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.

On October 116, 2018 AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) reported that they were granted orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for Lynparza (olaparib) for the treatment of pancreatic cancer (Press release, AstraZeneca, OCT 16, 2018, View Source [SID1234530239]).

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Pancreatic cancer is a rare, life-threatening disease that accounts for about 3% of all cancers in the US.i Due to the late onset of symptoms, patients are often diagnosed after the cancer has progressed to locally advanced or metastatic stages of the disease.ii Five-year survival rates remain low in the US at 8.5%.iii

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer said: "Pancreatic cancer is an area of significant unmet medical need. This is especially true for patients with metastatic disease where the benefits of current treatment options are very limited."

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, at MSD Research Laboratories, said: "Pancreatic cancer is a relatively less common, but life-threatening, form of cancer. The FDA granting Orphan Drug Designation is a positive step for patients with pancreatic cancer and continues to reinforce the importance of our collaboration in bringing Lynparza to more patients in need."

ODD status was granted for the treatment of ovarian cancer in October 2013. Earlier this year an amended ODD status was granted to include both fallopian tube and primary peritoneal cancers following the expanded US approval of Lynparza in August 2017 for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

The use of Lynparza in pancreatic cancer is being assessed in the ongoing Phase III POLO trial, which is testing Lynparza as maintenance monotherapy vs placebo in patients with germline BRCA-mutated metastatic pancreatic cancer whose disease has not progressed following 1st-line platinum-based chemotherapy. Results from the POLO trial are expected in the first half of 2019.

About the POLO Phase III trial

POLO is a Phase III, randomised, double-blinded, placebo-controlled trial to evaluate the efficacy and safety of Lynparza tablets (300 mg twice daily) as maintenance monotherapy compared with placebo, in patients with germline BRCA-mutated metastatic pancreatic cancer whose disease has not progressed following 1st-line platinum-based chemotherapy. The trial randomised 145 patients to receive Lynparza or placebo (3:2). The primary endpoint is progression-free survival.

About Lynparza

Lynparza (olaparib) was the first in class PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells. Specifically, in vitro studies have shown that Lynparza-induced cytotoxicity may involve inhibition of PARP-enzymatic activity and increased formation of PARP-DNA complexes, resulting in DNA damage and cancer cell death.

Lynparza, which has the broadest clinical development programme of any PARP inhibitor, is being investigated in a range of DDR-deficient tumour types, and is the foundation of AstraZeneca’s industry-leading portfolio of compounds targeting DDR mechanisms in cancer cells.

About the AstraZeneca and MSD Strategic Oncology Collaboration

In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the United States and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the world’s first PARP inhibitor and potential new medicine selumetinib, a MEK inhibitor, for multiple cancer types. Working together, the companies will develop Lynparza and selumetinib in combination with other potential new medicines and as monotherapies. Independently, the companies will develop Lynparza and selumetinib in combination with their respective PD-L1 and PD-1 medicines.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance Oncology as a key growth driver focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

On October 16, 2018 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that results of the Oraxol (oral paclitaxel and HM30181A) pharmacokinetics and phase II clinical trial in the treatment of breast cancer patients who failed previous chemotherapies will be presented on October 21, 2018 at a Poster Discussion in the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Munich, Germany (Press release, Athenex, OCT 16, 2018, View Source;p=RssLanding&cat=news&id=2371846 [SID1234529936]).

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This study has completed patient recruitment and encouraging positive efficacy and safety data will be reported. Oraxol was granted the Promising Innovative Medicine Designation by the United Kingdom Medicines and Healthcare Products Regulatory Agency in December 2017.

Details on the Poster Discussion session are listed below.

Title: Oral paclitaxel and HM30181A demonstrate clinical activity in metastatic breast cancer (MBC) patients
Presentation Number: 287PD
Presenter: Ming-Shen Dai (Taipei, TW)
Session Name: Poster Discussion session – Breast cancer, metastatic
Date / Time / Location: October 21, 2018; 9:15 AM – 10:30 AM (local time); ICM – Room 1, ICM München
The Poster presentation at ESMO (Free ESMO Whitepaper) will be available on the ESMO (Free ESMO Whitepaper) website at 12:00 CEST on Friday, October 19, 2018.