On April 17, 2017 OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, reported top-line results from the company’s randomized 145-patient Phase 2 PINNACLE clinical trial of tarextumab (anti-Notch2/3, OMP-59R5) in combination with etoposide plus either cisplatin or carboplatin chemotherapy ("chemotherapy") in previously untreated patients with extensive-stage small cell lung cancer (Press release, OncoMed, APR 17, 2017, View Source [SID1234518580]). Results for the combination of tarextumab plus chemotherapy were undifferentiated from those of chemotherapy plus placebo, and therefore the trial did not meet its primary endpoint of progression-free survival or secondary endpoints of overall survival and biomarkers reflective of Notch pathway gene activation.

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"Small cell lung cancer is a very difficult-to-treat disease and unfortunately, tarextumab did not show benefit over placebo in this Phase 2 trial," said Paul J. Hastings, OncoMed’s Chairman and CEO. "We deeply appreciate the participation by the investigators and staff, patients and caregivers who all contributed to the conduct and completion of this Phase 2 clinical trial."

OncoMed also announced today that it will discontinue enrollment in the Phase 1b clinical trial of brontictuzumab (anti-Notch1, OMP-52M51) in combination with trifluridine/tipiracil (Lonsurf) in third-line colorectal cancer patients. The combination of brontictuzumab plus chemotherapy was not tolerable in this patient population.

"Based on the events of today and last week, we will be undertaking a comprehensive portfolio prioritization review immediately," continued Mr. Hastings. "The immediate task ahead is to thoroughly examine the available data, our resources and the opportunities to re-focus our efforts. We ended the first quarter of 2017 with $156.9 million in cash and short-term investments."

The median progression-free survival (mPFS) for tarextumab plus chemotherapy was 5.6 months versus 5.5 months for chemotherapy plus placebo (HR=0.969). The median overall survival (mOS) analysis did not show a benefit for tarextumab in combination with chemotherapy (mOS=9.3 months) compared to the chemotherapy plus placebo arm (10.3 months; HR=1.01). Five individual Notch biomarkers (Hes1, Hes6, Hey1, Hey2 and Notch3) failed to identify a definitive subset of patients with a treatment effect on either mPFS or mOS. Overall response rates were 68.5% and 70.8% in the tarextumab and placebo arms respectively. The combination of tarextumab plus chemotherapy was well tolerated. The safety profile appeared to be similar between the two groups except for diarrhea and thrombocytopenia, which were more prevalent in the tarextumab treatment arm, and constipation, which was more prevalent in the placebo arm.

OncoMed management will host a conference call today at 8:30 a.m. ET/5:30 a.m. PT to discuss the PINNACLE clinical trial data. OncoMed plans to present full study findings, including results from the biomarker analyses, at a future scientific conference.

About the Phase 2 PINNACLE Trial
Patients enrolled in the randomized, double-blinded, multi-center PINNACLE clinical trial were randomized into two study arms and received either 15mg/kg of tarextumab every three weeks in combination with six cycles of etoposide and either cisplatin or carboplatin chemotherapy followed by tarextumab maintenance to progression or six cycles of chemotherapy and a placebo. The primary endpoint of the trial was progression-free survival. Secondary endpoints included overall survival and overall response rate, pharmacokinetics, safety and biomarker analyses. Overall survival, progression-free survival and overall response rates are also being assessed against elevated tumor expression of the Notch pathway genes Hes1, Hes6, Hey1, Hey2 and Notch3 as a secondary endpoint. The PINNACLE trial was conducted at 36 sites in the United States.

About Tarextumab (anti-Notch2/3, OMP-59R5)
Tarextumab (anti-Notch2/3, OMP-59R5) is a fully human monoclonal antibody that targets the Notch2 and Notch3 receptors. Preclinical studies suggested that tarextumab exhibits two mechanisms of action: (1) by downregulating Notch pathway signaling, tarextumab appears to have anti-cancer stem cell effects, and (2) tarextumab affects pericytes, impacting stromal and tumor microenvironment. Tarextumab is part of OncoMed’s collaboration with GlaxoSmithKline (GSK).

