Medtronic EVP & RTG President Geoff Martha to Speak at Citi Global Healthcare Conference

On December 1, 2017 Medtronic plc (NYSE:MDT), the global leader in medical technology, reported that it will participate in the Citi 2017 Global Healthcare Conference on Wednesday, December 6, 2017, in New York City (Press release, Medtronic, DEC 1, 2017, View Source;p=RssLanding&cat=news&id=2319639 [SID1234522334]).

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Geoff Martha, executive vice president and president of the Medtronic Restorative Therapies Group (RTG), will answer questions about the company beginning at 8:45 a.m. EST (7:45 a.m. CST).

A live audio webcast of the presentation will be available on December 6, 2017, by clicking on the Investor Events link at View Source, and an archive of the session will be available on the same webpage later in the day.

Carrick Therapeutics announces first patient dosed in phase 1 clinical trial of its oral CDK7 inhibitor: CT7001

On December 1, 2017 Carrick Therapeutics, a biopharmaceutical company focusing on the innovative research and development of transformative oncology medicines, reported that the first patient has been dosed in the phase 1 clinical programme of CT7001 – an orally bio-available Cyclin-dependent Kinase 7 (CDK7) selective inhibitor, that has shown striking efficacy in multiple pre-clinical cancer models (Press release, Evotec, DEC 1, 2017, View Source [SID1234522324]).

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Elaine Sullivan, chief executive of Carrick Therapeutics, said:

"We are excited by the potential of CT7001 to make a major difference in cancer treatment, and intend to rapidly progress CT7001 through clinical development and bring this promising new medicine to patients as quickly as possible. This is a significant achievement for Carrick to take a pre-clinical candidate to first patient dosed in less than two years."

CDK7 inhibition has emerged as a promising strategy in a range of cancer indications. CDK7 acts as a master regulator of transcription, as well as a regulator of the cell cycle through phosphorylation of members of the CDK family. Inhibition of CDK7 suppresses the expression of key oncogenes such as c-Myc.

CT7001 was found to be effective in pre-clinical models of breast cancer, both hormone receptor positive and triple-negative, and transcriptionally driven cancers such as acute myeloid leukemia and small-cell lung cancer (SCLC). All these cancers continue to have major unmet medical need, for example, very little progress has been made for decades in the treatment of SCLC and triple-negative breast cancer (TNBC). Due to its differentiated mechanism, CT7001 is also predicted to be efficacious where resistance has developed to current therapies.

CT7001 originated from Cancer Research UK funded scientists at Imperial College London and was licensed to Carrick by the charity’s Commercial Partnerships Team. Rapid subsequent preclinical development by the company’s experienced research and development team has led to approval for the first-in-human Phase I study. Efficacy studies are planned to start in 2018.

Carrick Therapeutics was established with an initial funding round that saw it raise $95 million, and continues to build its portfolio through partnering. Significantly, whilst other companies bank on a single molecule or biological mechanism, Carrick will build a portfolio that targets multiple mechanisms that drive cancer. In close partnership with a network of clinicians and scientists in internationally leading research institutes and hospitals, the business will drive its portfolio of ground-breaking cancer therapies from laboratories to the clinic.

The funding of Carrick Therapeutics was co-led by ARCH Venture Partners and Woodford Investment Management, with participation from Cambridge Enterprise, Cambridge Innovation Capital, Evotec, GV (formerly Google Ventures), and Lightstone Ventures.

