On December 18, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported that trading of its common stock has been halted (Press release, Epizyme, DEC 18, 2019, View Source [SID1234552484]). The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) is meeting at 8:00 a.m. ET today to discuss Epizyme’s New Drug Application (NDA) for tazemetostat, an oral, first-in-class EZH2 inhibitor, for the treatment of patients with metastatic or locally advanced epithelioid sarcoma (ES) who are not eligible for curative surgery.

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Epizyme’s NDA submission is based primarily on data from the 62 patient ES cohort of its ongoing Phase 2 study of tazemetostat. The ODAC is scheduled to start at 8:00 a.m. ET. The briefing materials can be found on FDA’s website here. Tazemetostat was submitted under the Accelerated Approval pathway and is under Priority Review with FDA, with an assigned Prescription Drug User Fee Act (PDUFA) date of Jan. 23, 2020.

Today’s advisory committee vote will be non-binding, but FDA takes its recommendations into consideration when reviewing related applications for marketing approval.

On December 18, 2019 Centene Corporation (NYSE: CNC) ("Centene") reported the extension of the expiration date of the offers to exchange (the "Exchange Offers") notes (the "WellCare Notes") issued by WellCare Health Plans, Inc. (NYSE: WCG) ("WellCare") for up to $1,950,000,000 aggregate principal amount of new notes to be issued by Centene (the "Centene Notes") and cash and the related consent solicitations (the "Consent Solicitations") being made by Centene on behalf of WellCare to adopt certain proposed amendments (the "Amendments") to the indentures governing the WellCare Notes (Press release, Centene , DEC 18, 2019, View Source [SID1234552483]). Centene hereby extends such expiration date from 5:00 p.m., New York City time, on December 18, 2019, to 5:00 p.m., New York City time, on January 8, 2020 (as the same may be further extended, the "Expiration Date").

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On November 14, 2019, requisite consents were received and supplemental indentures were executed, eliminating substantially all restrictive covenants and certain events of default and other provisions in each of the indentures governing the WellCare Notes. Such supplemental indentures will only become operative upon the settlement date of the Exchange Offers.

The Exchange Offers and Consent Solicitations are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement dated November 1, 2019, as amended on November 12, 2019 and the related letter of transmittal and consent hereby, each as amended by the press release dated December 2, 2019 and as amended hereby, and are conditioned upon the closing of Centene’s acquisition of WellCare (the "Merger"), which condition may not be waived by Centene, and certain other conditions that may be waived by Centene.

The settlement date for the Exchange Offers is expected to occur promptly after the Expiration Date and immediately prior to the closing of the Merger, which is expected to occur by the first half of 2020. As a result, the Expiration Date may be further extended one or more times. Centene will provide notice of any such extension in advance of the Expiration Date.

Except as described in this press release, all other terms of the Exchange Offers and Consent Solicitations remain unchanged.

As of 5:00 p.m., New York City time, on December 18, 2019, the principal amounts of WellCare Notes set forth in the table below had been validly tendered and not validly withdrawn:

WellCare Notes Tendered as of 5:00 p.m., New York City time, on December 18, 2019

Documents relating to the Exchange Offers and Consent Solicitations will only be distributed to eligible holders of WellCare Notes who complete and return an eligibility form confirming that they are either a "qualified institutional buyer" under Rule 144A or not a "U.S. person" and outside the United States under Regulation S for purposes of applicable securities laws. Except as amended by the press release dated December 2, 2019 and as amended hereby, the complete terms and conditions of the Exchange Offers and Consent Solicitations are described in the confidential offering memorandum and consent solicitation statement dated November 1, 2019 as amended on November 12, 2019 and the related letter of transmittal and consent, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent and information agent in connection with the Exchange Offers and Consent Solicitations, at (866) 470-4200 (U.S. toll-free) or (212) 430-3774 (banks and brokers). The eligibility form is available electronically at: View Source

This press release does not constitute an offer to sell or purchase, or a solicitation of an offer to sell or purchase, or the solicitation of tenders or consents with respect to, any security. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such an offer, solicitation or sale would be unlawful. The Exchange Offers and Consent Solicitations are being made solely pursuant to the offering memorandum and consent solicitation statement dated November 1, 2019, as amended on November 12, 2019 and as amended by the press release dated December 2, 2019 and as amended hereby and the related letter of transmittal and consent, and only to such persons and in such jurisdictions as are permitted under applicable law.