About Small Cell Lung Cancer
According to the American Cancer Society, lung cancer (both small cell and non-small cell) is the second most common cancer in men and women and is by far the leading cause of cancer death. Small cell lung cancer is expected to make up about 10%-15% of the 224,390 newly diagnosed lung cancer cases and the 158,080 deaths estimated to occur in the U.S. in 2016. Small cell lung cancer tends to grow and spread quickly, and is typically not discovered until it has metastasized to other parts of the body (extensive stage). The current standard of care in treating small cell lung cancer is the chemotherapeutic etoposide in combination with either cisplatin or carboplatin. In spite of a high sensitivity to chemotherapy and remission rates of up to 80% following initial treatment, the median overall survival is less than one year for patients with extensive stage disease1.

On April 13, 2017 argenx (Euronext Brussels: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported the achievement of the first of two preclinical milestones on its way to the investigational new drug (IND) filing of ARGX-115, triggering a $ 10 million payment from AbbVie (Press release, arGEN-X, APR 13, 2017, View Source [SID1234518538]).

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In April 2016, argenx entered into a collaboration agreement with AbbVie to develop and commercialize ARGX-115. Under the terms of the collaboration agreement, argenx is responsible for conducting and funding all ARGX-115 research and development activities up to completion of IND-enabling studies.

argenx has granted AbbVie an exclusive option, for a period following completion of IND-enabling studies, to obtain a worldwide, exclusive license to the ARGX-115 program to develop and commercialize products. argenx is eligible to receive two near-term preclinical milestones of $ 10 million each. The first milestone was achieved today.

About ARGX-115

ARGX-115 employs argenx’s SIMPLE Antibody technology and works by stimulating a patient’s immune system after a tumor has suppressed the immune system by co-opting immunosuppressive cells such as activated regulatory T-cells (Tregs). While the normal function of Tregs is to suppress portions of the immune system to prevent a self-directed immune response through the release of active transforming growth factor beta (TGF-β), Tregs can also prevent the immune system from recognizing and suppressing pathogenic cells including cancer cells. By binding to glycoprotein A repetitions predominant (GARP), which plays a key role in the regulation of production and release of active TGF-β, ARGX-115 works to limit the immunosuppressive activity of Tregs and thereby stimulate the immune system to attack cancer cells. We believe this specific inhibition of TGF-β release by Tregs is potentially superior as a therapy to systemic inhibition of TGF-β activity or the depletion of Tregs with a potentially improved safety profile.

ARGX-115 was discovered under argenx’s Innovative Access Program with the de Duve Institute / Université Catholique de Louvain / WELBIO.

The initial offering amount is for $115M and will be used to advance the development of trilaciclib, G1T38, G1T48 for treatment of breast cancer and small cell lung cancer (Filing, S-1, G1 Therapeutics, APR 13, 2017, View Source [SID1234518582]).

The stock will trade on the Nasdaq with symbol "GTHX."

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On April 11, 2017 PureTech Health plc ("PureTech Health" or the "Company", LSE: PRTC), an advanced, clinical-stage biopharmaceutical company, reported the launch of a new immuno-oncology program developing monoclonal antibodies to target newly discovered immunosuppressive mechanisms in pancreatic cancer and other solid tumors (Press release, PureTech Health, APR 11, 2017, View Source [SID1234535429]).

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"Pancreatic cancer is the only major cancer with a five-year survival rate in the single digits, and there has been far too little progress towards meaningful treatments"
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The approach is based on the work of Dr. George Miller, Director of S. Arthur Localio Laboratories and Director of the Cancer Immunology Program at NYU School of Medicine. Part of the body of data supporting this approach was published recently in Nature Medicine and builds upon his work previously published in Cell.