Oncolytics Biotech® Establishes Scientific Advisory Board Focused on REOLYSIN® Registration Study in Metastatic Breast Cancer

On November 30, 2017 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech company developing REOLYSIN, also known as pelareorep, an intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems to turn ‘cold’ tumors ‘hot’, reported the establishment of its Scientific Advisory Board (SAB) (Press release, Oncolytics Biotech, NOV 30, 2017, View Source [SID1234522318]). The SAB will provide Oncolytics with significant clinical expertise and experience in breast cancer drug development in both the U.S. and Europe with the following initial members:

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Dr. Mattine Piccart, M.D., Ph.D., Professor of Oncology, Université Libre de Bruxelles, Director of the Medicine Department, TRANSBIG and Jules Bordet Institute, Brussels, Belgium, Member, BCRF Scientific Advisory Board
Dr. Aleix Prat, M.D., Ph.D., Head, Medical Oncology Department, Hospital Clinic of Barcelona & Associate Professor, University of Barcelona, SOLTI – Breast Cancer Research Group
Dr. Padmanee Sharma, M.D., Ph.D., Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
"As we continue to expand our collaborative third-party expertise to build on the momentum of our phase 3 program in metastatic breast cancer, we are delighted to introduce a strong Scientific Advisory Board comprised of world-renowned clinical and medical oncologists," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "Drs. Piccart, Prat and Sharma will provide crucial guidance based on their specializations in breast cancer drug development and cancer immunotherapy, which parallel the development plan we have established for REOLYSIN."

Dr. Mattine Piccart is a Professor of Oncology at the Université Libre de Bruxelles and a member of the Breast Cancer Research Foundation (BCRF) SAB. She is a member of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Magnitude of Clinical Benefit Scale Working Group and co-founder and Chair of the Breast International Group (BIG), an international group that includes more than 56 cooperative groups, more than 10,000 experts and links more than 3,000 hospitals. Dr. Piccart was President of ESMO (Free ESMO Whitepaper) from 2012 to 2013 and the European Cancer Organization (ECCO) from 2014 to 2015. She is a former president of the European Organisation for Research and Treatment of Cancer (EORTC) and served on the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Board. Author or co-author of more than 470 peer-reviewed publications, she has received numerous prestigious awards, including the Jill Rose Award, the William L. McGuire Award, the Umberto Veronesi Award for the Future Fight against Cancer, and 2013 David A. Karnofsky Memorial Award, Dr. Piccart obtained both her M.D. and Ph.D. degrees from the Université Libre de Bruxelles.

Dr. Aleix Prat is the Head of Medical Oncology of the Hospital Clinic of Barcelona, Associate Professor of the University of Barcelona and the Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS). Dr. Prat designs and leads clinical trials for novel drugs and approaches, and has a particular interest in the clinical implications of different subtypes of breast cancer. He is currently the scientific coordinator of SOLTI, a Spanish breast cancer cooperative group, and was recently named as a Member of the Executive Committee of BIG. In 2008, Dr. Prat became a postdoctoral research associate at the Lineberger Comprehensive Cancer Center (University of North Carolina), and in 2012, returned to Barcelona as the Head of the Translational Genomics Group at Vall d´Hebron Institute of Oncology (VHIO). Dr. Prat obtained his M.D. degree in 2003 from the University of Barcelona and completed a medical oncology fellowship in 2008 at VHIO.

At the University of Texas MD Anderson Cancer Center, Dr. Padmanee Sharma is a Professor at the Department of Genitourinary Medical Oncology, the Co-Director of the Parker Institute for Cancer Immunotherapy and Scientific Director of the Immunotherapy Platform at the Department of Immunology. She has participated in 54 research outputs since 1996, focusing primarily on immunotherapy, and is principal investigator of several immunotherapy clinical trials that study immune and anti-tumor responses in cancer patients. Dr. Sharma has served as a member of the BMS Immuno-Oncology Network, a Member of the SAB at Kite Pharma, Inc. and also recently became a member of Constellation Pharmaceuticals, Inc.’s SAB. Dr. Sharma holds a Ph.D. in immunology and an M.D. from Pennsylvania State University.

MorphoSys Signs Regional License Agreement for Antibody MOR202 with I-Mab

On November 30, 2017 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) and I-Mab reported that they have entered into an exclusive regional licensing agreement to develop and commercialize MOR202 in China, Taiwan, Hong Kong and Macao (Press release, MorphoSys, NOV 30, 2017, View Source [SID1234522310]). MOR202 is MorphoSys’s proprietary investigational antibody against CD38, for which recruitment of a European Phase 1/2a clinical study in relapsed/refractory multiple myeloma has been concluded.

