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Adastra Pharmaceuticals Announces FDA and EMA Orphan Drug Designation Has Been Granted for Zotiraciclib in the Treatment of Glioma

On December 4, 2019 Adastra Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of first-in-class therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted Orphan Drug Designation to zotiraciclib for the treatment of glioma (Press release, Adastra Pharmaceuticals, DEC 4, 2019, View Source [SID1234551941]). Zotiraciclib is currently the subject of two separate Phase 1b clinical trials in glioblastoma (GBM). Adastra expects to report results from the two studies during 2020.

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The first Phase 1b clinical trial, sponsored by the National Cancer Institute (NCI), is a multi-arm, dose-finding study examining the combination of zotiraciclib and temozolomide (TMZ) for the treatment of recurrent malignant gliomas. Having recently enrolled the Phase 1 portion, the NCI and Adastra expect to report top-line data early in 2020, expanding upon results previously reported at the 2019 ASCO (Free ASCO Whitepaper) Annual meeting and also via e-Poster at the 2019 Society of Neuro Oncology.

The second Phase 1b trial of zotiraciclib is being conducted by the European Organisation for Research and Treatment of Cancer (EORTC) and is designed as a three-parallel cohort, open-labeled, non-randomized, multicenter study in elderly patients with IDH1R132H-non mutant and MGMT promoter-unmethylated anaplastic astrocytoma or glioblastoma. Group A consists of First-Line patients with unmethylated disease and is designed to determine the application of zotiraciclib in combination with radiation. Group B consists of First-Line patients with methylated disease and is designed to determine zotiraciclib use in combination with TMZ. Group C consists of patients with recurrent GBM and is single agent zotiraciclib intended to measure progression free survival at six months.

"We are very pleased to have been granted Orphan Drug Designation by the FDA and EMA for zotiraciclib in the treatment of glioma. These designations are important in the continued development of zotiraciclib and the ongoing clinical trials in the U.S. at the NCI and throughout Europe with the EORTC," said Scott Megaffin, Chief Executive Officer of Adastra. "Though rare, glioblastoma is one of the most devasting and difficult-to-treat cancers, urgently necessitating the development of new treatments with unique mechanisms of action. Data from the ongoing clinical trials of zotiraciclib have been encouraging and are suggestive of a therapy that is safe and capable of eliciting clinical benefit in high grade gliomas. We greatly look forward to reporting top-line data from the NCI Phase 1b study in early 2020, as well as completing enrollment in two of the EORTC study cohorts later in the year."

About Orphan Drug Designation
The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. and not more than five in 10,000 in the E.U. Orphan Drug Designation provides important incentives, including marketing exclusivity upon approval and tax credits for qualified clinical testing, as well as fee exemptions and reductions.

Accelerate Diagnostics to Participate in 31st Annual Piper Jaffray Healthcare Conference in New York on December 4, 2019

On December 4, 2019 Accelerate Diagnostics, Inc. (NASDAQ: AXDX) reported that Larry Mehren, chief executive officer, will participate in a 25-minute question and answer session at the 31st Annual Piper Jaffray Healthcare Conference in New York on December 4, 2019 at 3:30 p.m. Eastern Time (Press release, ACCELERATED MEDICAL DIAGNOSTICS, DEC 4, 2019, View Source [SID1234551940]). Jack Phillips, chief operating officer, and Steve Reichling, the company’s chief financial officer, will accompany Mr. Mehren.

A live audiocast of the session will be accessible through the company’s investor relations website at ir.axdx.com. A replay of the audiocast will be available for at least 30 days following the conference.

Roche Holdings, Inc. Announces Pricing of its Debt Tender Offer and Increase to the Maximum Tender Amount

On December 4, 2019 Roche Holdings, Inc. (the "Offeror") reported the pricing of its previously announced tender offer (the "Offer") to purchase for cash for a combined aggregate purchase price (exclusive of Accrued Interest (as defined herein)) of up to $2,000,000,000 the 7.00% Notes due 2039 (the "2039 Notes") issued by the Offeror and guaranteed by Roche Holding Ltd (the "Company"), the 3.35% Notes due 2024 issued by the Offeror and guaranteed by the Company, the 3.25% Notes due 2023 issued by the Offeror and guaranteed by the Company, the 3.00% Notes due 2025 issued by the Offeror and guaranteed by the Company, the 2.875% Notes due 2021 issued by the Offeror and guaranteed by the Company, and the 5.25% Senior Notes due 2035 issued by the Offeror’s subsidiary, Genentech, Inc. ("Genentech") (together, the "Securities") (Press release, Roche Deutschland Holding, DEC 4, 2019, View Source [SID1234551939]). In addition, the Offeror announced that it has increased the maximum combined aggregate purchase price (exclusive of Accrued Interest) to $2,873,519,181.27 (such amended amount, the "Maximum Tender Amount").

