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Results to be presented at the 2017 American Society of Clinical Oncology Annual Meeting Phase 2 clinical trial to be initiated in second half of 2017 exploring two metastatic breast cancer populations: HER2-positive patients and hormone receptor-positive/HER2-low patients UTRECHT, The Netherlands, May 17, 2017 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics, today announced the results of their first-in-human Phase 1/2 study of MCLA-128 in solid tumors, including final Phase 1 data and promising preliminary activity in patients with HER2-positive metastatic breast cancer (MBC) from the Phase 2 portion of the trial.  MCLA-128 is a full-length IgG bispecific antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) activity targeting HER2 and HER3 receptors.  The results will be presented in a poster session on the morning of June 5, 2017 at the American Society of Clinical Oncology (ASCO) Annual Meeting. In the Phase 1 portion of the Phase 1/2 study, the recommended Phase 2 dose (RP2D) for future studies with MCLA-128 was established as 750 mg every 3 weeks, based on safety and pharmacokinetic data.  The Phase 2 portion of the study is ongoing, exploring selected metastatic indications including breast, endometrial, ovarian, gastric and non-small cell lung cancers.  MCLA-128 was well tolerated, with the ongoing Phase 2 portion confirming the safety profile seen in the dose escalation cohort.  The most frequent adverse events observed were mild (G1/G2) infusion-related reactions and gastrointestinal toxicities.  No clinically significant cardiotoxicity was reported. As part of the ongoing study, a cohort of 11 HER2-positive MBC patients has been treated with single agent MCLA-128 (9 patients at RP2D and 2 patients at 480 mg q3 weeks from part 1). These MBC patients were all heavily pretreated, having received a median of 6 prior lines of metastatic therapy, all having 2-5 prior HER2 inhibitor therapies, and some of the patients with outright disease progression to the last line of therapy.  One MBC patient achieved a confirmed partial response (>8+ months) and 7 had stable disease (including 4 sustained stabilizations lasting ≥5 months).  The clinical benefit rate (complete and partial responses plus stable disease lasting at least 12 weeks) among the cohort of MBC patients was 64% (7/11).  Evaluation of additional MBC patients and other indications is ongoing. With single agent activity established in MBC, Merus also announced today plans to initiate a Phase 2, open-label, multicenter, international clinical study to evaluate MCLA-128-based combinations in two MBC populations: 1) confirmed HER2-positive MBC patients (progressing on anti-HER2 therapies including TDM-1) who will receive MCLA-128 in combination with trastuzumab and chemotherapy, and 2) confirmed hormone receptor positive status and HER2-low (IHC HER2 1+ or 2+ and FISH negative for HER2 amplification) MBC patients progressing on hormone therapies and CDK4/6 who will receive MCLA-128 in combination with fulvestrant.  In addition to these early clinical results, study of MCLA-128 in these combinations and populations is supported by activity observed in preclinical models.  This Phase 2 study is expected to be launched in Europe and the US in the second half of 2017. “These clinical results demonstrate that single agent MCLA-128 is active and well tolerated in heavily pretreated metastatic breast cancer patients,” said Professor Josep Tabernero, MD, PhD, Head of Medical Oncology and the Institute of Oncology at Vall d'Hebron University Hospital.  “This positions MCLA-128 as a promising agent for further development as combination therapy in the treatment paradigm of metastatic breast cancer.  I look forward to seeing how these results translate in the planned Phase 2 combination studies.” “With demonstrated activity in an aggressive disease population, our goal now is to understand where MCLA-128, in combination with current standards of care, can address unmet needs in this disease and deliver improved outcomes and greater optionality to patients in need,” said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus.  “We see opportunities in HER2-positive MBC and hormone-resistant estrogen receptor positive MBC, where escape from hormone therapy is often via HER2/3 signaling.  We also look forward to continuing to evaluate MCLA-128 in other tumor types, including endometrial, ovarian, gastric and NSCLC cancers in this ongoing study.” About MCLA-128 MCLA-128 is designed to block HER3/heregulin-dependent tumor growth and survival as well as enhance immune-mediated cytotoxicity in tumors. MCLA-128 employs a ‘dock and block’ mechanism in which the mode of HER2 receptor binding orientates the HER3 binding arm to effectively block oncogenic signaling through the HER2:HER3 heterodimer even under high heregulin concentrations.  In addition, MCLA-128 is engineered for enhanced ADCC in order to recruit and activate immune effector cells to directly kill tumor cells. About Merus N.V. Merus is a clinical-stage immuno-oncology company developing innovative full-length human bispecific antibody therapeutics, referred to as Biclonics®. Biclonics® are based on the full-length IgG format, are manufactured using industry standard processes and have been observed in preclinical studies to share several features of conventional monoclonal antibodies, such as long half-life and low immunogenicity.  Merus' lead bispecific antibody candidate, MCLA-128, is being evaluated in a Phase 1/2 clinical trial in Europe as a potential treatment for HER2-expressing solid tumors.  Merus' second bispecific antibody candidate, MCLA-117, is being developed in a Phase 1 clinical trial in patients with acute myeloid leukemia.  