AMG 570 is a bispecific antibody-peptide conjugate that targets BAFF and ICOSL. It is being investigated as a treatment for systemic lupus erythematosus. AMG 570 is being jointly developed in collaboration with AstraZeneca. AMG 592 Fusion Protein Inflammation AMG 592 is an IL-2 mutein Fc fusion protein. It is being investigated as a treatment for inflammatory diseases. AMG 820 Monoclonal Antibody Hematology/ Oncology AMG 820 is a human monoclonal antibody that inhibits c-fms and decreases tumor-associated macrophage (TAM) function. It is being investigated as a treatment for various cancer types. AMG 986 n/a Cardiovascular AMG 986 is being investigated for the treatment of heart failure. IMLYGIC (t alimogene laherparepvec) tal im’ oh jeen la her" pa rep’ vek Oncolytic Immunotherapy Hematology/ Oncology IMLYGIC is an oncolytic immunotherapy derived from HSV-1. It is being investigated as a combination treatment in patients with mid-to late-stage metastatic melanoma (Phase 1b/3) and in other cancer types (Phase 1).

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On April 5, 2017 APAC Biotech, reported that it was granted with a commercial license by Indian FDA (CDSCO – Central Drugs Standard Control Organization) to market product, APCEDEN, a Dendritic cell-based autologous Immuno-oncology product for four cancer indication namely Prostate, Ovarian, Colo-rectal and Non Small Cell Lung carcinoma (Press release, APAC Biotech, APR 5, 2017, View Source [SID1234562370]).

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The Indian Food and Drug Administration authorities, after their stringent review of the application, have issued the commercial license (Form 46) to conduct a post marketing surveillance on statistically significant number of patients for each indication.

Other products namely STEMPEUCEL, an allogeneic-cultured mesenchymal cells from Stempeutics and OSSORON, an autologous-cultured adult osteoblast and CHONDRON, an autologous-cultured adult chondrocyte from Regenerative Medical Services, Mumbai, also received the marketing license at the same time.

"The past decades have seen revolutionary progress in the development and application of cell and genetic engineering in an effort to personalize the treatment of cancer. We are now confident that it is possible to treat cancer patients using this approach as observed during clinical trials across India. The results are encouraging and mark a potential new paradigm in treating these solid tumors that do not respond to standard therapies," said a leading oncologist, Dr. Ashok Vaid.

APCEDEN, an autologous monocyte-derived mature Dendritic cell when loaded with tumor antigen have the ability to generate an effective immune response against the tumor. In the year 2011, an ATTEST trial was conducted where refractory solid tumor with multiple chemo failure patients were enrolled and administered with APCEDEN. The results were published in International Journal of Cytotherapy in the year 2014. ATTEST study included a stringent logistics management and was uniquely, effectively, conducted under the leadership of Principal investigator, Medical oncologist, Dr. P P Bapsy.

The trial was designed to understand the potential benefits and risk of the therapy. In the trial 28.9% of cases showed stability of disease with good quality of life. A retrospective study was also conducted on the advice of CBBTDEC (Cell Biology Based Therapeutic Drug Evaluation Committee), ICMR (Indian Council of Medical Research) where more than 200 days’ of survival benefit was observed as compared to the retrospective control group.

On April 5, 2017 Alligator presented at DNB Small and Medium Enterprises (SME) Conference in Oslo (Presentation, Alligator Bioscience, APR 5, 2017, View Source [SID1234538701]).

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On April 4, 2017 Oxis International Inc. (OTCQB: OXIS and Euronext Paris OXI.PA) reported that the Food and Drug Administration has cleared the way for the Company’s wholly owned subsidiary, Oxis Biotech Inc., to begin a FDA Phase 2 clinical trial for its promising cancer treatment OXS-1550 in the treatment of lymphoma and leukemia (Press release, OXIS International, APR 4, 2017, View Source [SID1234539558]).

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Oxis Biotech, a targeted immuno-oncology company focused on novel antibody constructs, owns the worldwide rights to commercialize OXS-1550.

The FDA Phase 2 clinical trial will be conducted with Oxis’ partner, the University of Minnesota’s Masonic Cancer Center. Researchers at the University of Minnesota recently completed a FDA Phase 1 trial of OXS-1550. The Phase 1 portion of the trial completed a safety review to determine the safe and effective dose of the drug.

OXS-1550 uses a proprietary immunoconjugate platform technology, as a treatment for leukemia and other blood-born cancers. What sets OXS-1550 (DT2219ARL) apart from other treatments, such as chemotherapy, is that it is designed to specifically target and kill cancer cells minimizing damage to normal tissues.

"This milestone represents a major step forward for our technology. The product has performed well in its phase 1 studies in blood cancers and we look forward to positive results in Phase 2," said Anthony Cataldo, Chairman and Chief Executive Officer of Oxis. "This next generation drug has the possibility of treating a number of different liquid tumors and, if successful, will drastically change the paradigm now being developed that relies on highly expensive autologous cell therapies such as presented by Kite Pharma, Inc. (KITE), Juno Therapeutics, Inc. (JUNO) and other autologous or semi-autologous and adoptive therapy approaches currently under development."

Dr. Daniel Vallera, director of the section on Molecular Cancer Therapeutics at the University of Minnesota Cancer Center, lead developer of OXS-1550 said, "The FDA’s clearance for Phase 2 is an important step forward for this cancer treatment."

Dr. Vallera has spent 35 years with the University of Minnesota’s cancer center, where he oversees a laboratory specializing in the development of biological recombinant drugs focusing on bispecific antibody therapies that directly deliver toxic signals to cancer cells.

"We are excited to see this new therapy proceed to Phase 2," Dr. Vallera said. "So many of these patients presenting with chemotherapy refractory cancer have few, if any, alternative choices for cancer treatment."

On April 4, 2017 OncoResponse, an immuno-oncology antibody discovery company, reported that Chief Executive Officer Clifford J. Stocks will present an update on the Company and the status of its discovery and development pipeline at the 24th annual Future Leaders in the Biotech Industry conference hosted by BioCentury (Press release, OncoResponse, APR 4, 2017, View Source [SID1234522896]). The presentation will take place at 11:00am ET on April 7, 2017 at the Millennium Broadway hotel in New York City, NY.

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OncoResponse utilizes a clinically validated platform technology to rapidly screen antibodies made by the human immune system and identify those antibodies with exceptional activity to cancer from elite responders following immunotherapy. The Company has a strategic alliance with the MD Anderson Cancer Center, which provides broad access to patient samples across multiple cancer indications and to oncology and translational medicine expertise including clinical and regulatory advice.

OncoResponse recently closed a $22.5 million Series A financing with a syndicate of blue chip venture capital and strategic investors including MD Anderson Cancer Center, ARCH Venture Partners, GreatPoint Ventures, Helsinn Investment Fund, Shire, Canaan Partners, HT Family Office (of China), Alexandria Real Estate Equities and William Marsh Rice University.