On April 9, 2018 Immunomedics, Inc., (NASDAQ:IMMU) ("Immunomedics" or the "Company"), a leader in the field of antibody-drug conjugates (ADCs), reported the appointment of Robert Iannone, M.D., M.S.C.E., as Head of Research & Development and Chief Medical Officer, effective today (Press release, Immunomedics, APR 9, 2018, View Source [SID1234525811]). In his new role, Dr. Iannone will oversee and lead all clinical development, regulatory, pre-clinical, translational research and medical affairs strategies and activities of the Company. Dr. Iannone brings more than thirteen years of experience in clinical drug development, including the approval of several targeted and immuno-oncology medicines at AstraZeneca/MedImmune and Merck & Co.

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"Rob is not only a highly accomplished oncology drug developer but also is deeply rooted in science with outstanding development experience and an established track record in a number of disease settings of interest to Immunomedics. We are thrilled that Rob is bringing his strong industry, medical, scientific and strategic leadership to Immunomedics," commented Michael Pehl, President and Chief Executive Officer. "Through his unique expertise, Rob will be instrumental in aggressively advancing development of our programs with the right drug combinations and in the most appropriate patient segments. I look forward to working closely with Rob to unlock the full potential of our ADC platform and further strengthen Immunomedics as a leader in this field."

Dr. Iannone comes to Immunomedics from AstraZeneca/MedImmune where he oversaw the development of Imfinzi and was, most recently, Senior Vice President and Head of Immuno-oncology, Global Medicines Development. He joined AstraZeneca/MedImmune in July 2014 as Global Products Vice President. Prior to AstraZeneca/MedImmune, Dr. Iannone served as Executive Director, Clinical Research, and Section Head of Oncology at Merck Research Laboratories and was a development leader for Keytruda.

"Immunomedics has a unique and highly differentiated ADC pipeline and platform technology. I am very excited to be joining the Company to help develop sacituzumab govitecan and other pipeline assets, to be foundational therapies in a wide variety of hard-to-treat solid cancer indications, in both early- and late-line settings, including the potential for combining with immune checkpoint inhibitors and other targeted cancer therapies," remarked Dr. Iannone.

Dr. Iannone received his M.D. from Yale University School of Medicine with Alpha Omega Alpha honors and a Master of Science in Clinical Epidemiology from the University of Pennsylvania School of Medicine. Dr. Iannone completed his Residency at Johns Hopkins

Hospital, where he also served as Chief Resident for one year and completed his Pediatric Hematology and Oncology Fellowship. Dr Iannone is the author or co-author of numerous articles in peer-reviewed journals and has served on the Biomarkers Consortium of the Cancer Steering Committee of the Foundation for the National Institutes of Health since 2011.

On April 9, 2018 Amgen (NASDAQ:AMGN) reported that new pre-clinical data for several of its novel investigational oncology candidates will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, April 14-18, 2018 (Press release, Amgen, APR 9, 2018, View Source;p=RssLanding&cat=news&id=2341642 [SID1234525232]). Data spans Amgen’s early pipeline, including the first presentation of data for its most advanced chimeric antigen receptor (CAR) T cell therapy programs, targeting DLL3 in small cell lung cancer and FLT3 in acute myeloid leukemia (AML). In addition, pre-clinical data for Amgen’s DLL3 CAR T cell therapy and bispecific T cell engager (BiTE) program will be featured in an oral presentation.

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"As part of our overarching research and development strategy, Amgen is committed to advancing multiple modalities to gain biological insights before selecting the optimal treatment approach," said David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen. "With a variety of tools in our toolkit, we have the ability to comprehensively evaluate these novel approaches to determine how each may perform in different treatment settings. We look forward to seeing how the pre-clinical data ultimately translate in the clinic."

Research presented at the meeting will also include pre-clinical studies examining pharmacodynamic markers for Mcl-1 inhibition, as well as the combination of Amgen’s Mcl-1 inhibitor (AMG 176) with a selective BCL-2 inhibitor in models of AML. AMG 176 is a highly selective and reversible Mcl-1 inhibitor and is being studied in a Phase 1 clinical trial involving patients with relapsed or refractory AML or multiple myeloma. Studies have shown that hematologic malignancies including AML, multiple myeloma and non-Hodgkin lymphoma are particularly sensitive to Mcl-1 inhibition.