The Company also has a pipeline of proprietary bispecific antibody candidates in preclinical development, including MCLA-158, which is designed to bind to cancer stem cells and is being developed as a potential treatment for colorectal cancer and other solid tumors, as well as Biclonics® designed to bind to various combinations of immunomodulatory molecules, including PD-1 and PD-L1. Forward Looking Statement Except for the historical information set forth herein, this press release contains predictions, estimates and other forward-looking statements, including without limitation, statements regarding: the impact of our collaboration with Incyte on the clinical development of our bispecific antibody candidates, anticipated clinical data points for 2017, the timing of presentations, clinical data announcements, and regulatory filings, the potential payments under our collaboration agreement with Incyte, each statement under “Anticipated Milestones,” and the treatment potential of our bispecific antibody candidates. These forward-looking statements are based on management’s current expectations.  These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or bispecific antibody candidates; potential delays in regulatory approval, which would impact the ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; we may not identify suitable bispecific antibody candidates under our collaboration with Incyte or Incyte may fail to perform adequately under our collaboration; and our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts. These and other important factors discussed under the caption “Risk Factors” in our Form 20-F filed with the Securities and Exchange Commission, or SEC, on April 28, 2017, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release.  Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law.  These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.


Results to be presented at the 2017 American Society of Clinical Oncology Annual Meeting Phase 2 clinical trial to be initiated in second half of 2017 exploring two metastatic breast cancer populations: HER2-positive patients and hormone receptor-positive/HER2-low patients UTRECHT, The Netherlands, May 17, 2017 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics, today announced the results of their first-in-human Phase 1/2 study of MCLA-128 in solid tumors, including final Phase 1 data and promising preliminary activity in patients with HER2-positive metastatic breast cancer (MBC) from the Phase 2 portion of the trial.  MCLA-128 is a full-length IgG bispecific antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) activity targeting HER2 and HER3 receptors.  The results will be presented in a poster session on the morning of June 5, 2017 at the American Society of Clinical Oncology (ASCO) Annual Meeting. In the Phase 1 portion of the Phase 1/2 study, the recommended Phase 2 dose (RP2D) for future studies with MCLA-128 was established as 750 mg every 3 weeks, based on safety and pharmacokinetic data.  The Phase 2 portion of the study is ongoing, exploring selected metastatic indications including breast, endometrial, ovarian, gastric and non-small cell lung cancers.  MCLA-128 was well tolerated, with the ongoing Phase 2 portion confirming the safety profile seen in the dose escalation cohort.  The most frequent adverse events observed were mild (G1/G2) infusion-related reactions and gastrointestinal toxicities.  No clinically significant cardiotoxicity was reported. As part of the ongoing study, a cohort of 11 HER2-positive MBC patients has been treated with single agent MCLA-128 (9 patients at RP2D and 2 patients at 480 mg q3 weeks from part 1). These MBC patients were all heavily pretreated, having received a median of 6 prior lines of metastatic therapy, all having 2-5 prior HER2 inhibitor therapies, and some of the patients with outright disease progression to the last line of therapy.  One MBC patient achieved a confirmed partial response (>8+ months) and 7 had stable disease (including 4 sustained stabilizations lasting ≥5 months).  The clinical benefit rate (complete and partial responses plus stable disease lasting at least 12 weeks) among the cohort of MBC patients was 64% (7/11).  Evaluation of additional MBC patients and other indications is ongoing. With single agent activity established in MBC, Merus also announced today plans to initiate a Phase 2, open-label, multicenter, international clinical study to evaluate MCLA-128-based combinations in two MBC populations: 1) confirmed HER2-positive MBC patients (progressing on anti-HER2 therapies including TDM-1) who will receive MCLA-128 in combination with trastuzumab and chemotherapy, and 2) confirmed hormone receptor positive status and HER2-low (IHC HER2 1+ or 2+ and FISH negative for HER2 amplification) MBC patients progressing on hormone therapies and CDK4/6 who will receive MCLA-128 in combination with fulvestrant.  In addition to these early clinical results, study of MCLA-128 in these combinations and populations is supported by activity observed in preclinical models.  This Phase 2 study is expected to be launched in Europe and the US in the second half of 2017. “These clinical results demonstrate that single agent MCLA-128 is active and well tolerated in heavily pretreated metastatic breast cancer patients,” said Professor Josep Tabernero, MD, PhD, Head of Medical Oncology and the Institute of Oncology at Vall d'Hebron University Hospital.  “This positions MCLA-128 as a promising agent for further development as combination therapy in the treatment paradigm of metastatic breast cancer.  