"Most solid, malignant tumors establish an immunosuppressive environment to ward off the body’s natural defenses. Dr. Miller’s work in pancreatic ductal carcinoma has revealed that inflammatory processes drive the immunosuppression through certain gamma delta T cells and macrophages," said Dr. Joseph Bolen, Chief Scientific Officer of PureTech Health. "Our novel approach builds on this finding and selectively disrupts the immunosuppression to potentially have a therapeutic effect on cancer."

This technology, exclusively licensed from the NYU School of Medicine, is being developed in a new subsidiary of PureTech Health called Nybo Therapeutics. Nybo builds on PureTech’s strength in immunology and joins PureTech’s advanced pipeline of immunology and T cell biology programs that includes a Phase IIB immunosenescence program, microbiome-based T cell mediated therapies, and CAR-T therapies.

"Pancreatic cancer is the only major cancer with a five-year survival rate in the single digits, and there has been far too little progress towards meaningful treatments," said Dr. Diane Simeone, Director of the Pancreatic Cancer Center at NYU School of Medicine and a member of Nybo’s Scientific Advisory Board. "Novel therapeutic approaches are important to pursue, and I look forward to helping advance this promising technology."

Dr. Miller commented on this announcement, "I am excited to translate our findings into first-in-class therapies for patients who desperately need new treatment options. Our work on immunosuppressive mechanisms in pancreatic cancer has shed light on new therapeutic approaches that form the foundation for Nybo, and we look forward to a great partnership with PureTech Health with whom to advance these findings."

PureTech Health has gathered a group of leading expert collaborators and advisors around this platform, including:

Erin Adams, Ph.D., is the Joseph Regenstein Professor at the Department of Biochemistry and Molecular Biology, and on the Committees of Immunology and Cancer Biology at the University of Chicago. Dr. Adams’ research is focused on understanding how events at the molecular level allow the immune system to differentiate between self and non-self with particular attention given to nonconventional T cell recognition, such as that of gamma delta T cells. The scientific approach she undertakes to tackle these questions spans multiple levels including genetics, protein biochemistry, structure, biophysics, function and cell biology and imaging. Dr. Adams is one of the pioneer researchers discovering how gamma delta T cells recognize antigens and how this recognition process regulates their activity in various tissues in which they reside.

Elizabeth Jaffee, M.D., currently serves as Deputy Director for the Johns Hopkins Kimmel Cancer Center, Associate Director of the Bloomberg-Kimmel Institute for Cancer Immunotherapy; Associate Director for Translational Research, Co-Director of Gastrointestinal cancer and diseases program, and Co-Director of the Skip Viragh Center for Pancreatic Cancer Clinical Research and Patient Care. Dr. Jaffee is chair and member of the National Cancer Advisory Board, and served as co-chair of the NCI Blue Ribbon Panel for the National Moonshot Initiative. Dr. Jaffee is an active member of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), and has just been named President-Elect of AACR (Free AACR Whitepaper) (2017-2018). She will assume the presidency in April, 2018.

Steven Leach, M.D., is the Director of the David M. Rubenstein Center for Pancreatic Cancer Research of Memorial Sloan-Kettering. Prior to this, Dr. Leach served as Professor of Surgery, Oncology and Cell Biology, and the Paul K. Neumann Professor in Pancreatic Cancer at Johns Hopkins Medicine. Dr. Leach received his undergraduate degree from Princeton University, where he currently serves on the Board of Trustees. He then pursued his MD degree at Emory University, followed by postdoctoral training at Yale University and at M.D. Anderson. Dr. Leach is also the current Chair of the Pancreatic Cancer Action Network’s Scientific and Medical Advisory Board.

George Miller, M.D., is the Director of S. Arthur Localio Laboratories, vice chair for research in NYU, Langone’s Department of Surgery and the leader of Perlmutter Cancer Center’s Immunology Program, as well as the director of the only training program in the country in gastrointestinal oncology that is funded by the National Institutes of Health. In addition to his laboratory research, Dr. Miller is a highly experienced pancreatic and hepatobiliary surgeon with an extensive background in the evaluation and treatment of pancreatic tumors, as well as liver, bile duct cancers.