The Centene Notes offered in the Exchange Offers have not been registered under the Securities Act of 1933, as amended, or any state securities laws. Therefore, the Centene Notes may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act of 1933, as amended, and any applicable state securities laws.

On December 18, 2019 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune diseases, asthma and allergic diseases, reported the appointment of Allen Yang, M.D., Ph.D., as senior vice president and chief medical officer (Press release, Xencor, DEC 18, 2019, View Source [SID1234552481]). He will be responsible for leading clinical development strategy and overseeing clinical operations for Xencor’s portfolio of XmAb antibody drug candidates, including bispecific antibodies and cytokines. Dr. Yang joins Xencor from Jazz Pharmaceuticals, where he served as senior vice president, head of clinical development and acting chief medical officer.

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"We are delighted to welcome Allen to Xencor. He joins our team with a strong record of successful drug development in oncology, including T-cell engaging bispecific antibodies, and a wealth of experience in translational research and as a practicing oncologist. As our bispecific oncology pipeline matures and as we continue to explore novel target combinations in the clinic, Xencor will benefit immensely from Allen’s leadership and expertise," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor.

"Xencor’s bispecific platform has generated a diverse set of product candidates that explore novel biological mechanisms, which hold the potential to address unmet needs for the treatment of patients with cancer," said Dr. Yang. "I look forward to contributing to the advancement of the Company’s growing portfolio of novel bispecific antibodies and cytokines."

Before assuming his most recent role at Jazz, Dr. Yang was the therapeutic area head for hematology and oncology, assembling its clinical development team and overseeing several oncology products, including Erwinaze, Defitelio and Vyxeos. Prior to Jazz, Dr. Yang led clinical development and clinical operations groups at Spectrum Pharmaceuticals, where he was vice president of clinical research. Previously, he held several roles of increasing responsibility at Amgen, including those of global development leader for Aranesp in oncology and clinical research medical director for Blincyto, the first bispecific antibody approved by the FDA. Before transitioning to the biopharmaceutical industry, Dr. Yang practiced medicine for several years as an academic oncologist at the University of Southern California, where he led a translational cancer research laboratory. Dr. Yang earned a B.A. in molecular biology from the University of California, Berkeley, and a Ph.D. in biochemistry and an M.D. from the University of Southern California. He completed his medical oncology fellowship at the MD Anderson Cancer Center.

Erwinaze is a registered trademark of Porton Biopharma Limited. Defitelio and Vyxeos are registered trademarks of Jazz Pharmaceuticals plc or its subsidiaries. Aranesp and Blincyto are registered trademarks of Amgen Inc.

On December 18, 2019 Zentalis Pharmaceuticals (the "Company" or "Zentalis"), a clinical-stage biopharmaceutical company focused on developing clinically differentiated, novel small molecule therapeutics that target fundamental pathways in cancer, reported that the U.S. Food and Drug Administration (FDA) has previously cleared its Investigational New Drug (IND) application for its third oncology drug candidate, ZN-c3, and that it has dosed the first patient in a Phase 1/2 clinical trial evaluating ZN-c3 in patients with advanced solid tumors (Press release, Zentalis Pharmaceuticals, DEC 18, 2019, View Source [SID1234552480]).