I look forward to seeing how these results translate in the planned Phase 2 combination studies.” “With demonstrated activity in an aggressive disease population, our goal now is to understand where MCLA-128, in combination with current standards of care, can address unmet needs in this disease and deliver improved outcomes and greater optionality to patients in need,” said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus.  “We see opportunities in HER2-positive MBC and hormone-resistant estrogen receptor positive MBC, where escape from hormone therapy is often via HER2/3 signaling.  We also look forward to continuing to evaluate MCLA-128 in other tumor types, including endometrial, ovarian, gastric and NSCLC cancers in this ongoing study.” About MCLA-128 MCLA-128 is designed to block HER3/heregulin-dependent tumor growth and survival as well as enhance immune-mediated cytotoxicity in tumors. MCLA-128 employs a ‘dock and block’ mechanism in which the mode of HER2 receptor binding orientates the HER3 binding arm to effectively block oncogenic signaling through the HER2:HER3 heterodimer even under high heregulin concentrations.  In addition, MCLA-128 is engineered for enhanced ADCC in order to recruit and activate immune effector cells to directly kill tumor cells. About Merus N.V. Merus is a clinical-stage immuno-oncology company developing innovative full-length human bispecific antibody therapeutics, referred to as Biclonics®. Biclonics® are based on the full-length IgG format, are manufactured using industry standard processes and have been observed in preclinical studies to share several features of conventional monoclonal antibodies, such as long half-life and low immunogenicity.  Merus' lead bispecific antibody candidate, MCLA-128, is being evaluated in a Phase 1/2 clinical trial in Europe as a potential treatment for HER2-expressing solid tumors.  Merus' second bispecific antibody candidate, MCLA-117, is being developed in a Phase 1 clinical trial in patients with acute myeloid leukemia.  The Company also has a pipeline of proprietary bispecific antibody candidates in preclinical development, including MCLA-158, which is designed to bind to cancer stem cells and is being developed as a potential treatment for colorectal cancer and other solid tumors, as well as Biclonics® designed to bind to various combinations of immunomodulatory molecules, including PD-1 and PD-L1. Forward Looking Statement Except for the historical information set forth herein, this press release contains predictions, estimates and other forward-looking statements, including without limitation, statements regarding: the impact of our collaboration with Incyte on the clinical development of our bispecific antibody candidates, anticipated clinical data points for 2017, the timing of presentations, clinical data announcements, and regulatory filings, the potential payments under our collaboration agreement with Incyte, each statement under “Anticipated Milestones,” and the treatment potential of our bispecific antibody candidates. These forward-looking statements are based on management’s current expectations.  These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or bispecific antibody candidates; potential delays in regulatory approval, which would impact the ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; we may not identify suitable bispecific antibody candidates under our collaboration with Incyte or Incyte may fail to perform adequately under our collaboration; and our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts. These and other important factors discussed under the caption “Risk Factors” in our Form 20-F filed with the Securities and Exchange Commission, or SEC, on April 28, 2017, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release.  Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law.  These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.


Results to be presented at the 2017 American Society of Clinical Oncology Annual Meeting Phase 2 clinical trial to be initiated in second half of 2017 exploring two metastatic breast cancer populations: HER2-positive patients and hormone receptor-positive/HER2-low patients UTRECHT, The Netherlands, May 17, 2017 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics, today announced the results of their first-in-human Phase 1/2 study of MCLA-128 in solid tumors, including final Phase 1 data and promising preliminary activity in patients with HER2-positive metastatic breast cancer (MBC) from the Phase 2 portion of the trial.  MCLA-128 is a full-length IgG bispecific antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) activity targeting HER2 and HER3 receptors.  The results will be presented in a poster session on the morning of June 5, 2017 at the American Society of Clinical Oncology (ASCO) Annual Meeting. In the Phase 1 portion of the Phase 1/2 study, the recommended Phase 2 dose (RP2D) for future studies with MCLA-128 was established as 750 mg every 3 weeks, based on safety and pharmacokinetic data.  The Phase 2 portion of the study is ongoing, exploring selected metastatic indications including breast, endometrial, ovarian, gastric and non-small cell lung cancers.  MCLA-128 was well tolerated, with the ongoing Phase 2 portion confirming the safety profile seen in the dose escalation cohort.  The most frequent adverse events observed were mild (G1/G2) infusion-related reactions and gastrointestinal toxicities.  No clinically significant cardiotoxicity was reported. As part of the ongoing study, a cohort of 11 HER2-positive MBC patients has been treated with single agent MCLA-128 (9 patients at RP2D and 2 patients at 480 mg q3 weeks from part 1). These MBC patients were all heavily pretreated, having received a median of 6 prior lines of metastatic therapy, all having 2-5 prior HER2 inhibitor therapies, and some of the patients with outright disease progression to the last line of therapy.  