In addition, Amgen will present for the first time pre-clinical data evaluating its half-life extended (HLE) anti-BCMA BiTE for the treatment of multiple myeloma. A phase 1 study evaluating Amgen’s anti-BCMA HLE-BiTE (AMG 701) is ongoing.

With the exception of late-breaking research, abstracts are available and can be reviewed on the AACR (Free AACR Whitepaper) website at View Source Identified below are select abstracts of interest on Amgen research:

Immuno-oncology

Targeting DLL3 with BiTE antibody constructs and cell-based therapies for the treatment of SCLC
Abstract #DDT02, Oral Presentation, Sunday, April 15 from 3:24-3:48 p.m. CT at McCormick Place South (Level 1), Room S103
Generation and evaluation of a FLT3 CAR-T cell therapy for the treatment of acute myeloid leukemia
Abstract #2559/18, Poster Session, Monday, April 16 from 1-5 p.m. CT at McCormick Place, Exhibit Hall A, Poster Section 24
Cynomolgus monkey plasma cell gene signature to quantify the in vivo activity of a half-life extended anti-BCMA BiTE for the treatment of multiple myeloma
Abstract #LB-299/21, Poster Presentation, Tuesday, April 17 from 1-5 p.m. CT at McCormick Place, Exhibit Hall A, Poster Section 44
Mcl-1 Inhibition

The utilization of a human MCL-1 knock-in mouse suggests that reductions in B-cells and monocytes may serve as clinically relevant pharmacodynamic markers of MCL-1 inhibition
Abstract #2978, Oral Presentation, Monday, April 16 from 4:35-4:50 p.m. CT at McCormick Place North (Level 4), Room N427
Combined inhibition of MCL-1 and BCL-2 with AMG 176 and venetoclax induces apoptosis and tumor regression in models of acute myeloid leukemia
Abstract #3972/6, Poster Session, Tuesday, April 17 from 8 a.m.-noon CT at McCormick Place, Exhibit Hall A, Poster Section 41
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 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 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.

On April 9, 2018 Morphotek, Inc., a subsidiary of Eisai Inc., reported that it licensed its eribulin-linker payload to Bliss Biopharmaceutical Co., Ltd. (BlissBio) of China (Press release, Morphotek, APR 9, 2018, View Source [SID1234527215]). The licensing agreement grants BlissBio the exclusive right to use the eribulin-linker payload to develop a therapeutic ADC against an undisclosed oncology target for the China market. The licensing agreement includes an upfront payment, milestones and sales royalty payments, which are undisclosed. BlissBio has an exclusivity option to expand the territory beyond China to the global market and to develop therapeutic ADCs to two additional undisclosed oncology targets.

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Morphotek’s ADC Services offer third parties the opportunity to license the proprietary eribulin-linker payload to develop investigational ADCs using either Morphotek’s REsidue-SPEcific Conjugation Technology (RESPECT) or an alternative approach to conjugation. The eribulin-linker payload consists of a cytotoxic agent, eribulin, modified by a chemical linker to facilitate optimal conjugation. Eribulin’s anti-tumor activity is mediated by the inhibition of microtubule elongation and mitotic spindle formation, resulting in apoptosis. Eribulin mesylate, marketed as Halaven, is approved in the U.S. for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease, including an anthracycline and a taxane in either the adjuvant or metastatic setting.

Our end-to-end ADC Services provide multiple entry points for clients, starting from development of an antigen site-specific bioconjugate-ready monoclonal antibody and ADC through in vivo safety and efficacy validation. Additional options include manufacture of GMP clinical trial material, GLP toxicology studies and development of immunohistochemistry (IHC) companion diagnostics for patient screening. For more information on Morphotek’s ADC Services business and RESPECT platform, please contact [email protected].

*The ADCs described herein are investigational, as efficacy and safety have not been established. There is no guarantee that the ADCs will be available commercially.

On April 9, 2018 Otsuka Pharmaceutical Co., Ltd. reported that it has entered into an agreement with Takara Bio for co-development and exclusive sales rights in Japan for Takara’s NY-ESO-1 siTCRTM (TBI-1301, TBI-1301-A) and CD19 CAR (TBI-1501), both gene therapy products in development for cancer applications (Press release, Takara Holdings, APR 9, 2018, View Source [SID1234591489]).

