On October 25, 2018 Aurinia Pharmaceuticals Inc., (NASDAQ:AUPH) (TSX:AUP) reported that it will release its third quarter 2018 financial results on Thursday, November 8, 2018, after the market closes (Press release, Aurinia Pharmaceuticals, OCT 25, 2018, View Source [SID1234530151]). Aurinia’s management will host a conference call to discuss the company’s third quarter 2018 financial results and provide a general business update.

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The conference call and webcast is scheduled for November 8, 2018 at 4:30pm EDT. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

On October 25, 2018 RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases, reported that Mr. Adi Frish, Senior VP Business Development and Licensing, will present a corporate overview at the BIO-Europe 2018 Conference, on Tuesday, November 6, 2018, at 4:15 p.m. CET, at the Bella Center in Copenhagen, Denmark (Press release, RedHill Biopharma, OCT 25, 2018, View Source [SID1234530282]).

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A copy of the presentation to be delivered by Mr. Frish will be available on the Company’s website and may be viewed at: View Source

On October 24, 2018 Melinta Therapeutics, Inc., (NASDAQ: MLNT), a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, reported that its board of directors has appointed John H. Johnson as interim chief executive officer (CEO), effective immediately (Press release, Cempra, OCT 24, 2018, View Source [SID1234530248]). Mr. Johnson, a director of Melinta, succeeds Dan Wechsler, who is stepping down from his role as president, CEO and director to pursue other opportunities. The Board and Mr. Wechsler mutually agreed that now is the right time to transition leadership of the Company.

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"John is an accomplished biopharmaceutical industry leader with more than 20 years of direct expertise in the antibiotics space, and we are pleased that he is leading Melinta during this pivotal time. Under John’s leadership, we are confident that sales of commercial products, Baxdela (delafloxacin), Vabomere (meropenem and vaborbactam), Orbactiv (oritavancin), and Minocin (minocycline) for Injection, will continue to accelerate, and that he will focus on strengthening the financial position of Melinta by optimizing the integrations of the infectious disease business of The Medicines Company and Cempra," said Kevin Ferro, chairman of Melinta Therapeutics.

"I am pleased to serve as interim CEO of Melinta and will continue to work closely with the board of directors, executive management and the broader team to further advance the Company’s mission to provide life-saving therapeutic solutions that address the evolving global threat of bacterial infections and antibiotic resistance. This is an exciting time for Melinta and I look forward to contributing to the continued growth and future success of the Company by delivering anti-infective solutions to patients," said John H. Johnson, interim chief executive officer and director of Melinta Therapeutics.

Mr. Ferro added, "On behalf of the board of directors, we would like to thank Dan for his contributions to the Company and we wish him well in his future endeavors."

John H. Johnson has more than 30 years of biopharmaceutical industry, executive leadership and commercial experience at leading global organizations, including Johnson & Johnson, Eli Lilly & Company, ImClone and Pfizer, Inc. In addition to Melinta, Mr. Johnson currently serves on the boards of Aveo Oncology, Histogenics Corporation, Portola Pharmaceuticals, Inc., and is chairman of Strongbridge Biopharma plc. Mr. Johnson previously served as a director at Cempra and Sucampo. He also previously served as president and chief executive officer of Dendreon Corporation from February 2012, became chairman in July 2013, and served as chairman until June 2014 and president and chief executive officer until August 2014. Prior to this role, Mr. Johnson served as president of Eli Lilly & Company’s Global Oncology Unit following the company’s 2008 acquisition of ImClone Systems Incorporated, where he served as chief executive officer and on ImClone’s board. Prior to ImClone, Mr. Johnson served as the company group chairman of biopharmaceuticals within Johnson & Johnson, where he was responsible for biotechnology, immunology and oncology commercial business units. Prior to that role, he held several executive

positions at Johnson & Johnson, Parkstone Medical Information Systems, Inc., Ortho-McNeil Pharmaceutical Corporation and Pfizer Inc. While at Ortho-McNeil, Mr. Johnson was responsible for the company’s anti-infectives portfolio. During his career, Mr. Johnson also served as a member of the board of directors of Pharmaceutical Research and Manufacturers of America (PhRMA), the Health Section Governing Board of Biotechnology Industry Organizations (BIO), and BioNJ.