One MBC patient achieved a confirmed partial response (>8+ months) and 7 had stable disease (including 4 sustained stabilizations lasting ≥5 months).  The clinical benefit rate (complete and partial responses plus stable disease lasting at least 12 weeks) among the cohort of MBC patients was 64% (7/11).  Evaluation of additional MBC patients and other indications is ongoing. With single agent activity established in MBC, Merus also announced today plans to initiate a Phase 2, open-label, multicenter, international clinical study to evaluate MCLA-128-based combinations in two MBC populations: 1) confirmed HER2-positive MBC patients (progressing on anti-HER2 therapies including TDM-1) who will receive MCLA-128 in combination with trastuzumab and chemotherapy, and 2) confirmed hormone receptor positive status and HER2-low (IHC HER2 1+ or 2+ and FISH negative for HER2 amplification) MBC patients progressing on hormone therapies and CDK4/6 who will receive MCLA-128 in combination with fulvestrant.  In addition to these early clinical results, study of MCLA-128 in these combinations and populations is supported by activity observed in preclinical models.  This Phase 2 study is expected to be launched in Europe and the US in the second half of 2017. “These clinical results demonstrate that single agent MCLA-128 is active and well tolerated in heavily pretreated metastatic breast cancer patients,” said Professor Josep Tabernero, MD, PhD, Head of Medical Oncology and the Institute of Oncology at Vall d'Hebron University Hospital.  “This positions MCLA-128 as a promising agent for further development as combination therapy in the treatment paradigm of metastatic breast cancer.  I look forward to seeing how these results translate in the planned Phase 2 combination studies.” “With demonstrated activity in an aggressive disease population, our goal now is to understand where MCLA-128, in combination with current standards of care, can address unmet needs in this disease and deliver improved outcomes and greater optionality to patients in need,” said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus.  “We see opportunities in HER2-positive MBC and hormone-resistant estrogen receptor positive MBC, where escape from hormone therapy is often via HER2/3 signaling.  We also look forward to continuing to evaluate MCLA-128 in other tumor types, including endometrial, ovarian, gastric and NSCLC cancers in this ongoing study.” About MCLA-128 MCLA-128 is designed to block HER3/heregulin-dependent tumor growth and survival as well as enhance immune-mediated cytotoxicity in tumors. MCLA-128 employs a ‘dock and block’ mechanism in which the mode of HER2 receptor binding orientates the HER3 binding arm to effectively block oncogenic signaling through the HER2:HER3 heterodimer even under high heregulin concentrations.  In addition, MCLA-128 is engineered for enhanced ADCC in order to recruit and activate immune effector cells to directly kill tumor cells. About Merus N.V. Merus is a clinical-stage immuno-oncology company developing innovative full-length human bispecific antibody therapeutics, referred to as Biclonics®. Biclonics® are based on the full-length IgG format, are manufactured using industry standard processes and have been observed in preclinical studies to share several features of conventional monoclonal antibodies, such as long half-life and low immunogenicity.  Merus' lead bispecific antibody candidate, MCLA-128, is being evaluated in a Phase 1/2 clinical trial in Europe as a potential treatment for HER2-expressing solid tumors.  Merus' second bispecific antibody candidate, MCLA-117, is being developed in a Phase 1 clinical trial in patients with acute myeloid leukemia.  The Company also has a pipeline of proprietary bispecific antibody candidates in preclinical development, including MCLA-158, which is designed to bind to cancer stem cells and is being developed as a potential treatment for colorectal cancer and other solid tumors, as well as Biclonics® designed to bind to various combinations of immunomodulatory molecules, including PD-1 and PD-L1. Forward Looking Statement Except for the historical information set forth herein, this press release contains predictions, estimates and other forward-looking statements, including without limitation, statements regarding: the impact of our collaboration with Incyte on the clinical development of our bispecific antibody candidates, anticipated clinical data points for 2017, the timing of presentations, clinical data announcements, and regulatory filings, the potential payments under our collaboration agreement with Incyte, each statement under “Anticipated Milestones,” and the treatment potential of our bispecific antibody candidates. These forward-looking statements are based on management’s current expectations.  These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or bispecific antibody candidates; potential delays in regulatory approval, which would impact the ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; we may not identify suitable bispecific antibody candidates under our collaboration with Incyte or Incyte may fail to perform adequately under our collaboration; and our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts. These and other important factors discussed under the caption “Risk Factors” in our Form 20-F filed with the Securities and Exchange Commission, or SEC, on April 28, 2017, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release.  Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law.  These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.