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The Company is developing ZN-c3, an oral small molecule DNA Damage Response (DDR) drug candidate targeting WEE1 in cancer settings. WEE1 is a protein tyrosine kinase that regulates the cell cycle by serving as a checkpoint preventing DNA replication in the presence of DNA damage. The inhibition of WEE1 aims to generate sufficient DNA damage in cancer cells to cause them to undergo a programmed cell death called apoptosis, thereby preventing tumor growth. The Company has applied its medicinal chemistry expertise to design and synthesize its oral, small molecule compound, ZN-c3, with a potentially best-in-class product profile, including good solubility, selectivity and pharmacokinetic properties. We believe these characteristics will provide for a differentiated drug product to help fight cancer, if ZN-c3 is approved.

There is currently no FDA-approved WEE1 inhibitor. The Company is evaluating the potential of ZN-c3 in a Phase 1/2 clinical trial as monotherapy and in combination with an FDA-approved PARP inhibitor. As of December 16, 2019, the Company has enrolled two patients in this clinical trial. The Company expects to report preliminary data from this clinical trial in 2021.

"We are excited about targeting WEE1 because of its potential for potent anti-tumor activity across multiple cancer types," said Dr. Kevin Bunker, Chief Operating Officer at Zentalis Pharmaceuticals. "ZN-c3 is an internally developed drug candidate that was designed to be a best-in-class molecule with optimized selectivity, great oral bioavailability, and tolerability. We believe these characteristics will provide significant clinical benefit for cancer patients."

On December 18, 2019 Paige, the leader in computational pathology transforming the diagnosis and treatment of cancer, reported it has closed its Series B funding round of $45 million, bringing the Company’s total capital raised to over $70 million (Press release, Paige AI, DEC 18, 2019, View Source [SID1234552479]). Healthcare Venture Partners brought the largest contribution to the round, with Breyer Capital, Kenan Turnacioglu, and other funds participating. Paige will use this new capital to drive FDA clearance of its products and expand its portfolio, delving deeper into cancer pathology, novel biomarkers and prognostic capabilities. Additionally, the Company will accelerate commercial efforts in the U.S. and expansion in Europe, Brazil, and Canada.

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"This influx in funding reflects the acknowledgment and recognition that Paige’s technology is ready for prime time," said Leo Grady, CEO at Paige. "We believe that AI will have a transformative impact on pathology and cancer care by improving pathology quality, throughput, costs and by enabling new biomarkers and diagnostics. We are committed to offering these powerful technologies to hospitals around the world, and helping biopharma more effectively treat their patients and bring new therapies to market faster."

"The funding comes on the heels of a milestone year: Paige achieved the first FDA breakthrough designation for AI technology in Pathology and Oncology and later received the first CE mark in the space," added Thomas Fuchs, Founder of Paige and a researcher at Memorial Sloan Kettering (MSK). The Company also grew its digital slide archive to more than 1.2M images and is developing systems to combine digital slides with genomic, drug response and outcome information to create powerful new diagnostic solutions.

Paige continues its mission to create and deliver advanced computational diagnostics for pathologists and oncologists, which have been shown to work effectively across different slide preparation methodologies and the scanners used to digitize the images. The Company plans to deliver the powerful technology via partnerships, such as the recently announced Philips deal and Paige’s own AI-native platform, which is designed to help doctors maximize the benefits of these solutions while addressing the infrastructure and interoperability hurdles encountered by many of the early adopters of digital pathology.

"Paige exemplifies the benefits of digital pathology and represents the bright future of AI-driven medical diagnosis," said Jeff Lightcap of Healthcare Venture Partners. "As hospitals embark on digital transformations, they will face challenges associated with these transitions. We believe Paige addresses many of these issues by enhancing the ability of clinical teams and pathologists to collaborate. We’re confident in Paige’s future and believe they will continue to develop cutting-edge technologies that enable pathology departments to transform their practices, which have changed little in the last century."

"We applaud Paige’s commitment to building clinical AI products that will improve the diagnostic process and patient care," added Jim Breyer of Breyer Capital. "This is a critical time for Pathology, as pathologists are carrying a heavier workload than ever before. Paige understands their needs and the team has built cutting-edge technologies to address them. Paige represents the future of computational pathology and we look forward to their continued growth and success."