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Under the terms of the agreement, I-Mab Biopharma will assume exclusive responsibility for all subsequent development and commercialization of MOR202 in the agreed territory. MorphoSys receives an immediate upfront payment of USD 20 million. MorphoSys will be entitled to receive additional success-based clinical and commercial milestone payments from I-Mab of up to approximately USD 100 million, as well as tiered double-digit royalties on net sales of MOR202 in the territory.

In connection with the license agreement with I-Mab, MorphoSys has increased its financial guidance. For the year 2017, MorphoSys now expects revenues in the range from EUR 63 to 66 million (up from previously EUR 46 to 51 million) and earnings before interest and taxes (EBIT) of EUR -66 to -71 million (up from previously EUR -75 to -85 million). Guidance for revenues and EBIT includes royalty income on Tremfya(R) sales in Q3 2017, but does not include any royalty income on Tremfya(R) sales in Q4 2017. Following the partnering of MOR202, proprietary R&D expenses will be in the range from EUR 96 to 100 million (previously EUR 85 to 95 million).

I-Mab Biopharma intends to start clinical development of MOR202 to treat patients with multiple myeloma in China next year.

"Our deal with I-Mab is the first step in our plan to secure the development and commercialization of MOR202. In I-Mab, we have found an ideal partner with a highly dedicated and experienced team who are committed to developing MOR202 as fast as possible for the Chinese market", commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG.

"We are very excited to partner with MorphoSys to develop this highly differentiated investigational oncology medicine for unmet needs in China. This partnership marks a latest addition to our China portfolio of clinical stage assets, which parallels with our global immuno-oncology portfolio of innovative biologics", said Jingwu Zang, founder and CEO of I-Mab Biopharma.

About MOR202 and the ongoing phase 1/2a study in multiple myeloma
The investigational drug MOR202 is a human HuCAL antibody directed against CD38, a highly expressed and validated target in multiple myeloma. Preclinical findings also support an anti-CD38 approach in other therapeutic fields beyond multiple myeloma including solid tumors and autoimmune diseases. MOR202 is currently in a phase 1/2a, open-label, multi-center, dose-escalation clinical study conducted in several sites in Germany and Austria. The study is evaluating the safety and preliminary efficacy of MOR202 with low dose dexamethasone and in combination with the immunomodulatory drugs (IMiDs) pomalidomide (POM) and lenalidomide (LEN) plus DEX in patients with relapsed/refractory multiple myeloma. The primary endpoints of the trial are the safety, tolerability and recommended dose of MOR202 with DEX and in combination with the IMiDs. Secondary outcome measures are pharmacokinetics and preliminary efficacy based on overall response rate, duration of response, time-to-progression, and progression-free survival.

About Multiple Myeloma:
Multiple myeloma (MM), a cancer derived from plasma cells, ranks second among hematological malignancies in many countries. In China, there would be an estimated 27,800 new cases each year and a total of 200,000 cases. With the acceleration of the aging process in China, it is predicted that MM, with a rapid growth in incidence, will become one of the more significant diseases that affect people’s health. Patients who are refractory to the existing treatments have a very poor prognosis. MOR202 could be a highly differentiated innovative medicine for the treatment of multiple myeloma.

Eleven Biotherapeutics to Present at the LD Micro Main Event 2017

On November 30, 2017 Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, reported that Stephen Hurly, President and Chief Executive Officer, will present a company overview at the LD Micro Main Event 2017 in Los Angeles, CA on Thursday, December 7, 2017 at 8:30 a.m. PST (Press release, Eleven Biotherapeutics, NOV 30, 2017, View Source [SID1234522322]).

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A live webcast can be accessed from the Investors & Media section of Eleven’s website, www.elevenbio.com. An archived replay of the webcast will be available on the Company’s website for 90 days after the conference.