News Article | May 4, 2017
Site: globenewswire.com

MENLO PARK, Calif., May 04, 2017 (GLOBE NEWSWIRE) -- GRAIL, Inc., a life sciences company whose mission is to detect cancer early when it can be cured, today announced the appointment of José Baselga, M.D., Ph.D., Brook Byers and Kaye Foster to its Board of Directors. The three new board members will join GRAIL’s existing board of directors: Bill Rastetter, Jeff Huber, Richard Klausner and Robert Nelsen. “I am very pleased to welcome José, Brook and Kaye, three extremely seasoned and accomplished executives, to our Board at this pivotal time for GRAIL,” said Jeff Huber, GRAIL’s Chief Executive Officer. “With these leaders, we are increasing the breadth of strategic leadership, industry experience and operational excellence within our Board. As we work to expand our operations and build integrated programs in science, technology and clinical development, their expertise and counsel will be invaluable. We are looking forward to working with them in our pursuit to transform the way cancer is diagnosed and treated.” José Baselga is the Physician-in-Chief and Chief Medical Officer at Memorial Sloan Kettering Cancer Center (MSK) and Professor of Medicine at Weill Cornell Medical College. Prior to MSK, Dr. Baselga was the Chief of the Division of Hematology/Oncology, Associate Director of the Massachusetts General Hospital Cancer Center and Professor of Medicine at Harvard Medical School. He also was the Chairman of Medical Oncology and Founding Director of the Vall d’Hebron Institute of Oncology in Barcelona, Spain. Dr. Baselga is a past President of the American Association of Cancer Research (AACR) and of the European Society for Medical Oncology, and a past member of the Board of Directors for the American Society of Clinical Oncology (ASCO) and AACR. He is an elected member of the National Academy of Medicine, the American Society of Clinical Investigation, the Association of American Physicians, and a Fellow of the AACR Academy. He is a past member of the Editorial Boards of Cancer Cell, Journal of Clinical Oncology, and Clinical Cancer Research and is the founding editor-in-chief for the AACR flagship journal Cancer Discovery. In addition to joining GRAIL’s Board of Directors, Dr. Baselga is also the Chairman of GRAIL’s Scientific Advisory Board. Dr. Baselga earned his M.D. from Universitat Autonoma de Barcelona and completed residencies in internal medicine at Vall d'Hebron University Hospital and SUNY - Health Sciences Center at Brooklyn. Brook Byers is a senior partner and founding member of the venture capital firm Kleiner Perkins Caufield & Byers (KPCB). Mr. Byers formed the first life sciences practice group in the venture capital profession and led KPCB to become a premier venture capital firm in the medical, healthcare, and biotechnology sectors. Brook has been a pioneer in the fields of precision medicine, molecular diagnostics and genomics, serving as a Steering Committee member for the Coalition of 21st Century Medicine, and through investment and board leadership in companies such as Foundation Medicine, Genomic Health and Veracyte. Brook currently serves on the Board of Directors of Cell Design Labs, Enjoy, Newsela, and Zephyr Health. He also serves on the Board of Overseers of the University of California San Francisco medical campus and hospitals, the Stanford Medicine Advisory Council and the Board of Directors of the New Schools Foundation. Mr. Byers holds a bachelor’s degree in Electrical Engineering from Georgia Institute of Technology and an MBA from Stanford University. He is also the recipient of an honorary Ph.D. from Georgia Institute of Technology. Kaye Foster has over 25 years of experience in the pharmaceutical industry leading large, global human resources organizations. She currently advises CEOs and leadership teams focusing on business transformations, talent management strategy and Human Resources strategy development and implementation. Most recently, she was Senior Vice President, Global Human Resources for Onyx Pharmaceuticals where she led all aspects of human resources for U.S. and global operations. Ms. Foster joined Onyx from Johnson & Johnson where she served as an Executive Committee member and Chief Human Resources Officer, leading a worldwide team of over 3,000 human resources professionals. She also held several Human Resources executive positions with Pfizer Inc., supporting its pharmaceutical businesses in Japan, Asia, Africa, Middle East and Latin America, and she led the integration of both the Warner-Lambert and Pharmacia mergers for these regions. She is a Senior Advisor with The Boston Consulting Group (BCG) and sits on the Board of Directors of Agios Pharmaceuticals as well as the Board of Trustees of Spelman College, Stanford Healthcare, ValleyCare Health System and Glide Memorial Church in San Francisco. Kaye holds a bachelor’s degree from Baruch College and an MBA from Columbia Business School. About GRAIL GRAIL is a life sciences company whose mission is to detect cancer early when it can be cured. GRAIL is using the power of high-intensity sequencing, population-scale clinical trials, and state of the art Computer Science and Data Science to enhance the scientific understanding of cancer biology and develop blood tests for early-stage cancer detection. The company’s funding was led by ARCH Venture Partners and includes Amazon, Bezos Expeditions, Bill Gates, Bristol-Myers Squibb, Celgene, GV, Illumina, Johnson & Johnson Innovation, Merck, McKesson Ventures, Sutter Hill Ventures, Tencent, Varian Medical Systems, and other financial partners. For more information, please visit www.grail.com.


SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that data from three Phase III studies of its investigational medicine OCREVUS™ (ocrelizumab) – the OPERA I and OPERA II studies in relapsing multiple sclerosis (RMS) and the ORATORIO study in primary progressive multiple sclerosis (PPMS) – were published in the December 21, 2016 online issue of the New England Journal of Medicine (NEJM). Data from the OCREVUS Phase III studies showed consistent and clinically meaningful reductions in major markers of disease activity and progression compared with Rebif® (interferon beta-1a) in RMS and with placebo in PPMS. The primary endpoint was met in all three studies, which includes relative reduction of annualized relapse rate in the RMS studies and relative reduction in the progression of clinical disability sustained for at least 12 weeks in the PPMS study. Key secondary endpoints in all three studies were also met, including multiple measures of disability progression and brain lesion activity. “These publications that indicate that B cells play a central role in MS are the result of a longstanding collaboration between the scientific community and industry for the benefit of people with MS,” said Stephen Hauser, M.D., Chair of the Scientific Steering Committee of the OPERA studies, Director of the Weill Institute for Neurosciences and Chair of the Department of Neurology at the University of California, San Francisco. “In the OPERA I and OPERA II RMS studies, OCREVUS consistently and significantly reduced disease activity and disability progression compared with a standard-of-care high-dose interferon while demonstrating a favorable safety profile. The consistency of these pioneering data, the effect seen in these clinical studies and the favorable safety profile may support treating MS earlier with a high-efficacy disease-modifying medicine.” Data from two identical studies (OPERA I and OPERA II) in RMS showed OCREVUS was superior to high-dose Rebif (interferon beta-1a), a well-established MS therapy, in reducing three major markers of disease activity: relapses (primary endpoint), disability progression and brain lesion activity over the two-year controlled treatment period. In a separate PPMS study (ORATORIO), OCREVUS significantly reduced the risk of confirmed disability progression sustained for at least 12 weeks (primary endpoint) and 24 weeks (a key secondary endpoint) compared with placebo. OCREVUS treatment was also superior to placebo on other key measures of disease progression in PPMS patients including the time required to walk 25 feet, the volume of chronic brain lesions and brain volume loss. “OCREVUS is the first and only investigational medicine to significantly reduce the progression of physical disability in primary progressive MS in a large Phase III study,” said Xavier Montalban, M.D., Ph.D., Chair of the Scientific Steering Committee of the ORATORIO study and Professor of Neurology and Neuroimmunology at Vall d’Hebron University Hospital, Research Institute and Cemcat, Barcelona, Spain. “Over the last decade, other molecules have tried and failed to demonstrate efficacy for PPMS, so the positive results for OCREVUS mark an important step in our understanding of this highly disabling form of the disease.” The OCREVUS safety profile was evaluated in the three Phase III studies. In the RMS studies, the proportion of patients with serious adverse events and serious infections was similar between the OCREVUS and interferon beta-1a treatment groups. In the PPMS study, the proportion of patients with adverse events and serious adverse events was similar between the OCREVUS and placebo treatment groups. Safety analyses continue in the open-label extension studies in both RMS and PPMS. Marketing applications for OCREVUS, submitted for RMS and PPMS, have been accepted and are currently under review by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). As previously announced, OCREVUS was granted Priority Review Designation by the FDA with a targeted action date of March 28, 2017. OCREVUS™ is the proprietary name submitted to the FDA for the investigational medicine ocrelizumab. About the OPERA I and OPERA II studies in RMS OPERA I and OPERA II are Phase III, randomized, double-blind, double-dummy, global multi-center studies evaluating the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion every six months) compared with interferon beta-1a (44 mcg administered by subcutaneous injection three times per week) in 1,656 people with relapsing forms of MS. In these studies, relapsing MS (RMS) was defined as relapsing-remitting MS (RRMS) and secondary progressive MS (SPMS) with relapses. The primary and key secondary endpoints were previously presented at the 2015 congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Data from the Phase III OPERA studies in patients with RMS showed: As previously reported at the 2016 American Academy of Neurology Annual Meeting (AAN), OCREVUS increased the proportion of patients who achieved no evidence of disease activity (NEDA) by 64 percent and 89 percent compared with interferon beta-1a at 96 weeks in OPERA I and OPERA II, respectively (p<0.001 and p<0.001). The exploratory endpoint is based on a combination of three major markers of disease activity (relapses, disability progression and inflammatory and chronic MRI activity) and provides a more comprehensive measurement of disease activity and the effect of treatment than any single endpoint. Overall, the proportion of patients in the OCREVUS group with adverse events was similar to interferon beta-1a in both studies (80.1 percent in the OCREVUS group vs. 80.9 percent in the interferon beta-1a group in OPERA I and 86.3 percent in the OCREVUS group vs. 85.6 percent in the interferon beta-1a group in OPERA II); the most common adverse event associated with OCREVUS was infusion-related reactions (34.3 percent of patients who received OCREVUS experienced at least one infusion-related reaction vs. 9.9 percent for interferon beta-1a). The proportion of patients in the OCREVUS group with serious adverse events, including serious infections, was also similar to interferon beta-1a (6.9 percent in the OCREVUS group vs. 7.8 percent in the interferon beta-1a group in OPERA I and 7.0 percent in the OCREVUS group vs. 9.6 percent in the interferon beta-1a group in OPERA II). About the ORATORIO study in PPMS ORATORIO is a Phase III, randomized, double-blind, global multi-center study evaluating the efficacy and safety of OCREVUS (600 mg administered by intravenous infusion every six months; given