The following table sets forth certain pricing information for the Offer, including the Total Consideration (as defined below) determined based on yields on the applicable Reference U.S. Treasury Securities at 10:00 a.m., New York City time, today:

Inclusive of Early Tender Premium.

The Offeror has accepted for purchase on the Early Settlement Date (as defined below) all Securities that were validly tendered at or before the Early Tender Date.

The Offer is being made upon and is subject to the terms and conditions set forth in the offer to purchase dated November 19, 2019 (the "Offer to Purchase," as amended hereby). The Offer will expire at 11:59 p.m., New York City time, on December 17, 2019, unless extended or earlier terminated by the Offeror (as it may be extended or earlier terminated with respect to a series of Securities, the "Expiration Date"). The deadline to validly withdraw tenders of Securities was 5:00 p.m., New York City time, on December 3, 2019; therefore, Securities that have been tendered and not validly withdrawn, and Securities tendered after that date, may not be withdrawn unless otherwise required by applicable law.

The consideration to be paid in the Offer for each series of Securities that are purchased pursuant to the Offer was determined in the manner described in the Offer to Purchase at 10:00 a.m., New York City time, today by reference to the applicable fixed spread specified for each series of Securities in the table above over the yield based on the bid side price of the applicable U.S. Treasury Security specified for each series of Securities in the table above (the "Total Consideration"). Holders of Securities that were validly tendered and not withdrawn on or prior to 5:00 p.m., New York City time, on December 3, 2019 (the "Early Tender Date") and accepted for purchase will receive the applicable Total Consideration, which includes an early tender premium of $30 per $1,000 principal amount of the Securities accepted for purchase (the "Early Tender Premium").

Payment for Securities that were validly tendered on or prior to the Early Tender Date and accepted for purchase will be made promptly following the Early Tender Date, expected to be December 5, 2019 (such date, the "Early Settlement Date"). Payments for Securities purchased in the Offer will include accrued and unpaid interest from and including the last interest payment date applicable to the relevant series of Securities up to, but not including, the Early Settlement Date for such Securities accepted for purchase (the "Accrued Interest"). No tenders submitted after the Expiration Date will be valid.

Since the Offer was fully subscribed as of the Early Tender Date, holders who validly tender Securities following the Early Tender Date will not have any of their Securities accepted for purchase.

The Offeror reserves the right, subject to applicable law, to: (i) waive any and all conditions to the Offer; (ii) extend or terminate the Offer; (iii) increase or decrease the Maximum Tender Amount and/or the Acceptance Sublimit; or (iv) otherwise amend the Offer in any respect.

J.P. Morgan Securities LLC and Barclays Capital Inc. are acting as dealer managers for the Offer (the "Dealer Managers"). The information agent and tender agent (the "Information and Tender Agent") for the Offer is D.F. King & Co., Inc. Copies of the Offer to Purchase and related offering materials are available by contacting the Information and Tender Agent at +1 (866) 829-0541 (toll-free) or +1 (212) 269-5550 (collect) or email [email protected]. Questions regarding the Offer should be directed to J.P. Morgan Securities LLC, Liability Management Group, at +1 (866) 834-4666 (toll-free) or +1 (212) 834-8553 (collect) or London +44 207 134 2468, or to Barclays Capital Inc., Liability Management Group, at +1 (212) 528-7581 (collect) or +1 (800) 438-3242 (toll-free).

This announcement shall not constitute an offer to purchase or sell or a solicitation to buy or sell any securities. The Offer is being made only pursuant to the Offer to Purchase and only in such jurisdictions as is permitted under applicable law.

Ardelyx Announces Proposed Public Offering of Common Stock

On December 4, 2019 Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with cardiorenal diseases, reported that it has commenced an underwritten public offering of up to $80,000,000 of shares of its common stock (Press release, Ardelyx, DEC 4, 2019, View Source [SID1234551936]). All shares of common stock to be sold in the offering will be offered by Ardelyx. In addition, Ardelyx intends to grant the underwriters of the offering the right for a period of 30 days to purchase up to an additional $12,000,000 of shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Ardelyx intends to use its existing cash, cash equivalents and short-term investments and the net proceeds from the offering to support its activities for the clinical development and potential commercialization of tenapanor for the treatment of hyperphosphatemia in patients with chronic kidney disease, or CKD, on dialysis, for regulatory activities to support the submission of a New Drug Application, in such indication, as well as for clinical trials and nonclinical studies for other product candidates, and for general corporate purposes and working capital.

Citigroup, Cowen, SVB Leerink and Piper Jaffray are acting as joint book-running managers for the proposed offering.

A registration statement on Form S-3 (File No. 333-217441) relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on May 4, 2017. The offering is being made only by means of a written prospectus and prospectus supplement that will form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source When available, copies of the preliminary prospectus supplement and accompanying prospectus can be obtained by contacting Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY,11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132 or by e-mail at [email protected]; or Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by e-mail at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

Servier Showcases Robust Presence at ASH 2019

On December 4, 2019 Servier Group and Servier Pharmaceuticals, the U.S. subsidiary of the global French pharmaceutical company, reported that data from multiple studies will be presented at the 61st Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Orlando, from December 7-10, 2019 (Press release, Servier, DEC 4, 2019, View Source [SID1234551937]).

