On October 16, 2018 Epigene Therapeutics Inc. reported that data on NEO2734, its investigational, first-in-class, dual inhibitor of both the Bromodomain (BRD) and Extra-Terminal domain (BET) family of proteins and the Cyclic AMP response element binding protein (CREB)-binding protein (CBP) and E1A interacting protein of 300 kDa (EP300 or P300) will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress taking place in Munich, Germany from October 19th to the 23rd, 2018 (Press release, Epigene Therapeutics, OCT 16, 2018, View Source [SID1234529949]). The data being presented at ESMO (Free ESMO Whitepaper) 2018 will include a poster presentation on NEO2734 activity in the VCaP prostate cancer model and the MC38 colon cancer model.

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"Epigenetic changes are a major force in the genetic dysregulation that underlies the development and progression of human cancer", stated Professor Razelle Kurzrock, Chief, Division of Hematology and Oncology, University of California, San Diego, Senior Deputy Center Director, Clinical Science, Director, Center for Personalized Cancer Therapy University of California, San Diego – Moores Cancer Center, San Diego, CA and member of the Epigene Therapeutics Scientific Advisory Board (SAB). "We have made limited progress in deriving meaningful clinical benefit from the use of epigentic modifying agents. While the traditional BET inhibitors have shown consistent clinical promise in a spectrum of both hematologic maligancies and solid tumors, none have been granted regulatory approval. Developmental therapeutics efforts are now focused primarily on finding the right partner agents for BET inhibitors in order to increase their activity in patients. NEO2734 mediates multiple epigenetic modifer effects in a single agent and thus represents a unique, very exciting novel therapeutic approach"

"NEO2734 simultaneously inhibits two very well established classes of major epigenetic targets in patients with cancer", said Dr. Elena Garralda, Principal Investigator and Executive Director of the Early Drug Development Unit Vall d’ Hebron Institute of Oncology, Barcelona, who is also a member of the Epigene Therapeutics SAB. "Intensive efforts are ongoing to define the role of BET inhibitors as anti-cancer therapies while the CBP-EP300/P300 family of transcriptional coactivators are emerging as independent important therapeutic targets in oncology. NEO2734 offers us the unique opportunity to inhibit chromatin readers and writers with a single agent. The pre-clinical data being presented at ESMO (Free ESMO Whitepaper) on its activity in both colon and prostate cancers are particularly important in this context as our knowledge on the connections between specific epigenetic changes, deficiencies in DNA repair mechanisms, and therapeutic targets rapidly evolve."

"Synergistic activity against two independent important targets in cancer delivered by a single agent is a very rare phenomenon," said Francis Giles, Epigene Therapeutics’ Chief Medical Officer & Chief Operating Officer. "NEO2734 is unique in delivering that activity against both the BET and CBP-P300 targets and thus provides novel opportunities to both optimize the activity of the BET inhibitors and utilize CBP-P300 as a target. On-going IND-enabling work combined with multiple collaborations between Epigene Therapeutics and global academic leaders are rapidly defining the path to clinic for NEO2734"

Poster details:

"NEO2734: A novel potent oral dual BET and P300/CBP inhibitor"
(Abstract #429P, poster display session Hall A3 – Developmental Therapeutics)
– Monday, 22 October 2018 from 12:45 p.m. CEST to 1:45 p.m. CEST

Full session details and data presentation listings for ESMO (Free ESMO Whitepaper) 2018 can be found at: View Source

On October 16, 2018 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that it will announce its third quarter 2018 financial results on Tuesday, October 30, 2018, after the close of the U.S. financial markets (Press release, Clovis Oncology, OCT 16, 2018, View Source [SID1234529932]). Clovis’ senior management will host a conference call and live audio webcast at 4:30 p.m. ET to discuss the company’s results in greater detail.

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The conference call is being webcast and can be accessed from the Clovis Oncology website at www.clovisoncology.com. A replay of the webcast will be available for 30 days.

Conference Call Details

Clovis will hold a conference call to discuss third quarter 2018 results on October 30 at 4:30 p.m. ET. The conference call will be simultaneously webcast on the Company’s web site at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants 866.393.4306, International participants 734.385.2616; conference ID: 5885294.

On October 16, 2018 BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) reported that the Company earned $15 million in milestone payments from Pfizer Inc (Press release, BioMarin, OCT 16, 2018, View Source [SID1234529934]). These milestone payments were triggered by the U.S. Food and Drug Administration (FDA) approval of Talzenna (talazoparib) for the treatment of adult patients with deleterious or suspected deleterious germline BRCA (gBRCA)-mutated, HER2-negative locally advanced (LA) or metastatic breast cancer (MBC). Patients are selected for therapy based on an FDA-approved companion diagnostic. These milestone payments are part of an agreement made with Medivation, Inc. when Medivation purchased talazoparib. Medivation was acquired by Pfizer.