as two 300 mg infusions two weeks apart) compared with placebo in 732 people with PPMS. In contrast to the OPERA I and OPERA II studies, where the blinded treatment period was two years, the blinded treatment period of the ORATORIO study continued beyond that until all patients had received at least 120 weeks of either OCREVUS or placebo and a predefined number of confirmed disability progression (CDP) events was reached overall in the study. The primary and key secondary endpoints were previously presented at the 2015 congress of ECTRIMS. Data from the Phase III ORATORIO study in patients with PPMS showed: Overall, the proportion of patients in the OCREVUS group with adverse events was similar to placebo (95.1 percent vs. 90.0 percent, respectively); the most common adverse event associated with OCREVUS was infusion-related reactions (39.9 percent vs. 25.5 percent for placebo). The proportion of patients in the OCREVUS group with serious adverse events, including serious infections, was also similar to placebo (20.4 percent vs. 22.2 percent, respectively). OCREVUS is an investigational, humanized monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, and therefore important functions of the immune system may be preserved. Multiple sclerosis (MS) is a chronic disease that affects an estimated 400,000 people in the U.S., for which there is currently no cure. MS occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the brain, spinal cord and optic nerves, causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including muscle weakness, fatigue and difficulty seeing, and may eventually lead to disability. Most people with MS experience their first symptom between 20 and 40 years of age, making the disease the leading cause of non-traumatic disability in younger adults. Approximately 95 percent of people with MS have a relapsing form or primary progressive MS at diagnosis. Relapsing-remitting MS (RRMS) is the most common form of the disease and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Over time, some people with RRMS experience steadily worsening symptoms and transition to secondary progressive MS (SPMS), with or without relapses. Disease activity and progression can occur even when people do not show signs or symptoms of MS, despite available relapsing MS treatments. Primary progressive MS (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 10-15 percent of people with MS are diagnosed with the primary progressive form of the disease. There are no approved treatments for PPMS. Neuroscience is a major focus of research and development at Genentech and Roche. The company’s goal is to develop treatment options based on the biology of the nervous system to help improve the lives of people with chronic and potentially devastating diseases. Roche has more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, Alzheimer’s disease, spinal muscular atrophy, Parkinson’s disease and autism. Founded 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com. All trademarks used or mentioned in this release are protected by law. Rebif is a registered trademark of Merck KGaA and EMD Serono, Inc.


News Article | December 1, 2016
Site: www.eurekalert.org

Researchers of the Sarcoma research group of the Bellvitge Biomedical Research Institute (IDIBELL), led by Dr. Òscar Martínez-Tirado, have first described the methylation profile of Ewing's sarcoma (ES), a cancer of bone and soft tissues that mainly affects children and teenagers. Their analysis has unveiled the potential of the PTRF gene as a prognostic marker of the disease and as a possible future therapeutic target in conjunction with the new genomic editing tools available. "This is the first time that the methylation profile of Ewing's sarcoma has been described," explains Dr. Òscar Martínez-Tirado, lead author of the study. DNA methylation is a type of epigenetic modification capable of controlling gene expression, that is, it can activate or deactivate genes that enhance to or block characteristics and processes in individuals, including the development of tumors. Using bioinformatic tools, the research team looked for common elements that allowed them to relate the set of differentially hypomethylated or hypermethylated genes they found in the tumor samples. The researchers identified a group of 12 genes related to the structure of the cell membrane; Among them, the precursor of the protein PTRF particularly called their attention by its relation with the caveolae, small invaginations that are present in the membrane of some cells; the IDIBELL group has extensive experience in the study of these structures and their relationship with ES. The team correlated the presence of PTRF in samples from 67 patients. "Initially, we saw that those patients who express PTRF have a better survival, therefore, we could consider this protein as a potential marker of prognosis of the disease," concludes Martinez-Tirado. Normal cells with caveolae express both the PTRF protein and caveolin-1 (CAV1), another protein related to caveolae formation. In contrast, tumor cells in ES do not have caveolae, nor express PTRF. "This made us think about the possibility of exogenously reintroducing the precursor gene PTRF into the study cell lines", explains the researcher. "In those that also expressed CAV1, the reintroduction of PTRF triggered caveolae formation. For tumor cells, this modification of the structure is so stressful that it destroys them". In addition, researchers have shown that the formation of the caveolae in these cells activates a known cell death signaling pathway promoted by the p53 protein. Current epigenetic drugs are rather nonspecific, but new CRISPR genomic editing tools have the potential to be used to demethylate specific genes from a tumor cell in the future. "If we are able to specifically act on the PTRF promoter gene so that the protein is expressed at normal levels, we would induce cell death and therefore we would have a promising new personalized therapeutic option for ES." This has been a highly collaborative work, both at the research level, as researchers by two groups from IDIBELL's epigenetics and cancer biology program, Germans Trias Institute, Institute of biomedicine of Seville, University Hospital la Paz, Children's University Hospital Niño Jesús, San Juan de Dios Hospital, Vall d'Hebron University Hospital and Virgen del Rocío University Hospital have collaborated, as well as at a financial level level, given that the project is funded by the Carlos III Health Institute, the AECC and the Alba Pérez Foundation.