"As a patient-centric, innovation-driven organization, we believe it is critical to foster scientific exchange and discussion around novel approaches to treating hematologic-oncologic conditions and addressing unmet needs," said Claude Bertrand, Executive Vice President of Research and Development, Servier Group. "Oncology is one of Servier’s strategic priorities, and these new data findings to be presented at ASH (Free ASH Whitepaper) 2019 demonstrate our expanding pipeline of drug candidates, including allogeneic CAR-T therapy.*"

A complete listing of this year’s Servier abstracts* are available on the ASH (Free ASH Whitepaper) website. Notable abstracts include:

Sunday, December 8, 6:00 PM; Orange County Convention Center, Hall B

Allogeneic Anti-CD19 CAR T Cells Manufactured from Healthy Donors Provide a Unique Cellular Product with Distinct Phenotypic Characteristics Compared to CAR T Cells Generated from Patients with Mature B Cell Malignancies
Poster presentation in collaboration with Allogene Therapeutics
Session: 703. Adoptive Immunotherapy: Mechanisms and New Approaches: Poster II
Abstract: 3228
Preclinical Activity of the MPS1 Inhibitor S81694 in Acute Lymphoblastic Leukemia (ALL)
Session: Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation: Poster II
Abstract: 2631
Monday, December 9, 2019, 6:00 PM; Orange County Convention Center, Hall B

Initial findings of the Phase 1 Trial of PBCAR0191, a CD19 Targeted Allogeneic CAR-T Cell Therapy
Poster presentation in collaboration with Precision BioSciences
Session: 627. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas) – Results from Retrospective/Observational Studies: Poster III
Abstract: 4107
Additionally, on Friday, December 6, from 12:30 p.m. to 4:30 p.m., Medscape has a Continued Medical Education Program (CME) entitled "New Data and Paradigms in ALL: Insights and Applications." This CME event will take place at the Hyatt Regency Orlando Hotel, 9801 International Drive, Room Plaza International I-K. ASH (Free ASH Whitepaper) attendees can register here to attend. This CME event is supported by an independent educational grant from Servier, and all content discussed and presented is developed independently of commercial interests by Medscape’s Education staff.

"Since opening our U.S. headquarters in 2018, we have remained squarely focused on advancing and launching innovative treatment options for patients in need and are agnostic to where that innovation comes from," said David K. Lee, Chief Executive Officer, Servier Pharmaceuticals. "The presence of Servier Pharmaceuticals and our strategic partners at ASH (Free ASH Whitepaper) 2019 further exemplifies our commitment and dedication to developing new medicines in a way that’s most meaningful for patients."

More than 40 percent† of Servier Group’s investments in R&D are devoted to fighting cancer. Servier’s research in oncology focuses on therapies aimed at restoring programmed cell death (apoptosis) in cancer cells and at mobilizing the immune system against cancer cells (immuno-oncology).

To further accelerate the research and development of innovative treatments, Servier Group has instituted a policy of open innovation and has established more than 50 strategic partnerships. Partnership models are uniquely tailored to the engagement and span industry and academia.

In oncology, 13 drugs are currently being developed as an outgrowth of this collaborative research approach. These drugs target different types of lymphomas and leukemia, and other solid tumors, including gastrointestinal and lung. These drugs are investigational and have not yet been reviewed by the U.S. Food and Drug Administration (FDA) for safety and efficacy.

To learn more about Servier and their R&D efforts visit booth #955 in the Exhibition Hall.

About UCART19
UCART19 is being jointly developed under a clinical development collaboration between Servier and Allogene based on an exclusive license granted by Cellectis to Servier. UCART19 utilizes TALEN gene-editing technology pioneered and owned by Cellectis. Servier grants to Allogene exclusive rights to UCART19 in the U.S. while Servier retains exclusive rights for all other countries.

About PBCAR0191
In partnership with Servier, Precision BioSciences is responsible for early-stage research activities, manufacturing and Phase 1 execution for PBCAR0191. Servier has exclusive worldwide rights to opt-in for late-stage development and commercialization, and Precision has the right to participate in the development and commercialization of any licensed products resulting from the collaboration through a 50/50 co-development and co-promotion option in the U.S.

About Servier in the U.S.
Servier Pharmaceuticals LLC is a commercial-stage pharmaceuticals company with a passion for innovation and improving the lives of patients and their families and caregivers. With 13 additional oncology projects currently in clinical development, Servier is the partner of choice for leading academic institutions and a growing number of pharmaceutical companies. Servier BioInnovation is a joint initiative between Servier Group R&D and Global Business Development for external innovation. The initiative is focused on identifying new early-stage R&D opportunities and expediting business development and licensing activities in the U.S. Learn more at www.servier.us.