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In August 2015, Medivation, Inc. and BioMarin Pharmaceutical Inc. entered into an asset purchase agreement under which Medivation acquired all worldwide rights to Talzenna (talazoparib), a once-daily, oral poly ADP ribose polymerase (PARP) inhibitor. Under the agreement, Medivation, acquired by Pfizer, is responsible for all research, development, regulatory and commercialization activities for all indications on a global basis.

Under the terms of the agreement, Medivation paid BioMarin $410 million upfront, and BioMarin was entitled to receive up to an additional $160 million (in aggregate) upon the achievement of regulatory and sales-based milestones, of which $35 million has been earned to date, as well as mid-single digit royalties for Talzenna (talazoparib). In June of this year, the European Medicines Agency accepted the Marketing Application for talazoparib for this patient population and is currently reviewing the application.

The European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) (ESMO 2018) congress takes place in Munich, Germany between 19 Oct – 23 Oct 2018.

This conference features more than 2000 abstracts and a global presence of companies ranging from big pharma to startups like Arcus Biosciences (USA), CStone Pharmaceuticals (China), Neon Therapeutics (USA), NEOMED Therapeutics 1 (Canada) and Oblique Therapeutics (Sweden).

Read more below on the latest and hottest from companies like Arcus, AstraZeneca, Merck & Co or any of the other 40+ selection of companies generating heat about their presence at ESMO (Free ESMO Whitepaper) 2018.

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On October 15, 2018 F-star, a clinical-stage biopharmaceutical company pioneering the development of novel bispecific antibodies that target the immune system to fight cancer, reported the appointment of Dr Eliot Forster as Chief Executive Officer. Dr Forster succeeds former CEO Dr John Haurum (Press release, f-star, OCT 15, 2018, View Source [SID1234529916]).

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Eliot brings more than 25 years of extensive leadership experience in clinical-stage biopharmaceutical companies. Most recently, he served as CEO of Immunocore where he successfully steered the company’s strategy in immuno-oncology (IO), raising a $320M Series A and establishing clinical collaborations with global pharmaceutical companies including AstraZeneca, GSK and Roche. Prior to Immunocore, Eliot held senior leadership positions at Pfizer (including Head of EU Development & Operations) and GSK. During his pharma tenure, he played a critical role in the clinical development of Celebrex (celecoxib) and Relpax (eletriptan).

"Over recent years, IO has transformed the oncology treatment paradigm, offering significantly better options to patients. The co-administration of immunotherapies is expected to be the next cornerstone in cancer treatments. I believe that F-star’s first-in-class molecules bring together in a single form, the full power of IO and combinations. We anticipate this synergistic benefit will deliver more targeted, potent and safer treatment options for cancer patients," said Eliot Forster MBA, PhD, CEO of F-star. "I am honoured and excited to be joining the F-star team, to lead the Company through its next phase of development and bring life-changing medicines to patients sooner."

F-star’s Modular Antibody Technology is leading a paradigm shift in IO, with the potential to leapfrog current combination approaches. The platform, based on superior and clinically-relevant novel biology, introduces an additional antigen-binding site in the Fc region of an antibody that allows for a ‘plug-and-play’ insertion into any monoclonal antibody. The resulting novel, bivalent binding bispecific antibodies (mAb2 TM) preserve the simplicity and manufacturability of the IgG format at the same time as creating extensive bispecific treatment opportunities. F-star’s pipeline targets patients who have either limited or partial response to existing IO treatment regimens and aims to stimulate the immune response through a tumour-directed activation while reducing systemic toxicity. FS118, F-star’s lead Phase I candidate, is partnered with Merck KGaA and the Company is rapidly moving the next wave of its proprietary bispecific IO products towards clinical development.

"We are delighted to welcome Eliot as F-star’s new CEO. His proven track record in leading and developing biotech IO companies will be essential in driving F-star forward to deliver the next wave of immunotherapies for cancer patients," said Nessan Bermingham PhD, Executive Chair of F-star. "The Board is grateful to John for the pivotal role he has played in leading the Company in developing and executing a transformative strategy, positioning F-star for long-term success."

During his leadership as CEO, John led the transformation of F-star from a drug discovery platform into a successful, clinical-stage IO company. Under his leadership, F-star launched new innovative cancer drug development capabilities and established a substantial pipeline of candidates with the potential to benefit patients, especially those who are not well served by existing cancer therapies.

"It has been rewarding to lead F-star through a period of significant growth, to become a recognised leader in the bispecific space. Our approach has been validated through a series of strategic collaborations with leading pharmaceutical and biotechnology partnerships in IO with AbbVie and Merck KGaA, and in central nervous system disorders with Denali Therapeutics. We have established a pipeline with two candidates entering the clinic and generated circa $250M in funding and investment," said John Haurum MD, PhD, former CEO of F-star. "I am pleased to hand over the reins to Eliot, who is highly experienced and well positioned to lead F-star and its extraordinary staff, pipeline and partnerships, as it continues to discover and develop transformative IO therapeutics for patients in need."