On February 21, 2018 PDL BioPharma, Inc. presented the 2018 RBC Capital Market’s Global Healthcare Conference presentation (Presentation, PDL BioPharma, FEB 21, 2018, View Source [SID1234524081]).

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On February 21, 2018 Ophthotech Corporation (Nasdaq:OPHT) reported that it will report its fourth quarter and full year 2017 financial and operating results on Tuesday, February 27, 2018 (Press release, Ophthotech, FEB 21, 2018, View Source [SID1234524103]). Following the announcement, Ophthotech’s management team will host a live conference call and webcast at 8:00 a.m. Eastern Time to discuss the Company’s financial results and provide a general business update.

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To participate in this conference call, dial 800-239-9838 (USA) or 323-794-2551 (International), passcode 9171013. A live, listen-only audio webcast of the conference call can be accessed on the Investor Relations section of the Ophthotech website at: www.ophthotech.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 888-203-1112 (USA Toll Free), passcode 9171013.

On February 21, 2018 Clovis Oncology, Inc. (NASDAQ: CLVS) reported an update to the ongoing regulatory review for the Marketing Authorization Application (MAA) for rucaparib tablets as monotherapy for the treatment of a limited population of advanced ovarian cancer patients with deleterious BRCA mutation (germline and/or somatic) (Press release, Clovis Oncology, FEB 21, 2018, View Source;p=RssLanding&cat=news&id=2333860 [SID1234524094]). The indication under consideration by the Committee for Medicinal Products for Human Use (CHMP) focuses on a subset of platinum-sensitive disease where there is particular unmet medical need.

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Following a Scientific Advisory Group (SAG) – Oncology last week and an oral explanation this week, the European Union’s (EU) European Medicines Agency (EMA) CHMP has communicated a positive trend vote for the rucaparib MAA and their intention to hold a final vote on the treatment indication at their March meeting (March 19-22, 2018).

"We are pleased with this positive trend vote and the potential for a formal positive vote on the later-line treatment indication next month, especially for a patient population with a significant unmet clinical need," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "This potential approval also paves the way to a rapid review and potential CHMP vote for the maintenance indication by year-end in an earlier-line and all-comers population for women with advanced ovarian cancer."

The CHMP application for the treatment indication currently under review was submitted during the fourth quarter of 2016 and was based on objective response rate and duration of response results from two multicenter, single-arm, open-label clinical trials, Study 10 and ARIEL2, in women with advanced BRCA-mutant ovarian cancer who had progressed after two or more prior chemotherapies. Patients received rucaparib orally 600 mg twice daily as monotherapy until disease progression or unacceptable toxicity. Objective response rate (ORR) and duration of response (DOR) were assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The most common Grade 3/4 adverse event was anemia.

Pending an approval for the treatment indication, Clovis plans to submit a variation to the MA based on data from the phase 3 ARIEL3 clinical trial, which found that rucaparib significantly improved progression-free survival in all ovarian cancer patient populations studied. ARIEL3 is a double-blind, placebo-controlled trial of rucaparib that enrolled 564 women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer. The primary efficacy analysis evaluated three prospectively defined molecular sub-groups in a step-down manner: 1) BRCA-mutant (BRCAmut+); 2) HRD-positive (HRD+) inclusive of BRCA-mutant; and finally, 3) the intent-to-treat population, or all patients treated in ARIEL3. The variation to the MA will be directed at the broader intent-to-treat or "all comers" population.

Clovis announced positive topline results from the ARIEL3 clinical trial in June 2017. The comprehensive dataset from the trial was presented at the 2017 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Conference in Madrid, Spain,i and subsequently published in The Lancet.ii

In the event of a negative vote next month by the CHMP, Clovis is prepared to submit a new MAA for the maintenance indication.

About Rucaparib

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. In December 2017, the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental New Drug Application (sNDA) for rucaparib for a second line or later maintenance treatment indication in ovarian cancer based on the ARIEL3 data. The FDA granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for rucaparib. Rucaparib is an unlicensed medical product in the EU.

On February 20, 2018 Propanc Biopharma Inc. (OTCQB: PPCB) ("Propanc Biopharma" or the "Company"), a clinical stage biopharmaceutical company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported allowance of a key patent application from the European Patent Office (EPO) covering a pharmaceutical composition for treating cancer comprising trypsinogen and chymotrypsinogen within the European Union (Press release, Propanc, FEB 20, 2018, View Source [SID1234524077]). The allowed patent application is the first approval for the Company in the EU, which protects the Company’s lead product candidate, PRP, a solution for once-daily intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen.

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"We continue to make significant progress with respect to building our intellectual property portfolio, which is an important cornerstone for biotech companies like ours," said James Nathanielsz, Propanc Biopharma’s Chief Executive Officer. "In addition to our lead patent application, we also have three patents entering national phase this year and another patent application currently under preparation. It is a promising sign that we are advancing a world class portfolio covering a new therapeutic approach using pancreatic proenzymes for the treatment and prevention of metastatic cancer from solid tumors."

Currently progressing towards a First-In-Human study, PRP aims to prevent tumor recurrence and metastasis from solid tumors. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. According to the World Health Organization, 8.2 million people died from cancer in 2012. Consequently, a report by IMS Health states innovative therapies are driving the global oncology market to meet demand, which is expected to reach $150 billion by 2020. The Company’s initial target patient populations are pancreatic, ovarian and colorectal cancers, representing an estimated combined market segment of $14 billion in 2020, according to GBI Research.

