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Quantum Leap Healthcare Collaborative Announces the Selection of Regeneron’s Libtayo® (cemiplimab) and REGN3767 for Injection in the I-SPY 2 TRIAL for Breast Cancer

On December 18, 2019 Quantum Leap Healthcare Collaborative (QLHC), sponsor and manager of the I-SPY TRIALs for Breast Cancer, reported an evaluation of two drugs developed by Regeneron in a new randomized, investigational treatment arm for the ongoing I-SPY 2 TRIAL for neoadjuvant treatment of locally advanced breast cancer (Press release, QuantumLeap, DEC 18, 2019, View Source [SID1234552486]). This treatment arm will focus on the release of immune checkpoints, an increasingly accepted strategy for improving outcomes in breast and other cancers. Monoclonal antibodies that target the immune checkpoint receptors lymphocyte-activation gene 3 (LAG-3) and programmed cell death protein-1 (PD-1) have shown enhanced clinical antitumor activity when given in combination.

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This study arm will evaluate Regeneron’s Libtayo (cemiplimab), an IgG4 antibody that binds to PD-1, and REGN3767, an analogous antibody that binds to LAG-3 to disrupt non-redundant inhibitory pathways to further restore exhausted T-cell function in order to target immune pathways.

The goal of this study is to evaluate the safety and efficacy of Libtayo + REGN3767 when used in the neoadjuvant chemotherapy setting in combination with paclitaxel in HER2- patients followed by doxorubicin hydrochloride /cyclophosphamide chemotherapy (AC) and surgical resection of breast tissue.

"The I-SPY 2 TRIAL is designed to evaluate multiple emerging new agents simultaneously with the goal of getting effective and potentially less toxic treatments to patients much more quickly. We are excited to add Libtayo and REGN3767, into I-SPY 2, with the goal of determining whether adding Libtayo and REGN3767 to standard neoadjuvant paclitaxel and AC, increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy alone, for the biomarker signatures established at trial entry, and to determine for each experimental agent used, the predictive probability of success in a subsequent phase 3 trial for each possible biomarker signature," stated Dr. Laura J. Esserman, MD, MBA, Principal Investigator of I-SPY 2 and Director of the Carol Franc Buck Breast Care Center at the UCSF Helen Diller Family Comprehensive Cancer Center.

The I-SPY 2 TRIAL, sponsored by Quantum Leap, is a standing phase 2 randomized, controlled, multicenter study with an innovative Bayesian adaptive randomization design aimed to rapidly screen and identify promising new treatments in specific subgroups of adults with newly-diagnosed, high-risk (high likelihood of recurrence), locally-advanced breast cancer (Stage II/III). Regeneron will provide funding and the drugs, Libtayo and REGN3767.

Libtayo and REGN3767 are currently under clinical development for breast cancer, and their safety and efficacy have not been evaluated by any regulatory authority for this disease.

About REGN3767 and Libtayo

REGN3767 is a fully human monoclonal antibody that binds with high affinity to the immune checkpoint receptor LAG-3 on T-cells. Once bound, REGN3767 is designed to block suppressive LAG-3 signals and take the brakes off T-cell killing of cancer cells.

Libtayo is a fully-human monoclonal antibody designed to target the immune checkpoint receptor PD-1 on T-cells to block suppressive signals. It is approved in the U.S., European Union, Canada and Brazil for adult patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

About the I-SPY TRIALs

The I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 16 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit ispytrials.org.

Bausch Health Announces Conditional Redemption Of Existing Senior Notes

On December 18, 2019 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that it issued today a conditional notice of redemption for $1.240 billion aggregate principal amount of the Company’s outstanding 5.875% Senior Notes due 2023 (the "2023 Notes") (Press release, Bausch Health, DEC 18, 2019, View Source [SID1234552485]). The redemption of the 2023 Notes is conditioned upon the closing of an offering of debt securities by the Company generating gross proceeds of at least $2,500,000,000. The Company expects to satisfy this condition with its recently announced offering of $1,250,000,000 aggregate principal amount of 5.000% senior notes due 2028 (the "2028 Notes") and $1,250,000,000 aggregate principal amount of 5.250% senior notes due 2030 (the "2030 Notes" and, together with the 2028 Notes, the "New Notes"), which was priced on Dec. 17, 2019 and is expected to close on Dec. 30, 2019, subject to customary closing conditions.

On Dec. 18, 2019, a copy of the conditional notice of redemption with respect to the 2023 Notes was issued to record holders. Payment of the redemption price and surrender of the 2023 Notes for redemption will be made through the facilities of the Depository Trust Company in accordance with the applicable procedures of the Depository Trust Company on Jan. 16, 2020. The name and address of the paying agent are as follows: The Bank of New York Mellon Trust Company, N.A., c/o The Bank of New York Mellon Trust Company, N.A.; 111 Sanders Creek Parkway, East Syracuse, N.Y. 13057; Attn: Redemption Unit; Tel: (800) 254-2826.

Epizyme (EPZM) Trading of Stock Halted; Oncology Drug Advisory Committee to Review Tazemetostat at 8:00 a.m. ET Today

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.

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.

Centene Corporation Announces Extension of Exchange Offers and Consent Solicitations for WellCare Notes

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").

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.

Xencor Appoints Allen Yang, M.D., Ph.D., as Senior Vice President and Chief Medical Officer

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.

"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.