Diane M. Simeone, M.D., is currently the director of the Pancreatic Cancer Center at the NYU School of Medicine and the Associate Director of Translational Research, Perlmutter Cancer Center, NYU Langone Medical Center. She is the chair-elect of the Scientific and Medical Advisory Board of the Pancreatic Cancer Action Network, one of the country’s leading organizations advancing the battle against the disease through research funding, community engagement and government advocacy. She is a member of the Institute of Medicine of the National Academy of Sciences, serves on the National Cancer Institute’s Pancreatic Cancer Task Force, and previously was president of the Society of University Surgeons and the American Pancreatic Association.

"We will be exploring both pancreatic cancer and other solid tumor types such as colorectal cancer. In addition to monotherapy, Dr. Miller’s work suggests that this approach may enhance the effect of checkpoint inhibitors that have historically not worked in pancreatic cancer opening up the possibility of combination therapy," commented Dr. Aleksandra Filipovic, Therapeutic Lead for Oncology at PureTech.

The underlying research described above has been supported by the NYU School of Medicine’s drug discovery accelerator, the Office of Therapeutics Alliances.

About NYU Office of Therapeutics Alliances and Office of Industrial Liaison
The NYU Office of Therapeutics Alliances (OTA) was created in 2013 to accelerate and de-risk drug discovery projects developed at NYU School of Medicine towards partnerships with investors, biopharma, and non-profits. The NYU Office of Industrial Liaison (OIL) promotes the commercial development of NYU discoveries and actively seeks commercial partners for licensing and research collaborations. Over the past ten years NYU has ranked first among all universities in income from technology licensing. For more information, please visit View Source and View Source

About Nybo Therapeutics
Nybo Therapeutics, a subsidiary of PureTech Health (LSE: PRTC), is developing first-in-class immuno-oncology programs dedicated to the targeting of immune-suppressive gamma delta T cells and other related mechanisms in pancreatic cancer and other solid tumors. It aims to address the great unmet need in malignancies with dismal prognoses that derive little benefit from current standards of care.

PureTech Health plc (PRTC.L) owns approximately 93.5% of the company on a diluted basis as of 11 April 2017. This calculation includes issued and outstanding shares as well as options to purchase shares and written commitments to issue shares or options, but excludes unallocated shares authorized to be issued pursuant to equity incentive plans.

About PureTech Health
PureTech Health (PureTech Health plc, PRTC.L) is an advanced, clinical-stage biopharmaceutical Company developing novel medicines that modulate the adaptive human systems. PureTech’s therapies target the dysfunctions in the immune, nervous, and gastro-intestinal systems by addressing the underlying pathophysiology of disease from a systems perspective rather than through a single receptor or pathway. The Company is advancing a rich pipeline that includes multiple human proof-of-concept studies and pivotal or registration studies expected to read out over the next 12-18 months. PureTech Health’s growing research and development pipeline has been developed in collaboration with some of the world’s leading scientific experts, who along with PureTech’s experienced team and a stellar Board identify, analyses and advance very selectively the opportunities the Company believes hold the most promise for patients. This experienced and engaged team places PureTech Health at the forefront of ground-breaking science and technological innovation and leads the Company between and beyond existing disciplines. For more information, visit www.puretechhealth.com or connect with us on Twitter @puretechh.

On April 11, 2017 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) reported that it will present at the following conferences (Press release, MorphoSys, APR 11, 2017, View Source [SID1234556344]):

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10th Kempen Life Sciences Conference
Date: April 19, 2017
Venue: Amsterdam, Netherlands
Presenter: Jens Holstein, Chief Financial Officer of MorphoSys AG

UBS Global Healthcare Conference
Date: May 22/23, 2017
Venue: New York, NY, USA
Presenter: Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG

Berenberg European Conference
Date: May 24, 2017
Venue: Tarrytown, NY, USA
Presenter: Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG

A PDF version of the presentation will be provided at www.morphosys.com.

The Annual General Meeting of MorphoSys AG will take place on May 17, 2017 in Munich. A live webcast of the event and all related information are available on www.morphosys.com/agm.