To view Propanc Biopharma’s "Mechanism of Action" video on anti-cancer product candidate, PRP, please click on the following link: View Source

To be added to Propanc Biopharma’s email distribution list, please click on the following link: View Source and submit the online request form.

On February 20, 2018 Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced today that the first subject has been treated in the DIMENSION study of FATE-NK100 for the treatment of advanced solid tumors (Press release, Fate Therapeutics, FEB 20, 2018, View Source [SID1234524182]). The clinical trial is intended to evaluate the safety and determine the maximum dose of FATE-NK100, the Company’s first-in-class, allogeneic donor-derived adaptive memory natural killer (NK) cell cancer therapy, when administered as a monotherapy and in combination with trastuzumab or cetuximab, two FDA-approved targeted monoclonal antibody therapies that are widely used today to treat various cancers.

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"Patients with cancer often have deficient or dysfunctional natural killer cells. The co-administration of FATE-NK100 alongside a targeted monoclonal antibody therapy is a novel approach to restore a patient’s immune cell function and to selectively recognize and kill antibody-coated tumor cells," said Manish R. Patel, D.O., Assistant Professor of Medicine, Division of Hematology, Oncology and Transplantation at the University of Minnesota and the lead investigator of the clinical trial at the Masonic Cancer Center. "We are excited to have initiated what we believe to be the first clinical investigation of healthy allogeneic donor NK cell therapy in combination with FDA-approved monoclonal antibody therapy for solid tumor malignancies. This new treatment paradigm holds great promise for cancer patients who have progressed on or failed monoclonal antibody therapy and have no other therapeutic options."

Monoclonal antibodies are a well-established class of cancer immunotherapy agents designed to selectively target and bind to proteins on the surface of tumor cells. Compelling clinical data indicate that NK cells mediate the therapeutic effect of monoclonal antibody therapy by recognizing and efficiently killing antibody-coated tumor cells via a potent immune response mechanism known as antibody-dependent cellular cytotoxicity (ADCC). The combination of FATE-NK100 and monoclonal antibody therapy is designed to enhance ADCC by administering an activated population of healthy allogeneic donor NK cells to augment the killing of antibody-coated tumor cells. It is estimated that the worldwide market for cancer monoclonal antibodies is over $30 billion, and is poised to reach $45 billion by the end of 2020.

DIMENSION is the third clinical trial of FATE-NK100 currently being conducted. FATE-NK100 is also being clinically investigated in the VOYAGE study for the treatment of refractory or relapsed acute myelogenous leukemia and in the APOLLO study for the treatment of ovarian cancer resistant to, or recurrent on, platinum-based treatment.

About DIMENSION
DIMENSION is a multi-center, open-label, accelerated dose-escalation Phase 1 clinical trial of FATE-NK100 in subjects with advanced solid tumors who have progressed on or failed available approved therapies. The clinical trial is designed to evaluate the safety and determine the maximum dose of a single intravenous infusion of FATE-NK100 when administered as a monotherapy and in combination with monoclonal antibody therapy after outpatient lymphoconditioning therapy followed by sub-cutaneous IL-2 administration. Other endpoints to be assessed include objective response rates and progression-free and overall survival.

The clinical trial is being conducted across three independent treatment arms: (i) as a monotherapy for advanced solid tumor malignancies, including small cell lung cancer and hepatocellular carcinoma; (ii) in combination with trastuzumab for advanced human epidermal growth factor receptor 2 positive (HER2+) cancers, including breast and gastric cancers; and (iii) in combination with cetuximab for advanced epidermal growth factor receptor 1 positive (EGFR1+) cancers, including colorectal and head and neck cancers. In the combination arms, subjects will receive the monoclonal antibody therapy two days prior to and seven days following administration of FATE-NK100. Subjects with evidence of tumor shrinkage at Day 29 following administration of FATE-NK100 may be considered for retreatment.

Up to three dose levels in the monotherapy arm, and up to four dose levels in the monoclonal antibody therapy arms, of FATE-NK100 are intended to be assessed. In the event a dose limiting toxicity is observed in an arm, the arm will convert to a 3+3 design. Following dose escalation, expansion cohorts of 20 subjects per arm may be enrolled.

About FATE-NK100
FATE-NK100 is a first-in-class, allogeneic donor-derived natural killer (NK) cell cancer immunotherapy comprised of adaptive memory NK cells, a highly specialized and functionally distinct subset of activated NK cells expressing the maturation marker CD57. Higher frequencies of CD57+ NK cells in the peripheral blood or tumor microenvironment in cancer patients have been linked to better clinical outcomes. In preclinical studies, FATE-NK100 has demonstrated enhanced anti-tumor activity across a broad range of hematologic and solid tumors, with augmented cytokine production, improved persistence, enhanced antibody-dependent cellular cytotoxicity and increased resistance to immune checkpoint pathways compared to other NK cell therapies that are being clinically administered today. FATE-NK100 is produced through a feeder-free, seven-day manufacturing process during which NK cells sourced from a healthy allogeneic donor are activated ex vivo with pharmacologic modulators. In August 2017, non-clinical data describing the unique properties and anti-tumor activity of FATE-NK100 were published by Cancer Research (doi:10.1158/0008-5472.CAN-17-0799), a peer-reviewed journal of the American Association of Cancer Research.