News Article | December 19, 2016
Site: www.eurekalert.org

Mosaic Biomedicals SL today announced a merger with Northern Biologics Inc. that will enable the accelerated development of MSC-1, a humanized antibody expected to begin clinical trials across several tumor types in 2017, with multiple sites planned throughout Europe and North America. MSC-1 is a first-in-class antibody that targets LIF, a pleiotropic cytokine that is overexpressed in certain solid tumors. LIF promotes cancer progression by regulating the tumor microenvironment as well as inducing self-renewal in tumor-initiating cells. Pioneering work on the role of LIF in oncogenesis, and the discovery of MSC-1, was performed under the leadership of Joan Seoane, Ph.D., a co-founder of Mosaic and Director of Translational Research at the Vall d'Hebron Institute of Oncology (VHIO). Versant Ventures has expanded its series A commitment to the company and Celgene Corp. has exercised an option to acquire certain rights to the MSC-1 program under its existing agreement with Northern Biologics. Following the transactions, full funding is in place for the early clinical development of MSC-1, in addition to a preclinical portfolio of therapeutic antibodies. Dr. Seoane, who has joined the Board of Directors of the merged company, observes: "This merger is a fantastic way for the Mosaic Biomedicals team to join forces with Northern and bring together the capital, know-how, talent, and international leadership required to develop the most effective therapeutic antibodies as quickly as possible." "With the support of key partners and the financial strength to give MSC-1 the highest chance of success, this agreement represents unparalleled opportunity for Mosaic to reach its full potential," added Dr. Judit Anido, co-founder of Mosaic and member of the Executive Team. Dr. José Baselga, also a Mosaic co-founder, will serve as Chair and Senior Medical Advisor on the Scientific Advisory Board of the newly merged company. Mosaic was established by Dr. Seoane at VHIO, a comprehensive cancer center set within the privileged location of the Vall d´Hebron University Hospital. VHIO researchers and physician-scientists adopt a purely translational research model, working as multidisciplinary teams to accelerate and advance personalized and targeted therapies against cancer. Mosaic is VHIO's first spinout company, set up in partnership with ICREA and the Vall d'Hebron Research Institute (VHIR). Public funding received from the Retos de Colaboración program, ENISA, CDTI and ERC´s PoC, among others, have been essential in fueling Mosaic's creation, aimed at rapidly translating scientific discovery into benefits at the patient level. The company will also become an economic engine returning value to the very society that has invested in cancer research" say Dr. Seoane and Dr. Anido, who also gratefully acknowledged the support received from the first Business Angels and friends who believed in the project from the outset and provided funding for the initial set-up steps. Subsequent investment from Versant and Caixa Capital Risc, spurred further development of Mosaic Biomedicals and drove MSC-1 to the verge of clinical trials. The merger with Northern Biologics and significant new investment has further raised the team's ambitions and will bring the project to an exciting new stage in clinical development. "None of this would have been possible without outstanding teamwork -- from within my research group in particular, working daily on what really matters, namely, pushing the boundaries in cancer science. This tremendous undertaking, now supported by optimal financial and technical conditions, will allow us to continue to progress and ultimately improve the treatment and care of an increasing number of patients with cancer," said Dr. Seoane. Mosaic Biomedicals is a Barcelona-based company that develops personalized cancer treatments with a dual mechanism of action to eliminate cancer stem cells and reactivate the tumor's immune system. Mosaic is a spin-off of the Vall d'Hebron Institute of Oncology, Institució Catalana de Recerca i Estudis Avançats (ICREA) and the Vall d'Hebron Institute of Research (VHIR), backed by Versant Ventures, Caixa Capital Risc and several angel investors. Northern Biologics was launched in June 2014 by Blueline Bioscience, a Canadian biotechnology incubator backed by venture capital firm Versant Ventures, in partnership with the University of Toronto and University Health Network's Princess Margaret Cancer Centre. Headquartered in the MaRS Discovery District of Toronto, the company is developing a portfolio of antibody-based therapeutics for oncology and fibrosis.

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