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Anixa Biosciences Announces Collaboration with Urology San Antonio on Cchek™ Prostate Cancer Study

On October 25, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system in the fight against cancer, reported its collaboration with Urology San Antonio, PA in Anixa’s ongoing Cchek prostate cancer study (Press release, Anixa Biosciences, OCT 25, 2019, View Source [SID1234542520]).

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Urology San Antonio, PA joins a large and growing team of collaborators advancing the Cchek liquid biopsy technology toward commercialization.

Study enrollment will be led by board-certified urologist Dr. David R. Talley.

"We are excited to join Anixa’s Cchek prostate cancer study, and through this collaboration we hope to improve patient care," stated Dr. Talley. "Prostate cancer is one of the most common types of cancer in men, and if detected early, has a better chance of successful treatment. While several advancements have been made in recent years, there is much room for improvement in detecting the disease early and efficiently."

Dr. Amit Kumar, Anixa’s Chief Executive Officer, stated, "We are pleased to have Urology San Antonio join our Cchek prostate cancer study. The continued addition of influential physicians and urology practices to our team of collaborators is key to the eventual commercialization of our Cchek Prostate Cancer Confirmation test. We are confident this technology utilizing flow cytometry coupled with artificial intelligence to detect cancer early will make a significant impact in the overall testing paradigm."

About Cchek
Cchek is an early cancer detection technology, which measures a patient’s immunological response to a malignancy by analyzing immune system cells in peripheral blood. The goal is to utilize the technology to determine a patient’s cancer status from a simple blood draw, eliminating the need for a biopsy, which can be an expensive, painful and invasive procedure. Further, conventional methods using current cancer screening tests often lack accuracy and reliability. Anixa’s orthogonal approach using flow cytometry coupled with artificial intelligence provides an alternative method with greater affordability, efficacy and efficiency. To date, Anixa has successfully used Cchek to detect the presence of 20 different cancers including lung, colon, breast and prostate. The robust cancer detection performance of Cchek makes it a platform from which multiple cancer diagnostic tests may be developed. The first such test, a prostate cancer confirmation test, is slated for commercial launch by the end of 2019.

European Commission Approves Astellas’ XOSPATA™ (gilteritinib) as a Monotherapy for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation

On October 25, 2019 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that the European Commission (EC) has approved the oral once-daily therapy XOSPATA (gilteritinib) as a monotherapy for the treatment of adult patients with relapsed or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation (FLT3mut+) (Press release, Astellas, OCT 25, 2019, View Source [SID1234542517]). Gilteritinib has the potential to improve treatment outcomes for AML patients with two forms of the most common mutation—FLT3 internal tandem duplication (ITD) and FLT3 tyrosine kinase domain (TKD) mutation.1,2

This approval is based on results from the Phase 3 ADMIRAL trial, which investigated gilteritinib versus salvage chemotherapy in patients with relapsed or refractory FLT3mut+ AML. Patients treated with gilteritinib had significantly longer overall survival (OS) than those who received salvage chemotherapy. Median OS for patients who received gilteritinib was 9.3 months, compared to 5.6 months for patients who received salvage chemotherapy (Hazard Ratio = 0.64 (95% CI 0.49, 0.83), P=0.0004). Rates of one-year survival were 37% for patients who received gilteritinib, compared to 17% for patients who received salvage chemotherapy.3,4

"AML is a rare cancer and patients with a FLT3 mutation have a particularly poor prognosis, with a median survival of less than six months following treatment with salvage chemotherapy," said Giovanni Martinelli, M.D., Institute of Hematology, S.Orsola-Malpighi University Hospital, Bologna, Italy, an investigator in the ADMIRAL trial. "Gilteritinib is a new and clinically meaningful treatment option that provides a welcome advance for patients and health care professionals across the European Union."

The EC marketing authorization for gilteritinib in relapsed or refractory FLT3mut+ AML is applicable to the European Union (EU) member countries, and is also valid in Iceland, Norway and Liechtenstein. Gilteritinib has been designated an orphan medicinal product and also received accelerated assessment from the European Medicines Agency earlier this year, which reduced the timeframe for approval.5,6,7

"Today’s approval marks a significant advance for patients living with relapsed or refractory, FLT3 mutation-positive acute myeloid leukemia," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development, Astellas. "We look forward to working with health authorities across the EU to bring gilteritinib to patients who need it the most, as soon as possible."