On October 24, 2018 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported that a Pre-Submission (Pre-Sub) meeting with the US FDA has been scheduled on Monday, December 17, 2018 (Press release, Anixa Biosciences, OCT 24, 2018, View Source [SID1234530499]). The meeting is to discuss the proposed preclinical and clinical performance testing plan required to support a pre-market application, and to determine the appropriate regulatory pathway for the Cchek prostate cancer confirmation test.

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The purpose of a Pre-Sub meeting is to permit a dialogue between the FDA and a diagnostic developer to facilitate a better understanding of the regulatory path enabling commercialization. With the Pre-Sub request, Anixa presented to the FDA a clinical trial plan and a group of questions on which it would like comment and clarification. After the meeting, and receipt of official minutes from the meeting, Anixa expects to have a better understanding of the regulatory pathway and anticipated timeline for commercialization.

"We are pleased that we were able to get our meeting with the FDA scheduled before the end of the year. We are looking forward to a productive discussion with the FDA that will help clarify the commercialization pathway for Cchek as a prostate cancer diagnostic test. I want to make clear that this new dialogue with the FDA is independent of and in addition to the dialogue we have already started regarding our CAR-T therapy. Both programs and corresponding interactions with the FDA will move forward independently at their own pace," stated Dr. Amit Kumar, President and CEO of Anixa Biosciences. "For Anixa Biosciences, this is an exciting time as we now have two technologies and products, regarding which we are working with regulators."

On October 24, 2018 SignPath Pharma Inc. reported in the October issue of "Cancer Chemotherapy and Pharmacology"*, a leading cancer journal, the final results of a Phase 1b cancer study of proprietary Liposomal Curcumin (Press release, SignPath Pharma, OCT 24, 2018, View Source [SID1234530192]). The study showed that the Liposomal Curcumin formulation (Lipocurc) can result in blood levels up to 1000 times that achieved with oral curcumin. In addition, no major toxicity was noted at these high blood levels. Specifically no toxicity was found in kidney, lung, liver and heart organs. The study involved 31 heavily pretreated cancer patients. Significant tumor marker responses and transient clinical benefit were also observed.

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Curcumin has long been of interest as an anti-inflammatory modulator and as a potential therapeutic agent for cancer, central nervous system and other diseases. Orally administered curcumin has not been able to achieve sufficient blood levels. LipoCurc addresses these limitations and has the potential to be a potent, non-toxic modality for treating these dire conditions.

Although Phase 1b studies are designed to determine safety of a drug and not to measure efficacy, two patients had obvious and important signs of tumor response. One was a 75 year old male with colon cancer, who had previously failed seven multi-drug chemotherapy combinations. On Lipocurc, his CEA, a tumor-marker which is elevated in patients with cancer, fell from above 18,000 to just above 6,000, and he showed clinical improvement. The other was a patient with prostate cancer who had previously failed radiation therapy as well as six chemotherapy combinations. His PSA level fell from 649 to 350 and he also showed clinical improvement.

On the basis of these results, SignPath is planning several phase 2 trials to test the efficacy of Lipocurc against specific cancer types. Trials are planned in patients with glioblastoma, in multiple myeloma, and in mesothelioma. Dr. Peter Sordillo, Chief Medical Officer of SignPath Pharma, states "We are very pleased with the Phase 1b results with LipoCurc and look forward to testing it in Phase 2 clinical trials. We believe LipoCurc has the potential to be a new potent, non-toxic therapeutic strategy for cancer and other diseases."

SignPath Pharma, Inc. is a clinical stage biopharmaceutical company developing two major drug platforms:

LipoCurc for cancer, neurodegenerative diseases and sepsis.
SPP 4040 for prevention of drug-induced cardiac arrhythmias, and prevention of heart damage and congestive heart failure secondary to chemotherapy.