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Under the agreement, the companies will aim for early regulatory approval for the manufacture and sale of the two therapeutic products in Japan. Takara Bio will be responsible for manufacturing and quality control of the two investigational products, while Otsuka will be responsible for clinical trials, other clinical studies, regulatory submissions, product sales and safety data collection. There are no limitations on the target indications in the agreement. Otsuka also holds a right of first refusal for nine Asian countries outside Japan.

Takara Bio will receive upfront and milestone payments from Otsuka, dependent upon the achievement of specified development targets. Takara Bio will supply Otsuka with the products based on specified financial terms. For the NY-ESO-1 siTCRTM gene therapy product, Takara Bio will receive milestone payments upon the achievement of target sales in addition to a running royalty on net sales. The upfront and milestone payments will be up to a maximum total amount of approximately 6.3 billion yen.

Toshiki Sudo, executive director, Research and Otsuka board member noted that, "We are striving to develop innovative products that contribute to the health of humankind around the world, a part of which is co-development cooperation with Takara Bio. We know from our collaboration with Takara Bio on their oncolytic virus HF10 that they have highly advanced biotechnologies and manufacturing facilities dedicated to cell therapy. We aspire jointly to advance biologics research including gene and cell therapy to satisfy currently unsatisfied medical needs."

Masanobu Kimura, Takara Bio board member and president of the Gene Therapy Business Unit, commented that the collaboration with Otsuka, which has broad experience in clinical development, pharmaceutical affairs and sales of pharmaceutical products, will contribute to the development, commercialization and value maximization of the therapeutic products. "We are convinced of further progress on the effective development, aided by the designation of NY-ESO-1・siTCRTM gene therapy product under "SAKIGAKE Designation System" (prioritized review) by the Japanese Ministry of Health, Labour and Welfare on March 27, 2018."

For more information about Takara Bio, please click here: View Source

On April 9, 2018 OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported that five posters will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held April 14-18, 2018, in Chicago (Press release, OncoMed, APR 9, 2018, View Source [SID1234525233]). Among the presentations will be preclinical data for OncoMed’s novel anti-TIGIT (OMP-313M32) immuno-oncology program, which is currently in a Phase 1a single-agent clinical study. Preclinical data for OncoMed’s differentiated clinical-stage GITRL-Fc (OMP-336B11) program will also be featured. In addition, preclinical immuno-oncology data for OncoMed’s Wnt antagonist vantictumab (anti-FZD, OMP-18R5) in combination with immune checkpoint inhibitors will be presented.

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Details on the poster presentations are provided below:

Poster 20; Abstract 70: Effect of aging on the antitumor activity of GITRL-Fc
Session: Tumor Biology, Dormancy and Aging: The Influential Microenvironment
Date and Time: Sunday Apr 15, 2018 1:00 PM – 5:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 3

Poster 28; Abstract 1733: Wnt antagonists synergize with immune checkpoint inhibitors to enhance anti-tumor responses
Session: Immunology, Immune Responses to Therapies 2
Date and Time: Monday Apr 16, 2018 8:00 AM – 12:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 32

Poster 18; Abstract 2726: In vitro functional activity of OMP-336B11, a GITRL-Fc fusion protein, on primary human immune cells
Session: Immunology, Immune Checkpoints 2
Date and Time: Monday Apr 16, 2018 1:00 PM – 5:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 32

Poster 16; Abstract 3826: GITRL-Fc biomarker and mechanism study: GITRL-Fc reduces Treg frequency in tumors and requires effector function for inhibition of tumor growth
Session: Immunology, Therapeutic Antibodies, Including Engineered Antibodies 3
Date and Time: Tuesday Apr 17, 2018 8:00 AM – 12:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 34

Poster 22; Abstract 5627: Anti-TIGIT biomarker study: Inhibition of TIGIT induces loss of Tregs from tumors and requires effector function for tumor growth inhibition
Session: Clinical Research, Therapeutic Antibodies, Including Engineered Antibodies 4
Date and Time: Wednesday Apr 18, 2018 8:00 AM – 12:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 28

Following the presentations, the posters will be available on the Pipeline section of OncoMed’s website, www.oncomed.com.

Additional information on the meeting can be found on the AACR (Free AACR Whitepaper) website www.aacr.org