Patients’ FLT3mut+ status can change over the course of AML treatment, even after relapse. Due to the poor outcomes associated with FLT3mut+ AML, patients’ FLT3 mutation status may be confirmed to help inform the best treatment approach.8,9,10

Astellas reflected the impact from this approval in its financial forecast of the current fiscal year ending March 31, 2020.

About XOSPATA (gilteritinib)
Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and commercialize gilteritinib. Gilteritinib was approved in the U.S. and Japan in 2018 for the treatment of adult patients who have relapsed or refractory FLT3mut+ AML.11,12

Astellas is currently investigating gilteritinib in various FLT3 mutation-positive AML patient populations through several clinical trials. Visit View Source to learn more about ongoing gilteritinib clinical trials.

About the ADMIRAL Trial
The Phase 3 ADMIRAL trial (NCT02421939) was an open-label, multicenter, randomized study of gilteritinib versus salvage chemotherapy in adult patients with FLT3mut+ who are refractory to or have relapsed after first-line AML therapy. The co-primary endpoints of the trial were OS and CR/CRh rates; OS, the primary endpoint at the trial’s final analysis, was the basis of EC approval. The study enrolled 371 patients with relapsed or refractory AML and FLT3mut+ present in bone marrow or whole blood. Subjects were randomized in a 2:1 ratio to receive gilteritinib (120 mg) or salvage chemotherapy.13

The most common adverse events (AEs) across both treatment arms of the ADMIRAL trial were febrile neutropenia (43.7%), anemia (43.4%), and pyrexia (38.6%). Common grade ≥3 AEs related to gilteritinib were anemia (19.5%), febrile neutropenia (15.4%), thrombocytopenia (12.2%), and decreased platelet count (12.2%). Adjusted for exposure duration, serious treatment-emergent AEs per patient year were less common with gilteritinib (7.1%) than salvage chemotherapy (9.2%).3

Athenex, Inc. to Report Third Quarter 2019 Earnings Results on November 7, 2019

On October 24, 2019 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 it will release third quarter and nine-months ended September 30, 2019 financial results on Thursday, November 7, 2019, before the market opens, and host a conference call and live audio webcast 8:00am Eastern Time to discuss the financial results and provide a business update (Press release, Athenex, OCT 24, 2019, View Source [SID1234573884]).

To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13694941. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at View Source

OPKO Health, Inc. Announces Pricing of its Offering of Common Stock

On October 24, 2019 OPKO Health, Inc. ("OPKO Health" or the "Company") (NASDAQ:OPK) reported the pricing of an underwritten public offering of 50 million shares of its common stock (the "Shares") at a price of $1.50 per Share, resulting in gross proceeds to the Company, before deducting underwriting discounts and commissions and estimated offering expenses, of $75,000,000 (Press release, Opko Health, OCT 24, 2019, View Source [SID1234542529]). The Company has also granted the underwriters an option for a period of 30 days to purchase up to an additional 7.5 million Shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about October 29, 2019, subject to customary closing conditions.

The Company intends to use the net proceeds received from the offering of the Shares to fund research and development to further develop and commercialize its portfolio of proprietary pharmaceutical and diagnostic products and for working capital, capital expenditures, acquisitions and other general corporate purposes.

Jefferies LLC, Piper Jaffray & Co. and Guggenheim Securities, LLC are acting as joint book-running managers for the offering.

The offering of the Shares is being made by means of a prospectus supplement to the prospectus forming a part of the Company’s effective shelf registration statement on Form S-3 (Registration No. 333-229400) filed with the Securities and Exchange Commission (the "SEC") on January 28, 2019 and other related documents. You may obtain these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies of the final prospectus supplement may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY, 10022, by email at [email protected] or by phone at +1 877 821 7388; Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by email at [email protected] or by phone: 1-800-747-3924; and Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by email at [email protected] or by phone at +1 212 518 5548. Before you invest, you should read the prospectus supplement and the accompanying base prospectus along with other documents that the Company has filed with the SEC for more complete information about the Company and these offerings.

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

Gilead Sciences Announces Fourth Quarter 2019 Dividend

On October 24, 2019 Gilead Sciences, Inc. (Nasdaq: GILD) reported that the company’s Board of Directors has declared a cash dividend of $0.63 per share of common stock for the fourth quarter of 2019 (Press release, Gilead Sciences, OCT 24, 2019, View Source [SID1234542528]). The dividend is payable on December 30, 2019, to stockholders of record at the close of business on December 13, 2019. Future dividends will be subject to Board approval.